Art. 8 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd — Dried human coagulation factor IX

I. Requirements applying to donors Donors must be in good health and, in particular, free from any communicable disease in accordance with the criteria adopted for dried human plasma. II. Requirements applying to the concentrate Sterility and atoxicity - The final product, tested by appropriate methods must be sterile, pyrogen-free and free from undesirable vaso-depressor or respiratory effects. The test for absence of vaso-depressor effects, should be performed on a dog or cat. Solubility - The addition of the indicated quantity of the solvent must result in complete solution in 10 minutes at 37° C. Thromboplastin activity and absence of free thrombin - The recalcification time of a normal plasma measured at 37° C in the presence of an equal volume of various dilutions of the reconstituted product, must not be less than 40 seconds. The reconstituted product, with an equal volume of fibrinogen (3g/l) added to it, must not coagulate within six hours at 37° C. Potency - The reconstituted preparation must contain the indicated minimum quantity of factor IX, 1 unit corresponding to the potency of 1 ml of average normal fresh plasma, the potency being determined by a method approved by the competent national authority. Yield and stability in vivo - The method of preparation must be such that the injection of a dose of 50 units per kg body weight, rapidly, administered intravenously, using several batches of material given to several patients, shall cause, in 15 minutes, in the absence of a specific inhibitor and in basal conditions, an average rise of not less than 300 units per litre plasma, and of the persistence, after 24 hours of an average rise of not less than 60 units per litre plasma. Identification - Precipitation tests with specific antisera shall show that the product contains solely human plasma proteins. Loss of mass on drying - When dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm of mercury for 24 hours, the product must not lose more than 1.5 per cent of its weight. Storage - The preparations must be stored dry at a temperature below 5° C. The period of storage must not exceed two years, unless the potency of the preparation has been re-tested. III. Labelling The label on the preparation shall give all the information shown on the model label (Annex 8).

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