Immunate

Treatment & prevention of bleeding in congenital (haemophilia A) or acquired factor VIII deficiency. Bleeding in patients w/ von Willebrand's disease w/ factor VIII deficiency if no specific prep is available, & when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

IV infusion Max rate: 2 mL/min. Individualized dosage. Prophylaxis of bleeding Usual dose: 20-40 IU factor VIII/kg at 2-3 days intervals. Early haemarthrosis, muscle or oral bleeding 20-40 IU/dL. Repeat every 12-24 hr for at least 1 day until bleeding is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding or haematoma 30-60 IU/dL. Repeat every 12-24 hr for 3-4 days or more until pain & acute disability are resolved. Life-threatening haemorrhages 60-100 IU/dL. Repeat every 8-24 hr until threat is resolved. Minor surgery including tooth extraction 30-60 IU/dL every 24 hr, at least 1 day, until healing is achieved. Major surgery 80-100 IU/dL (pre- & post-op). Repeat every 8-24 hr until adequate wound healing then continue for at least 7 days to maintain factor VIII at 30-60% (IU/dL).

Hypersensitivity.

Discontinue inj/infusion immediately if allergic reactions & early symptoms of anaphylactic shock (eg, flush, rash, hives, wheals, generalised itching, swelling of lips, eyelid & tongue, dyspnoea, wheezing, chest pain, chest tightness, general feeling of being unwell, dizziness, faster heart beat & low BP) or extreme dizziness, loss of consciousness & extreme difficulty in breathing occur. Haemolysis following repetitive administration at short intervals or of very large doses in patients w/ blood group A, B or AB; thromboembolic events may occur. May develop neutralizing Ab (inhibitors) to von Willebrand factor in patients w/ von Willebrand's disease especially type 3. Possible passing of infections. Patients w/ depressed immune system or some types of anaemia (eg, sickle cell disease or haemolytic anaemia). Perform appropriate lab tests to ensure current dose is sufficient to reach & maintain adequate factor VIII or von Willebrand levels especially if having majoy surgery; confirm development of neutralizing Ab (inhibitors). Carefully select blood & plasma donors. Consider vaccination against hepatitis A & B in patients receiving regular/repeated human plasma-derived factor VIII products. Monitor patients on low Na diet. Not to be mixed w/ other medicinal products or solvents, except enclosed sterilised water for inj. Risk of serious Parvorirus B19 infection during pregnancy. Lactation. Childn <6 yr.

Anaphylactic or allergic reactions (eg, flush, rash, hives, wheals, generalised itching, swelling of lips & tongue, dyspnoea, wheezing, chest tightness, low or drop in BP, general feeling of being unwell, & dizziness). Formation of neutralising Ab (inhibitors) to factor VIII or von Willebrand factor. Haemolysis in blood group A, B or AB.

Haemostatics

B02BD06 - von Willebrand factor and coagulation factor VIII in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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