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Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A
- Source :
- Haemophilia, Haemophilia, 2020, 26 (3), pp.478-486. ⟨10.1111/hae.13997⟩, Haemophilia, Wiley, 2020, 26 (3), pp.478-486. ⟨10.1111/hae.13997⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
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
- 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)
Subjects
Details
- Language :
- English
- ISSN :
- 13518216 and 13652516
- Database :
- OpenAIRE
- Journal :
- Haemophilia, Haemophilia, 2020, 26 (3), pp.478-486. ⟨10.1111/hae.13997⟩, Haemophilia, Wiley, 2020, 26 (3), pp.478-486. ⟨10.1111/hae.13997⟩
- Accession number :
- edsair.doi.dedup.....6a3ed319c05fc86c4468abc086150d49