Retrovir Oral Solution

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ZIDOVUDINE/AZIDOTHYMIDINE

Verfügbar ab:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Internationale Bezeichnung):

ZIDOVUDINE/AZIDOTHYMIDINE

Einheiten im Paket:

200ml mL

Hergestellt von:

GLAXOSMITHKLINE INC.

Gebrauchsinformation

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
_ _
RETROVIR ORAL SOLUTION
_ _
Zidovudine (50mg/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What RETROVIR is used for
2.
How RETROVIR works
3.
Before you use RETROVIR
4.
How to use RETROVIR
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
RETROVIR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RETROVIR IS USED FOR
RETROVIR is used to treat HIV
(human immunodeficiency virus)
infection.
RETROVIR is used, in combination
with other medicines (‘combination
therapy’), to treat HIV infection in
adults and children.
If you are pregnant, your doctor
may want you to take RETROVIR,
to help prevent you passing HIV on
to your unborn baby. After the
birth, your baby may be given
RETROVIR to help prevent HIV
infection.
HOW RETROVIR WORKS
The active ingredient in
RETROVIR is zidovudine.
RETROVIR is a type of medicine
known as an anti-retroviral. It
belongs to a group of medicines
called
_nucleoside analogue reverse _
_transcriptase inhibitors_
(NRTIs)
_. _
RETROVIR does not cure HIV
infection; it reduces the amount of
virus in your body, and keeps it at a
low level. RETROVIR also
increases the
_CD4 cell count_
in
your blood. CD4 cells are white
blood cells that are important in
helping your body to fight
infection.
BEFORE YOU USE RETROVIR
-
_When you must not use it _
Do not take RETROVIR:
•
if you are allergic
(hypersensitive) to zidovudine or
any of the other ingredients of
RETROVIR.
•
if you have a very low white
blood cell count
_ (neutropenia) _
or
a very low red blood cell count
(
_anaemia_
).
If you think any of these apply to
you, do not take RETROVIR until
you have checked with your doctor.
-
_Before you start to use it _
Before you take RETROVIR your
doctor needs to know:
•
If you have ever had liver disease
(including hepatitis B or C)
•
If you have a blood disorder
Talk to your doctor if any of these
apply to you. You may need extra
check-ups, including blood tests,
while you’re taking

Fachinformation

CONFIDENTIAL
RETROVIR
Zidovudine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution containing 50 mg zidovudine per 5 ml. It is clear, pale yellow, strawberry-
flavoured.
PHARMACEUTICAL FORM
Oral solution.
CLINICAL PARTICULARS
Indications
RETROVIR is indicated in combination with other anti -retroviral agents for the treatment
of Human Immunodeficiency Virus (HIV) infection in adults and children.
RETROVIR is indicated for use in HIV -positive pregnant women and their newborn
infants as it has been shown to reduce the rate of maternal -foetal transmission of HIV
( see Pregnancy and Lactation ).
Dosage and Administration
RETROVIR therapy should be initiated by a physician experienced in the management of
HIV infection.
• Adults and adolescents weighing at least 30 kg
The recommended dose of RETROVIR in combination with other anti -retroviral agents is
250 or 300 mg twice daily .
• Children
Oral solution:
Children weighing at least 9 kg and less than 30 kg:
The recommended dose of RETROVIR is 0.9 mL/kg ( 9 mg/kg) twice daily in
combination with other anti -retroviral agents (e.g. a 15 kg child would require a 13.5 mL
dose or oral solution twice daily) . The maximum dosage should not exceed 300 mg (30
mL) twice daily .
Children weighing at least 4 kg and less than 9 kg: