ENTECAVIR-TEVA FC TABLETS 0.5MG

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Entecavir Monohydrate 0.533mg equivalent to Entecavir

Disponible des:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Codi ATC:

J05AF10

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Entecavir Monohydrate 0.533mg equivalent to Entecavir 0.5mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

Remedica Ltd.

Estat d'Autorització:

ACTIVE

Data d'autorització:

2021-01-31

Fitxa tècnica

06
27.07.2020
InA
16.09.2020
InA
310x400 mm
Remedica Ltd
5 pt
28.07.2020
5.08.2020
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AAAM2918 - Entecavir All strengths, PIL, Singapore
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Product’s Name
ENTECAVIR-TEVA
(ENTECAVIR TABLETS)
ENTECAVIR-TEVA FC TABLETS 0.5 MG
ENTECAVIR-TEVA FC TABLETS 1 MG
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-
INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in
patients who have discontinued anti-hepatitis B therapy, including
entecavir. Hepatic function should be monitored
closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue anti-hepatitis B therapy.
If appropriate, initiation of anti-hepatitis B
therapy may be warranted [see _WARNINGS AND PRECAUTIONS (4.1)_].
Limited clinical experience suggests there is a potential for the
development of resistance to HIV (human immunodeficiency virus)
nucleoside reverse transcriptase inhibitors if
ENTECAVIR is used to treat chronic hepatitis B virus (HBV) infection
in patients with HIV infection that is not being treated. Therapy with
ENTECAVIR is not recommended for HIV/
HBV co-infected patients who are not also receiving highly active
antiretroviral therapy (HAART) [see Warnings and Precautions (4.2)].
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogues
alone or in combination with antiretrovirals
[see _WARNINGS AND PRECAUTIONS (4.3)_].
1 INDICATIONS AND USAGE
Entecavir is indicated for the treatment of chronic hepatitis B virus
infection in adults with evidence of active viral replication and
either evidence of persistent elevations in serum
aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with
Entecavir:
This indication is based on histologic, virologic, biochemical, and
serologic responses