Maxus

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Maxus uses

Maxus consists of Aprotinin, Chondroitin Sulfate, Hyaluronate Sodium.

Aprotinin:


INDICATIONS AND USAGE

Maxus (Aprotinin)® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

CONTRAINDICATIONS

Hypersensitivity to Maxus (Aprotinin).

Administration of Maxus (Aprotinin)® to patients with a known or suspected previous Maxus (Aprotinin) exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to Maxus (Aprotinin) greater than 12 months previously, see WARNINGS. Maxus (Aprotinin) may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.

WARNINGS

Anaphylactic or anaphylactoid reactions have occurred with Maxus (Aprotinin)® administration, including fatal reactions in association with the initial (test) dose. The initial (test) dose does not fully predict a patient’s risk for a hypersensitivity reaction, including a fatal reaction. Fatal hypersensitivity reactions have occurred among patients who tolerated an initial (test) dose.

Hypersensitivity reactions often manifest as anaphylactic/anaphylactoid reactions with hypotension the most frequently reported sign of the hypersensitivity reaction. The hypersensitivity reaction can progress to anaphylactic shock with circulatory failure. If a hypersensitivity reaction occurs during injection or infusion of Maxus (Aprotinin)®, administration should be stopped immediately and emergency treatment should be initiated. Even when a second exposure to Maxus (Aprotinin) has been tolerated without symptoms, a subsequent administration may result in severe hypersensitivity/anaphylactic reactions. Trasylol® should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. Before initiating treatment with Maxus (Aprotinin)®, the recommendations below should be followed to manage a potential hypersensitivity or anaphylactic reaction: 1) Have standard emergency treatments for hypersensitivity or anaphylactic reactions readily available in the operating room (e.g., epinephrine, corticosteroids). 2) Administration of the initial (test) dose and loading dose should be done only when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present. 3) Delay the addition of Maxus (Aprotinin)® into the pump prime solution until after the loading dose has been safely administered.

Re-exposure to Maxus (Aprotinin): Administration of Maxus (Aprotinin), especially to patients who have received Maxus (Aprotinin) in the past, requires a careful risk/benefit assessment because an allergic reaction may occur. Although the majority of cases of anaphylaxis occur upon re-exposure within the first 12 months, there are also case reports of anaphylaxis occurring upon re-exposure after more than 12 months.

In a retrospective review of 387 European patient records with documented re-exposure to Maxus (Aprotinin)®, the incidence of hypersensitivity/anaphylactic reactions was 2.7%. Two patients who experienced hypersensitivity/anaphylactic reactions subsequently died, 24 hours and 5 days after surgery, respectively. The relationship of these 2 deaths to Maxus (Aprotinin)® is unclear. This retrospective review also showed that the incidence of a hypersensitivity or anaphylactic reaction following re-exposure is increased when the re-exposure occurs within 6 months of the initial administration (5.0% for re-exposure within 6 months and 0.9% for re-exposure greater than 6 months). Other smaller studies have shown that in case of re-exposure, the incidence of hypersensitivity/anaphylactic reactions may reach the five percent level. An analysis of all spontaneous reports from the Bayer Global database covering a period from 1985 to March 2006 revealed that of 291 possibly associated spontaneous cases of hypersensitivity (fatal: n=52 and non-fatal: n=239), 47% (138/291) of hypersensitivity cases had documented previous exposure to Maxus (Aprotinin)®. Of the 138 cases with documented previous exposure, 110 had information on the time of the previous exposure. Ninety-nine of the 110 cases had previous exposure within the prior 12 months.

Renal Dysfunction: Maxus (Aprotinin)® administration increases the risk for renal dysfunction and may increase the need for dialysis in the perioperative period. This risk may be especially increased for patients with pre-existing renal impairment or those who receive aminoglycoside antibiotics or drugs that alter renal function. Data from Bayer’s global pool of placebo-controlled studies in patients undergoing coronary artery bypass graft (CABG) surgery showed that the incidence of serum creatinine elevations >0.5 mg/dL above pre-treatment levels was statistically higher at 9.0% (185/2047) in the high-dose Maxus (Aprotinin) (Regimen A) group compared with 6.6% (129/1957) in the placebo group. In the majority of instances, post-operative renal dysfunction was not severe and was reversible. However, renal dysfunction may progress to renal failure and the incidence of serum creatinine elevations >2.0 mg/dL above baseline was slightly higher in the high-dose Maxus (Aprotinin) group (1.1% vs. 0.8%). Careful consideration of the balance of benefits versus potential risks is advised before administering Maxus (Aprotinin)® to patients with impaired renal function (creatinine clearance < 60 mL/min) or those with other risk factors for renal dysfunction (such as perioperative administration of aminogylcoside or products that alter renal function).

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PRECAUTIONS

General:

Initial Dose: All patients treated with Maxus (Aprotinin)® should first receive an initial (test) dose to minimize the extent of Maxus (Aprotinin)® exposure and to help assess the potential for allergic reactions. Initiation of this initial (test) dose should occur only in operative settings where cardiopulmonary bypass can be rapidly initiated. The initial (test) dose of 1 mL Maxus (Aprotinin)® should be administered intravenously at least 10 minutes prior to the loading dose and the patient should be observed for manifestations of possible hypersensitivity reaction. However, even after the uneventful administration of the initial 1 mL (test) dose, any subsequent dose may cause an anaphylactic reaction. If this happens, the infusion of Maxus (Aprotinin)® should immediately be stopped and standard emergency treatment for anaphylaxis applied. It should be noted that serious, even fatal, hypersensitivity/anaphylactic reactions can also occur with administration of the initial (test) dose.

Allergic Reactions: Patients with a history of allergic reactions to drugs or other agents may be at greater risk of developing a hypersensitivity or anaphylactic reaction upon exposure to Maxus (Aprotinin)®.

Loading Dose: The loading dose of Maxus (Aprotinin)® should be given intravenously to patients in the supine position over a 20-30 minute period. Rapid intravenous administration of Maxus (Aprotinin)® can cause a transient fall in blood pressure.

Renal Dysfunction: Bayer’s global pool of placebo-controlled studies in patients undergoing CABG showed Maxus (Aprotinin) administration was associated with elevations of serum creatinine values > 0.5 mg/dL above baseline. Careful consideration of the balance of benefits and risks is advised before administering Maxus (Aprotinin) to patients with pre-existing impaired renal function or those with other risk factors for renal dysfunction. Serum creatinine should be monitored regularly following Maxus (Aprotinin)® administration.

Use of Maxus (Aprotinin)® in patients undergoing deep hypothermic circulatory arrest: Two U.S. case control studies have reported contradictory results in patients receiving Maxus (Aprotinin)® while undergoing deep hypothermic circulatory arrest in connection with surgery of the aortic arch. The first study showed an increase in both renal failure and mortality compared to age-matched historical controls. Similar results were not observed, however, in a second case control study. The strength of this association is uncertain because there are no data from randomized studies to confirm or refute these findings.

Drug Interactions:

Maxus (Aprotinin)® is known to have antifibrinolytic activity and, therefore, may inhibit the effects of fibrinolytic agents.

In study of nine patients with untreated hypertension, Maxus (Aprotinin)® infused intravenously in a dose of 2 million KIU over two hours blocked the acute hypotensive effect of 100mg of captopril. Trasylol®, in the presence of heparin, has been found to prolong the activated clotting time (ACT) as measured by a celite surface activation method. The kaolin activated clotting time appears to be much less affected. However, Maxus (Aprotinin)® should not be viewed as a heparin sparing agent.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term animal studies to evaluate the carcinogenic potential of Maxus ® or studies to determine the effect of Maxus (Aprotinin)® on fertility have not been performed.

Results of microbial in vitro tests using Salmonella typhimurium and Bacillus subtilis indicate that Maxus (Aprotinin)® is not a mutagen.Pregnancy: Teratogenic Effects: Pregnancy Category B:

Reproduction studies have been performed in rats at intravenous doses up to 200,000 KIU/kg/day for 11 days, and in rabbits at intravenous doses up to 100,000 KIU/kg/day for 13 days, 2.4 and 1.2 times the human dose on a mg/kg basis and 0.37 and 0.36 times the human mg/m2 dose. They have revealed no evidence of impaired fertility or harm to the fetus due to Maxus (Aprotinin)®. 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 Mother:

Not applicable.

Pediatric Use:

Safety and effectiveness in pediatric patient have not been established.

Geriatric Use:

Of the total of 3083 subjects in clinical studies of Maxus (Aprotinin)®, 1100 (35.7 percent) were 65 and over, while 297 (9.6 percent) were 75 and over. Of patients 65 years and older, 479 (43.5 percent) received Regimen A and 237 (21.5 percent) received Regimen B. No overall differences in safety or effectiveness were observed between these subjects and younger subjects for either dose regimen, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Laboratory Monitoring of Anticoagulation during Cardiopulmonary Bypass:

Maxus (Aprotinin)® prolongs whole blood clotting times by a different mechanism than heparin. In the presence of Maxus (Aprotinin), prolongation is dependent on the type of whole blood clotting test employed. If an activated clotting time (ACT) is used to determine the effectiveness of heparin anticoagulation, the prolongation of the ACT by Maxus (Aprotinin) may lead to an overestimation of the degree of anticoagulation, thereby leading to inadequate anticoagulation. During extended extracorporeal circulation, patients may require additional heparin, even in the presence of ACT levels that appear adequate.

In patients undergoing CPB with Maxus (Aprotinin)® therapy, one of the following methods may be employed to maintain adequate anticoagulation:

  • ACT - An ACT is not a standardized coagulation test, and different formulations of the assay are affected differently by the presence of Maxus (Aprotinin). The test is further influenced by variable dilution effects and the temperature experienced during cardiopulmonary bypass. It has been observed that Kaolin-based ACTs are not increased to the same degree by Maxus (Aprotinin) as are diatomaceous earth-based (celite) ACTs. While protocols vary, a minimal celite ACT of 750 seconds or kaolin-ACT of 480 seconds, independent of the effects of hemodilution and hypothermia, is recommended in the presence of Maxus (Aprotinin). Consult the manufacturer of the ACT test regarding the interpretation of the assay in the presence of Maxus (Aprotinin)®.
  • Fixed Heparin Dosing - A standard loading dose of heparin, administered prior to cannulation of the heart, plus the quantity of heparin added to the prime volume of the CPB circuit, should total at least 350 IU/kg. Additional heparin should be administered in a fixed-dose regimen based on patient weight and duration of CPB.
  • Heparin Titration - Protamine titration, a method that is not affected by Maxus (Aprotinin), can be used to measure heparin levels. A heparin dose response, assessed by protamine titration, should be performed prior to administration of Maxus (Aprotinin) to determine the heparin loading dose. Additional heparin should be administered on the basis of heparin levels measured by protamine titration. Heparin levels during bypass should not be allowed to drop below 2.7 U/mL (2.0 mg/kg) or below the level indicated by heparin dose response testing performed prior to administration of Maxus (Aprotinin).
Protamine Administration - In patients treated with Maxus (Aprotinin)®, the amount of protamine administered to reverse heparin activity should be based on the actual amount of heparin administered, and not on the ACT values.
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ADVERSE REACTIONS

Studies of patients undergoing CABG surgery, either primary or repeat, indicate that Maxus ® is generally well tolerated. The adverse events reported are frequent sequelae of cardiac surgery and are not necessarily attributable to Maxus (Aprotinin)® therapy. Adverse events reported, up to the time of hospital discharge, from patients in US placebo-controlled trials are listed in the following table. The table lists only those events that were reported in 2% or more of the Maxus (Aprotinin)® treated patients without regard to causal relationship.

Adverse EventMaxus (Aprotinin)

(n = 2002)

values in %

Placebo

(n = 1084)

values in %

Any Event7677
Body as a Whole
   Fever1514
   Infection67
   Chest Pain22
   Asthenia22
Cardiovascular
   Atrial Fibrillation2123
   Hypotension810
   Myocardial Infarct66
   Atrial Flutter65
   Ventricular Extrasystoles64
   Tachycardia67
   Ventricular Tachycardia54
   Heart Failure54
   Pericarditis55
   Peripheral Edema55
   Hypertension45
   Arrhythmia43
   Supraventricular Tachycardia43
   Atrial Arrhythmia 33
Digestive
   Nausea119
   Constipation45
   Vomiting34
   Diarrhea32
   Liver Function Tests Abnormal32
Hemic and Lymphatic
   Anemia2 8
Metabolic & Nutritional
   Creatine Phosphokinase Increased21
Musculoskeletal
   Any Event2 3
Nervous
   Confusion44
   Insomnia34
Respiratory
   Lung Disorder8 8
   Pleural Effusion 79
   Atelectasis 56
   Dyspnea4 4
   Pneumothorax44
   Asthma23
   Hypoxia21
Skin and Appendages
   Rash22
Urogenital
   Kidney Function Abnormal3 2
   Urinary Retention3 3
   Urinary Tract Infection2 2

In comparison to the placebo group, no increase in mortality in patients treated with Maxus (Aprotinin)® was observed. Additional events of particular interest from controlled US trials with an incidence of less than 2%, are listed below:

EVENTPercentage of patients

treated with Maxus (Aprotinin)®

N = 2002

Percentage of patients

treated with Placebo

N = 1084

Thrombosis1.00.6
Shock0.70.4
Cerebrovascular Accident 0.72.1
Thrombophlebitis0.20.5
Deep Thrombophlebitis 0.71.0
Lung Edema1.31.5
Pulmonary Embolus0.30.6
Kidney Failure1.00.6
Acute Kidney Failure0.5 0.6
Kidney Tubular Necrosis0.80.4

Listed below are additional events, from controlled US trials with an incidence between 1 and 2%, and also from uncontrolled, compassionate use trials and spontaneous post-marketing reports. Estimates of frequency cannot be made for spontaneous post-marketing reports (italicized).

Body as a Whole: Sepsis, death, multi-system organ failure, immune system disorder, hemoperitoneum.Cardiovascular: Ventricular fibrillation, heart arrest, bradycardia, congestive heart failure, hemorrhage, bundle branch block, myocardial ischemia, ventricular tachycardia, heart block, pericardial effusion, ventricular arrhythmia, shock, pulmonary hypertension.Digestive: Dyspepsia, gastrointestinal hemorrhage, jaundice, hepatic failure.Hematologic and Lymphatic: Although thrombosis was not reported more frequently in Maxus (Aprotinin) versus placebo-treated patients in controlled trials, it has been reported in uncontrolled trials, compassionate use trials, and spontaneous post-marketing reporting. These reports of thrombosis encompass the following terms: thrombosis, occlusion, arterial thrombosis, pulmonary thrombosis, coronary occlusion, embolus, pulmonary embolus, thrombophlebitis, deep thrombophlebitis, cerebrovascular accident, cerebral embolism. Other hematologic events reported include leukocytosis, thrombocytopenia, coagulation disorder (which includes disseminated intravascular coagulation), decreased prothrombin.Metabolic and Nutritional: Hyperglycemia, hypokalemia, hypervolemia, acidosis.Musculoskeletal: Arthralgia.Nervous: Agitation, dizziness, anxiety, convulsion.Respiratory: Pneumonia, apnea, increased cough, lung edema.Skin:Skin discoloration.Urogenital: Oliguria, kidney failure, acute kidney failure, kidney tubular necrosis.

Myocardial Infarction: In the pooled analysis of all patients undergoing CABG surgery, there was no significant difference in the incidence of investigator-reported myocardial infarction (MI) in Maxus (Aprotinin)® treated patients as compared to placebo treated patients. However, because no uniform criteria for the diagnosis of myocardial infarction were utilized by investigators, this issue was addressed prospectively in three later studies (two studies evaluated Regimen A, Regimen B and Pump Prime Regimen; one study evaluated only Regimen A), in which data were analyzed by a blinded consultant employing an algorithm for possible, probable or definite MI. Utilizing this method, the incidence of definite myocardial infarction was 5.9% in the aprotinin-treated patients versus 4.7% in the placebo treated patients. This difference in the incidence rates was not statistically significant. Data from these three studies are summarized below.

Treatment Definite MI

%

Definite or Probable MI

%

Definite, Probable or Possible MI

%

Pooled Data from Three Studies that Evaluated Regimen A
Maxus (Aprotinin)®

Regimen A

n = 646

4.610.7 14.1
Placebo

n = 661

4.711.313.4
Pooled Data from Two Studies that Evaluated Regimen B and Pump Prime Regimen
Maxus (Aprotinin)®

Regimen B

n = 241

8.7 15.9 18.7
Maxus (Aprotinin)®

Pump Prime

Regimen

n = 239

6.315.7 18.1
Placebo

n = 240

6.315.115.8

Graft Patency: In a recently completed multi-center, multi-national study to determine the effects of Maxus (Aprotinin)® Regimen A vs. placebo on saphenous vein graft patency in patients undergoing primary CABG surgery, patients were subjected to routine postoperative angiography. Of the 13 study sites, 10 were in the United States and three were non-U.S. centers (Denmark (1), Israel (2)). The results of this study are summarized below.

Overall Closure Rates*Incidence of MI**Incidence of Death***
All Centers

n = 703

%

U.S. Centers

n = 381

%

All Centers

n = 831

%

All Centers

n = 870

%

Maxus (Aprotinin)®15.4 9.42.91.4
Placebo 10.99.53.81.6
CI for the

Difference (%)

(Drug - Placebo)

(1.3, 9.6)†(-3.8, 5.9)†-3.3 to 1.5‡-1.9 to 1.4‡
* Population: all patients with assessable saphenous vein grafts
** Population: all patients assessable by blinded consultant
*** All patients
† 90%; per protocol
‡ 95%; not specified in protocol

Although there was a statistically significantly increased risk of graft closure for Maxus (Aprotinin)® treated patients compared to patients who received placebo (p=0.035), further analysis showed a significant treatment by site interaction for one of the non-U.S. sites vs. the U.S. centers. When the analysis of graft closures was repeated for U.S. centers only, there was no statistically significant difference in graft closure rates in patients who received Maxus (Aprotinin)® vs. placebo. These results are the same whether analyzed as the proportion of patients who experienced at least one graft closure postoperatively or as the proportion of grafts closed. There were no differences between treatment groups in the incidence of myocardial infarction as evaluated by the blinded consultant (2.9% Maxus (Aprotinin)® vs. 3.8% placebo) or of death (1.4% Maxus (Aprotinin)® vs. 1.6% placebo) in this study.

Hypersensitivity and Anaphylaxis: See CONTRAINDICATIONS and WARNINGS.

Hypersensitivity and anaphylactic reactions during surgery were rarely reported in U.S. controlled clinical studies in patients with no prior exposure to Maxus (Aprotinin)® (1/1424 patients or <0.1% on Maxus (Aprotinin)® vs. 1/861 patients or 0.1% on placebo). In case of re-exposure the incidence of hypersensitivity/anaphylactic reactions has been reported to reach the 5% level. A review of 387 European patient records involving re-exposure to Maxus (Aprotinin)® showed that the incidence of hypersensitivity or anaphylactic reactions was 5.0% for re-exposure within 6 months and 0.9% for re-exposure greater than 6 months.

Laboratory Findings

Serum Creatinine: Maxus (Aprotinin)® administration is associated with a risk for renal dysfunction.

Serum Transaminases: Data pooled from all patients undergoing CABG surgery in U.S. placebo-controlled trials showed no evidence of an increase in the incidence of postoperative hepatic dysfunction in patients treated with Maxus (Aprotinin)®. The incidence of treatment-emergent increases in ALT (formerly SGPT) > 1.8 times the upper limit of normal was 14% in both the Maxus (Aprotinin)® and placebo-treated patients (p=0.687), while the incidence of increases > 3 times the upper limit of normal was 5% in both groups (p=0.847).

Other Laboratory Findings: The incidence of treatment-emergent elevations in plasma glucose, AST (formerly SGOT), LDH, alkaline phosphatase, and CPK-MB was not notably different between Maxus (Aprotinin)® and placebo treated patients undergoing CABG surgery. Significant elevations in the partial thromboplastin time (PTT) and celite Activated Clotting Time (celite ACT) are expected in Maxus (Aprotinin)® treated patients in the hours after surgery due to circulating concentrations of Maxus (Aprotinin)®, which are known to inhibit activation of the intrinsic clotting system by contact with a foreign material (e.g., celite), a method used in these tests.

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OVERDOSAGE

The maximum amount of Maxus (Aprotinin)® that can be safely administered in single or multiple doses has not been determined. Doses up to 17.5 million KIU have been administered within a 24 hour period without any apparent toxicity. There is one poorly documented case, however, of a patient who received a large, but not well determined, amount of Maxus (Aprotinin)® (in excess of 15 million KIU) in 24 hours. The patient, who had pre-existing liver dysfunction, developed hepatic and renal failure postoperatively and died. Autopsy showed hepatic necrosis and extensive renal tubular and glomerular necrosis. The relationship of these findings to Maxus (Aprotinin)® therapy is unclear.

DOSAGE AND ADMINISTRATION

Maxus ® given prophylactically in both Regimen A and Regimen B (half Regimen A) to patients undergoing CABG surgery significantly reduced the donor blood transfusion requirement relative to placebo treatment. In low risk patients there is no difference in efficacy between regimen A and B. Therefore, the dosage used (A vs. B) is at the discretion of the practitioner.

Maxus (Aprotinin)® is supplied as a solution containing 10,000 KIU/mL, which is equal to 1.4 mg/mL. All intravenous doses of Maxus (Aprotinin)® should be administered through a central line. DO NOT ADMINISTER ANY OTHER DRUG USING THE SAME LINE. Both regimens include a 1 mL initial (test) dose, a loading dose, a dose to be added while recirculating the priming fluid of the cardiopulmonary bypass circuit (“pump prime” dose), and a constant infusion dose. To avoid physical incompatibility of Maxus (Aprotinin)® and heparin when adding to the pump prime solution, each agent must be added during recirculation of the pump prime to assure adequate dilution prior to admixture with the other component. Regimens A and B, both incorporating a 1 mL initial (test) dose, are described in the table below:

INITIAL (TEST)

DOSE

LOADING

DOSE

“PUMP PRIME”

DOSE

CONSTANT

INFUSION DOSE

Maxus (Aprotinin)®

REGIMEN A

1 mL

(1.4 mg, or

10,000 KIU)

200 mL

(280 mg, or

2.0 million KIU)

200 mL

280 mg, or

2.0 million KIU)

50 mL/hr

(70 mg/hr, or

500,000 KIU/hr)

Maxus (Aprotinin)®

REGIMEN B

1 mL

(1.4 mg, or

10,000 KIU)

100 mL

(140 mg, or

1.0 million KIU)

100 mL

(140 mg, or

1.0 million KIU)

25 mL/hr

(35 mg/hr, or

250,000 KIU/hr)


The 1 ml initial (test) dose should be administered intravenously at least 10 minutes before the loading dose. With the patient in a supine position, the loading dose is given slowly over 20-30 minutes, after induction of anesthesia but prior to sternotomy. In patients with known previous exposure to Maxus (Aprotinin)®, the loading dose should be given just prior to cannulation. When the loading dose is complete, it is followed by the constant infusion dose, which is continued until surgery is complete and the patient leaves the operating room. The “pump prime” dose is added to the recirculating priming fluid of the cardiopulmonary bypass circuit, by replacement of an aliquot of the priming fluid, prior to the institution of cardiopulmonary bypass. Total doses of more than 7 million KIU have not been studied in controlled trials.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discard any unused portion.

Renal and Hepatic Impairment:

Maxus (Aprotinin)® administration is associated with a risk for renal dysfunction. Changes in Maxus (Aprotinin) pharmacokinetics with age or impaired renal function are not great enough to require any dose adjustment. Pharmacokinetic data from patients with pre-existing hepatic disease treated with Maxus (Aprotinin)® are not available.

HOW SUPPLIED

HOW SUPPLIED
Size StrengthNDC
100 mL vials1,000,000 KIU0026-8196-36
200 mL vials2,000,000 KIU0026-8197-63

STORAGE

Maxus (Aprotinin)® should be stored between 2° and 25°C (36° - 77°F).

Protect from freezing.

Bayer Pharmaceuticals Corporation

400 Morgan Lane

West Haven, CT 06516

Made in Germany

©2006 Bayer Pharmaceuticals Corporation

Printed in USA

12/06

Hyaluronate Sodium:


CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Maxus (Hyaluronate Sodium)TM (hyaluronate sodium) injectable solution is a clear, colorless solution of low viscosity. Maxus (Hyaluronate Sodium)TM injectable solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous injection. Hyaluronic acid, the conjugate acid of Maxus (Hyaluronate Sodium) sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids. Maxus (Hyaluronate Sodium)TM injectable solution is supplied in 4 mL (40 mg) vials.

Each mL contains 10 mg Maxus (Hyaluronate Sodium) sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.

CHEMISTRY:

Hyaluronic acid, a glycosaminoglycan, can exist in the following forms depending upon the chemical environment in which it is found: as the acid, hyaluronic acid; as the sodium salt, sodium Maxus (Hyaluronate Sodium) (hyaluronate sodium); or as the Maxus (Hyaluronate Sodium) anion. These terms may be used interchangeably but in all cases, reference is made to the glycosaminoglycan composed of repeating subunits of D-glucuronic acid and N-acetyl-Dglucosamine linked together by glycosidic bonds. Since this product originates from a microbial source, there is no potential for contamination with dermatan or chondroitin sulfate or any other glycosaminoglycan.

CLINICAL

Pharmacology:

Hyaluronic acid is a naturally occurring substance present in connective tissue, skin, vitreous humor and the umbilical cord in all mammals. High concentrations of hyaluronic acid are also found in the synovial fluid. It also constitutes the major component of the capsule of certain microorganisms. The hyaluronic acid produced by bacteria is the same structure and configuration as that found in mammals.

The actual mechanism of action for Maxus (Hyaluronate Sodium) sodium in the healing of degenerative joint disease is not completely understood. One major function appears to be the regulation of normal cellular constituents. This effect decreases the impact of exudation, enzyme release and subsequent degradation of joint integrity. Additionally, Maxus (Hyaluronate Sodium) sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages.1

Maxus (Hyaluronate Sodium) molecules are long chains which form a filter network interspersed with normal cellular fluids. It is widely accepted that injection directly into the joint pouch enhances the healing of inflamed synovium by restoring lubrication of the joint fluid. This further supplements the visco-elastic properties of normal joint fluid.

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INDICATIONS:

Maxus (Hyaluronate Sodium)TM (hyaluronate sodium) injectable solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.

DOSAGE AND ADMINISTRATION:

4 mL (40 mg) injected intravenously. Treatment may be repeated at weekly intervals for a total of three treatments. Use aseptic technique and inject slowly into the jugular vein. Horses should be given stall rest after treatment before gradually resuming normal activity.

Discard any unused portion of the drug and the empty vial after opening.

CONTRAINDICATIONS:

There are no known contraindications for the use of Maxus (Hyaluronate Sodium)TM (hyaluronate sodium) injectable solution in horses.

WARNING:

Do not use in horses intended for human consumption.

HUMAN WARNINGS:

Not for use in humans. Keep this and all other drugs out of reach of children.

ANIMAL SAFETY WARNING:

Not for intra-articular use.

PRECAUTIONS:

Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fractures.

The safety of Maxus (Hyaluronate Sodium)TM injectable solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.

ADVERSE REACTIONS:

No local or systemic side effects were observed in the clinical field studies using Maxus (Hyaluronate Sodium) sodium injectable solution.

POST-APPROVAL EXPERIENCE:

While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting for Maxus (Hyaluronate Sodium) sodium injectable solution: Occasional depression, lethargy, and fever.

For medical emergencies or to report adverse reactions, call 1-888-549-4503.

EFFECTIVENESS:

Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with Maxus (Hyaluronate Sodium) sodium injectable solution in a well controlled clinical field trial conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with Maxus (Hyaluronate Sodium) sodium injectable solution.

ANIMAL SAFETY:

Maxus (Hyaluronate Sodium) sodium injectable solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with Maxus (Hyaluronate Sodium) sodium injectable solution as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.

STORAGE:

Store below 25°C (77°F).

HOW SUPPLIED:

Maxus (Hyaluronate Sodium)TM injectable solution is supplied in cartons containing twelve x 4 mL (40 mg) vials.

REFERENCES:

1 Swanstrom, O.G. 1978. Maxus (Hyaluronate Sodium) (hyaluronic acid) and its use, Proc. American Assoc. Equine Pract., 24th annual convention, pp. 345-348.

For customer service or to obtain product information, including a Material Safety Data Sheet, call:1-706-549-4503. After hours, call 1-706-353-2442 or 1-706-714-7373.

February 2011

ANADA 200-432, Approved by FDA

Maxus 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.


Maxus 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.


Maxus 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.


Maxus 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.


Maxus 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."NEXHA (HYALURONATE SODIUM) INJECTION, SOLUTION [BIONICHE ANIMAL HEALTH USA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Chondroitin sulfate". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Chondroitin sulfate - DrugBank". http://www.drugbank.ca/drugs/DB0930... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Maxus?

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

Visitor reports

Visitor reported useful

No survey data has been collected yet

One visitor reported side effects

Did you get side effects while taking the Maxus drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Maxus medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
It has side effects1
100.0%

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Two visitors reported doses

What is the dose of Maxus drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 6-10mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
6-10mg1
50.0%
201-500mg1
50.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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

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