Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
human coagulation factor IX
Sanquin Plasma Products B.V.
B02BD04
human coagulation factor IX
Antihemorrhagics
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Revision: 9
Withdrawn
2001-07-03
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nonafact contains 100 IU/ml (500 IU/5ml or 1000 IU/10ml) human coagulation factor IX when reconstituted with 5 m l or 10 ml, respectively, of water for injections. Each vial contains 500 IU or 1000 IU of human coagulation factor IX. The potency (IU) is determined using a method equivalent to the test method described in the European Pha rmacopoeia. The specific activity of Nonafact is at least 200 IU/mg protein. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haem ophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dose and the duration of substitution therapy depend on the severity of the factor IX deficiency. Other determining factors are the site and extent of the haemorrhage and the patient’s clinical condition. The number of units of factor IX administered is expressed in International Units (IU), which are related to the current International Standard for factor IX concentrat e as approved by the WHO. Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma). One International Unit (IU) of factor IX activity is rel ated to the quantity of factor IX in the International Standard for factor II, VII, IX and X in human plasma (approved by the WHO) which approximates to the quantity of factor IX in one ml of normal human plasma. The calculation of the required dosage of factor IX is based on the empirical findin Pročitajte cijeli dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nonafact contains 100 IU/ml (500 IU/5ml or 1000 IU/10ml) human coagulation factor IX when reconstituted with 5 m l or 10 ml, respectively, of water for injections. Each vial contains 500 IU or 1000 IU of human coagulation factor IX. The potency (IU) is determined using a method equivalent to the test method described in the European Pha rmacopoeia. The specific activity of Nonafact is at least 200 IU/mg protein. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haem ophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dose and the duration of substitution therapy depend on the severity of the factor IX deficiency. Other determining factors are the site and extent of the haemorrhage and the patient’s clinical condition. The number of units of factor IX administered is expressed in International Units (IU), which are related to the current International Standard for factor IX concentrat e as approved by the WHO. Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma). One International Unit (IU) of factor IX activity is rel ated to the quantity of factor IX in the International Standard for factor II, VII, IX and X in human plasma (approved by the WHO) which approximates to the quantity of factor IX in one ml of normal human plasma. The calculation of the required dosage of factor IX is based on the empirical findin Pročitajte cijeli dokument