Retrovir Oral Solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZIDOVUDINE/AZIDOTHYMIDINE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

ZIDOVUDINE/AZIDOTHYMIDINE

Unit dalam pakej:

200ml mL

Dikeluarkan oleh:

Bora Pharmaceutical Services Inc.

Risalah maklumat

_ _
_ _
_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

Ciri produk

CONFIDENTIAL
RETROVIR
ZIDOVUDINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution containing 50 mg zidovudine per 5 ml. It is clear, pale
yellow, strawberry-
flavoured.
CLINICAL INFORMATION
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
PHARMACEUTICAL FORM:
Oral solution.
_ _
_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 of 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: _
The recommended dose of
_RETROVIR_
is 1.2 mL/kg (12 mg/kg) twice daily in combination
with other antiretroviral agents (e.g. a 5 kg neonate would require a
6 mL dose of oral
solution twice daily).
CONFIDENTIAL
Available data are insufficient to propose specific dosage
recommendations for children
weighing
less
than
4
kg
(
_see _
_Prevention _
_of _
_maternal _
_foetal _
_transmission _
_and _
_Pharmacokinetics_
).
•
ELDERLY
Zidovudine pharmacokinetics have not been studied in patients over 65
years of age and
no specific data are available. However, since special care is advised
in this age group due
to age-associated changes such as the decrease in renal function and
alterations in
haematological par