Zutectra
Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Δανικά
Πηγή: EMA (European Medicines Agency)
Φύλλο οδηγιών χρήσης
(PIL)
13-02-2024
Αρχείο Π.Χ.Π.
(SPC)
13-02-2024
Δημόσιας Έκθεσης Αξιολόγησης
(PAR)
23-02-2016
Δραστική ουσία:
human hepatitis B immunoglobulin
Διαθέσιμο από:
Biotest Pharma GmbH
Φαρμακολογική κατηγορία (ATC):
J06BB04
INN (Διεθνής Όνομα):
human hepatitis B immunoglobulin
Θεραπευτική ομάδα:
Immune sera og immunoglobuliner,
Θεραπευτική περιοχή:
Immunization, Passive; Hepatitis B; Liver Transplantation
Θεραπευτικές ενδείξεις:
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.
Περίληψη προϊόντος:
Revision: 16
Καθεστώς αδειοδότησης:
autoriseret
Ημερομηνία της άδειας:
2009-11-30
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504 ERROR
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