Retrovir 100mg/10ml oral solution

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Zidovudine

Dostępny od:

ViiV Healthcare UK Ltd

Kod ATC:

J05AF01

INN (International Nazwa):

Zidovudine

Dawkowanie:

10mg/1ml

Forma farmaceutyczna:

Oral solution

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05030100; GTIN: 5010706004535 05000123115389

Ulotka dla pacjenta

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

Charakterystyka produktu

OBJECT 1
RETROVIR 100 MG/10 ML, ORAL SOLUTION
Summary of Product Characteristics Updated 09-May-2017 | ViiV
Healthcare UK Ltd
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:_ Pregn