Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
FACTOR VIII (HUMAN)
MEDICI MEDICAL LTD, ISRAEL
B02BD02
POWDER FOR SOLUTION FOR INJECTION
FACTOR VIII (HUMAN) 1000 IU
I.V
Required
INSTITUTO GRIFOLS S.A.,SPAIN,BARCELONA
COAGULATION FACTOR VIII
COAGULATION FACTOR VIII
Is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical hemophilia A . Fanhdi is not effective in controlling the bleeding of patients with Von Willebrond's disease.
2020-12-31
Page 1 of 7 1. NAME OF THE MEDICINAL PRODUCT FANHDI ® 25 IU/ML (FACTOR VIII) FANHDI ® 50 IU/ML (FACTOR VIII) FANHDI ® 100 IU/ML 1000 IU/10 ML (FACTOR VIII) FANHDI ® 100 IU/ML, 1500 IU/15 ML (FACTOR VIII) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human coagulation factor VIII, Ph. Eur. Fanhdi® is presented as a lyophilised powder for solution for injection containing nominally 250, 500, 1000 or 1500 IU human coagulation factor VIII per vial. The product contains approximately 25, 50 or 100 IU/ml of human coagulation factor VIII when reconstituted with 10 ml of Water for Injections for the presentations of 250, 500 and 1000 IU. The presentation of 1500 IU is reconstituted with 15 ml of Water for Injections and contains approximately 100 IU/ml. The factor VIII:C potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Fanhdi® is at least 2.5 to 10 IU factor VIII:C/mg protein depending on its strength (250, 500, 1000 or 1500 IU). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Vial containing white or pale yellow powder and syringe with Water for Injections (solvent). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fanhdi ® is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical hemophilia A. Fanhdi ® is not effective in controlling the bleeding of patients with von Willebrand's disease. 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 Belgenin tamamını okuyun