RETROVIR IV FOR INFUSION

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ZIDOVUDINE

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

J05AF01

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

ZIDOVUDINE 200 MG / 20 ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

GLAXO OPERATIONS (UK) LIMITED

Terapeutisk gruppe:

ZIDOVUDINE

Terapeutisk område:

ZIDOVUDINE

Indikasjoner:

Retrovir IV for infusion is indicated for the short term management of serious manifestations of Human immunodeficiency Virus (HIV) infection in patients with Acquired Immuno Deficiency Syndrome (AIDS) or AIDS who are unable to take Retrovir oral formulations.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 I.V. should only be used when oral treatment is not possible (except during labour and delivery).

Autorisasjon dato:

2021-04-30

Informasjon til brukeren

نأ نكمي ىرخأ ضارعأ نإف ،هاندأ ةلصفملا
ضارعلأل ةفاضإ
.HIV ـل كرتشم جلاع للاخ روطتت
ىرخأ ةلمتحم ةيبناج ضارعأ" يف تامولعملا
أرقت نأ مهملا نم
←
."HIV ـل كرتشم جلاعل
ً
ادج ةعئاش ةيبناج ضارعأ
:صاخشأ 10 لك نم 1 نم رثكأ ىدل رهظت دق هذه
عادص ●
.نايثغ ●
ةعئاش ةيبناج ضارعأ
:صاخشأ 10 لك نم 1 ىتح ىدل رهظت دق هذه
ؤيقت ●
لاهسإ
●
نطبلا يف ملاآ
●
راودب روعشلا
●
ةيلضع ملاآ
●
.ديج ريغ ماع روعش ●
:يه كمد صوحف يف رهظت دق يتلا ةعئاش
ةيبناج ضارعأ
ضفخنم دادعت وأ )
مد رقف
( ءارمحلا مدلا ايلاخل ضفخنم دادعت ●
)
ضيبلا تايركلا ةلق وأ تلادعلا ةلق
( ءاضيبلا مدلا ايلاخل
دبكلا تاميزنإ ةبسن عافترإ
●
يتلا )دبكلا يف جتنت ةدام( مدلا يف
نيبوريليبلا ةبسن عافترإ
●
.رفصأ نولب ودبي كدلج لعجت دق
ةعئاش ريغ ةيبناج ضارعأ
:صخش 100 لك نم 1 ىتح ىدل رهظت دق هذه
)كاح وأ زراب ،رمحأ دلج( دلجلا يف حفط ●
)قانتخإ( ءاوهلا يف صقنب روعشلا
●
ةنوخس ●
ةماع عاجوأو ملاآ
●
)ةخفن( تازاغ ●
.ماع فعض ●
:وه كمد صوحف يف رهظي دق يذلا عئاش ريغ
يبناج ضرع
ةلق
( مدلا رثخت يف ةمهاسملا ايلاخلا ددع يف
ضافخنإ
●
.)
ةلماشلا تايركلا ةلق
( مدلا ايلاخ عاونأ ةفاك يف وأ ،)
تاحيفصلا
ةردان ةيبناج ضارعأ
:صخش 1,000 لك نم 1 ىتح ىدل رهظت دق هذه
يف
ً
اقحلا رظنأ ؛مدلا يف نبللا ضمح ضئاف(
ينبل ضامح ●
)"HIV ـل كرتشملا جلاعلل ىرخأ ةلمتحم
ةيبناج �

Preparatomtale

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RETROVIR IV FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Retrovir IV
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
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.
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 multi-drug treatment regimen.
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Patients should receive Retrovir IV for Infusion only until oral
therapy can be administered.
_Dosage in children_