- Approval Id
- 38aa6e9d8c986a79
- Drug Name
- FANHDI FOR INJECTION 500 IU/VIAL
- Product Name
- FANHDI FOR INJECTION 500 IU/VIAL
- Approval Number
- SIN11523P
- Approval Date
- 2001-05-17
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Posology</strong><br>
The dose and duration of Fanhdi® treatment must be adjusted according to each patient's needs.<br>
The required dosage may be estimated using the following formula:</p>
<img src="/TGIF/Fanhdi-Formula1.png" alt="Fanhdi Dosage Formula 1" /><br><br>
<p>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).<br>
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.</p>
<img src="/TGIF/Fanhdi-Table1.png" alt="Fanhdi Dosage Table 1" /><br><br>
<p><u>Patients with inhibitors</u><br>
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.</p>
<p><u>Prophylaxis</u><br>
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.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Fanhdi® is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical haemophilia A.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Caution is advised in patients with known allergic reactions to constituents of the preparation.</p>
- Atc Code
- B02BD02
- Atc Item Name
- coagulation factor VIII
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
