PMS-ENTECAVIR FILM COATED TABLET 0.5mg

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

ENTECAVIR

MAH:

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

ATC_code:

J05AF10

pharmaceutical_form:

TABLET, FILM COATED

composition:

ENTECAVIR 0.50 mg

administration_route:

ORAL

prescription_type:

Prescription Only

manufactured_by:

Pharmascience Inc

authorization_status:

ACTIVE

authorization_date:

2021-02-02

SPC

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