RETROVIR IV FOR INFUSION 1%

Страна: Малайзия

Язык: английский

Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активный ингредиент:

ZIDOVUDINE/AZIDOTHYMIDINE

Доступна с:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

ИНН (Международная Имя):

ZIDOVUDINE/AZIDOTHYMIDINE

Штук в упаковке:

5Units Units

Производитель:

GLAXO WELLCOME OPERATIONS UK LTD

тонкая брошюра

Not Applicable

Характеристики продукта

CONFIDENTIAL
RETROVIR
ZIDOVUDINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials containing 200 mg of zidovudine in 20 ml solution (10 mg
zidovudine/ml).
_RETROVIR_
I.V. for Infusion is a clear, colourless to slightly yellow, sterile
aqueous
solution.
PHARMACEUTICAL FORM
Solution for infusion.
CLINICAL INFORMATIONPARTICULARS
INDICATIONS
_RETROVIR_
I.V. 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.
_RETROVIR_
is indicated for use in HIV-positive pregnant women (over 14 weeks of
gestation) and their newborn infants, as it has been shown to reduce
the rate of maternal-
foetal transmission of HIV (
_see Pregnancy and Lactation_
).
DOSAGE AND ADMINISTRATION
PHARMACEUTICAL FORM:
Solution for infusion.
_RETROVIR_
therapy should be initiated by a physician experienced in the
management of
HIV infection.
The required dose of
_RETROVIR_
I.V. for Infusion must be administered by slow
intravenous i.v. infusion of the diluted product over a one-hour1 h
period.
_RETROVIR_
I.V. for Infusion must
NOT
be given intramuscularly.
Patients should receive
_RETROVIR_
I.V. for Infusion only until oral therapy can be
administered.
COMMENTED [MP1]:
Information moved down in line with the
IPI template update
REFERENCE:
1. Retrovir IPI11
COMMENTED [MP2]:
Section name adjusted in line with the IPI
template update
REFERENCE:
1. Retrovir IPI11
COMMENTED [MP3]:
Information moved from above in line with
the IPI template update
REFERENCE:
1. Retrovir IPI11
COMMENTED [MP4]:
Editorial update in line with IPIv11
REFERENCE:
1. Retrovir IPI11
CONFIDENTIAL
_DILUTION _
_RETROVIR_
I.V. for Infusion
MUST
be diluted prior to administration (
_see Instructions for _
_Use/ and Handling_
).
•
_ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE_
A dosage of
_RETROVIR_
I.V. for Infusion of 1 or 2 mg zidovudine/kg every four hours4 h
provides similar exposure (AUC) to an or