Art. 6 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Dried Human Fibrinogen is a dried preparation which contains the soluble constitutent of liquid human plasma which, on the addition of thrombin, is transformed to fibrin. The method of preparation used should be one which produces a material meeting the requirements herein prescribed and which minimises the risk of transmitting serum hepatitis. Plasma pools used in the preparation of fibrinogen should contain as few donations as possible. During preparation no antiseptic or bacteriostatic substance shall be added. The final product shall be freeze-dried. Solubility - Add water to the recommended volume; the dried preparation must be completely soluble. No precipitation shall occur within 60 minutes of reconstitution. Identification By precipitation tests with specific antisera, it must be shown to contain only human plasma proteins. The freshly reconstituted product has the property of clotting on the addition of thrombin. When thrombin is added to a solution of Human Fibrinogen of the same concentration as that in fresh normal plasma, clotting shall occur in not more than twice the time taken for clotting to occur in fresh normal plasma after the addition of thrombin. Clottable protein. Not less than 50% of the total protein shall be clottable by thrombin. Loss of mass on drying - Preparations, when dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm of mercury for 24 hours, must not lose more than 0.5% of their weight. Sterility - The final product after reconstitution shall be sterile when examined by a suitable bacteriological method. Storage - Human Fibrinogen shall be kept in an atmosphere of nitrogen or in a vacuum in a sterile container, sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at the temperature recommended. Labelling - The label on the container shall give all the information shown on the model label (Annex 6). The date of preparation is the date of placing into final solution before freeze-drying.

Rechtspraak bij dit artikel