ZIAGEN TABLET

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

ABACAVIR SULFATE

Mevcut itibaren:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Adı):

ABACAVIR SULFATE

Paketteki üniteler:

60 Tablets; 60 Tablets

Tarafından üretildi:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Bilgilendirme broşürü

_ _
_ _
_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

Ürün özellikleri

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 d