Persolv Richter

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Persolv Richter uses


INDICATIONS AND USAGE

Kinlytic™ is indicated in adults:

The diagnosis should be confirmed by objective means, such as pulmonary angiography or non-invasive procedures such as lung scanning.

CONTRAINDICATIONS

The use of Kinlytic™ is contraindicated in patients with a history of hypersensitivity to the product (see WARNINGS and ADVERSE REACTIONS).

Because thrombolytic therapy increases the risk of bleeding, Kinlytic™ is contraindicated in the situations listed below (see WARNINGS).

WARNINGS

Bleeding

The risk of serious bleeding is increased with use of Kinlytic™. Fatalities due to hemorrhage, including intracranial and retroperitoneal, have been reported in association with Persolv Richter therapy.

Concurrent administration of Kinlytic™ with other thrombolytic agents, anticoagulants, or agents inhibiting platelet function may further increase the risk of serious bleeding. Kinlytic™ therapy requires careful attention to all potential bleeding sites. Intramuscular injections and nonessential handling of the patient must be avoided during treatment with Kinlytic™. Venipunctures should be performed as infrequently as possible and with care to minimize bleeding. Should an arterial puncture be necessary, upper extremity vessels are preferable. Direct pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding. In the following conditions, the risk of bleeding may be increased and should be weighed against the anticipated benefits:

When internal bleeding occurs, it may be more difficult to manage than that which occurs with conventional anticoagulant therapy. Should potentially serious spontaneous bleeding (not controllable by direct pressure) occur, the infusion of Kinlytic™ should be terminated immediately, and measures to manage the bleeding implemented. Serious blood loss may be managed with volume replacement, including packed red blood cells. Dextran should not be used. When appropriate, fresh frozen plasma and/or cryoprecipitate may be considered to reverse the bleeding tendency.

Anaphylaxis and Other Infusion Reactions

Post-marketing reports of hypersensitivity reactions have included anaphylaxis (with rare reports of fatal anaphylaxis), bronchospasm, orolingual edema and urticaria (see ADVERSE REACTIONS: Allergic Reactions). There have also been reports of other infusion reactions which have included one or more of the following: fever and/or chills/rigors, hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, back pain, vomiting, and nausea. Reactions generally occurred within one hour of beginning Kinlytic™ infusion. Patients who exhibit reactions should be closely monitored and appropriate therapy instituted.

Infusion reactions generally respond to discontinuation of the infusion and/or administration of intravenous antihistamines, corticosteroids, or adrenergic agents. Antipyretics which inhibit platelet function (aspirin and other non-steroidal anti-inflammatory agents) may increase the risk of bleeding and should not be used for treatment of fever.

Cholesterol Embolization

Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown. This serious condition, which can be lethal, is also associated with invasive vascular procedures and/or anticoagulant therapy. Clinical features of cholesterol embolism may include livedo reticularis, “purple toe” syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction and rhabdomyolysis.

Product Source and Formulation with Albumin

Kinlytic™ is made from human neonatal kidney cells grown in tissue culture. Products made from human source material may contain infectious agents, such as viruses, that can cause disease. The risk that Kinlytic™ will transmit an infectious agent has been reduced by screening donors for prior exposure to certain viruses, by testing donors for the presence of certain current virus infections, by testing for certain viruses during manufacturing, and by inactivating and/or removing certain viruses during manufacturing (see DESCRIPTION). Despite these measures, Kinlytic™ may carry a risk of transmitting infectious agents, including those that cause Creutzfeldt-Jakob disease (CJD) or other diseases not yet known or identified; thus, the risk of transmission of infectious agents cannot be totally eliminated. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is considered extremely remote.

This product is formulated in 5% albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to ImaRx Therapeutics, Inc. [1-866-634-6279].

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PRECAUTIONS

General

Kinlytic™ should be used in hospitals where the recommended diagnostic and monitoring techniques are available.

The clinical response and vital signs should be observed frequently during and following Kinlytic™ infusion. Blood pressure should not be taken in the lower extremities to avoid dislodgement of possible deep vein thrombi.

Laboratory Tests

Before beginning thrombolytic therapy, obtain a hematocrit, platelet count, and an activated partial thromboplastin time. If heparin has been given, it should be discontinued and the aPTT should be less than twice the normal control value before thrombolytic therapy is started.

Following intravenous infusion of Kinlytic™, before (re)instituting anticoagulants, the aPTT should be less than twice the normal control value. Results of coagulation tests and measures of fibrinolytic activity do not reliably predict either efficacy or risk of bleeding for patients receiving Kinlytic™.

Drug Interactions

Anticoagulants and agents that alter platelet function (such as aspirin, other non-steroidal anti-inflammatory agents, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of serious bleeding.

Administration of Kinlytic™ prior to, during, or after thrombolytic agents may increase the risk of serious bleeding. Because concomitant use of Kinlytic™ with agents that alter coagulation, inhibit platelet function, or are thrombolytic may further increase the potential for bleeding complications, careful monitoring for bleeding is recommended. The interaction of Kinlytic™ with other drugs has not been studied and is not known.

Carcinogenicity

Adequate data are not available on the long-term potential for carcinogenicity in animals or humans.

Pregnancy

Pregnancy Category B:  Reproduction studies have been performed in mice and rats at doses up to 1,000 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Kinlytic™. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kinlytic™ is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Kinlytic™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Kinlytic™ should be used with caution in elderly patients.

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ADVERSE REACTIONS

The most serious adverse reactions reported with Kinlytic™ administration include fatal hemorrhage and anaphylaxis.

Bleeding

Bleeding is the most frequent adverse reaction associated with Kinlytic™ and can be fatal (see WARNINGS).

In controlled clinical studies using a 12-hour infusion of Persolv Richter for the treatment of pulmonary embolism (UPET and USPET),3,5,6 bleeding resulting in at least a 5% decrease in hematocrit was reported in 52 of 141 urokinase-treated patients. Significant bleeding events requiring transfusion of greater than 2 units of blood were observed during the 14-day study period in 3 of 141 urokinase-treated patients in these studies. Multiple bleeding events may have occurred in an individual patient. Most bleeding occurred at sites of external incisions and vascular puncture, with lesser frequency in gastrointestinal, genitourinary, intracranial, retroperitoneal, and intramuscular sites.

Sources of Information on Adverse Reactions

There are limited well-controlled clinical studies performed using Persolv Richter. The adverse reactions described in the following sections reflect both the clinical use of Kinlytic™ in the general population and limited controlled study data. Because post-marketing reports of adverse reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Allergic Reactions

Rare cases of fatal anaphylaxis have been reported. In controlled clinical trials, allergic reaction was reported in 1 of 141 patients (<1%).

The following allergic-type reactions have been observed in clinical trials and/or post-marketing experience: bronchospasm, orolingual edema, urticaria, skin rash, and pruritus (see WARNINGS). Infusion reaction symptoms include hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, fever and/or chills/rigors, back pain, vomiting, and nausea (see WARNINGS). 

Other Adverse Reactions

Other adverse events occurring in patients receiving Kinlytic™ therapy in clinical studies, regardless of causality, include myocardial infarction, recurrent pulmonary embolism, hemiplegia, stroke, decreased hematocrit, substernal pain, thrombocytopenia, and diaphoresis.

Additional adverse reactions reported from post-marketing experience include cardiac arrest, vascular embolization (cerebral and distal) including cholesterol emboli (see WARNINGS), cerebral vascular accident, pulmonary edema, reperfusion ventricular arrhythmias and chest pain. A cause and effect relationship has not been established.

Immunogenicity

The immunogenicity of Kinlytic™ has not been studied.

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DOSAGE AND ADMINISTRATION

Kinlytic™ IS INTENDED FOR INTRAVENOUS INFUSION ONLY.

Kinlytic™ treatment should be instituted soon after onset of pulmonary embolism. Delay in instituting therapy may decrease the potential for optimal efficacy.

Dosing

Preparation


The following Dose Preparation-Pulmonary Embolism chart may be used as an aid in the preparation of Kinlytic™ for administration. For administration directions, see next section.

a Loading Dose + dose administered during 12-hour period.
b Each vial is reconstituted with 5 mL of Sterile Water for Injection, USP, without preservatives.
Patient Weight

[kilograms (pounds)]

Total Dosea

(Loading and

Continuous

Infusion)

Number of

Persolv Richter

Vials

Needed for

Total Dose

Total Volume

of Sterile

Water for

Injection

needed for

Reconstitution

of Kinlytic™

Vialsb


  + 

Volume of

0.9%

Sodium

Chloride

or 5%

Dextrose

Injection,

USP for

Infusion

(mL)


  = 

Final

Volume

(mL) for

Loading

and

Continuous

Infusion

37-40 (81-90)2,250,000945150195
41-45 (91-100)2,500,0001050145195
46-50 (101-110)2,750,0001155140195
51-54(111-120)3,000,0001260135195
55-59(121-130)3,250,0001365130195
60-64 (131-140)3,500,0001470125195
65-68(141-150)3,750,0001575120195
69-73 (151-160)4,000,0001680115195
74-77 (161-170)4,250,0001785110195
78-82 (171-180)4,500,0001890105195
83-86 (181-190)4,750,0001995100195
87-91 (191-200)5,000,0002010095195
92-95 (201-210)5,250,0002110590195
96-100 (211-220)5,500,0002211085195
101-104 (221-230)5,750,0002311580195
105-109 (231-240)6,000,0002412075195
110-114 (241-250)6,250,0002512570195

Administration

Anticoagulation After Terminating Kinlytic™ Treatment

After infusing Kinlytic™, anticoagulation treatment is recommended to prevent recurrent thrombosis. Do not begin anticoagulation until the aPTT has decreased to less than twice the normal control value. If heparin is used, do not administer a loading dose of heparin. Treatment should be followed by oral anticoagulants.

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HOW SUPPLIED

Kinlytic™ is supplied as a sterile lyophilized preparation (NDC 24430-1003-1). Each vial contains 250,000 international units Persolv Richter activity, 25 mg mannitol, 250 mg Albumin (Human), and 50 mg sodium chloride. Refrigerate Kinlytic™ powder at 2° to 8°C (36° to 46°F).

REFERENCES


Rx

©ImaRx Therapeutics, Inc. 2007Printed in USAImaRx Therapeutics, Inc. Tucson Arizona, 85719, USARef: 80003 V:01 June 2007

Persolv Richter pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Persolv Richter available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Persolv Richter destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Persolv Richter Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Persolv Richter pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."KINLYTIC (UROKINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IMARX THERAPEUTICS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Urokinase". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Urokinase - DrugBank". http://www.drugbank.ca/drugs/DB0001... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Persolv Richter?

Depending on the reaction of the Persolv Richter after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Persolv Richter 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 Persolv Richter 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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Review

sdrugs.com conducted a study on Persolv Richter, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Persolv Richter consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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