ZOVILAM Tablets 150mg300mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

PATIENT INFORMATION LEAFLET
ZOVILAM TABLETS 150MG/300MG
LAMIVUDINE / ZIDOVUDINE TABLETS 150MG/300MG
READ THIS ENTIRE LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet; you may need
to read it again.

If you have any further
questions, ask your doctor or
pharmacist.

This medicine has been prescribed
for you personally. Do not pass it
on to others. It may harm them
even if their symptoms are the
same as yours.

If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
WHAT IS IN THIS LEAFLET?
1.
What ZOVILAM is used for
2.
How ZOVILAM works
3.
Before you take ZOVILAM
4.
How to take ZOVILAM
5.
While you are using
ZOVILAM
6.
Side effects
7.
Storage and Disposal of
ZOVILAM
8.
Product description
9.
Manufacturer
10.
Date of Revision
1.
WHAT ZOVILAM IS USED FOR
ZOVILAM is used to treat HIV
(human immunodeficiency virus)
infection in adults and children.
_2._
HOW ZOVILAM WORKS
ZOVILAM 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_ (_NRTI’s_)_._
ZOVILAM does not completely
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 ZOVILAM in the
same way. Your doctor will
monitor the effectiveness of your
treatment.
3.
BEFORE YOU TAKE ZOVILAM
WHEN YOU MUST NOT TAKE IT

If you’re ALLERGIC
(hypersensitive) to lamivudine or
zidovudine, or any of the other
ingredients of ZOVILAM (listed
in section 8)

If you have A VERY LOW RED BLOOD
CELL COUNT (anaemia) or A VERY
LOW WHITE BLOOD CELL COUNT
(neutropenia).
_CHECK WITH YOUR DOCTOR if you_
_think any of these apply to you._
BEFORE YOU START TO TAKE I

Ciri produk

ZOVILAM
(LAMIVUDINE AND ZIDOVUDINE TABLETS USP 150 MG/300 MG)
1. NAME OF THE MEDICINAL PRODUCT
Zovilam
(Lamivudine and Zidovudine Tablets USP 150 mg/300 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Lamivudine USP 150 mg and Zidovudine
USP 300 mg.
For a full list of excipients see 6.1.
3. PHARMACEUTICAL FORM
A white to off white, film-coated, capsule shaped, biconvex tablet
debossed with M on one side of the
score and 2 on other side of score on one side of the tablet and L on
one side of the score and Z on other
side of the score on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZOVILAM
is
indicated
in
antiretroviral
combination
therapy
for
the
treatment
of
Human
Immunodeficiency Virus (HIV) infection .
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
ZOVILAM 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, tablets may be crushed
and added to a small amount of
semi-solid food or liquid, all of which should be consumed immediately
_Adults and adolescents weighing at least 30 kg:_ the recommended dose
of ZOVILAM is one tablet twice
daily.
_Children weighing between 21 kg and 30 kg:_ the recommended oral dose
of ZOVILAM 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
ZOVILAM is one-half tablet taken
twice daily.
A
pharmacokinetic
overexposure
of
zidovudine
can
occur,
therefore
close
safety
monitoring
is
warranted in these patients. If gastrointestinal intolerance occurs in
patients weighing 21-30 kg, an
alternative dosing schedule with one-half tablet taken thrice daily
can be applied in attempt to improve
tolerability.
ZOVILAM tablets should not be used for children weighing less than 14
kg, since doses cannot be
appropriately adj