BUCRETIS

দেশ: ইন্দোনেশিয়া

ভাষা: ইন্দোনেশীয়

সূত্র: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

সক্রিয় উপাদান:

ENTECAVIR MONOHYDRATE

থেকে পাওয়া:

ABBOTT INDONESIA - Indonesia

INN (আন্তর্জাতিক নাম):

ENTECAVIR MONOHYDRATE

ডোজ:

0.53 MG

ফার্মাসিউটিকাল ফর্ম:

ORODISPERSIBLE FILM

প্যাকেজ ইউনিট:

DUS, 15 AMPLOP @ 1 ORODISPERSIBLE FILM

Manufactured by:

CTCBIO INC - Republic Of Korea

অনুমোদন তারিখ:

2019-08-29

পণ্য বৈশিষ্ট্য

BUCRETIS
TM ®
ENTECAVIR
Orodispersible Films
WARNINGS: 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].
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].
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].
DESCRIPTION
BUCRETIS
TM
is the tradename for entecavir, a guanosine nucleoside analogue with
selective activity against hepatitis B virus (HBV).
The chemical name for entecavir is
2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-
6_H_-purin-6-one, monohydrate. Its molecular formula is C
12
H15N50
3
•H
2
0, which corresponds to a molecular weight of 295.3.
Entecavir has the following structural formula:
Entecavir is a white to off-white powder. It is slightly soluble in
water (2.4 mg/mL), and the pH of the saturated solution in water
is 7.9 at 25° ± 0.5°C.
BUCRETIS
TM
Orodispersible Films are available for oral administration in
strengths of 0.5 mg and 1 mg of entecavir. BUCRETIS
TM
0.5 mg and 1 mg Orodispers