LAMIHOPE-T (LAMIVUDINE 300MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG FILM-COATED TABLETS)

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Tilgjengelig fra:

SYNERRV SDN BHD

INN (International Name):

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Enheter i pakken:

30 Tablets

Produsert av:

Macleods Pharmaceuticals Ltd

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LAMIHOPE-T FILM-COATED TABLET
Lamivudine and Tenofovir Disoproxil Fumarate 300 mg / 300 mg
1
WHAT IS IN THIS LEAFLET
1.
What
_Lamihope-T _
is used for
2.
How
_Lamihope-T _
works
3.
Before you use
_Lamihope-T _
4.
How to use
_Lamihope-T _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Lamihope-T _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LAMIHOPE-T _IS USED FOR
_Lamihope-T _
is used for the treatment
of human immunodeficiency virus
(HIV) infection in adults and
adolescents over 12 years of age.
HOW _LAMIHOPE-T _WORKS
_Lamihope-T_
contains the active
substances lamivudine and tenofovir
disoproxil fumarate. Both are
antiviral medicines. Lamivudine is a
nucleoside reverse - transcriptase
inhibitors and tenofovir is a
nucleotide reverse transcriptase
inhibitor. Both substances interfere
with enzymes used by HIV for
making copies of itself and thereby
block the reproduction of the virus.
Antiviral medicines used for HIV
infection are known as
antiretrovirals. To prevent the virus
from becoming resistant,
_Lamihope-_
_T_
should always be given in
combination with at least one other
antiretroviral when treating HIV.
This medicine is not a cure for HIV
infection. While taking
_Lamihope-T_
you may still develop infections or
other illnesses associated with HIV
infection.
BEFORE YOU USE _LAMIHOPE-T _
- _When you must not use it _
If you are allergic (hypersensitive) to
lamivudine, tenofovir disoproxil
fumarate or any of the other
ingredients of
_Lamihope-T _
listed at
the end of this leaflet. If this applies
to you, tell your doctor immediately
and don’t take
_Lamihope-T._
_Pregnancy and lactation _
-
Ask your doctor or pharmacist for
advice before taking any
medicine. Be sure to tell your
doctor or health care provider
immediately if you are or may be
pregnant.
_ _
-
In babies born to mothers who
have taken antiretroviral
medicines comprising nucleoside
and nucleotide analogues, the
benefit o

Preparatomtale

Lamihope -T
Lamivudine 300 mg & Tenofovir Disoproxil Fumarate 300 mg Film-coated Tablets
Macleods Pharmaceuticals Ltd.
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory Lamihope-T
Lamivudine 300 mg & Tenofovir Disoproxil Fumarate 300 mg Film-coated Tablets
COMPOSITION
Each film coated tablet contains:
Lamivudine USP.............................….300 mg
Tenofovir Disoproxil Fumarate…….. 300 mg
LIST OF EXCIPIENTS
Microcrystalline cellulose, Croscarmellose Sodium, Magnesium Stearate, Hypromellose, Lactose
Monohydrate, Titanium Dioxide, Triacetin
PRODUCT DESCRIPTION
White to off white, capsule shaped biconvex, film -coated tablet debossed “CL 71 “on one side of the tablet
and plain on other surface.
PHARMACOKINETICS
Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate is a water -soluble ester prodrug, which is rapidly converted in vivo to tenofovir
and formaldehyde. Tenofovir is converted intracellularly to tenofovir monophosphate and to the active
component, tenofovir diphosphate.
Absorption
Following oral administration of tenofovir disoproxil fumarate to HIV infected patients, tenofovir disoproxil
fumarate is rapidly absorbed and converted to tenofovir.
Following single dose administration of Lamivudine/Tenofovir Disoproxil Fumarate 300 mg/300 mg Tablets
in healthy volunteers, the mean (± SD ) tenofovir Cmax value was 249 ng/ml (± 73) and the corresponding
value for AUC was 1795 ng.h/ml (± 391). The mean (± SD) tenofovir Tmax value was 1.07 (± 0.40) hours.