Art. 7 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd — Dried or frozen human coagulation factor VIII

I. Requirements applying to donors Donors must be in good health and, in particular, free of any communicable disease, in accordance with the criteria adopted for dried human plasma. II. Requirements applying to preparations Sterility and atoxicity - The final product must be sterile and pyrogen-free. Where cryoprecipitation is performed in plastic bags, the product must not contain organic solvent or other foreign substances present in the freezing mixture. The passage of such products through the walls of the plastic bag can be prevented by placing the bag in a second impermeable bag during the whole period of immersion. The risk of the plastic bag tearing during storage in the frozen state can be reduced by keeping each bag in a protective box. Erythrocytes, leukocytes and platelets - Centrifuging should be such as to eliminate the formed elements of the blood as soon and as completely as possible after its collection. Solubility - The addition of the indicated quantity of appropriate solvent must result in the complete solution of the dry product in less than 30 minutes at 37° C. Small and easily separable aggregates of fibrinogen may persist. Stability - The preparation conserved at 20° C, must not show any sign of precipitation within three hours after it has been dissolved. Potency - The reconstituted preparation should contain the indicated minimum quantity of factor VIII, one 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. Absence of irregular antibodies and, if the preparation is intended for patients of any ABO group, a titre of anti-A and anti-B antibodies not exceeding 32. Identification - Precipitation tests with specific antisera shall show that the product contains only human plasma proteins. Loss of mass on drying - Freeze-dries preparations, when dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm of mercury for 24 hours must not lose more than 1.5 per cent of their weight. Storage - Human factor VIII shall be stored in the deep frozen state at a temperature under - 30° C, and in the freeze-dried state below 5° C, and protected from light. The dried preparation shall be kept in an atmosphere of nitrogen or in vacuo, in a sterile vial, stoppered so as to exclude all micro-organisms and, as far as possible, all humidity. Storage in the frozen state shall not exceed six months, in the dried state one year, unless the preparation has been retested for minimum required potency. III. Labelling The label on the preparation shall give all the information shown on the model label (Annex 7).

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