TENVIR EM TABLETS (TENOFOVIR DISOPROXIL FUMARATE & EMTRICITABINE TABLETS)

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

可用日期:

CIPLA MALAYSIA SDN BHD

INN（国际名称）:

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

每包单位数:

30Tablet Tablets

厂商:

CIPLA LTD

产品特点

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
TENVIR-EM
(Tenofovir Disoproxil Fumarate & Emtricitabine Tablets)
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER
ANTIRETROVIRALS (SEE WARNINGS AND PRECAUTIONS).
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM IS NOT INDICATED FOR THE TREATMENT OF CHRONIC
HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND EFFICACY OF
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM HAVE NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED
WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B
HAVE
BEEN
REPORTED
IN
PATIENTS
WHO
HAVE
DISCONTINUED
EMTRICITABINE OR TENOFOVIR DF. HEPATIC FUNCTION SHOULD BE
MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-
UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM
TENVIR-EM AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROPRIATE,
INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE
WARNINGS AND PRECAUTIONS).
COMPOSITION
Each film coated tablet contains
Tenofovir disoproxil fumarate ………… 300 mg
equivalent to Tenofovir disoproxil ........ 245 mg
Emtricitabine ..…………………………… 200 mg
DESCRIPTION
Blue coloured capsule shaped biconvex film coated tablet plain on both
sides.
DOSAGE FORM
Tablets
PHARMACOLOGY
PHARMACODYNAMICS
Emtricitabine is an NRTI that is converted intracellularly to its
active metabolite,
emtricitabine 5’-triphosphate
[1]
Tenofovir DF is an ester prodrug of the NRTI,
tenofovir.
[2]
The prodrug is hydrolysed intracellularly to tenofovir, which is then
converted to the active metabolite, tenofovir diphosphate. The active
metabolites of
the drugs compete with deoxycytidine 5’-triphosphate (emtricitabine
5’-triphosphate)
or deoxyadenosine 5’- triphosphate (tenofovir diphosphate) for
incorporation into
HIV DNA, thereby terminating viral DNA chain growth and inhibiting the
activit