Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**Posology** The dose and duration of Fanhdi® treatment must be adjusted according to each patient's needs. The required dosage may be estimated using the following formula:  This calculation is based on the empirical finding that 1 international unit of factor VIII per kg body weight raises the plasma factor VIII activity approximately 2% (i.e. 0.5 international units/kg are required for 1% increase in plasma factor VIII level). The patient's plasma factor VIII levels should be determined and monitored during treatment with Fanhdi®. This is particularly important in the case of surgical procedures.  Patients with inhibitors If plasma factor VIII does not reach the expected levels or if the bleeding cannot be controlled after the administration of the adequate dose, the presence of inhibitors should be suspected. Haemophiliacs with antibodies against factor VIII (inhibitors) need a specific therapy. Immunotolerance can be achieved by treatment with human plasma coagulation factor VIII concentrate. Prophylaxis For long-term prophylaxis against bleeding in patients with severe haemophilia A, Fanhdi® should be administered at doses of 10 to 50 international units/kg, given at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
INTRAVENOUS
Medical Information
**Therapeutic indications** Fanhdi® is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical haemophilia A.
**Contraindications** Caution is advised in patients with known allergic reactions to constituents of the preparation.
B02BD02
coagulation factor VIII
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
INSTITUTO GRIFOLS, S.A.
ROVI PHARMA INDUSTRIAL SERVICES, S.A. (alternate manufacturer for WFI)
Grifols Biologicals LLC (alternate manufacturing site for Cryoprecipitate)
Active Ingredients
Documents
Package Inserts
Fanhdi For Injection PI.pdf
Approved: November 28, 2006