Retrovir 100 mg/10 ml oral solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Zidovudine

Disponibbli minn:

ViiV Healthcare BV

Kodiċi ATC:

J05AF; J05AF01

INN (Isem Internazzjonali):

Zidovudine

Dożaġġ:

100 milligram/ 10 millilitre

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Nucleoside and nucleotide reverse transcriptase inhibitors; zidovudine

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2011-09-30

Fuljett ta 'informazzjoni

1
RETROVIR
100 MG / 10 ML ORAL SOLUTION
ZIDOVUDINE
INFORMATION FOR THE PATIENT
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
1
WHAT RETROVIR IS AND WHAT IT IS USED FOR
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

Karatteristiċi tal-prodott

Health Products Regulatory Authority
06 September 2022
CRN00D0T7
Page 1 of 12
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.
Excipient(s) with known effect:
10 ml of solution contains 6.4 g of maltitol
10 ml of solution contains 20 mg of sodium benzoate
10 ml of solution contains 96 mg of propylene glycol
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 b