Retrovir 10 mg/ml IV concentrate for solution for infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Zidovudine

から入手可能:

ViiV Healthcare BV

ATCコード:

J05AF; J05AF01

INN（国際名）:

Zidovudine

投薬量:

10 milligram(s)/millilitre

医薬品形態:

Concentrate for solution for infusion

処方タイプ:

Not applicable

治療領域:

Nucleoside and nucleotide reverse transcriptase inhibitors; zidovudine

認証ステータス:

Marketed

承認日:

2011-07-29

情報リーフレット

1
RETROVIR
10 MG / ML IV CONCENTRATE FOR SOLUTION FOR INFUSION
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.
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’RE GIVEN RETROVIR
3
HOW RETROVIR IS GIVEN
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, by sharing injection needles).
2
2
WHAT YOU NEED TO KNOW BEFORE YOU
’
RE GIVEN RETROVIR
DON’T TAKE RETROVIR:
•
IF YOU

製品の特徴

Health Products Regulatory Authority
06 September 2022
CRN00D0T7
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Retrovir 10 mg/ml IV concentrate for solution for infusion
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
Concentrate for solution for infusion (sterile concentrate)
Retrovir IV for Infusion is a clear, nearly colourless, sterile
aqueous solution with a pH of approximately 5.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Retrovir IV for Infusion is indicated for the short-term management of
serious manifestations of Human Immunodeficiency
Virus (HIV) infection in patients with Acquired Immune Deficiency
Syndrome (AIDS) who are unable to take Retrovir oral
formulations. If at all possible Retrovir IV should not be used as
monotherapy for this indication (see section 5.1).
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. Retrovir IV should only be
used when oral treatment is not possible (except during labour and
delivery – see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Retrovir should be prescribed by physicians who are experienced in the
treatment of HIV infection.
The required dose of Retrovir IV for Infusion must be administered by
slow intravenous infusion of the diluted product over a
one-hour period.
Retrovir IV for Infusion must NOT be given intramuscularly.
_Dilution: _Retrovir IV for Infusion MUST be diluted prior to
administration (see section 6.6).
_Dosage in adults:_ A dose for Retrovir IV for Infusion of 1 or 2 mg
zidovudine/kg bodyweight every 4 hours provides similar
exposure