Retrovir

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Zidovudine 100mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Zidovudine 100 mg

Dosage:

100 mg

Pharmaceutical form:

Capsule

Composition:

Active: Zidovudine 100mg Excipient: Gelatin Ink Magnesium stearate Maize starch Microcrystalline cellulose Sodium starch glycolate

Units in package:

Blister pack, 100 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aurobindo Pharma Limited

Therapeutic indications:

Retrovir Oral Formulations are indicated in combination with other anti-retroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 capsules - 60 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE, - 100 capsules - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1991-11-04

Patient Information leaflet

RETROVIR
®
1
RETROVIR
_CAPSULES AND SYRUP _
_zidovudine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start Retrovir.
This leaflet answers some common
questions about Retrovir. It does not
contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Retrovir
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RETROVIR IS USED
FOR
Retrovir contains zidovudine which
belongs to a group of medicines
called antiretrovirals.
Retrovir is used, alone or with other
antiretrovirals, to slow down the
progression of human immuno-
deficiency virus (HIV) infection,
which can lead to Acquired Immune
Deficiency Syndrome (AIDS) and
other related illnesses (e.g. AIDS-
related Complex or ARC).
Retrovir does not cure AIDS or HIV
infection, but slows production of
human immunodeficiency virus. In
this way it stops ongoing damage to
the body's immune system, which
fights infection.
While taking Retrovir and/or any
other therapy for HIV disease, you
may continue to develop other
infections and other complications of
HIV infection. You should keep in
regular contact with your doctor.
Retrovir has been extensively studied
but for limited periods of time. The
long-term risks and benefits of taking
Retrovir are not known; especially in
patients without symptoms of HIV
infection, or with early HIV disease.
Your doctor may have prescribed
Retrovir for another reason. Ask your
doctor if you have any questions
about why Retrovir has been
prescribed for you.
Retrovir is not addictive.
BEFORE YOU TAKE
RETROVIR
_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE RETROVIR IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO ZIDOVUDINE OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
RETROVIR zidovudine (AZT) 100 mg capsules
RETROVIR zidovudine (AZT) 10 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RETROVIR 100 mg capsules contain 100 mg zidovudine.
RETROVIR oral solution/syrup contains 50 mg zidovudine per 5mL.
3.
PHARMACEUTICAL FORM
RETROVIR 100 mg capsules have an opaque white cap and body and is
coded GSYJU.
RETROVIR oral solution is a clear, pale yellow, strawberry-flavoured,
sugar-
free oral solution. The pack contains a 10 mL oral-dosing syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RETROVIR Oral Formulations are 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 section 4.6 Fertility, Pregnancy and
Lactation)_._
4.2
DOSE AND METHOD OF ADMINISTRATION
RETROVIR therapy should be initiated by a physician experienced in the
management of HIV infection.
DOSE
DOSAGE IN ADULTS AND ADOLESCENTS WEIGHING AT LEAST 30KG
The recommended dose of RETROVIR in combination with other anti-
retroviral agents is 250 or 300 mg twice daily.
2
DOSAGE IN CHILDREN
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 zidovudine 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).
Available data are insufficient to propose specific dosage
recommendations
for children weighing less than 4 kg (see section 4.2 Dose and method
of
administra