PMID- 15072119
OWN - NLM
STAT- MEDLINE
DCOM- 20041104
LR  - 20161124
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 13
IP  - 3
DP  - 2004 Mar
TI  - A retrospective survey on the safety of Replenine, a high-purity factor IX 
      concentrate.
PG  - 187-95
AB  - PURPOSE: To assess the safety of a plasma-derived highly purified factor IX 
      concentrate (Replenine) in routine clinical use. METHODS: Following guidelines 
      entitled Safety Assessment of Marketed Medicines (SAMM), safety data were 
      collected in the UK by retrospective review of the hospital notes of 114 patients 
      who received an estimated 14.8 million IU of Replenine. Included were 40 patients 
      undergoing 44 surgical procedures or dental extractions [corrected]. RESULTS: The 
      study detected a total of nine adverse events (AEs), four of which were possibly 
      product-related, four that were unrelated to the product and one whose causality 
      was unknown. None of these cases had been notified to the manufacturer through 
      conventional spontaneous reporting procedures. One patient was switched from 
      Replenine because of infusion site irritation, but no unexpected adverse 
      reactions were noted. There were no reports of virus transmission or new factor 
      IX inhibitor development. The mean factor IX recovery value was 1.44 IU/dl per 
      IU/kg (95%CI: 1.31-1.57 IU/dl per IU/kg). CONCLUSIONS: The study was a practical 
      application of the SAMM guidelines to the collection of pharmacovigilance data on 
      patients with Haemophilia B. Replenine is well tolerated in routine clinical 
      practice.
FAU - Gascoigne, E W
AU  - Gascoigne EW
AD  - Bio Products Laboratory, Dagger Lane, Elstree, Herts, UK. 
      ernie.gascoigne@bpl.co.uk
FAU - Dash, C H
AU  - Dash CH
FAU - Harman, C
AU  - Harman C
FAU - Wilmot, D
AU  - Wilmot D
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 9001-28-9 (Factor IX)
SB  - IM
EIN - Pharmacoepidemiol Drug Saf. 2004 Apr;13(4):267
MH  - Adult
MH  - Data Collection/methods
MH  - Demography
MH  - Drug Administration Schedule
MH  - Factor IX/administration & dosage/*adverse effects/therapeutic use
MH  - Female
MH  - Hemophilia A/blood/complications/drug therapy
MH  - Hemophilia B/blood/complications/drug therapy
MH  - Humans
MH  - Infusions, Intravenous
MH  - Injections, Intravenous
MH  - Male
MH  - Patient Selection
MH  - Pharmacology, Clinical
MH  - *Product Surveillance, Postmarketing
MH  - *Retrospective Studies
MH  - Surgical Procedures, Operative/classification
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - United Kingdom
MH  - Virus Diseases/complications/diagnosis/drug therapy
EDAT- 2004/04/10 05:00
MHDA- 2004/11/05 09:00
CRDT- 2004/04/10 05:00
PHST- 2004/04/10 05:00 [pubmed]
PHST- 2004/11/05 09:00 [medline]
PHST- 2004/04/10 05:00 [entrez]
AID - 10.1002/pds.911 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2004 Mar;13(3):187-95. doi: 10.1002/pds.911.