[Factor VIII preparation produced by recombinant DNA-technology is approved in Norway]. / Faktor VIII-preparat fremstilt ved rekombinant DNA-teknologi er godkjent i Norge.

Recombinant factor VIII (Baxter) is approved by the Norwegian Medicines Control Authority. The product represents an alternative to plasma-derived factor VIII in the treatment of patients with haemophilia A. Its use should be guided by clinical experts in care of haemophilia. Characterization studies of this and another recombinant factor VIII preparation have revealed no significant differences from plasma-derived factor VIII as regards biochemical and functional properties. Clinical studies have demonstrated similar in vivo recovery, plasma half-life and haemostatic activity as for plasma-derived factor VIII. Recombinant factor VIII should carry a low, if any, risk of transmitting blood-borne viruses pathogenic to man. The product includes pasteurized human albumin added as stabilizer, which has a well-documented safety record. There is no clear evidence of increased incidence of factor VIII inhibitors than with plasma-derived factor VIII. Further long-term surveillance studies are needed, however, to elucidate these matters.

The international collaborative study on the first international standard of birch (Betula verrucosa)-pollen extract.

A selected candidate international standard preparation of birch (Betula verrucosa)-pollen extract was studied together with other birch-pollen extracts in a multinational study involving 20 laboratories in 11 countries. The biologic activity of the extract had previously been demonstrated in quantitative skin prick testing. The study methods comprised RAST inhibition, histamine release, quantitative immunoelectrophoresis, isoelectric focusing, and other methods. The results from RAST inhibition were calculated as parallel-line assays with statistical tests for linearity and parallelism. Analysis of variance was applied to test the significance of differences between potency estimates. In all assay methods, the candidate standard could be used to assign relative potencies to other birch-pollen extracts. The candidate standard was adequately stable during 36 months of storage at or below 5 degrees C. On the basis of this study, the World Health Organization has established the preparation as the International Standard for birch-pollen extract with assigned units of 100,000 IU per ampule.