Journal article
Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: Experience in the standard clinical setting
Abstract
The safety of full-length sucrose-formulated recombinant factor VIII (rFVIII-FS; Kogenate FS) for up to 24 months of use was evaluated in a postmarketing observational study in Europe. Long-term safety and efficacy data were available for 212 patients with severe haemophilia A, including 13 previously untreated patients (PUPs) and 12 patients with 1-19 exposure days (EDs). Patients accumulated a mean (+/- SD) of 187 (121) EDs to rFVIII-FS and …
Authors
Musso R; Santagostino E; Faradji A; Iorio A; van der Meer J; Ingerslev J; Lambert T; Maas-Enriquez M; Gorina E
Journal
Thrombosis and Haemostasis, Vol. 99, No. 01, pp. 52–58
Publisher
Thieme
Publication Date
2008
DOI
10.1160/th07-06-0409
ISSN
0340-6245
Associated Experts
Fields of Research (FoR)
Medical Subject Headings (MeSH)
AdolescentAdultBlood Coagulation Factor InhibitorsBlood Loss, SurgicalChemistry, PharmaceuticalChildChild, PreschoolCoagulantsEuropeExcipientsFactor VIIIHemophilia AHemorrhageHumansInfantInfusions, ParenteralMaleProduct Surveillance, PostmarketingProspective StudiesRecombinant ProteinsSeverity of Illness IndexSucroseTime FactorsTreatment Outcome