COMBIVIR TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
COMBIVIR TABLET
_ _
_ _
Lamivudine/Zidovudine (150 mg/300 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Combivir is used for
2.
How Combivir works
3.
Before you use Combivir
4.
How to use Combivir
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Combivir
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT COMBIVIR IS USED FOR
Combivir is used to treat HIV
(human immunodeficiency
virus) infection in adults and in
children.
HOW COMBIVIR WORKS
Combivir contains two active
ingredients that are used to treat
HIV infection: lamivudine and
zidovudine. Both of these
belong to a group of anti-
retroviral medicines called
nucleoside analogue reverse
transcriptase inhibitors (NRTIs).
Combivir does not cure HIV
infection; it reduces the amount
of virus in your body, and keeps
it at a low level. It also increases
the CD4 cell count in your
blood. CD4 cells are a type of
white blood cells that are
important in helping your body
to fight infection. Not everyone
responds to treatment with
Combivir in the same way. Your
doctor will monitor the
effectiveness of your treatment.
BEFORE YOU USE COMBIVIR
-
_When you must not use it _
Do not take this medicine:
•
If you are allergic
(hypersensitive) to
lamivudine or zidovudine, or
any other ingredients of
Combivir tablets.
•
If you have a very low red
blood cell count (
_anaemia_
)
or a very low white blood
cell count (
_neutropenia_
).
If you think any of these apply
to you, don’t take Combivir
until you have checked with
your doctor.
-
_Before you start to use it _
Before you take Combivir your
doctor needs to know:
•
If you have ever had liver
disease, including hepatitis B
or C
•
If you have kidney disease
•
If you have a blood disorder
Talk to your doctor if any of
these apply to you. You may
need extra check-ups, including
blood tests, while you’re taking
your medication.
Conditions you need to look out
for:
Combivir can cause serious side
effects. You must loo

Ciri produk

CONFIDENTIAL
COMBIVIR
Lamivudine-Zidovudine
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMBIVIR tablets contain 150 mg lamivudine and 300 mg zidovudine and
are white to off-
white capsule-shaped, scored tablets, engraved with GX FC3 on both
faces.
CLINICAL INFORMATION
Indications
COMBIVIR is indicated for the treatment of HIV infection.
Dosage and Administration
Pharmaceutical Form: Film-coated tablets.
COMBIVIR therapy should be initiated and monitored by a physician
experienced in the
management of HIV infection.
COMBIVIR may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, they may be
crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately (see
Pharmacokinetics).
Populations

Adults and adolescents weighing at least 30 kg:
The recommended dose of COMBIVIR is one tablet twice daily.
•
Children weighing between 21 kg and 30 kg
The recommended oral dose of COMBIVIR is one-half tablet taken in the
morning and one
whole tablet taken in the evening.
•
Children weighing from 14 kg to 21 kg
The recommended oral dose of COMBIVIR is one-half tablet taken twice
daily.
For children weighing less than 14 kg, lamivudine (3TC) and zidovudine
(RETROVIR) should
be taken as separate formulations according to the prescribed dosing
for these products.
If a reduction in dose of COMBIVIR appears clinically indicated, or if
one of the components
of COMBIVIR (lamivudine or zidovudine) requires reduction or
discontinuation, separate
CONFIDENTIAL
preparations of lamivudine (3TC) and zidovudine (RETROVIR) are
available in tablets/capsules
and oral solution.

Elderly
No specific data are available, however special care is advised in
this age group due to age
associated changes such as the decrease in renal function and
alteration of haematological
parameters.

Renal impairment
Dosage adjustment of lamivudine is required in patients wi