[Factor VIII preparation produced by recombinant DNA-technology is approved in Norway].
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.
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Statens legemiddelkontroll Sven Oftedals vei 6, Oslo.
Arntzen
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D004274:DNA, Recombinant; D004335:Drug and Narcotic Control; D005169:Factor VIII / Q000235:genetics* / Q000627:therapeutic use; D005818:Genetic Engineering; D006801:Humans; D009664:Norway
D004274:DNA, Recombinant; D005169:Factor VIII
Faktor VIII-preparat fremstilt ved rekombinant DNA-teknologi er godkjent i Norge.