Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
ENTECAVIR
MEDICELL PHARMACEUTICAL (S) PTE. LTD.
J05AF10
TABLET, FILM COATED
ENTECAVIR 0.50 mg
ORAL
Prescription Only
Pharmascience Inc
ACTIVE
2021-02-02
1 Pr PMS-ENTECAVIR Entecavir Tablets, USP 0.5 mg and 1 mg 1 INDICATIONS AND USAGE pms-ENTECAVIR (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 pms-ENTECAVIR: This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease [see _Clinical Studies _ _(12)_ ]. 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 PMS- ENTECAVIR IS USED TO TREAT CHRONIC HEPATITIS B VIRUS (HBV) INFECTION IN PATIENTS WITH HIV INFECTION THAT IS NOT BEING TREATED. THERAPY WITH PMS-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)_]. 2 • Virologic, biochemical, serologic, and safety da Przeczytaj cały dokument