Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Entecavir Monohydrate 1.066 mg equivalent to Entecavir
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
J05AF10
TABLET, FILM COATED
Entecavir Monohydrate 1.066 mg equivalent to Entecavir 1mg
ORAL
Prescription Only
Remedica Ltd.
ACTIVE
2021-01-31
06 27.07.2020 InA 16.09.2020 InA 310x400 mm Remedica Ltd 5 pt 28.07.2020 5.08.2020 1. Profile 2. 3. 1. black 2. 3. 4. 5. 6. AAAM2918 - Entecavir All strengths, PIL, Singapore P18-xxxxxxxxxxxxxx 0000 P18-xxxxxxxxxxxxxx 0000 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 Læs hele dokumentet