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FANHDI FOR INJECTION 500 IU/VIAL [SIN11523P]

Active ingredients: FANHDI FOR INJECTION 500 IU/VIAL

Last updated 26 October 2025

Product Info

FANHDI FOR INJECTION 500 IU/VIAL

[SIN11523P]

Product information

Active Ingredient and Strength

ANTIHEMOPHILIC FACTOR VIII (HUMAN) - 500 INTERNATIONAL UNITS/VIAL

Dosage Form

INJECTION, POWDER, FOR SOLUTION

Manufacturer and Country

INSTITUTO GRIFOLS, S.A. - SPAIN
ROVI PHARMA INDUSTRIAL SERVICES, S.A. (ALTERNATE MANUFACTURER FOR WFI) - SPAIN
GRIFOLS BIOLOGICALS LLC (ALTERNATE MANUFACTURING SITE FOR CRYOPRECIPITATE) - UNITED STATES

Registration Number

SIN11523P

Licence Holder

GRIFOLS ASIA PACIFIC PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

B02BD02

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.

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:

Fanhdi Dosage Formula 1



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.

Fanhdi Dosage Table 1



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.

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