TECAVIR FILM COATED TABLETS 0.5 MG

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Entecavir Monohydrate equivalent to Entecavir

Предлага се от:

HETERO SINGAPORE PTE. LTD.

АТС код:

J05AF10

Лекарствена форма:

TABLET, FILM COATED

Композиция:

Entecavir Monohydrate equivalent to Entecavir 0.500 mg

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

Hetero Labs Limited

Статус Оторизация:

ACTIVE

Дата Оторизация:

2023-05-23

Данни за продукта

Dosage adjustment of Entecavir is recommended for patients with
creatinine clearance less than 50 mL/min, including patients on
hemodialysis or CAPD [see _Dosage and Administration _and _Clinical _
_Pharmacology_].
RENAL IMPAIRMENT
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_].
DOSAGE AND ADMINISTRATION
HEPATIC IMPAIRMENT
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 optimal duration of treatment with ENTECAVIR for patients with
chronic hepatitis B virus infection and the relationship between
treatment and long-term outcomes such as cirrhosis and hepatocellular
carcinoma are unknown.
ENTECAVIR is contraindicated in patients with previously demonstrated
hypersensitivity to entecavir or any component of the product.
Virologic, biochemical, serologic, and safety data are available for a
limited number of adult subjects with HIV/HBV co-infection who have
received prior lamivudine therapy [see _Warnings and Precautions _
and _Clinical Studies_].
PATIENTS CO-INFECTED WITH HIV AND HBV
_DECOMPENSATED LIVER DISEASE_
TECAVIR 0.5 MG AND 1 MG
INDICATIONS AND USAGE
Entecavir Tablets 0.5 mg and 1 mg
RECOMMENDED DOSAGE
The recommended dose of ENTECAVIR for chronic hepatitis B virus
infection in adults with decompensated liver disease is 1 mg once
daily, which must be taken on an empty stomach (at least 2 hours after
a
meal and 2 hours before the next meal).
RENAL IMPAIRMENT
In subjects with renal impairment, the apparent oral clearance of
entecavir decreased as creatinine clearance decreased [see _Clinical
Pharmacology_]. Dosage adjustment is recommended for patients with
creatinine clearance less