ZIAGEN ORAL SOLUTION

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

ABACAVIR SULFATE

Prieinama:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Tarptautinis Pavadinimas):

ABACAVIR SULFATE

Vienetai pakuotėje:

1Units Units

Pagaminta:

Bora Pharmaceutical Services Inc.

Pakuotės lapelis

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 you're pregnant and
advise you if you should

Prekės savybės

CONFIDENTIAL
ZIAGEN
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.
CLINICAL INFORMATION
Indications
ZIAGEN
is
indicated
in
antiretroviral
combination
therapy
for
the
treatment
of
Human
Immunodeficiency Virus (HIV) infection in adults and children.
Dosage and Administration
Pharmaceutical Form: Film-coated scored tablets and Oral solution.
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 unable 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 25 kg
Tablets:
The recommended dose of ZIAGEN tablets is 600 mg daily. This may be
administered as either
300 mg (one tablet) twice daily or 600 mg (two tablets) once daily.
CONFIDENTIAL
Oral Solution:
The recommended dose of ZIAGEN oral solution is 300 mg (15 ml) twice
daily or 600 mg (30 ml)
once daily.

Children from three months and weighing less than 25 kg
Tablets:
Children weighing 14 to < 20 kg: one-half of a scored abacavir tablet
twice daily.
Children weighing ≥ 20 kg to < 25 kg: one-half of a scored abacavir
tablet taken in the morning
and one whole tablet taken in the evening.
Children weighing at least 25 kg: the adult dosage of 300 mg twice
daily or 600 mg once daily
should be taken.
The oral solution may be administered to childr