RETROVIR 100 mg/10ml Oral Solution

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

ZIDOVUDINE

Disponibil de la:

ViiV Healthcare UK Ltd

Codul ATC:

J05AF01

INN (nume internaţional):

ZIDOVUDINE

Dozare:

100 mg/10ml

Forma farmaceutică:

Oral Solution

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Nucleoside and nucleotide reverse transcriptase inhibitors

Statutul autorizaţiei:

Authorised

Data de autorizare:

2011-09-30

Prospect

Retrovir
100 MG / 10 ML ORAL SOLUTION
ZIDOVUDINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Keep this leaflet. You may need to read
it again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them even if their signs of illness
seem to be the same as yours.
IF YOU GET ANY SIDE EFFECTS TALK TO YOUR
DOCTOR OR PHARMACIST. THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET. See section 4.
What is in this leaflet
1
WHAT RETROVIR IS AND WHAT
IT IS USED FOR
2
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE RETROVIR
3
HOW TO TAKE RETROVIR
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RETROVIR
6
CONTENTS OF THE PACK AND
OTHER INFORMATION
RETROVIR IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION.
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 get rid of 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
a type of white blood cells that are important
in helping your body to fight infection.
Retrovir is used, in combination with other
medicines (‘combination therapy’), to treat
HIV in adults and children. To control your HIV
infection, and to stop your illness getting worse,
you must keep taking all your medicines.
If you’re 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 it from getting infected with HIV.
HIV infection is spread by sexual contact
with someone who’s got the infection, or by
transfer of infected blood (for example, by
sharing injection needles).
Don’t take Retrovir:
•
IF YOU’RE ALLER

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Retrovir 100 mg/10 ml oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 ml of solution contains 100 mg zidovudine.
10 ml of solution contains 6.4 g of maltitol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Retrovir 100 mg/10ml oral solution/syrup
A clear, pale yellow, strawberry-flavoured, sugar-free oral solution.
The pack contains an oral-dosing syringe which should be fitted to the
bottle before use.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Retrovir oral
formulations are indicated in anti-retroviral
combination therapy for Human Immunodeficiency Virus
(HIV) infected adults and children.
Retrovir chemoprophylaxis is indicated for use in HIV-positive
pregnant
women (over 14 weeks of
gestation) for
prevention of maternal-foetal HIV transmission and for primary
prophylaxis of HIV infection in newborn infants.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Retrovir should be prescribed by physicians who are experienced in the
treatment of HIV infection.
_Dosage in adults and adolescents weighing at least 30 kg:_ The usual
recommended dose of Retrovir in combination
with other anti-retroviral agents is 250 or 300 mg twice daily.
_Dosage in children:_ Retrovir 100 mg capsules are also available for
use in children.
_Children weighing at_
_least_
_9 kg and less than 30 kg:_ The recommended dose of Retrovir is 9
mg/kg twice daily in
combination with other antiretroviral agents. The maximum dosage
should not exceed 300 mg twice daily.
_Children weighing at_
_least_
_4 kg and less than 9 kg:_ The recommended dose of Retrovir is 12
mg/kg twice daily in
combination with other antiretroviral agents.
Available data are insufficient to propose specific dosage
recommendations for children weighing less than 4 kg_ (See_
_below -maternal foetal transmission and section 5.2)._
_Dosage in the prevention of_
_maternal-foetal_
_transmission:_
Pregnant
women (over 14 weeks of gestation) should be
given 500 mg/day orally (100 mg