Art. 1 bis Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

A human red cell concentrate is a unit of Whole Human Blood from which most of the plasma has been removed. It contains most of the red cells of the unit from which it has been prepared; other cell components may be present or may have been partially removed. The liquid content of the concentrate will consist either of the residual plasma, or of an appropriate isotonic artificial aqueous solution added after the plasma was removed. The volume of red cells should constitute between 65 and 75% of the total volume of the product, but if a greater red cell concentration is applied the approximate percentage of erythrocyte volume (haematocrit) shall be indicated on the label. All operations required in the preparation shall be carried out under aseptic conditions: decantation shall be carried out using a sterile, closed system and by compression only. No antiseptic or bacteriostatic agents should be added. Blood group and storage - as for Whole Human Blood. Labelling - The label on the container shall give all the information shown on the model label (Annex 2 bis). The Rhesus group shall be written as "Positive" or "Negative" or, in abbreviated form, "POS" or "NEG". If an artificial aqueous solution has been added, the label shall also indicate its volume and composition.

Human red cell concentrate

Rechtspraak bij dit artikel