Zutectra
País: União Europeia
Língua: dinamarquês
Origem: EMA (European Medicines Agency)
Folheto informativo - Bula
(PIL)
13-02-2024
Características técnicas
(SPC)
13-02-2024
Relatório de Avaliação Público
(PAR)
23-02-2016
Ingredientes ativos:
human hepatitis B immunoglobulin
Disponível em:
Biotest Pharma GmbH
Código ATC:
J06BB04
DCI (Denominação Comum Internacional):
human hepatitis B immunoglobulin
Grupo terapêutico:
Immune sera og immunoglobuliner,
Área terapêutica:
Immunization, Passive; Hepatitis B; Liver Transplantation
Indicações terapêuticas:
Forebyggelse af hepatitis B virus (HBV) re-infektion hos HBsAg og HBV-DNA-negative voksne patienter mindst en uge efter levertransplantation for hepatitis B induceret leversvigt. HBV-DNA-negativ status bør bekræftes inden for de sidste 3 måneder før OLT. Patienterne bør være HBsAg-negative før behandlingen starter. Samtidig brug af passende virostatic agenter bør betragtes som standard for hepatitis B re-infektion profylakse.
Resumo do produto:
Revision: 16
Status de autorização:
autoriseret
Data de autorização:
2009-11-30
Folheto informativo - Bula
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