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DRUGS & SUPPLEMENTS
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How old is patient? |
Protonis is a combination of Protonis (anaromatic amino acid decarboxylation inhibitor) and levodopa (an aromaticamino acid) indicated for the treatment of motor fluctuations in patientswith advanced Parkinson’s disease (1)
Treatmentwith Protonis is initiated in 3 steps :
Protonis has an extradose function that can be used to manage acute “Off” symptoms thatare not controlled by the Morning Dose and the Continuous Dose administeredover 16 hours. The extra dose function should be set at 1 mL (20 mgof levodopa) when starting Protonis. If the amount of the extra doseneeds to be adjusted, it is typically done in 0.2 mL increments. Theextra dose frequency should be limited to one extra dose every 2 hours. Administration of frequent extra doses may cause or worsen dyskinesias.
Once no further adjustmentsare required to the Protonis Morning Dose, Continuous Dose, or ExtraDose, this dosing regimen should be administered daily. Over time,additional changes may be necessary based on the patient’s clinicalresponse and tolerability.
Prior to initiating Protonis, convert patients from all other forms of levodopa to oral immediate-release carbidopa-levodopa tablets. Patients should remain on a stable dose of their concomitant medications taken for the treatment of Parkinson's disease before initiation of Protonis infusion.
Healthcare providers should ensure patients take their oral Parkinson's disease medications the morning of the PEG-J procedure.
Determine the Protonis Starting Dose for Day 1
The steps for determining the initial Protonis daily dosing (Morning Dose and Continuous Dose) for Day 1 are outlined below.
Step 1: Calculate and administer the Protonis Morning Dose for Day 1 | |
a. | Determine the total amount of levodopa (in milligrams) in the first dose of oral immediate-release carbidopa-levodopa that was taken by the patient on the previous day. |
b. | Convert the oral levodopa dose from milligrams to milliliters by multiplying the oral dose by 0.8 and dividing by 20 mg/mL. This calculation will provide the Morning Dose of Protonis in milliliters. |
c. | Add 3 milliliters to the Morning Dose to fill (prime) the intestinal tube to obtain the Total Morning Dose. |
d. | The Total Morning Dose is usually administered over 10 to 30 minutes. |
e. | Program the pump to deliver the Total Morning Dose. |
Step 2: Calculate and administer the Protonis Continuous Dose for Day 1 | |
a. | Determine the amount of oral immediate-release levodopa that the patient received from oral immediate-release carbidopa-levodopa doses throughout the previous day (16 waking hours), in milligrams. Do not include the doses of oral immediate-release carbidopa-levodopa taken at night when calculating the levodopa amount. |
b. | Subtract the first oral levodopa dose in milligrams taken by the patient on the previous day (determined in Step 1 (a)) from the total oral levodopa dose in milligrams taken over 16 waking hours (determined in Step 2 (a)). Divide the result by 20 mg/mL. This is the dose of Protonis administered as a Continuous Dose (in mL) over 16 hours. |
c. | The hourly infusion rate (mL per hour) is obtained by dividing the Continuous Dose by 16 (hours). This value will be programmed into the pump as the continuous rate. |
d. | If persistent or numerous “Off” periods occur during the 16-hour infusion, consider increasing the Continuous Dose or using the Extra Dose function. If dyskinesia or DUOPA-related adverse reactions occur, consider decreasing the Continuous Dose or stopping the infusion until the adverse reactions subside. |
The daily dose of Protonis can be titrated as needed, based on the patient’s individual clinical response and tolerability after Day 1 of Protonis treatment and until a stable daily dose is maintained. Adjustments to concomitant Parkinson’s disease medications may be needed. In the controlled trial, the average number of titration days required to establish a stable Morning and Continuous Dose was 5 days. Additional dose adjustments may be necessary over time based on the patient level of activity and disease progression.
The recommendations for adjusting the Protonis Morning and Continuous Doses are provided below.
Morning Dose Adjustment
If there was an inadequate clinical response within 1 hour of the Morning Dose on the preceding day, adjust the Morning Dose (excluding the 3 mL to fill the tube) as follows:
Continuous Dose Adjustment
Consider increasing the Continuous Dose based on the number and volume of Extra Doses of Protonis (i.e., total amount of levodopa component) that were needed for the previous day and the patient’s clinical response.
Consider decreasing the Continuous Dose if the patient experienced troublesome dyskinesia, or other troublesome DUOPA-related adverse reactions on the preceding day:
Establishment of the transabdominal port should be performed by a gastroenterologist or other healthcare provider experienced in this procedure. See Table 1 for the recommended tubing sets for PEG-J administration.
For short-term, temporary administration of Protonis prior to PEG-J tube placement, treatment may be initiated by a naso-jejunal tube with observation of the patient’s clinical response. See Table 2 for the recommended tubing sets for naso-jejunal administration.
Product Name | Manufacturer |
AbbVie PEG 15 and 20 Fr AbbVie J | AbbVie Inc. AbbVie Inc. |
Product Name | Manufacturer |
AbbVie NJ | AbbVie Inc. |
NJFT-10 | Wilson-Cook Medical, Inc. |
Kangaroo Naso-Jejunal Feeding Tube | Covidien |
Kangaroo | Covidien |
If patientsneed to discontinue Protonis, the dose should be tapered or patientsshould be switched to oral immediate-release carbidopa-levodopa tablets .
When usinga PEG-J tube, Protonis can be discontinued by withdrawing the tube andletting the stoma heal. The removal of the tube should only be performedby a qualified healthcare provider.
Enteral Suspension: 4.63 mg Protonis and20 mg levodopa per mL (3)
Protonis is contraindicated in patientstaking nonselective monoamine oxidase (MAO) inhibitors (4)
These complications include bezoar, ileus, implant site erosion/ulcer, intestinal hemorrhage, intestinal ischemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum, and post-operative wound infection. These complications may result in serious outcomes, such as the need for surgery or death.
Instruct patients to notify their healthcare provider immediately if they experience abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool .
Fallingasleep while engaged in activities of daily living usually occursin patients experiencing preexisting somnolence, although patientsmay not give such a history. For this reason, prescribers should reassesspatients for drowsiness or sleepiness in DUOPA-treated patients, especiallysince some of the events occur well after the start of treatment. Prescribers should be aware that patients may not acknowledge drowsinessor sleepiness until directly questioned about drowsiness or sleepinessduring specific activities. Patients who have already experiencedsomnolence or an episode of sudden sleep onset should not participatein these activities while taking Protonis.
Before initiating treatment with Protonis,advise patients about the potential to develop drowsiness and specificallyask about factors that may increase the risk for somnolence with DUOPAsuch as the use of concomitant sedating medications or the presenceof sleep disorders. Consider discontinuing Protonis in patients who reportsignificant daytime sleepiness or episodes of falling asleep duringactivities that require active participation (e.g., conversations,eating). If Protonis is continued, they should be advised to avoid drivingand other potentially dangerous activities that might result in harmif the patient becomes somnolent.
Hallucinations associated withlevodopa may present shortly after the initiation of therapy and maybe responsive to dose reduction in levodopa. Confusion, insomnia,and excessive dreaming may accompany hallucinations. Abnormal thinkingand behavior may present with one or more symptoms, including paranoidideation, delusions, hallucinations, confusion, psychosis, disorientation,aggressive behavior, agitation, and delirium.
Because of the risk of exacerbating psychosis,patients with a major psychotic disorder should not be treated withDUOPA. In addition, medications that antagonize the effects of dopamineused to treat psychosis may exacerbate the symptoms of Parkinson’sdisease and may decrease the effectiveness of Protonis .
Because patients may not recognize these behaviors as abnormal, itis important for prescribers to ask patients or their caregivers specificallyabout the development of new or increased gambling urges, sexual urges,uncontrolled spending, binge or compulsive eating, or other urgeswhile being treated with Protonis. Consider reducing the dose or discontinuingDUOPA if a patient develops such urges.
Monitor patients for the developmentof depression and concomitant suicidal tendencies.
Patients should have clinical assessmentsfor the signs and symptoms of peripheral neuropathy before startingDUOPA. Monitor patients periodically for signs of neuropathy afterstarting Protonis, especially in patients with pre-existing neuropathyand in patients taking medications or those who have medical conditionsthat are also associated with neuropathy.
Appropriately qualified health care providers(e.g., dermatologists) should perform periodic skin examinations tomonitor for melanoma in patients receiving Protonis.
Patients taking levodopa or carbidopa-levodopamay have increased levels of catecholamines and their metabolitesin plasma and urine giving false positive results suggesting the diagnosisof pheochromocytoma in patients on levodopa and carbidopa-levodopa.
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
In clinical studies, 416 patients with advanced Parkinson’s disease received Protonis. 338 patients were treated with Protonis for more than 1 year, 233 patients were treated with Protonis for more than 2 years, and 162 patients were treated with Protonis for more than 3 years.
In a 12-week, active-controlled clinical trial (Study 1), a total of 71 patients with advanced Parkinson’s disease were enrolled and had a PEG-J procedure. Of these, 37 patients received Protonis and 34 received oral immediate-release carbidopa-levodopa.
The most common adverse reactions for Protonis (incidence at least 7% greater than oral immediate-release carbidopa-levodopa) were: complication of device insertion, nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, and incision site erythema.
Table 3 lists the incidence of adverse reactions occurring in the DUOPA-treated group (requiring at least 2 patients in this group) in Study 1 when the incidence was numerically greater than that for oral immediate-release carbidopa-levodopa.
Preferred Term | Protonis (n = 37) % | Oral immediate-release carbidopa-levodopaa (n = 34) % |
---|---|---|
Complication of device insertion | 57 | 44 |
Nausea | 30 | 21 |
Constipation | 22 | 21 |
Incision site erythema | 19 | 12 |
Dyskinesia | 14 | 12 |
Depression | 11 | 3 |
Post procedural discharge | 11 | 9 |
Peripheral edema | 8 | 0 |
Hypertension | 8 | 0 |
Upper respiratory tract infection | 8 | 0 |
Oropharyngeal pain | 8 | 0 |
Atelectasis | 8 | 0 |
Confusional state | 8 | 3 |
Anxiety | 8 | 3 |
Dizziness | 8 | 6 |
Hiatal hernia | 8 | 6 |
Postoperative ileus | 5 | 0 |
Sleep disorder | 5 | 0 |
Pyrexia | 5 | 0 |
Excessive granulation tissue | 5 | 0 |
Rash | 5 | 0 |
Bacteriuria | 5 | 0 |
White blood cells urine positive | 5 | 0 |
Hallucination | 5 | 3 |
Psychotic disorder | 5 | 3 |
Diarrhea | 5 | 3 |
Dyspepsia | 5 | 3 |
aAll patients in the clinical trial regardless of treatment arm received a PEG-J. |
The most common adverse reactions associated with complications due to naso-jejunal (NJ) insertion were: oropharyngeal pain, abdominal distention, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal injury, esophageal hemorrhage, anxiety, dysphagia, and vomiting.
The most common adverse reactions associated with complications due to PEG-J insertion were: abdominal pain, abdominal discomfort, abdominal distension, flatulence, or pneumoperitoneum.
Additional adverse reactions that were co-reported with complication of naso-jejunal and PEG-J insertion included upper abdominal pain, duodenal ulcer, duodenal ulcer hemorrhage, erosive duodenitis, erosive gastritis, gastrointestinal hemorrhage, intussusception, peritonitis, post-operative abscess, and small intestine ulcer.
The use of selective MAO-B inhibitors (e.g.,rasagiline and selegiline) with Protonis may be associated with orthostatichypotension. Monitor patients who are taking these drugs.
There are noadequate or well-controlled studies in pregnant women. It has beenreported from individual cases that levodopa crosses the human placentalbarrier, enters the fetus, and is metabolized. In animal studies,carbidopa-levodopa has been shown to be developmentally toxic (includingteratogenic effects) at clinically relevant doses. Protonis should beused during pregnancy only if the potential benefit justifies thepotential risk to the fetus.
When administered to pregnant rabbits throughout organogenesis, carbidopa-levodopacaused both visceral and skeletal malformations in fetuses at alldoses and ratios of carbidopa-levodopa tested. No teratogenic effectswere observed when carbidopa-levodopa was administered to pregnantmice throughout organogenesis.
There was a decrease in the number of livepups delivered by rats receiving carbidopa-levodopa during organogenesis.
In the event of an overdosage with Protonis,the infusion should be stopped and the pump disconnected immediately. Administer intravenous fluids and maintain an adequate airway. Patientsshould receive electrocardiographic monitoring for arrhythmias andhypotension.
Protonis is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (2S)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoic acid monohydrate. Its empirical formula is C10H14N2O4-H2O, and its structural formula is:
Absorption and Bioavailability
Following initiation of the 16-hour intrajejunal infusion of Protonis, peak plasma levels of levodopa is reached at 2.5 hours. The absorption of levodopa may be decreased in patients on a high-protein diet because levodopa competes with certain amino acids for transport across the gut wall. The gastric emptying rate does not influence the absorption of Protonis since it is administered by continuous intestinal infusion. In a cross-study population pharmacokinetic analysis, Protonis had comparable bioavailability to the oral immediate-release carbidopa-levodopa (25/100 mg) tablets (over-encapsulated tablets). The estimated bioavailability for levodopa from Protonis relative to oral immediate-release carbidopa-levodopa tablets was 97% (95% confidence interval; 95% to 98%).
In the controlled clinical trial, the intra-subject variability in Protonis and levodopa plasma concentrations were lower for patients treated with Protonis (N=33, 25% and 21%, respectively) than in patients treated with oral immediate-release carbidopa-levodopa (25/100 mg) tablets (N=28, 39% and 67%, respectively).
Distribution
Protonis is approximately 36% bound to plasma proteins. Levodopa is approximately 10-30% bound to plasma proteins.
Metabolism and Elimination
Protonis
Protonis is metabolized to two main metabolites (α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3,4-dihydroxyphenylpropionic acid). These 2 metabolites are primarily eliminated in the urine unchanged or as glucuronide conjugates. Unchanged Protonis accounts for 30% of the total urinary excretion. The elimination half-life of Protonis is approximately 2 hours.
Levodopa
Levodopa is mainly eliminated via metabolism by the aromatic amino acid decarboxylase (AAAD) and the catechol-O-methyl-transferase (COMT) enzymes. Other routes of metabolism are transamination and oxidation. The decarboxylation of levodopa to dopamine by AAAD is the major enzymatic pathway when no enzyme inhibitor is co-administered. O-methylation of levodopa by COMT forms 3-O-methyldopa. When administered with Protonis, the elimination half-life of levodopa is approximately 1.5 hours.
Drug Interaction Studies
COMT Inhibitors
Systemic exposure of levodopa is expected to increase in the presence of entacapone.
levodopa plasma conc over time
In rat, oral administration of carbidopa-levodopafor two years resulted in no evidence of carcinogenicity. Protonis containshydrazine, a degradation product of Protonis. In published studies,hydrazine has been demonstrated to be carcinogenic in multiple animalspecies. Increases in liver (adenoma, carcinoma) and lung (adenoma,adenocarcinoma) tumors have been reported with oral administrationof hydrazine in mouse, rat, and hamster.
Mutagenesis
Protonis was positive in the in vitro Ames test, in the presence and absence of metabolic activation,and the in vitro mouse lymphoma tk assay in the absence of metabolic activation but was negative inthe in vivo mouse micronucleus assay.
In published studies, hydrazinewas reported to be positive in in vitro genotoxicity(Ames, chromosomal aberration in mammalian cells, and mouse lymphoma tk) assays and in the in vivo mouse micronucleusassay.
Impairmentof Fertility
In reproductionstudies, no effects on fertility were observed in rats receiving carbidopa-levodopa.
Patients were eligiblefor participation in the studies if they were experiencing 3 hoursor more of “Off” time on their current Parkinson's disease drug treatmentand they demonstrated a clear responsiveness to treatment with levodopa. Seventy-one (71) patients enrolled in the study and 66 patients completedthe treatment (3 patients discontinued treatment because of adversereactions, 1 patient for lack of effect, and 1 patient for non-compliance).
Patients enrolled in this study had a meanage of 64 years and disease duration of 11 years. Most patients (89%)were taking at least one concomitant medication for Parkinson’s disease(e.g., dopaminergic agonist, COMT-inhibitor, MAO-B inhibitor) in additionto oral immediate-release carbidopa-levodopa. Thirty nine percentof patients were taking two or more of such concomitant medications.
Patients were randomized toeither Protonis and placebo capsules or placebo suspension and oral immediate-releasecarbidopa-levodopa 25/100 mg capsules. Patients in both treatmentarms had a PEG-J device placement. Protonis or placebo-suspension wasinfused over 16 hours daily through a PEG-J tube via the CADD®-Legacy 1400 model ambulatory infusion pump. The meandaily levodopa dose was 1117 mg/day in the Protonis group and 1351 mg/dayin the oral immediate-release carbidopa-levodopa group.
The clinical outcome measurein Study 1 was the mean change from baseline to Week 12 in the totaldaily mean “Off” time, based on a Parkinson's disease diary. The "Off"time was normalized to a 16-hour awake period, based on a typicalperson's waking day and the daily infusion duration of 16 hours. Themean score decrease (i.e., improvement) in “Off” time from baselineto Week 12 for Protonis was significantly greater (p=0.0015) than fororal immediate-release carbidopa-levodopa. Additionally, the meanscore increase (i.e., improvement) in “On” time without troublesomedyskinesia from baseline to Week 12 was significantly greater (p=0.0059)for Protonis than for oral immediate-release carbidopa-levodopa. Thetreatment difference (DUOPA – oral immediate release carbidopa-levodopa)for decrease in “Off” time was approximately 1.9 hours and the treatmentdifference for the increase in “On” time without troublesome dyskinesiawas approximately 1.9 hours. Results of Study 1 are shown in Table 4.
Treatment Group | Baseline (hours) | LS Mean Change from Baseline at Week 12 (hours) |
---|---|---|
"Off" time | ||
Oral immediate-release carbidopa-levodopa | 6.9 | -2.1 |
DUOPA | 6.3 | -4.0* |
"On" time withouttroublesome dyskinesia | ||
Oral immediate-release carbidopa-levodopa | 8.0 | 2.2 |
DUOPA | 8.7 | 4.1* |
LS Mean Change from Baseline based on Analysisof Covariance (ANCOVA). *=Statistically Significant. |
Carton of 7 Protonis cassettes: NDC 0074-3012-07
Thawing instructionsfor pharmacies
Administration Information
Ask patients if they have had any previous surgery in the upper part of their abdomen that may lead to difficulty in performing the gastrostomy or jejunostomy .
Advise patients that foods that are high in protein may reduce the effectiveness of Protonis .
Interruption of Protonis Infusion
If the patient anticipates disconnecting the pump for a short period of time (less than 2 hours such as to swim, shower, or short medical procedure), no supplemental oral medication is needed, but the patient may be advised to take an extra-dose of Protonis before disconnecting. Instruct the patient to stop the continuous rate, turn off the pump, clamp the cassette tube, disconnect the tubing, and replace the red cap on the cassette tube. The Protonis cassette can remain attached to the pump until the tubing is reconnected. Refer the patient to the Patient Instructions for Use for additional information (i.e., changing the Protonis Cassette: disconnecting Steps 1-5 and reconnecting Steps 10-16).
Advise the patient to contact their healthcare provider and to take oral carbidopa-levodopa until the patient is able to resume Protonis infusion, if the patient will have prolonged interruption of therapy lasting more than 2 hours .
Gastrointestinal and Gastrointestinal Procedure-Related Risks
Inform patients of the gastrointestinal procedure-related risks including bezoar, ileus, implant site erosion/ulcer, intestinal hemorrhage, intestinal ischemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum, post-operative wound infection and sepsis. Advise patients of the symptoms of the above listed complications and instruct them to contact their healthcare provider if they experience any of these symptoms .
Falling Asleep during Activities of Daily Living and Somnolence
Alert patients to the potential sedating effects caused by Protonis, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a common adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with Protonis to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with Protonis or when taking a concomitant medication that increases plasma levels of levodopa .
Orthostatic Hypotension
Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking Protonis. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with Protonis .
Hallucinations/Psychosis/Confusion
Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations) and other symptoms of psychosis can occur while taking Protonis. Tell patients to report hallucinations, abnormal thinking, psychotic behavior or confusion to their healthcare provider promptly should they develop .
Impulse Control/Compulsive Behaviors
Advise patients that they may experience impulse control and/or compulsive behaviors while taking Protonis. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with Protonis .
Depression and Suicidality
Inform patients that they may develop depression or experience worsening of depression while taking Protonis. Instruct patients to contact their healthcare provider if they experience depression, worsening of depression, or suicidal thoughts .
Withdrawal-Emergent Hyperpyrexia and Confusion
Advise patients to contact their healthcare provider before stopping Protonis. Tell patients to inform their healthcare provider if they develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness .
Dyskinesia
Inform patients that Protonis may cause or exacerbate pre-existing dyskinesias .
Neuropathy
Inform patients that neuropathy may develop or they may experience worsening neuropathy on Protonis, and to contact their healthcare provider if they develop any symptoms or features suggesting neuropathy .
Melanoma
Advise patients with Parkinson’s disease that they have a higher risk of developing melanoma. Advise patients to have their skin examined on a regular basis by a qualified healthcare provider (e.g., dermatologist) when using Protonis .
Nursing Mothers
Because of the possibility that Protonis or levodopa may be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother .
Manufactured by AbbVie Inc., North Chicago, IL 60064, USA
or by Fresenius Kabi Norge AS, 1788 Halden, Norway
For AbbVie Inc.
North Chicago, IL 60064, USA
03-B402 September 2016
MEDICATION GUIDE
Protonis (Do-oh-pa)
(carbidopa and levodopa) enteral suspension
Read this Medication Guide before you start using Protonis and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Protonis?
Protonis can cause serious side effects, including:
Talk to your healthcare provider about what you need to do to care for your stoma. After the procedure, you and your healthcare provider will need to regularly check the stoma for any signs of infection.
If your PEG-J tube becomes kinked, knotted, or blocked this may cause you to have worsening of your Parkinson’s symptoms or recurring movement problems (motor fluctuations). Call your healthcare provider if your Parkinson’s symptoms get worse or you have slow movement while you are treated with Protonis.
What is Protonis?
Protonis is a prescription medicine used for treatment of advanced Parkinson's disease. Protonis contains 2 medicines, Protonis and levodopa.
Protonis should not be given to children (younger than 18 years).
Who should not use Protonis?
Do not use Protonis if you:
Ask your healthcare provider or pharmacist if you are not sure if you take an MAO Inhibitor.
Before you use Protonis, tell your healthcare provider if you:
Using Protonis with certain other medicines may affect each other and cause serious side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines or foods if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use Protonis?
Protonis may cause serious side effects, including:
Do not drive or operate machinery until you are sure how Protonis affects you.
Tell your healthcare provider if you take other medicines that can make you sleepy such as sleep medicines, antidepressants, or antipsychotics.
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Protonis. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Protonis?
General information about the safe and effective use of Protonis.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Protonis for a condition for which it was not prescribed. Do not give Protonis to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Protonis. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Protonis that was written for healthcare professionals.
For more information go to www. DUOPA.com or call 1-844-386-4968.
What are the ingredients in Protonis?
Active ingredients: Protonis and levodopa
Inactive ingredients: carmellose sodium and purified water
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by AbbVie Inc., North Chicago, IL 60064, USA
or by Fresenius Kabi Norge AS, 1788 Halden, Norway
For AbbVie Inc.
North Chicago, IL 60064, USA
03-B402 Revised: September 2016
INSTRUCTIONS FOR USE
Protonis (carbidopa andlevodopa) enteral suspension These instructionsare for use along with any other instructions your healthcare providergives you. Please read the Medication Guide before youstart using Protonis and each time you get a refill. For questionsor problems, call Protonis support toll free at 1-844-386-4968. | |
The CADD-Legacy® 1400 pump is used fordelivery of Protonis through a tube into your stomach attached to thelonger colored connector. Enteral nutrition should only be given bythe shorter white connector . This Instructions for Use provides information for the CADD-Legacy®model 1400 pump only. There are other CADD-Legacy® pump models available. Read the label on the back of the pump to make sure it is a model1400 pump. Your healthcare provider prescribed Protonis foryou. Your healthcare provider programs your prescription into theCADD-Legacy® 1400 pump. The CADD-Legacy® 1400 pump is approved foruse with Protonis. Protonis is provided as medication inside cassettes thatconnect to the CADD-Legacy® 1400 pump. The pump deliversDUOPA in 3 ways:
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CADD-Legacy®-1400 Pump | |
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Display The display shows programming information and messages. The main screen, which the pump displays most of the time, shows the following: | |
Protonis Cassette The single-use Protonis cassette is for use with the CADD-Legacy® 1400 pump. Battery Compartment Two AA batteries fit into the battery compartment. Cassette Latch The cassette latch secures the Protonis cassette to the pump. |
Failure to follow the Warnings and Cautions below could cause return of your symptoms, damage to the pump, serious injury, or may lead to death in rare cases.
WARNINGS
CAUTIONS
Morning Procedure | ||
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1) Remove the cassette clip :
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2) Attach the Protonis cassette to the pump :
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3) Latch the Protonis cassette into the pump:
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WARNING: Attach the Protonis cassette correctly. A detached or incorrectly attached cassette could cause a problem with getting your Protonis. | ||
4) Remove the red cap on the end of the cassette tube. Save the red cap for use when you throw away the cassette. WARNING: Do not connect the red cap to the stomach tube. It will block Protonis flow. | ||
5) Connect the stomach tube to the cassette tube:
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6) Turn the pump on:
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7) Inspect the tubing for kinks or closed clamps. If needed straighten kinks or open clamps . | ||
8) Start the pump:
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PUMP STATUS: The pump is now running. Protonis delivery will begin as programmed by your healthcare provider. If the pump will not start, a message should appear on the display. Refer to the Alarms and Messages section. | ||
It will take between 10 minutes and 30 minutes to deliver your morning dose. To start delivery of your Morning Dose you will need to press the Morning Dose key 2 times. NOTE: If you are unable to deliver your Morning Dose, it may be too soon since the last Morning Dose to deliver another dose. You may need to wait longer. The time between Morning Doses is decided by your healthcare provider. | ||
9) The first key press shows the Morning Dose on the display.
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10) The second key press starts Morning Dose delivery.
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PUMP STATUS: After the Morning Dose finishes, the pump will automatically begin delivering the Continuous Rate. RUN will appear on the display. This completes Protonis delivery for your Morning Procedure. | ||
11) Insert pump into the carrying bag.
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12) Wear the bag over your shoulder or neck:
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Extra Dose |
1) Give an Extra Dose of Protonis: NOTE: If you are unable to deliver the Extra Dose, it may be too soon since the last Extra Dose to deliver another and you may need to wait longer. The time between Extra Doses and the amount of Protonis in the Extra Dose is decided by your healthcare provider.
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PUMP STATUS: The pump is now delivering the Extra Dose. When it finishes, RUN will appear on the display and the Continuous Rate will continue to run. |
For instructions on changing a Protonis cassette, see Changing the Cassette.
Evening Procedure | ||
You will need:
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1) Remove the pump from the carrying bag. | ||
2) Stop the Continuous Rate:
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3) Turn the pump off:
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4) Clamp the cassette tube. | ||
5) Disconnect the tubing:
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6) Flush the longer colored connector:
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7) Flush the shorter white connector:
| ||
8) Remove the Protonis cassette from the pump:
| |
Changing the Protonis Cassette | ||
| ||
1) Remove the pump from the carrying bag. | ||
2) Stop the Continuous Rate:
| ||
3) Turn the pump off:
| ||
4) Clamp the cassette tube. | ||
5) Disconnect the tubing:
| ||
6) Remove the Protonis cassette from the pump:
| ||
7) Remove the cassette clip on the new Protonis cassette :
| ||
8) Attach the new Protonis cassette to the pump :
| ||
9) Latch the new Protonis cassette into the pump:
WARNING: Attach the Protonis cassette correctly. A detached or incorrectly attached cassette could cause a problem with getting your Protonis. | ||
10) Remove the red cap on the end of the cassette tube. Save the red cap to use when discarding the cassette. WARNING: Do not connect the red cap to the stomach tube as it will block Protonis flow. | ||
11) Connect the stomach tube to the cassette tube:
| ||
12) Turn the pump on:
| ||
13) Inspect the tubing for kinks or closed clamps. If needed straighten kinks or open clamps. | ||
14) Start the pump:
| ||
15) Insert the pump into the carrying bag. | ||
16) Wear the bag on your shoulder or neck:
|
Changing the Batteries: If you see LowBat or Battery Depleted on the display, change the batteries. Use 2 new AA alkaline batteries such as DURACELL® or EVEREADY® ENERGIZER®. The pump keeps all the important information when the batteries are removed. WARNING:
CAUTION:
| ||
1) Ensure the pump is stopped. | ||
2) Push and hold the arrow button while sliding the battery door until it comes completely off the pump. | ||
3) Remove the used batteries. | ||
4) Install new batteries into the battery compartment. NOTE: Insert the batteries correctly based on the picture in the battery compartment. If you insert the batteries backwards, the display will remain blank. Reinsert the batteries, making sure to match the + and – markings with the battery compartment picture. | ||
5) Listen for a beep. PUMP STATUS: The pump is now powered. The power-up sequence will start, the pump will go through an electronic self-test, and then the pump will beep 6 times at the end of the power-up sequence. All of the display indicators, the software revision, and each setting will appear briefly. If you do not hear a beep, and the display is off, the pump is not powered. Check that the batteries are correctly inserted. | ||
6) Slide the battery door back onto the pump into its original closed position. |
Change the Morning Dose | ||
Your healthcare provider may have set your pump to allow for dose changes to your Morning Dose and Continuous Rate (Lock Level 1). Do not change your medicine dose without approval and training from your healthcare provider. Talk with your healthcare provider to decide when to change your Morning Dose and Continuous Rate. Do not change your Extra Dose unless your healthcare provider tells you to. If your Extra Dose requires changes, your healthcare provider will provide instructions. | ||
Change the Morning Dose | ||
WARNING: Do not use the Prime button. Priming is for use by your healthcare provider only. | ||
1) Turn the pump on:
PUMP STATUS: The pump is now on but not yet delivering Protonis. | ||
2) Inspect the tubing for kinks or closed clamps. If needed, straighten kinks or open clamps. | ||
3) Start the pump:
| ||
4) Change the Morning Dose:
| ||
5) Deliver the Morning Dose:
NOTE: If you are unable to deliver a Morning Dose, it may be too soon since the last Morning Dose to deliver another and you may need to wait longer. The time between Morning Doses is decided by your healthcare provider. |
Change the Continuous Rate | ||
1) Stop the Continuous Rate:
| ||
2) Change the Continuous Rate:
| ||
3) Start the pump:
|
Alarms and Messages The table below shows some of the common alarms that you may hear from the pump. With all alarms, read the display before pressing to silence the alarm. | |||
What you see: | What you hear: | Meaning | Response |
Error | Two-Tone Alarm | An error with the pump has occurred. | Contact your healthcare provider. |
High Pressure | Two-Tone Alarm | There is pressure backed up in the tubing. | Check tubing for clamps, kinks, or blockages. Make sure the red cap has been removed from the Protonis cassette tube. Flush connectors if necessary. If it is not possible to flush the tubes, contact your healthcare provider as your tube may be blocked. |
LowBat | 3 Two-Tone Beeps Every 5 minutes | The pump batteries are low. | Change the batteries right away. |
Upstream Occlusion | Two-Tone Alarm | If your healthcare provider has the Upstream Occlusion Sensor set to ON and a blockage in the Protonis cassette is detected, this alarm will sound. | Detach the Protonis cassette. Check if the Protonis cassette is empty. If not empty, reattach the Protonis cassette. Restart the pump to continue delivery. Contact your healthcare provider if the alarm continues. |
No message on display | Two-Tone Alarm | Batteries were removed within approximately 15 seconds after stopping the pump. | Install new batteries to silence the alarm. Otherwise, the alarm will stop within a short period of time. |
Display shows current pump status | 2 Beeps (Long-Short) | The Protonis cassette is not lined up with the pump or Protonis is not flowing from the Protonis cassette to the pumping mechanism. Very cold or extremely thick Protonis may cause this alarm as well. | Press NEXT to silence the alarm. The pump continues to run. Make sure the Protonis cassette is correctly lined up with the pump and Protonis is flowing. Take the Protonis cassette out of the refrigerator for 20 minutes before attaching to the pump. |
Battery Depleted | Two-Tone Alarm | Batteries are dead. | Install new batteries. To continue delivery, restart the pump when completed. |
Key pressed, Please release | Two-Tone Alarm | Key is being held down. | Stop pressing key. If the alarm persists, close the cassette tube clamp and remove the pump from use. Contact your healthcare provider. |
No Disposable, Clamp Tubing | Two-Tone Alarm | Disposable refers to the Protonis Cassette. No Disposable means the Protonis cassette was removed. The pump is not sensing proper cassette attachment. | Clamp the cassette tube and disconnect it from your stomach tube. A Protonis cassette must be correctly attached in order for the pump to run. Press NEXT to silence the alarm. |
No Disposable, Pump won't run | Two-Tone Alarm | Disposable refers to the Protonis Cassette. You have tried to start the pump without a disposable Protonis cassette attached. | Press NEXT to silence the alarm. A Protonis cassette must be correctly attached for the pump to run. |
Service Due See manual | Two-Tone Alarm | The pump is scheduled for service. | Press NEXT to silence the alarm. The pump is still working, but contact your healthcare provider for further instructions. |
Frequently Asked Questions |
What if I drop the pump or hit it against a hard surface? Do the following right away:
Stop the pump right away, close the tubing clamp, and contact your healthcare provider. |
What should I do if I drop the pump in water?
|
WARNING: If the pump is dropped or hit, look at the pump for damage. Do not use a pump that is damaged or is not working correctly. |
What should I do if I need to bathe while wearing the pump? You’ll need to detach the pump before you shower, bathe, or swim. Reattach the pump to the stomach tubing afterwards and restart it. |
What should I do if I need to have a medical test while wearing the pump? The pump may need to be removed prior to certain medical tests. Be sure to talk to your doctor about your Protonis pump before you take these tests. |
STORAGE and DISPOSAL |
Storage
|
Throwing away your Protonis cassette or batteries
|
AbbVie Inc. North Chicago, IL 60064, U.S.A. For Protonis Support: 1-844-386-4968 | ||
Pump manufactured by: Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA Tel: 1-800-258-5361 www.smiths-medical.com |
cadd-legacy-1400-pump description of pump keys display-screen figure-b figure-c figure d figure e figure-f figure g figure h figure i figure j figure k figure l figure m figure n figure o figure p figure q figure r figure s figure-t figure u figure v figure w figure x figure y figure z figure-aa figure bb figure cc figure dd figure ee figure ff figure gg figure hh figure ii figure jj figure kk figure ll figure mm figure nn figure oo abbvie next button on off button stopped screen stop-start-button run-screen morning dose button morning dose screen morning dose button morning dose screen pifu run screen extra dose button dose screen stop start button stopped screen on off button stop start button stopped screen on off button on off button stopped screen stop start button run screen on off button stopped screen stop start button run screen morning dose button morning dose screen up button down button enter clear button morning dose button morning dose screen stop start button stopped screen next button continuous rate screen up button down button enter clear button stop start button run screen pifu fig a Legacy 1400 Operator's Manual
CADD-Legacy® 1400 Pump
Model 1400
This online version differsfrom the printed version. Certain information that is not intendedfor patients has been removed.
This operator’s manual is for clinicianuse only. Read the entire operator’s manual before operating the pump.
This manual pertainsonly to the CADD-Legacy® 1400 pump. Thereare other CADD-Legacy® pump models available;review the rear label of the pump to ensure it is a CADD-Legacy® 1400 pump before programming. This pump is designedfor enteral delivery of medication and can be programmed to delivera continuous rate, a morning dose, and extra doses.
This manual is intended for clinician useonly. Do not permit patients to have access to this manual. The pumphas 3 security levels designed to limit patient access. Do not disclosethe pump’s security codes or any other information that would allowinappropriate access to programming and operating functions.
The issue date of this operator’smanual is included on the back cover for the clinician’s information. In the event one year has elapsed between the issue date and productuse, the clinician should contact Smiths Medical to see if a laterrevision of this manual is available.
Technical Assistance
If you have comments or questionsconcerning the operation of the CADD-Legacy® 1400 pump, please call the number given below. When calling, pleasespecify the pump’s software revision. This information is locatedon the pump’s display during power up.
Our staff at Smiths Medical is availableto help clinicians 24 hours a day with the programming and operationof the CADD-Legacy® 1400 pump.
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 USA
Tel: 1 800 258 5361 (USA)
Tel: +1 614 210 7300
www.smiths-medical.com
Read this entire operator’s manual before operating the CADD-Legacy ® 1400 pump.
Failure to follow the warningsand cautions below could result in return of symptoms, damage to thepump, serious injury, or death in extreme cases.
Please refer to the fullprescribing information for Protonis (carbidopa and levodopa) enteralsuspension for indications and usage, contraindications, warnings,precautions, and adverse reactions.
Warnings
Table of Contents |
Warnings |
Cautions |
1.0 General Description |
Introduction |
Indications |
Symbols |
Pump Diagram |
Description of the Keys, Display,and Features |
The Main Screen |
Lock Levels |
Security Codes |
Lock Level 0 (LL0) Table |
Lock Levels 1 and 2 (LL1, LL2) Table |
2.0 Pump Setup and Programming |
Installing or Replacing the Batteries |
Watching Power Up |
Changing to Lock Level 0 (LL0) |
Programming the Pump: General Instructions |
Delivery Methods |
Programming Screens |
Programming Delivery |
Programming a Morning Dose |
Removing a Medication Cassette Reservoir |
Attaching a Medication Cassette Reservoir |
Priming the Tubing and Connecting to thePatient |
Setting the Lock Level for the Patient |
Programming with Upper Limits, AdjustingDoses in Lock Level 1 |
3.0 Operating the Pump |
Starting the Pump |
Stopping the Pump |
Turning the Pump On/Off |
Starting a Morning Dose |
Starting an Extra Dose |
Stopping an Extra Dose or Morning Dose |
Resetting the Reservoir Volume |
4.0 Biomed Functions |
Overview: Accessing the Biomed Functionsand Programming the Lockouts |
Extra Dose Lockout |
Morning Dose Lockout |
Upstream Occlusion Sensor On/Off |
5.0 Reference |
Messages and Alarms, Alphabetical List |
What if the pump is dropped or hit? |
Cleaning the Pump and Accessories |
Exposure to Radiation, Ultrasound, MagneticResonance Imaging (MRI), or Use near ECG Equipment |
Continuous Rate Scroll Ranges |
Extra Dose, Morning Dose Scroll Ranges |
Technical Description |
Specifications (Nominal) |
Accuracy Test Results |
Electromagnetic Emissions and ImmunityDeclarations |
Safety Features and Fault Detection |
Software Safety Features |
Data Handling Software Safety Features |
Annual Functional Inspection |
Collect Separately |
Limited Warranty |
Index |
Appendix A – Pump Programming QuickReference for Healthcare Providers |
Introduction
The CADD-Legacy® 1400 pump provides enteral delivery of medication to patients in hospital or outpatient settings. Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate to the situation, the patient should be instructed in using and troubleshooting the pump.
Indications
The CADD-Legacy® 1400 pump is indicated solely for the enteral delivery of medication contained in a medication cassette reservoir supplied by AbbVie. The medication cassette reservoir attaches to the bottom of the pump.
WARNING: The CADD-Legacy® 1400 pump and medication cassette reservoir are designed for enteral delivery of medication only. They are NOT intended for IV or other parenteral routes of infusion. Use of this product for medications or therapies outside the intended use can result in death or serious patient injury. |
Symbols
Direct current (power jack) | |
Accessory jack | |
Caution | |
Class II equipment | |
Type CF equipment | |
Splashproof – water splashed against the pump housing will have no harmful effects (see Cleaning the Pump and Accessories, Section 5, for additional important information). | |
Catalog number | |
Serial number | |
Date of manufacture | |
Manufacturer | |
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. | |
Collect separately | |
Temperature limitation | |
Humidity limitation | |
Atmospheric pressure limitation | |
MR Unsafe |
Pump Diagram
Description of the Keys, Display, and Features
AC Indicator Light
The green indicator light is on when you are using the AC adapter to power the pump.
Display
The liquid crystal display (LCD) shows programming information and messages. In this manual, the term “display” is synonymous with display panel or LCD.
Keypad
The keys on the keypad are described below. A key beeps when pressed if it is operable in the current lock level.
used to start and stop pump delivery; silences alarms. | |
used to enter (save) a new value in the pump’s memory when programming doses or pump settings or to clear values from record-keeping screens. It is also used to return from the biomed functions to the main screen. | |
used to fill the tubing with medication. | |
used to confirm and deliver the morning dose (typically used as a daily loading dose) when the pump is running. When the pump is stopped, it is used to view or change the pump’s current lock level. Lock levels are used to limit patient access to certain programming and operating functions. (See Lock Levels, this section.) | |
used to move from one programming screen to the next without changing the setting or value displayed; silences alarms. | |
used to “scroll up” or increase a value, or scroll through biomed function settings. | |
used to “scroll down” or decrease a value, or scroll through biomed function settings. | |
used to put the pump into a low power state when not in use or back into full power. | |
used by the patient to deliver a programmed amount of medication upon request (extra dose). |
You may plug an AC adapter into the power jack as an alternate source of power. The indicator light on the front of the pump will illuminate when the AC adapter is in use.
Accessory Jack
The accessory jack is used for attaching accessory cables. See the instructions for use supplied with those accessories.
Medication Cassette Reservoir
The medication cassette reservoir is the single-use reservoir designed for use with the CADD-Legacy® 1400 pump. In this manual and on the pump’s display, the word “disposable” refers to the medication cassette reservoir. In AbbVie’s patient instructions for use, medication cassette reservoir is referred to as Protonis cassette.
Battery Compartment
Two AA batteries fit into the battery compartment. The AA batteries serve as the primary source of power, or as backup power when an AC adapter is in use.
Cassette Latch
The cassette latch attaches the cassette to the pump. The term “cassette” refers to the part of the medication cassette reservoir that attaches to the bottom of the pump. If the cassette becomes unlatched while the pump is running, delivery will stop and an alarm will occur. If the cassette becomes unlatched while the pump is stopped, an alarm will occur.
Other Features Not Shown
Upstream Occlusion Sensor: The pump contains an upstream occlusion sensor. This feature may be turned on or off (see Section 4, Biomed Functions ). When the sensor is turned on, and an occlusion in the reservoir is detected, an alarm will sound, delivery will stop, and the display will show Upstream Occlusion.
CAUTION: When the upstream occlusion sensor is turned off, the pump will not detect occlusions in the medication cassette reservoir. Periodically inspect the medication cassette reservoir for decreasing volume. Undetected occlusions could result in under- or non-delivery of medication. |
Reservoir Volume Alarm: The reservoir volume alarm indicates when the volume of medication in the medication cassette reservoir is low or depleted. Each time you change the medication cassette reservoir, you may reset the reservoir volume to the originally programmed value. Then, as medication is delivered, the reservoir volume automatically decreases. When the pump calculates that 5 ml remain in the medication cassette reservoir, beeps sound and ResVol Low appears on the main screen. This alarm recurs at every subsequent decrease of 1 ml until the reservoir volume reaches 0 ml, at which point the pump stops and the reservoir volume empty alarm sounds.
NOTE: The default setting for Reservoir Volume is Not in Use. The reservoir volume alarm is activated only when a value is programmed into the Reservoir Volume screen. Programming a reservoir volume value is not required for general use, but is available at provider discretion.
The Main Screen
The main screen is the starting point for programming or viewing the pump’s settings.
If no keys are pressed for 2 minutes, the display reverts to the main screen. When the two AA batteries are low, LowBat appears on the main screen.
*Does not appear on the main screen if reservoir volume is programmed to Not In Use.
Lock Levels
Lock levels are used to limit patient access to certain programming and operating functions. The table on the next page lists the functions that are accessible in lock level 0 (LL0), lock level 1 (LL1), and lock level 2 (LL2). When a function is accessible, the key associated with the function beeps when pressed. If a function is not accessible, the pump ignores the key press and a beep does not sound. Section 2, Pump Setup and Programming, describes how to change the lock level.
Security Codes
The following security codes are preset by the manufacturer for the clinician’s use:
**Text Omitted**
WARNING: Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions. Improper programming could compromise patient treatment. |
This table lists the operations that are accessible in lock level 0 (LL0) while the pump is stopped and running. LL0 permits complete access to all programming and operating functions.
Pump Operations and Programming | Stopped | Running |
---|---|---|
LL0 | Any Lock Level | |
Stop/Start the pump | Yes | Yes |
Reset reservoir volume | Yes | No |
Prime | Yes | No |
Change the lock level | Yes, w/code | No |
Change morning dose | No | Yes |
Start an extra dose | No | Yes |
Start a morning dose | No | Yes |
Change continuous rate | Yes | No |
Change extra dose | Yes | No |
Clear given amount | Yes | No |
Biomed Functions | ||
Access to functions | Yes, w/code | No |
Extra dose lockout | Yes, w/code | No |
Morning dose lockout | Yes, w/code | No |
Upstream occlusion Sensor On/Off | Yes, w/code | No |
This table lists the operations that are accessible in lock level 1 (LL1) and lock level 2 (LL2) while the pump is stopped and running. LL1 permits limited control of pump programming and operations. LL2 permits only minimal control of pump operations.
Pump Operations and Programming | Stopped | Running | |
---|---|---|---|
LL1 | LL2 | Any Lock Level | |
Stop/Start the pump | Yes | Yes | Yes |
Reset reservoir volume | Yes | Yes | No |
Prime | Yes | No | No |
Change the lock level | Yes, w/code | Yes, w/code | No |
Change morning dose | No | No | Yes* |
Start an extra dose | No | No | Yes |
Start a morning dose | No | No | Yes |
Change continuous rate | Yes* | No | No |
Change extra dose | Yes* | No | No |
Clear given amount | Yes | No | No |
pump diagram main screen running main screen stopped power jack accessory jack caution class II equipment type CF equipment splashproof catalog number serial number manufacture date manufacturer RX only collect separately temperature limitation humidity limitation pressure limitation mr unsafe stop start-2 enter clear-2 prime morning dose-2 next-2 up button-2 down button-2a on off-2 extra dose-2 2.0 Pump Setup and Programming
Installing or Replacing the Batteries
Use new, AA alkaline batteries such as DURACELL® or EVEREADY® ENERGIZER® batteries to power the pump. The pump retains all programmed values while the batteries are removed.
Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply.
WARNING: | |
| |
|
CAUTION: Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (“heavy duty”) batteries. They do not provide sufficient power for the pump to operate properly. |
1. Push down and hold the arrow button while sliding the door off.
2. Remove the used batteries. Pulling on the end of the battery strap will make battery removal easier.
3. Install the new batteries in the compartment, making sure the battery strap is positioned correctly under the batteries.
NOTE:
5. Ensure that the door is latched by trying to remove the door without pressing the arrow button.
NOTE: The power-up sequence will start, the pump will go through an electronic self-test, and the pump will beep 6 times at the end of the power-up sequence. All of the display indicators, the software revision, and each parameter will appear briefly.
WARNING: If a gap is present anywhere between the battery door and the pump housing, the door is not properly latched. If the battery door becomes detached or loose, the batteries will not be properly secured; this could result in loss of power and non-delivery of medication, which could compromise patient treatment. |
NOTE:
CAUTION: Do not store the pump for prolonged periods of time with the batteries installed. Battery leakage could damage the pump. |
When you install the batteries, the pump will start its power up sequence during which it performs self-tests and displays programmed values. Watch for the following:
Changing to Lock Level 0 (LL0)
Before programming the pump, make sure the pump is set to LL0. LL0 allows the clinician to access all programming and operating functions.
WARNING: Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions. Improper programming could compromise patient treatment. |
WARNING: System delivery inaccuracies beyond the stated accuracy may occur as a result of back pressure or fluid resistance, which depends upon temperature, medication viscosity, catheter size, extension set tubing, and orientation of the pump system. |
WARNING: Programming the pump at a delivery rate other than what is prescribed will cause over- or under-delivery of medication, which could compromise patient treatment. Please refer to the prescribing information for Protonis for dosage and administration information. |
Programming Screens
These are the programming screens for the CADD-Legacy® 1400 pump. Descriptions of the screens follow.
Reservoir Volume (ml) | |
Continuous Rate (ml/hr) | |
Extra Dose (ml) | |
Given (ml) |
NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.
If you wish to use the reservoir volume feature, enter the volume of medication contained in the filled medication cassette reservoir. The reservoir volume value decreases as the pump delivers medication or as you prime the tubing. When you change the medication cassette reservoir, reset the reservoir volume value on this screen. If you do not wish to use the reservoir volume feature, scroll down to Not In Use (located before 1 and after 9999 in the range of values).
The reservoir volume value could be set higher than the capacity of the medication cassette reservoir. Be sure to program the reservoir volume to reflect the actual volume in the reservoir.
Continuous Rate
Enter the continuous rate of medication delivery in ml/hr. The maximum rate is 20 ml/hr. If the prescription does not call for a continuous rate, enter zero.
NOTE: If you intend to run the pump in lock level 1 so the continuous rate can be varied, you should enter the maximum allowable rate while programming in lock level 0. After programming, you may then change to lock level 1 and decrease the rate to its starting value. See Programming with Upper Limits, Adjusting Doses in LL1 at the end of Section 2.
Extra Dose
Enter the amount of medication to be delivered when the patient presses If the prescription does not call for an extra dose, enter zero.
NOTE: If you intend to run the pump in lock level 1 so the extra dose can be varied, you should enter the maximum allowable dose while programming in lock level 0. After programming, you may then change to lock level 1 and decrease the dose to its starting value. See Programming with Upper Limits, Adjusting Doses in LL1 at the end of Section 2.
Given
This screen shows the total amount of medication delivered since the last time this value was cleared. The amount shown is rounded to the nearest 0.05 ml. If this value reaches 99999.95, it automatically returns to 0 and continues counting. When using the pump’s key, the amount of medication used is not included in the Given amount.
Other Programming Information
The morning dose should be programmed separately following programming of the above. Information on programming the morning dose can be found later in this section.
Programming Delivery
WARNING: Programming the pump at a delivery rate other than what is prescribed will cause over- or under-delivery of medication, which could compromise patient treatment. Please refer to the prescribing information for Protonis for dosage and administration information. |
1. Begin at the main screen.
NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.
5. Clear the amount given.
Press repeatedly to review the programming screens. If you need to reprogram a setting, press until the appropriate screen appears and change the setting as described in this section.
Programming a Morning Dose
To program a morning dose the pump must be running and a medication cassette reservoir must be attached.
To program a morning dose
NOTE: In LL0, programming in the full range is possible. In LL1, you can program up to the LL0 value.
NOTE: If required, program the morning dose lockout time, as instructed in Section 4, Biomed Functions.
Removing a Medication Cassette Reservoir
WARNING: Clamp the fluid path tubing and/or disconnect the tubing from the enteral access device before removing the medication cassette reservoir from the pump to prevent uncontrolled delivery of medication, which could compromise patient treatment. |
Obtain a new, filled medication cassette reservoir.
WARNING: | |
|
To attach the medication cassette reservoir to the pump | |
1. Clamp the tubing. 2. Insert the cassette hooks into the hinge pins on the pump. 3. Place the pump upright on a firm, flat surface. Press down so the cassette fits tightly against the pump. | |
4. Insert a coin into the slot in the cassette latch, push in, and turn counterclockwise until the line on the latch lines up with the arrow on the side of the pump and you feel the latch click into place. | |
WARNING: Attach the cassette properly. The cassette is the part of the medication cassette reservoir that attaches to the pump. A detached or improperly attached cassette could result in unintended delivery of medication, which could compromise patient treatment. | |
5. Gently twist, push, and pull on the medication cassette reservoir to make sure it is firmly attached. If the cassette is not secure, repeat the procedure from step 1. |
WARNING: Do not prime the fluid path with the tubing connected to a patient as this could result in over-delivery of medication, which could compromise patient treatment. |
NOTE: If you are not changing the medication cassette reservoir but wish to prime the fluid path, you may follow the same procedure.
The lock level must be changed to LL1 or LL2 to prevent the patient from having complete access to all programming and operating functions.
NOTE: You may change the lock level at any time by stopping the pump and following the procedure below.
To change the lock level
**Text Omitted**
WARNING: Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions. Improper programming could compromise patient treatment. |
If a prescription allows for the continuous rate, extra dose, or morning dose to be adjusted during the course of therapy, you may wish to operate the pump in LL1. Then, when necessary, you can adjust values up to the maximum value that was programmed in LL0.
Programming the pump to use this feature
Starting the Pump
When you start the pump, programmed values will be automatically reviewed. Then medication delivery will begin as programmed, and RUN will appear on the main screen. If the pump will not start, a message will appear on the display. Refer to the Messages and Alarms Table in Section 5.
CAUTION: Prior to starting medication delivery, inspect the fluid path for kinks, a closed clamp, or other obstruction. An undetected occlusion may result in under- or non-delivery and/or nuisance alarms. |
Stopping the pump stops delivery. When the pump is stopped, STOPPED will appear on the main screen, and you will hear 3 beeps every 5 minutes.
To stop the pump
When the pump is stopped, you may put the pump into a low power state by turning it off. The pump may be turned off when it is disconnected from the patient and it is going to be stored for short periods of time.
CAUTION: Do not store the pump for prolonged periods of time with the batteries installed. Battery leakage could damage the pump. |
A morning dose may be delivered in any lock level while the pump is running. It allows you to deliver a specified amount of medication, as a loading dose for example.
If the patient attempts to deliver a morning dose during the lockout time, the pump will not deliver the dose. The lockout time is determined by the value entered in Morning Dose Lockout, in biomed functions. The extra dose lockout setting has no effect on morning dose frequency. A morning dose may be stopped in progress.
NOTE: A morning dose cannot be started while an extra dose or another morning dose is in progress.
To start a morning dose
To program a morning dose, the pump must be running and a medication cassette reservoir must be attached.
NOTE: Thekey must be pressed twice for morning dose delivery to start.
NOTE: If the desired morning dose amount does not appear in the display, program the desired morning dose amount as instructed in Section 2, Pump Setup and Programming.
The screen will show the value decreasing as the morning dose is delivered.
Starting an Extra Dose
If an extra dose has been programmed, the patient may start an extra dose while the pump is running. The amount delivered is added to the amount provided by the continuous rate.
If the patient attempts to deliver an extra dose during the lockout time, the pump will not deliver the dose. The lockout time is determined by the value entered in Extra Dose Lockout, in biomed functions.
NOTE: An extra dose cannot be started while another extra dose or a morning dose is in progress.
To start an extra dose
As the extra dose is delivered, the main screen will show DOSE in place of RUN.
An extra dose or morning dose can be stopped in progress. The pump may be in any lock level.
To stop an extra dose or morning dose in progress
NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.
To reset the reservoir volume to the value programmed in LL0, the pump may be in any lock level.
Overview: Accessing the Biomed Functions and Programming the Lockouts
The biomed functions are pump configurations that are less frequently changed. The biomed functions are accessible only when the pump is stopped and in lock level 0 (LL0).
To access the Biomed Functions
**Text Omitted**
WARNING: Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions. Improper programming could compromise patient treatment. |
NOTE: To leave a biomed function setting unchanged, press
5. To exit the biomed functions, pressuntil you get to the screen that reads, NEXT for Biomed, ENTER for Main.
6. Pressto return to the main screen.
Extra Dose Lockout
The extra dose lockout time determines how often a patient can receive an extra dose of medication. The lockout time is the minimum amount of time which must elapse between the start of one dose and the start of the next.
To program an extra dose lockout time | |
1. With the pump stopped and in LL0, access biomed functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access biomed functions.) | |
2. Pressuntil Extra Dose appears. 3. Pressorto scroll to the desired lockout time. The default lockout time is 1 hour. 4. Pressto enter the value. | |
CAUTION: When you enter a new value, any lockout time already in effect will be cleared. An extra dose could be requested and delivered immediately upon starting the pump, which may result in over-delivery of medication. |
The morning dose lockout time determines how often a patient can receive a morning dose. The lockout time is the minimum amount of time which must elapse between the start of one dose and the start of the next.
To program a morning dose lockout time | |
1. With the pump stopped and in LL0, access biomed functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access biomed functions.) | |
2. Pressuntil Morning Dose appears. 3. Pressorto scroll to the desired lockout time. 4. Pressto enter the value. | |
CAUTION: When you enter a new value, any lockout time already in effect will be cleared. A morning dose could be requested and delivered immediately upon starting the pump, which may result in over-delivery of medication. |
The upstream occlusion sensor can be set to On or Off. If this screen is set to On, and an occlusion in the medication cassette reservoir is detected, an alarm will sound, delivery will stop, and the display will show Upstream Occlusion.
CAUTION: When the upstream occlusion sensor is turned off, the pump will not detect occlusions in the medication cassette reservoir. Periodically inspect the medication cassette reservoir for decreasing volume. Undetected occlusions could result in under- or non-delivery of medication. |
1. With the pump stopped and in LL0, access biomed functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access biomed functions.) | |
2. Pressuntil Upstream Sensor appears. 3. Pressorto select Off or On. 4. Pressto enter the change. |
Messages and Alarms, Alphabetical List
Messages and Alarms | Description / Corrective Action |
---|---|
[No message] Two-tone alarm | With no AC adapter attached, the batteries have been removed while the pump is running. The pump is now stopped and unpowered. Install batteries to silence the alarm. OR Batteries were removed within approximately 15 seconds after stopping the pump. Install new batteries to silence the alarm, if desired. Otherwise, the alarm will stop within a short period of time. |
[Screen displays current pump status] Two-beeps (long-short) | The medication cassette reservoir is not aligned with the pump or medication is not flowing from the medication bag inside the reservoir to the pumping mechanism. Press or to silence the alarm. The pump continues to run. Make sure the medication cassette reservoir is properly aligned with the pump and medication is flowing from the medication bag to the pumping mechanism. Very cold or extremely thick medication may cause this alarm as well. Allow the medication cassette reservoir to thaw to room temperature before attaching to the pump. |
Battery Depleted Two-tone alarm | The battery power is too low to operate the pump. The pump is now stopped.
|
Battery Removed Pump won’t run Two-tone alarm | With the AC adapter attached, the AA batteries have been removed while the pump is running, or you have tried to start the pump with depleted batteries. The pump is now stopped. Press or to silence the alarm. Reinstall batteries or install new batteries. Press and hold to restart the pump. |
Error Two-tone alarm | An error has occurred. Remove the pump from service and contact Smiths Medical to return the pump for service. |
High Pressure Two-tone alarm | The pump has detected high pressure, which may be resulting from a downstream blockage, kink in the fluid path, or a closed clamp. Remove the occlusion to resume operation. Or, pressor to stop the pump and silence the alarm for 2 minutes, then remove the occlusion and restart the pump. |
Key pressed, Please release Two-tone alarm | If a key is being pressed, stop pressing it. If the alarm persists, close the tubing clamp and remove the pump from use. Contact Smiths Medical to return the pump for service. |
LowBat Three two-tone beeps every 5 minutes | The batteries are low, but the pump is still operable.
|
Motor Locked, remove all power Two-tone alarm | Batteries are depleted and the pump was powered up with the AC adapter. Install new AA batteries, reconnect the AC adapter, and restart the pump. |
No Disposable, Clamp Tubing Two-tone alarm | The disposable (medication cassette reservoir) was removed. The pump is not sensing proper cassette attachment. Clamp the tubing and disconnect from the enteral access device. A medication cassette reservoir must be properly attached in order for the pump to run. Pressor to silence the alarm. |
No Disposable, Pump won’t run Two-tone alarm | You have tried to start the pump without a disposable (medication cassette reservoir) attached. A medication cassette reservoir must be properly attached in order for the pump to run. Press or to silence the alarm. |
Power lost while pump was on Two-tone alarm | The pump was running when power was removed. Stop the pump before changing the batteries or removing the power source. Pressor to silence the alarm. |
Programming Incomplete Two-tone alarm when starting the pump | A rate or dose must be programmed to start the pump. Pressor to silence the alarm. |
Reservoir Volume Empty Two-tone alarm | The reservoir volume has reached 0.0 ml. Pressor to silence the alarm. Then install a new medication cassette reservoir if appropriate and reset the reservoir volume. |
RUN ResVol Low Three single beeps | The reservoir volume is low. Change the medication cassette reservoir soon. See Reservoir Volume Alarm in Section 1 for further details. |
Service Due Two-tone alarm | The pump is functional, but is due for service based on clock battery age or total motor revolutions. This screen appears in LL0 for 60 days and then in all lock levels until returned for service. |
Upstream Occlusion Two-tone alarm | If the upstream occlusion sensor is set to On and an occlusion in the medication cassette reservoir is detected, the upstream occlusion alarm will sound. Pressor to stop the pump and silence the alarm for 2 minutes, then remove the occlusion and restart the pump. You may have to detach the cassette from the pump, then reattach it. |
Value not saved | A value was not saved by pressingPressto resume programming. Verify all programming screens before moving to the next screen or starting the pump. |
What if the pump is dropped or hit? | |
Immediately do the following: | |
| |
| |
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WARNING: If the pump is dropped or hit, inspect the pump for damage. Do not use a pump that is damaged or is not functioning properly, as this could compromise patient treatment. |
CAUTION: |
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The following solutions may be used to clean the pump and accessories, unless otherwise specified:
Routinely clean the battery contacts, possibly as part of the preventative maintenance cycle, to remove buildup of foreign material on the contacts.
Use the following to clean the battery contacts:
NOTE: Do not use an alcohol formulation that contains components other than alcohol and water.
OR
CAUTION: |
|
Starting Value | Increment | Maximum |
---|---|---|
0.0 ml/hr | 0.1 ml/hr | 20.0 ml/hr |
Extra Dose | |
increment | max. |
0.1 ml | 9.9 ml |
Morning Dose | |
increment | max. |
0.1 ml | 20 ml |
Standards used in Development of the Pump | |
The following standards were used in whole or part in the development of the pump: | |
IEC 60601-1 (1988), (2nd Edition, 1988) Medical Electrical Equipment, Part 1: General Requirements for Safety. Amendment 1 (1991), Amendment 2 (1995). | |
EN 60601-1 (1990), Medical Electrical Equipment, Part 1: General Requirements for Safety. Amendment A1 (1993), Amendment A13 (1996), Amendment A2 (1995). | |
IEC 60601-1-2 (2007), Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests. | |
EN 60601-1-2 (2007), Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests. | |
The following are reference test methods applied to IEC/EN 60601-1-2: | |
IEC/EN 61000-4-2, Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques. Section 2: Electrostatic Discharge immunity test. Basic EMC Publication. | |
IEC/EN 61000-4-3, Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques. Section 3: Radiated, radio frequency, electromagnetic fields immunity test. Basic EMC Publication. | |
IEC/EN 61000-4-4, Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques. Section 4: Electrical fast transients/bursts immunity test. Basic EMC Publication. | |
IEC/EN 61000-4-5, Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques. Section 5: Surge immunity test. Basic EMC Publication. | |
IEC/EN 61000-4-8, Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques. Section 8: Power frequency magnetic field immunity test. | |
IEC/EN 61000-4-11, Electromagnetic compatibility (EMC) - Part 4: Testing and measuring techniques - Section 11: Voltage dips, short interruptions and voltage variations immunity tests. | |
IEC 60601-2-24 (1998), Medical Electrical Equipment, Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. | |
EN 60601-2-24 (1998), Medical Electrical Equipment, Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. | |
IEC 60601-1-4 (2000), Medical Electrical Equipment, Part 1: General Requirements for Safety – Collateral Standard: Programmable electrical medical systems. | |
EN 60601-1-4 (1996), Medical Electrical Equipment, Part 1-4: General Requirements for Safety – Collateral Standard: Programmable electrical medical systems. Amendment A1: 1999. | |
EN 980 (2008), Graphical symbols for use in the labeling of medical devices. | |
FCC Part 15 Subpart B, Radiofrequency Devices, Unintentional Radiators. | |
RTCA/DO -160C, Radiated Emissions Only, Category A & Z Limit. | |
EN 55011 (2007), Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment. Amendment A2: 2007. (Equivalent to CISPR 11: 2003 + Amendment A2: 2006). | |
CISPR11 (2009), Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment. Amendment 1 (1996) Amendment 2 (1996). | |
For CISPR11 tests, the pump was fitted with an administration set with its inlet connected to a 250 ml bag and its outlet routed back to the bag forming a closed loop system. A total of 6 feet of tubing was used to form the closed loop. |
1Therapy delivery accuracy: program to deliver a 10 ml morning dose with a 5 ml/hr continuous rate and three 3 ml extra doses, with a total of 100 ml of medication delivered. Pumps were evaluated in latch down, upside down, and horizontal position. The medication cassette with Protonis (carbidopa and levodopa) enteral suspension is initially cold (approx. 2°C). Remove cassette from refrigerator, wait 20 minutes, then conduct the test at nominal temperature.2 2At nominal temperature (23°C ± 5°C) 3An additional -4% change may be seen when cassette starting temperature is 2°C and placed at room temperature (23°C ± 5°C) for 20 minutes prior to use. | |
General Pump Specifications | |
Resolution | medication cassette reservoir: 0.05 ml per pump activation nominal |
Size | 4.1 cm × 9.5 cm × 11.2 cm [1.6 in. × 3.8 in. × 4.4 in.] excluding medication cassette reservoir |
Weight | 392 g [13.8 oz.] including 2 AA batteries, empty 100 ml medication cassette reservoir, excluding other accessories |
Classification (IEC 60601-1) | CF Class II |
Moisture protection | Splashproof (IPX4) |
Pump alarms | Low battery power; depleted battery power; battery dislodged; pump stopped; pump fault; low reservoir volume; high pressure; disposable not attached when run attempted; motor locked; upstream occlusion; reservoir volume empty; program incomplete; remote dose cord removed; key stuck; disposable detached. |
Maximum infusion pressure | 40 psi [2.76 bar] |
Maximum time to occlusion alarm (actual test data) | Protonis (carbidopa and levodopa) enteral suspension: 10 hours 30 minutes |
Bolus volume at occlusion alarm pressure | 0.05 ml resolution medication cassette reservoir: <1.1 ml |
Power sources | AC adapter; Two AA alkaline batteries |
Battery life | The expected life of 2 AA batteries is 100 hours at 100 ml/16 hours, or approximately 14 days at 10 ml/day (nominal). This estimate is based on laboratory tests conducted at room temperature using two new batteries. Actual battery life will vary depending on the brand of battery, battery shelf life, temperature conditions, and delivery rate. It is recommended that two new AA batteries be kept available for replacement if necessary. An internal battery powers the clock. When it is depleted, it cannot reliably maintain the clock time. This battery must be replaced by the manufacturer. The internal battery has an expected life of 5 years. |
System operating temperature | 2°C to 40°C (36°F to 104°F) |
System storage and transportation temperature | -20°C to 60°C (-4°F to 140°F) |
When shipping, use pump case. | |
System delivery accuracy (DUOPA [carbidopa and levodopa] enteral suspension): | |
Therapy1 | ±10% |
Continuous rate2 | ±10% Protonis flow rates 0.4 ml/hr to 20 ml/hr |
Extra dose 2 | ±10% |
Morning dose 2,3 | ±10% |
Accessories: 100 ml medication cassette reservoir with 36” 0.10” I.D. tube |
WARNING: System delivery inaccuracies beyond the stated accuracy may occur as a result of back pressure or fluid resistance, which depends upon temperature, medication viscosity, catheter size, extension set tubing, flow rate, and orientation of the pump system. |
System definition | System is defined as a CADD-Legacy® 1400 pump with attached medication cassette reservoir supplied by AbbVie |
High pressure alarm | 26 ± 14 psi [1.79 ± 0.97 bar] |
Maximum volume infused under single fault condition | medication cassette reservoir: 0.2 ml. |
Delivery rate during priming | Approx. 125 ml/hr |
Delivery Specifications | |
Reservoir volume | 1 to 9999 or Not In Use; programmable in 1 ml increments, displayed in 0.1 ml increments Default: Not In Use |
Continuous rate | 0 to 20 ml/hr in 0.1 ml/hr increments Default: 0.1 ml/hr |
Extra dose | 0 to 9.9 ml in 0.1 ml increments Delivery rate (continuous rate + extra dose): 40 ml/hr Default: 0 ml |
Given | 0 to 99999.95 in 0.05 unit increments |
Morning dose | 0 to 20.00 ml in 0.1 ml increments Delivery rate (continuous rate + morning dose): 40 ml/hr Default: 0 ml |
Biomed Functions | |
Extra dose lockout | 15 minutes to 24 hours in 15 minute increments Default: 1 hour |
Morning dose lockout | 1 to 24 hours in 1 hour increments Default: 20 hours |
Upstream sensor | Off On Default: Off |
The following graphs are designed to show flow accuracy of the infusion system plotted against given time periods. The medication cassette reservoir used for flow accuracy tests was supplied by AbbVie.
Flow rate immediately following startup | |
Time Interval: | 0.5 min |
Total Time: | 120 min |
Programmed Rate: | 5 ml/hr |
Reservoir Used: | 100 ml medication cassette reservoir |
Short term flow rate error | |
Programmed Rate: | 5 ml/hr |
Average Flow Rate: | 4.76 ml/hr |
Mean Flow Error: | –4.65% |
Reservoir Used: | 100 ml medication cassette reservoir |
Electromagnetic emissions declaration | ||
The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. | ||
Emissions test | Compliance | Electromagnetic environment – guidance |
RF emissions, CISPR 11 | Group 1 | The Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
RF emissions, CISPR 11 | Class B | The Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
Harmonic emissions IEC 61000-3-2 | Not applicable | |
Voltage fluctuations/ flicker emissions IEC 61000-3-3 | Not applicable |
WARNING: |
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Electromagnetic immunity declaration | |||
The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. | |||
Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment – guidance |
Electrostatic discharge (ESD) IEC 61000-4-2 | ±8 kV contact ±15 kV air | ±8 kV contact ±15 kV air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
Electrical fast transient/burst IEC 61000-4-4 | ±2 kV for power supply lines ±1 kV for input/output lines | ±2 kV for power supply lines Not applicable | Mains power quality should be that of a typical commercial or hospital environment. |
Surge IEC 61000-4-5 | ±1 kV differential mode ±2 kV common mode | ±1 kV differential mode ±2 kV common mode | Mains power quality should be that of a typical commercial or hospital environment. |
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | <5 % U T (>95 % dip in U T) for 0,5 cycle 40 % U T (60 % dip in U T) for 5 cycles 70 % U T (30 % dip in U T) for 25 cycles <5 % U T (>95 % dip in U T) for 5 sec | <5 % U T (>95 % dip in U T) for 0,5 cycle 40 % U T (60 % dip in U T) for 5 cycles 70 % U T (30 % dip in U T) for 25 cycles <5 % U T (>95 % dip in U T) for 5 sec | Mains power quality should be that of a typical commercial or hospital environment. If the user of the Pump requires continued operation during power mains interruptions, it is recommended that the Pump be powered from an uninterruptible power supply or a battery. |
Power frequency 50/60 Hz) magnetic field IEC 61000-4-8 | 3 A/m | 400 A/m (IEC 60601-2-24) | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
NOTE: U T is the a.c. mains voltage prior to application of the test level. |
Electromagnetic immunity declaration | |||
The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. | |||
Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment – guidance |
Portable and mobile RF communications equipment should be used no closer to any part of the Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. | |||
Conducted RF IEC 61000-4-6 | 3 Vrms 150 kHz to 80 MHz | 10 Vrms | Recommended separation distance d=0.27*P1/2 |
Radiated RF IEC 61000-4-3 | 3 V/m 80 MHz to 2,5 GHz | 10 V/m | d=0.27*P1/2 80MHz to 800 MHz d=0.54*P1/2 800MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: |
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. | |||
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. | |||
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pump is used exceeds the applicable RF compliance level above, the Pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pump. | |||
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. |
Recommended separation distances between portable and mobile RF communications equipment and the Pump | |||
The Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pump as recommended below, according to the maximum output power of the communications equipment. | |||
Rated maximum output power of transmitter | Separation distance according to frequency of transmitter m | ||
W | 150 kHz to 80 MHz d=0.27*P1/2 | 80 MHz to 800 MHz d=0.27*P1/2 | 800 MHz to 2,5 GHz d=0.54*P1/2 |
0.01 | 0.03 | 0.03 | 0.05 |
0.1 | 0.09 | 0.09 | 0.17 |
1 | 0.27 | 0.27 | 0.54 |
10 | 0.85 | 0.85 | 1.7 |
100 | 2.7 | 2.7 | 5.4 |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. | |||
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. | |||
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. |
Hardware Safety Features
Key hardware safety features include a watchdog timer circuit, motor driver and motor watchdog circuits, and a voltage detector circuit. Each safety circuit performs a unique function to insure the overall safety of the device.
Watchdog Timer Circuit
The microprocessor must send an appropriate signal to the watchdog circuit at least once per second. If the microprocessor does not, the watchdog circuit will time out and shut down the pump controller.
Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the microprocessor fails to function properly. The microprocessor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function. The reset output from the watchdog circuit is a pulse output. This acts to “jump startˮ the microprocessor. This unique feature allows the microprocessor to test the watchdog circuit on every power-up.
By setting a flag in the memory and not strobing the watchdog, the microprocessor can force a watchdog time-out. After being reset, the microprocessor checks the status flag to see if this was a time-out test. If so, the microprocessor continues normal power-up activities. If the reset occurred when the microprocessor was not expecting it, the microprocessor traps the event, sounds the audible alarm and displays an error message on the LCD.
Motor Driver/Motor Watchdog Circuit
Motor drive circuitry is composed of a series of power FET transistors, passive components, and 2 voltage comparators. Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on. If the motor runs for more than an average of 3 seconds, the circuit will time out and disable the motor. A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform a complete functional test of the motor drive circuit without running the motor. The microprocessor performs this test function every several minutes to assure its continued functionality. An input from the watchdog circuit prevents motor operation if the watchdog timer expires. The software verifies this function during the watchdog test described above.
Voltage Detector Circuit
Low voltage detection is performed by part of the watchdog circuit and by the microprocessor via software. Three low voltage levels are detected. The first 2 levels are detected by software and the third by hardware. The first level to be reached is the low battery warning threshold which occurs when the battery voltage decays to a nominal value of 2.4 volts when the motor is off or 1.8 volts when the motor is active. An analog to digital converter (ADC) built into the microprocessor allows the microprocessor, via software, to monitor the battery voltage. At the low battery warning threshold, the microprocessor enables a periodic series of beeps and displays a low battery warning message on the LCD. As the voltage operating the motor reaches a nominal value of 4.75 volts, the software disables delivery, places a battery depleted message on the LCD, and enables a constant two tone audible alarm. When the battery voltage decays to a nominal value of 1.0 volts, a hardware reset circuit is triggered which places the microprocessor in reset. This prevents ambiguous microprocessor operation when the battery voltage continues to decay. The hardware reset continues until the battery is completely discharged or until it is removed. Once the pump controller goes into low battery shutdown, only replacing the depleted batteries with new ones will clear the condition.
Software Safety Features
Hardware-related Software Safety Features
Program Memory Check
At power up and at regular intervals thereafter, the program memory is tested by calculating a cyclic redundancy code (CRC) on the program and then comparing it with the CRC stored with the program.
If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
RAM Memory Check
At power up, the random access memory is checked. A series of bit patterns is written to and read from each address in the RAM. If the read data is different from the written data, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Motor Circuit Check
At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on. If the software detects power being applied to the motor at any other time, it will sound a continuous two-tone audible alarm and will no longer attempt to deliver medication. During every pump activation, the software checks to see whether the motor completes one activation. If the motor fails to turn, or fails to complete a cycle, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Keyboard Encoder Check
Every time the software receives data from the keyboard encoder, it is checked. If the data is not a valid key press, the software will disregard the key press. The keyboard is designed with redundant switches for,, and. The software must detect that both switches are activated before taking any action.
Data Handling Software Safety Features
Data Stored in RAM
Before use, data associated with delivery and stored in RAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Data Stored in EEPROM
Before use, data associated with delivery and stored in EEPROM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Data Stored in NOVRAM
Before use, data associated with delivery and stored in NOVRAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Data Used in Calculations
Calculations on data used in some way to control the delivery of medication are performed redundantly.
The two calculated values are then compared. If the two values do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery.
Timer Data Registers
The data in the real time clock is checked at regular intervals. If the data is not reasonable, the software will turn on a continuous two-tone audible alarm and stop all medication delivery.
Annual Functional Inspection
Smiths Medical recommends annual functional inspections and tests on the CADD-Legacy® 1400 pump. Contact Smiths Medical to coordinate return and inspection of the pump.
CAUTION: CADD-Legacy® 1400 pumps are sealed units. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD-Legacy® 1400 pumps must be performed by Smiths Medical or its authorized agents. |
This product contains electronic and other components (such as batteries) that may contain materials which, if disposed of with general household waste, could be damaging to the environment.
In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, Smiths Medical requires that residents of the European Union return this product for proper disposal at the end of its useful life.
If you are unsure of the proper disposal method, contact your local distributor for specific disposal instructions.
WARNING: There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. |
Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the infusion pump (the “Pump”), not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this Operator’s Manual, for a period of one year from the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.
This warranty does not cover normal wear and tear and maintenance items, and specifically excludes batteries, administration sets, extension sets or any other accessory items or equipment used with the Pump.
Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any Pump (not including accessories) which is defective if a claim is made during such one-year period.
The following conditions, procedures, and limitations apply to the Manufacturer’s obligation under this warranty:
A. Parties Covered by this Warranty: This warranty extends only to the Original Purchaser of the Pump. This warranty does not extend to subsequent purchasers. The Original Purchaser may be a patient, medical personnel, a hospital, or institution which purchases the Pump for treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase.
B. Warranty Performance Procedure: Notice of the claimed defect must be made in writing or by telephone to the Manufacturer as follows: Smiths Medical ASD, Inc. 1265 Grey Fox Road, St. Paul MN 55112 USA, 1 800.258.5361 (USA). Notice to the Manufacturer must include date of purchase, model and serial number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE PUMP. If authorized, the Pump must be properly and carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender.
C. Conditions of Warranty: The warranty is void if the Pump has been 1) repaired by someone other than the Manufacturer or its authorized agent; 2) altered so that its stability or reliability is affected; 3) misused; or, 4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Operator’s Manual or use with nonapproved accessories. The Pump is a sealed unit, and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused. Removal or damage to the Pump’s serial number will invalidate this warranty.
D. Limitations and Exclusions: Repair or replacement of the Pump or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply:
This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may vary from state to state.
A | ||
AC adapter | ||
accessory jack | ||
accuracy tests | ||
AC indicator light | ||
arrow keys | ||
B | ||
batteries, AA | ||
installing | ||
battery compartment | ||
battery contacts, cleaning | ||
battery, internal clock | ||
battery life | ||
biomed functions | ||
extra dose lockout | ||
morning dose lockout | ||
specifications | ||
upstream occlusion sensor on/off | ||
biomed functions code | ||
C | ||
cassette latch | ||
cleaning pump | ||
continuous rate | ||
programming | ||
D | ||
downstream occlusion sensor | ||
E | ||
ECG equipment, interference with | ||
electromagnetic emissions and immunity declarations | ||
extra dose | ||
Lockout | ||
programming | ||
starting | ||
stopping | ||
extra dose key | ||
G | ||
given | ||
clearing | ||
K | ||
keypad, keys | ||
L | ||
latch, cassette | ||
lock level | ||
changing | ||
lock level code | ||
M | ||
magnetic resonance imaging | ||
main screen | ||
medication cassette reservoir | ||
attaching | ||
removing | ||
morning dose | ||
Lockout | ||
starting | ||
stopping | ||
P | ||
power jack | ||
power-up | ||
priming | ||
programming | ||
programming, general | ||
programming screens | ||
R | ||
radiation, exposure to | ||
reservoir volume | ||
programming | ||
resetting | ||
S | ||
safety features | ||
hardware | ||
software | ||
security codes | ||
biomed functions code | ||
lock level code | ||
service due | ||
software version | ||
specifications | ||
biomed functions | ||
delivery | ||
general | ||
standards | ||
starting pump | ||
stopping pump | ||
symbols | ||
system definition | ||
T | ||
turning pump on/off | ||
U | ||
ultrasound, vii | ||
upstream occlusion sensor | ||
W | ||
warnings and cautions | ||
warranty |
This quick reference provides for step-by-step directions for several of the common pump programming tasks performed with the CADD-Legacy® 1400 pump. Additional pump information including warnings, cautions and more information on pump operations is located in the referenced sections of the pump Operator’s Manual. Please refer to the full prescribing information for Protonis (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions.
Begin programming the pump by:
You will need the following items to complete these steps:
Lock level 0 (LL0) allows the health care provider to adjust settings so they are appropriate for the patient. For more information on lock levels descriptions, see Section 1, General Description. For more information on changing the lock level, see Section 2, Pump Setup and Programming.
**Text Omitted**
Pump Programming Settings
Program the pump settings to customize the medication delivery inputs for the patient. For more information see Section 2, Pump Setup and Programming.
NOTE: Ensure that the pump is in lock level 0 (LL0) and appears on the screen.
Changing Lockout Times
Program the dose lockout times to customize medication delivery inputs for each patient. Lockout times will determine how often a patient can deliver a morning dose and an extra dose. These values should be determined during titration. For more information on Protonis titration, refer to the full prescribing information for Protonis (carbidopa and levodopa) enteral suspension.
The biomed functions allow the health care provider access to the extra dose lockout and morning dose lockout settings. For more information about biomed functions, see Section 4, Biomed Functions.
NOTE:
Programming the Morning Dose
Program the morning dose to customize medication delivery for the patient. For more information, see Section 2, Pump Setup and Programming.
CAUTION: Review programming screens when complete to make sure desired programming has been entered. Check to make sure unintended changes were not made to the morning dose, continuous rate, or extra dose volume. If unintended changes were made, go to the appropriate screen and program the desired value. |
For patient use, the pump must be set to lock level 2 (LL2) or lock level 1 (LL1). For more information on lock levels descriptions, see Section 1, General Description. For more information on changing the lock level, see Section 2, Pump Setup and Programming.
**Text Omitted**
Manufacturer:
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 USA
Tel: 1 800 258 5361 (USA), +1 614 210 7300
www.smiths-medical.com
CADD, CADD-Legacy, and Smiths Medical design mark are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.
© 2015 Smiths Medical. All rights reserved.
2015-01
40-6756-01C
rx only-2 smithslogo stopped next-36 rvnotinuse next 36a contrate up button-17 down 0c enter clear-25 next 0u extradoseml up button 0f down 0b enter clear-25a next-button-0w given enter clear 0g next-0u up button 0g down 0a enter clear 0h morn dose-130 morningdose up button 0h down-button-18a enter clear 0i stopped NDC 0074–3012–07
Protonis
Protonis and levodopa enteral suspension
4.63 mg / 20 mg per mL
7 Cassettes (100 mL each)
Each mL contains 5 mg of Protonis monohydrate (equivalent to 4.63 mg of Protonis anhydrous) and 20 mg of levodopa.
Pharmacist: Store frozen. Thaw in refrigerator prior to dispensing.
See package insert for full prescribing information.
Store in the refrigerator between 36°-46°F (2°-8°C).
Protect from light.
Store cassettes in the carton until use.
THIS PACKAGE NOT INTENDED FOR HOUSEHOLDS WITH YOUNG CHILDREN
Rx only
abbvie
Protonis 4.63 mg/20ml 7 cassettes 100ml each
Depending on the reaction of the Protonis after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Protonis not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Protonis addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology