RETROVIR 10 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZIDOVUDINE

Available from:

ViiV Healthcare UK Ltd

ATC code:

J05AF01

INN (International Name):

ZIDOVUDINE

Dosage:

10 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

Nucleoside and nucleotide reverse transcriptase inhibitors

Authorization status:

Authorised

Authorization date:

2011-07-29

Patient Information leaflet

FRONT PAGE
The following information is intended for
medical or healthcare professionals only
DOSAGE AND ADMINISTRATION INFORMATION ONLY
Please refer to the Summary of Product Characteristics for further
information
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RETROVIR
10 MG/ML IV CONCENTRATE FOR SOLUTION FOR
INFUSION
zidovudine
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Retrovir IV for Infusion is a clear, nearly
colourless, sterile aqueous solution with a pH of
approximately 5.5.
POSOLOGY AND METHOD OF ADMINISTRATION
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 Instructions for use
and handling).
_DOSAGE IN ADULTS_
A dose for Retrovir IV for Infusion of 1 or 2 mg
zidovudine/kg bodyweight every 4 hours
provides similar exposure (AUC) to an oral dose
of 1.5 or 3.0 mg zidovudine/kg every 4 hours
(600 or 1200 mg/day for a 70 kg patient).
The current recommended oral dose of Retrovir
is 250 or 300 mg twice daily. This current dose is
used as part of a multi-drug treatment regimen.
Patients should receive Retrovir IV for Infusion
only until oral therapy can be administered.
_DOSAGE IN CHILDREN_
Limited data are available on the use of
Retrovir IV for Infusion in children. A range of
intravenous dosages between 80-160 mg/m
2
every 6 hours (320-640 mg/ m
2
/day) have been
used. Exposure following the 120 mg/m
2
dose
every 6 hours approximately corresponds to an
oral dose of 180 mg/m
2
every 6 hours. An oral
dose of Retrovir of 360 to 480 mg/m
2
per day
approximately corresponds to an intravenous
dose of 240-320 mg/m
2
/day.
_DOSAGE IN THE PREVENTION OF MATERNAL-FOETAL _
_TRANSMISSION_
Although the optimal dosage schedule has not
been identified the following dosage regimen
has been shown to be effective. Pregnant
women (over 14 weeks of gestation) should be
given 500 mg/day orally (100 mg five times per

Summary of Product characteristics

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
Vials containing zidovudine 200 mg in 20 ml solution (10 mg
zidovudine/ml)
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 (AUC) to an oral dose of 1.5 or 3.0 mg zidovudine/kg
every 4 hours (600 or 1200 mg/day for a 70 kg
patient). The current recommended oral dose of Retrovir is 250 or 300
mg twice daily. This current dose is used as part
of a mul