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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
1999-2-4
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pubmed:abstractText |
Thirty-six haemophilia A, HIV-negative, previously treated patients were changed therapy to a highpurity and double-inactivated (solvent/detergent and dry-heating) previously unused factor VIII concentrate. The mean age of these patients was 27 years at the time of the change. Twenty-three patients were severe haemophiliacs (FVIII:C < 0.02 IU mL-1), seven moderate (FVIII:C between 0.02 and 0.05 IU mL-1) and six mild (FVIII:C > 0.05 IU mL-1). The mean follow-up with this single product was 16 months, with 82 accumulated exposure days and the mean consumption was 117,300 IU of FVIII corresponding to a mean of six batches per patient. No patient developed FVIII inhibitors (upper limit of the CI95: 7.98%), resulting in an incidence rate of 0/48 patient-years (upper limit of the CI95: 77/1000 patient-years). The change in therapy to this new factor VIII concentrate was not associated with the appearance of inhibitors.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jan
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pubmed:issn |
1351-8216
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
4
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
21-4
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pubmed:dateRevised |
2009-10-21
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pubmed:meshHeading |
pubmed-meshheading:9873861-Adolescent,
pubmed-meshheading:9873861-Adult,
pubmed-meshheading:9873861-Aged,
pubmed-meshheading:9873861-Child,
pubmed-meshheading:9873861-Factor VIII,
pubmed-meshheading:9873861-HIV Seronegativity,
pubmed-meshheading:9873861-Hemophilia A,
pubmed-meshheading:9873861-Humans,
pubmed-meshheading:9873861-Incidence,
pubmed-meshheading:9873861-Middle Aged,
pubmed-meshheading:9873861-Product Surveillance, Postmarketing,
pubmed-meshheading:9873861-Retrospective Studies,
pubmed-meshheading:9873861-Virus Activation
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pubmed:year |
1998
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pubmed:articleTitle |
Zero incidence of inhibitor development in previously treated haemophilia A, HIV-negative patients upon exposure to a plasma-derived high-purity and double viral inactivated factor VIII concentrate.
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pubmed:affiliation |
Unidad de Coagulopatías Congénitas, Hospital La Fe, Valencia, Spain.
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pubmed:publicationType |
Journal Article
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