Fanhdi® 25 I.U./ml, 50 I.U./ml and 100 I.U./ml (Factor VIII)

/ Medici

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: Number of factor VIII = Body weight (kg) x Desired factor VIII rise (%) x 0.5 units required (I.U.).
This calculation is based on the empirical finding that 1 I.U. of factor VIII per kg body weight raises the plasma factor VIII activity approximately 2% (i.e. 0.5 I.U./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. See prescribing information for full details.
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.
Hemophilic patients having antibodies against factor VIII (inhibitors) need a specific therapy.
Immunotolerance may occur after treatment with human plasma coagulation factor VIII concentrate.
Prophylaxis: For long-term prophylaxis against bleeding in patients with severe hemophilia A, Fanhdi® should be administered at doses of 10 to 50 I.U./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.
Method of administration: Use the product in room temperature not above 30°C. Fanhdi® is intended for intravenous administration only. Fanhdi® may be administered at a rate of no more than 10 ml/minute. (For full details of reconstitution and use refer to instructions for use/handling).

For the prevention and control of bleeding in patients with moderate or severe Factor VIII deficiency due to classical hemophilia A. Not effective in controlling the bleeding in patients with Von Willebrond’s disease.

Caution is advised in patients with known allergic reactions to constituents of the preparation.

If allergic or anaphylactic reactions occur, administration should be stopped immediately (the current specific guidelines of shock therapy should be followed). After repeated treatment with human plasma coagulation factor VIII concentrate, the level of inhibitor in plasma should be determined. When medicinal products prepared from human blood or plasma are administered, transmission of infective agents cannot be totally excluded. This also applies to pathogens of hitherto unknown nature. To reduce the risk of transmission of infective agents, selection of donors and donations using suitable methods is performed. Besides, removal and inactivation procedures are included in the production process.
For full details see prescribing information.

– Allergic or anaphylactic reactions are observed in rare cases.
– Increase in body temperature is observed in rare cases.
– Development of antibodies to FVIII.
– Although the isoagglutinin content is very low, there is a risk of intravascular hemolysis.
– The transmission of infectious agents cannot be totally excluded

None known.

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Studies carried out in animal models are not sufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development. Therefore, human plasma factor VIII concentrate may be used if clearly needed during pregnancy and lactation.

Consequences of overdose are not known since overdose cases have not been reported.