1. Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A
- Author
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Benoît Guillet, Jan Blatny, Jennifer Doralt, Srilatha Tangada, Gerald Spotts, Bénédicte Wibaut, Freimut H. Schilling, Andras Nagy, Jimena Goldstine, Werner Engl, Jayashree Motwani, Birmingham Children’s Hospital, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Baxalta Innovations GmbH [Vienna, Austria], Baxalta Innovations GmbH, a Takeda company, Vienna, Austria, Baxalta US Inc., a Takeda company, Westlake Village, CA, USA, Université d'Angers (UA)-Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
- Subjects
Male ,medicine.medical_specialty ,Antihaemophilic Factor ,[SDV]Life Sciences [q-bio] ,Haemophilia A ,haemophilia A ,030204 cardiovascular system & hematology ,Haemophilia ,Hemophilia A ,Injections ,on-demand ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,paediatric patients ,Adverse effect ,Clinical Haemophilia ,Child ,Genetics (clinical) ,on‐demand ,Safety surveillance ,Administration time ,Factor VIII ,business.industry ,Sterile water ,Infant, Newborn ,Infant ,Water ,Hematology ,General Medicine ,Original Articles ,medicine.disease ,3. Good health ,Tolerability ,Child, Preschool ,Epidemiological Monitoring ,Original Article ,Female ,prophylaxis ,business ,030215 immunology ,antihaemophilic factor (recombinant) - Abstract
International audience; Introduction - Antihaemophilic factor (recombinant) (rAHF; ADVATE ) is approved for prophylaxis and treatment of bleeding in children and adults with haemophilia A. Reconstitution in 2 mL sterile water for injection instead of 5 mL allows for a 60% reduction in infusion volume and administration time, but could increase the likelihood of hypersensitivity and infusion-related reactions, especially in children. Aim - To assess local tolerability, safety and effectiveness of rAHF 2 mL during routine clinical practice factor VIII (FVIII) replacement (on-demand and prophylaxis) in children with severe (FVIII
- Published
- 2020
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