KIVEXA TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMIVUDINE; ABACAVIR SULFATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

LAMIVUDINE; ABACAVIR SULFATE

Unit dalam pakej:

30Tablet Tablets; 30 Tablets

Dikeluarkan oleh:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
KIVEXA TABLETS
_ _
_ _
_ _
Abacavir sulfate/lamivudine (600 mg/300 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Kivexa is used for
2.
How Kivexa works
3.
Before you use Kivexa
4.
How to use Kivexa
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Kivexa
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT KIVEXA IS USED FOR
Kivexa is used to treat HIV
(human immunodeficiency
virus) infection in adults,
adolescents and in children
weighing at least 25 kg.
Kivexa contains two active
ingredients that are used to treat
HIV infection: abacavir and
lamivudine. These belong to a
group of anti-retroviral
medicines called
_nucleoside _
_analogue reverse transcriptase _
_inhibitors (NRTIs)_
.
HOW KIVEXA WORKS
Kivexa 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 Kivexa in the
same way. Your doctor will
monitor the effectiveness of
your treatment.
BEFORE YOU USE KIVEXA
-
_When you must not use it _
Do not take Kivexa:
•
If you are allergic
(hypersensitive) to abacavir
(or any other medicine
containing abacavir – (e.g.
Ziagen), lamivudine or any of
the other ingredients of this
medicine.
You are more likely to develop
this reaction if you have a gene
called HLA-B*5701 (but you
can get a reaction even if you do
not have this gene). You should
have been tested for this gene
before Kivexa was prescribed
for you. If you know you have
this gene, tell your doctor before
you take Kivexa.
Carefully read all the
information about
hypersensitivity reactions in
section “Side Effect”.
Check with your doctor if you
think this applies to you. Do not
take Kivexa.
_Pregnancy _
Kivexa is not recommended for
use during pregnancy. Kivexa
and similar medicines may
cause side ef

Ciri produk

CONFIDENTIAL
(ViiV logo)
KIVEXA
ABACAVIR SULFATE-LAMIVUDINE
1.
NAME OF THE MEDICINAL PRODUCT
Kivexa 600 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg of lamivudine.
EXCIPIENTS
Sunset yellow (E110)
1.7 mg per tablet
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, film-coated, modified capsule shaped tablets, debossed with GS
FC2 on one side.
4.
CLINICAL INRFOMATION
4.1
THERAPEUTIC INDICATIONS
_ _
Kivexa is indicated in antiretroviral combination therapy for the
treatment of Human
Immunodeficiency Virus (HIV) infection in adults, adolescents and
children weighing at least 25 kg
(see section 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be
performed in any HIV-infected patient, irrespective of racial origin
(see section 4.4). Abacavir should
not be used in patients known to carry the HLA-B*5701 allele.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children weighing at least 25 kg: _
The recommended dose of Kivexa is one tablet once daily.
_Children Under 25 kg: _
Kivexa should not be administered to children who weigh less than 25
kg because it is a fixed-dose
tablet that cannot be dose reduced.
CONFIDENTIAL
Kivexa is a fixed-dose tablet and should not be prescribed for
patients requiring dose adjustments.
Separate preparations of abacavir or lamivudine are available in cases
where discontinuation or dose
adjustment of one of the active substances is indicated. In these
cases the physician should refer to the
individual product information for these medicinal products.
_Special Populations _
_ _
_Elderly:_
No pharmacokinetic data are currently available in patients over 65
years of age. Special care is
advised in this age group due to age associated changes such as the
decrease in