Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
FACTOR IX, HUMAN
Bio Products Laboratory Limited
B02BD04
FACTOR IX, HUMAN
POWDER FOR SOLUTION FOR INJECTION
FACTOR IX, HUMAN 50 international unit(s)/millilitre
POM
ANTIHEMORRHAGICS
Authorised
2005-10-12
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Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS REPLENINE ® -VF High Purity Factor IX 1. NAME OF MEDICINAL PRODUCT Replenine ® -VF, 50 IU/mL human factor IX, a powder for solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Replenine-VF is a high purity factor IX. This product is prepared from plasma from screened donors. Donors are selected from the USA. Replenine-VF is presented as a sterile powder for solution, containing nominally 250 IU, 500 IU or 1000 IU human coagulation factor IX per vial. The product contains approximately 50 IU/mL when reconstituted with either 5 mL (250 IU vial), 10 mL (500 IU vial) or 20 mL (1000 IU vial) of Sterilised Water for Injections, Ph.Eur.. One mL of Replenine-VF contains approximately 100 IU of human coagulation factor IX after reconstitution at half volume (see 6.6). The potency (IU) is determined using the European Pharmacopoeia one stage clotting test. The specific activity of Replenine-VF is approximately 100 IU per mg of protein. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Replenine-VF is a powder for solution; it is a freeze-dried concentrate of factor IX for reconstitution with Sterilised Water for Injections, Ph.Eur.. After reconstitution with the supplied sterile water diluent, the product is administered intravenously. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis in patients with haemophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physic Izlasiet visu dokumentu