ZIAGEN ORAL SOLUTION

Country: Malaysia

Language: English

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

Active ingredient:

ABACAVIR SULFATE

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

ABACAVIR SULFATE

Units in package:

1Units Units

Manufactured by:

GLAXOSMITHKLINE INC.

Patient Information leaflet

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
ZIAGEN TABLET / ORAL SOLUTION
_ _
_ _
Abacavir sulfate (300mg, 20mg/mL)
1
WHAT IS IN THIS LEAFLET
1.
What Ziagen is used for
2.
How Ziagen works
3.
Before you use Ziagen
4.
How to use Ziagen
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Ziagen
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZIAGEN IS USED FOR
Ziagen contains the active ingredient
abacavir sulfate. This belongs to a
group of anti-retroviral medicines
called
_nucleoside analogue reverse _
_transcriptase inhibitors (NRTIs)_
, which
are used to treat Human
Immunodeficiency Virus (HIV)
infection.
HOW ZIAGEN WORKS
Ziagen 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 Ziagen in the same way. Your
doctor will monitor the effectiveness of
your treatment.
BEFORE YOU USE ZIAGEN
-
_When you must not use it _
_ _
Do not take Ziagen:
•
if you are allergic (hypersensitive) to
abacavir (or any other medicine
containing abacavir), or any other
ingredients of Ziagen.
Carefully read all the information
about hypersensitivity reactions in
section ‘Side Effects’.
If you think this applies to you, don’t
take Ziagen until you have checked
with your doctor.
-
_Before you start to use it _
Before you take Ziagen your doctor
needs to know:
_ _
•
if you have ever had liver disease,
including hepatitis B or C
Talk to your doctor if this apply to you.
You may need extra check-ups,
including blood tests, while you’re
taking your medicine.
_Pregnancy: _
If you are pregnant, or think you could
be, or if you are planning to become
pregnant, don’t take Ziagen without
checking with your doctor. Your
doctor will weigh up the benefit to you
against the risk to your baby of taking
Ziagen while yo

Summary of Product characteristics

[GSK logo]
ZIAGEN TM
Abacavir
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZIAGEN tablet contains 300 mg of abacavir as abacavir sulfate. The scored tablets are
yellow, biconvex, and capsule shaped. They are engraved with GX 623 on both sides.
ZIAGEN oral solution contains 20 mg/ml of abacavir as abacavir sulfate. ZIAGEN oral solution
is a clear to slightly opalescent yellowish , aqueous solution which may turn into a brown colour
over time with a fruity flavor.
PHARMACEUTICAL FORM
Film -coated scored tablets.
Oral solution.
CLINICAL PARTICULARS
Indications
ZIAGEN is indicated in antiretroviral combination therapy for the treatment of Human
Immunodeficiency Virus (HIV) infection in adults and children.
Dosage and Administration
Therapy should be initiated by a physician experienced in the management of HIV infection.
ZIAGEN can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without
crushing.
For patients who are un able to swallow tablets, ZIAGEN is available as an oral solution.
Alternatively, the tablets may be crushed and added to a small amount of semi -solid food or
liquid, all of which should be consumed immediately (see Pharmacokinetics).
• Adults , adolescents and children weighing at least 25kg
Style Definition: Postspace: Font: 13 pt, Italic, Font color: Auto
Commented [ET1]: Update to align with IPI12. Supported by justification of appearance at section E14.