RETROVIR CAPSULES 250 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

ZIDOVUDINE

Commercializzato da:

GLAXO SMITH KLINE (ISRAEL) LTD

Codice ATC:

J05AF01

Forma farmaceutica:

CAPSULES

Composizione:

ZIDOVUDINE 250 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Area terapeutica:

ZIDOVUDINE

Indicazioni terapeutiche:

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.

Data dell'autorizzazione:

2023-02-28

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed
with a physician’s prescription only
Retrovir Capsules 250 mg
Each Retrovir capsule 250 mg contains 250 mg
zidovudine.
For the list of the inactive and allergenic ingredients in the
preparation, see section 2 - “Important information about
some of the ingredients of the medicine” and section 6 -
“Additional information”.
Read this leaflet carefully in its entirety before using
the medicine. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the physician or pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if it seems to you
that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Retrovir is used together with additional anti-retroviral
medicines to treat adults and children infected with
human immunodeficiency virus (HIV).
Preventive treatment with Retrovir is indicated for pregnant
and HIV-positive women (after the 14th week of pregnancy)
to prevent intrauterine infection of the fetus and for primary
prevention of HIV infection in a newborn baby.
Therapeutic group: The active ingredient in Retrovir is
zidovudine. Retrovir belongs to a group of medicines
called _nucleoside analogue reverse transcriptase inhibitors _
_(NRTIs)_.
Retrovir does not eliminate the HIV virus; it reduces the
amount of virus in your body, and keeps it at a low level.
Retrovir 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.
HIV infection is spread by sexual contact with someone who
is infected, or by transfer of infected blood (for example,
when sharing injection needles).
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
∙ you are sensitive (allergic) to the active ingredient
or any of the additional ingredients contained in the
medicine (as listed in section 6).
∙ you ha

Scheda tecnica

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RETROVIR CAPSULES 250 MG
1.
NAME OF THE MEDICINAL PRODUCT
Retrovir 250 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg zidovudine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Hard gelatin capsules with opaque blue cap and opaque white body coded
GSJV2.
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 adolecents 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 and Retrovir 100 mg/10 ml oral solution are
available for use in children.
WEIGHT
(KG)
IN THE MORNING
IN THE EVENING
DAILY
DOSE
(MG)
8-13
one 100 mg capsule
one 100 mg capsule
200
14-21
one 100 mg capsule
two 100 mg capsules
300
22-30
two 100 mg capsules
two 100 mg capsules
400
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Alternatively children weighing at least 28 kg to 30 kg (included)
could take:
28-30
one 250 mg capsule
one 250 mg capsule
500
Oral solution is available for dosing children less than 8 kg and for
those children above 8 kg
unable to swallow capsules (see Oral Solution SPC).
_Dosage in the prevention of maternal-foetal transmission:_
Pregnant women (over 14 weeks
of gestation) should be given 500 mg/day orally (100 mg five times per
day) until the
beginning of labour. During labour and delivery Retrovir should be
administered
intravenously at 2 mg/kg bodyweight given over one hour followed by a
continuous
int