This medication is a freeze-dried sterile human plasma fraction with clotting factor, prescribed for bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients.
Contraindicated in patients who are known to have a normal coagulation mechanism, significant signs of disseminated intravascular coagulation, acute thrombosis or embolism (including myocardial infarction) and hypersensitivity.
IV- The recommended dose range is 50 to 100 Units/kg.Should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg of body weight.
Severe hemorrhages, such as CNS bleedings have been effectively treated with doses of 100 units per kg of body weight at 12-hour intervals.
In joint hemorrhage, a dose of 50 units per kg of body weight is recommended at 12-hour intervals, which may be increased to doses of 100 units per kg of body weight at 12-hour intervals.
In mucous membrane bleeding, a dose of 50 units per kg of body weight is recommended at 6-hour intervals under careful monitoring.
For serious soft tissue bleeding such as retroperitoneal bleeding, doses of 100 units per kg of body weight at 12-hour intervals are recommended.
It comes as a solution for injection, to be administered by a healthcare provider into the vein.
• Caution should be exercised in patients with history of crush injury, heart disease, narrowing of blood vessels, liver impairment, blood infection, or disseminated intravascular coagulation (DIC), recent heart attack, who are taking other medications, any allergy, elderly, newborns, during pregnancy and breastfeeding.
• It may cause dizziness, do not drive a car or operate machinery while taking this medication.
• Rarely patient may develop with viral disease (e.g., hepatitis, parvovirus B19) or a central nervous system disease called Creutzfeldt-Jakob disease; discuss about this with your healthcare provider before taking this medication.
• Monitor blood pressure, fibrinogen counts, and platelet counts regularly while taking this medication.
• Must be used only in patients with circulating inhibitors to one or more coagulation factors and should not be used for the treatment of bleeding episodes resulting from coagulation factor deficiencies.
Heart attack, allergic reactions (hives, rash), lack of taste, dizziness, sleeping for unusually long periods, nausea, chills, fever, headache, flushing, and changes in pulse rate.
Avoid excess dosage and rapid administration.
Store it in refrigerator (2 - 8°C). Do not freeze it. Within the indicated shelf life, the product may be stored at room temperature (not exceeding 25°C, 77°F) for up to 6 months.
After storage at room temperature, the product must not be returned to the refrigerator
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