Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
ZIDOVUDINE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF01
SOLUTION FOR INFUSION
ZIDOVUDINE 200 MG / 20 ML
I.V
Required
GLAXO OPERATIONS (UK) LIMITED
ZIDOVUDINE
ZIDOVUDINE
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).
2021-04-30
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 Perskaitykite visą dokumentą
Page 1 of 15 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. Page 2 of 15 Patients should receive Retrovir IV for Infusion only until oral therapy can be administered. _Dosage in children_ Perskaitykite visą dokumentą