Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
RANIBIZUMAB
NOVARTIS ISRAEL LTD
S01LA04
SOLUTION FOR INJECTION
RANIBIZUMAB 10 MG/ML
INTRAVITREAL
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
RANIBIZUMAB
RANIBIZUMAB
Treatment of patients with neovascular (wet) age-related macular degeneration (AMD). Treatment of adult patients with visual impairment due to diabetic macular oedema (DME) . The treatment of visual impairement due to macular oedema secondary to retinal vein occlusion (RVO). The treatment of visual impaiment due to choroidal neovascularization (CNV) . Lucentis is indicated in preterm infants for: the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.The treatment of proliferative diabetic retinopathy (PDR)
2022-05-31
ةيبناجلا ضارعلأا )4 ً اضارعأ ببسي دق سيتنيسول لامعتسإ نإ ،ءاود لكب امك ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا ضعب دنع ةيبناج .اهنم ً ايأ يناعت لاأ زئاجلا نم .ةيبناجلا نم سيتنيسول لامعتسإب قلعتت يتلا ةيبناجلا ضارعلأا ىلعو نقحلا ةيلمع نع وأ هتاذ ءاودلا نع مجنت نأ اهنأش .نيعلا ىلع رثؤت بلغلأا رابكلا نيجلاعتملا ىدل :يلي اميف ةلصف ُ م ةروطخ رثكلأا ةيبناجلا ضارعلأا 1 - 10 ىدل رهظت ضارعأ( ةعئاش ةريطخ ةيبناج ضارعأ ءزجلا يف ةقبطلا قزمت وأ لاصفنإ :)100 نيب نم نيلمعتسم كلذل ةجيتنو )ةيكبشلا قزمت وأ لاصفنإ( نيعلا نم يفلخلا روطتت يتلا ،ةمئاع ءايشأ عم ءوضلا نم تاضمو ثودح .)تكاراتاك( ةسدعلا ةيبابض وأ ةيؤرلا يف تقؤم نادقف ةجردل ىدل رهظت ضارعأ( ةعئاش ريغ ةريطخ ةيبناج ضارعأ نيعلا ةلقم ثولت ،ىمع :)1,000 نيب نم نيلمعتسم 1-10 .نيعلل يلخادلا ءزجلا باهتلإ عم )ةلقملا نطاب باهتلإ( ،نيعلا يف دئاز جاعزنإ وأ ملأ يه اهنم يناعت دق يتلا ضارعلأا ددع ةدايز ،ةيؤرلا يندت وأ شوشت ،نيعلا رارمحإ يف مقافت .ءوضلل ةدئاز ةيساسح وأ ةيؤرلا لاجم يف ةريغصلا تائيزجلا نم ً ايأ كيدل روطت اذإ بيبطلا ىلإ ً لااح هجوتلا بجي .ةيبناجلا ضارعلأا كلت اهنع غيلبتلا مت يتلا ً اعويش رثكلأا ةيبناجلا ضارعلأا :يلي اميف ةلصف ُ م نم رثكأ ىدل رهظت ضارعأ( ً ادج ةعئاش ةيبناج ضارعأ )ةرشع نيب نم دحاو لمعت Aqra d-dokument sħiħ
LUC API MAY23 V13 1 1. NAME OF THE MEDICINAL PRODUCT Lucentis, 10 mg/ml solution for injection in pre-filled syringe. Lucentis, 10 mg/ml solution for injection in a vial. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PRE-FILLED SYRINGE One ml contains 10 mg ranibizumab*. One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab. The extractable volume of one pre-filled syringe is 0.1 ml. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab. VIAL One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult patients and a single dose of 0.02 ml containing 0.2 mg ranibizumab to preterm infants. *Ranibizumab is a humanised monoclonal antibody fragment produced in _Escherichia coli_ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale brownish-yellow aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of patients with neovascular (wet) age-related macular degeneration (AMD) • Treatment of adult patients with visual impairment due to diabetic macular oedema (DME) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) • The treatment of visual impairment due to choroidal neovascularisation (CNV) • The treatment of proliferative diabetic retinopathy (PDR) Lucentis is indicated in preterm infants for: • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. LUC API MAY23 V13 2 Posology _Adults _ The recommended dose for Lucentis in adults is 0.5 mg given as a single intravitreal injection. This cor Aqra d-dokument sħiħ