Posology : מינונים

4.2 Posology and method of administration
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:
Number of factor VIII = Body weight x Desired factor VIII x 0.5 units required (I.U.)          (kg)             rise (%)
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.



Hemorrhagic event                      Therapeutically necessary        Period during which it is plasma level of FVIII activity   necessary to maintain the therapeutic plasma level of factor VIII activity
- Minor hemorrhages:                                                    At least 1 day, depending - H. into joints                                  30%                 on the severity of the hemorrhage
- Major hemorrhages:                                                    3 - 4 days or until adequate - H. into muscles                               40 - 50%              wound healing - Teeth extraction
- Mild trauma capitis
- Minor operations
- H. into the oral cavity

- Life-threatening hemorrhages:                                         During 7 days, then therapy - Major operations                             60 - 100%              for at least another 7 days - Gastro-intestinal bleeding
- Intracranial, intra-abdominal or intrathoracic hemorrhages
- Fractures



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 TEMPRATURE NOT ABOVE 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).