Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
BRINZOLAMIDE
NOVARTIS ISRAEL LTD
S01EC04
OPHTHALMIC SUSPENSION
BRINZOLAMIDE 1 %
OCULAR
Required
ALCON COUVREUR, BELGIUM
BRINZOLAMIDE
BRINZOLAMIDE
Alcon Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contra-indicated or as adjunctive therapy to beta-blockers.
2014-09-30
عضو زوجي لا .ئفادلا ءاملاب نيعلا لسغإ ،_ربكأ _ _ً_ _ايئاود _ _ً_ _ارادقم أطخلاب تلمعتسإ اذإ_ .يلاتلا يئاودلا رادقملا لامعتسإ دنع لاإ ً ايفاضإ ً ايئاود ً ارادقم ىلإ ً اروف هجوت ،ءاودلا نم أطخلاب لفط علب اذإ وأ ً اطرفم ً ايئاود ً ارادقم تلمعتسإ اذإ .كعم ءاودلا ةبلع رضحأو ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا روف ةدحاو ةرطق طيقنت بجي ،ددح ُ ملا تقولا يف _ءاودلا لامعتسإ تيسن اذإ_ ً افعاضم ً ايئاود ً ارادقم لامعتسإ زوجي لا .يدايتعلإا ماظنلل ةدوعلا مث نمو كركذت .يسنملا يئاودلا رادقملا نع ضيوعتلل نيب لقلأا ىلع قئاقد 5 راظتنلإا بجي ،رخآ عون نم نينيع تارطق لمعتست تنك اذإ يف نويعلا مهارم مدختسإ .ىرخأ نينيع تارطق لامعتسإو ءاودلا اذه لامعتسإ .بيبطلا هب ىصوأ امك جلاعلا ىلع ةبظاوملا بجي .ةياهنلا لبق ءاودلاب جلاعلا نع فقوتلا زوجي لا ،ةيحصلا كتلاح ىلع نسحت أرط اذإ ىتح .بيبطلا ةراشتسإ نيعلا لخاد طغضلا نإف _،بيبطلا ةراشتسإ نودب ءاودلا لامعتسإ نع تفقوت اذإ_ .رصبلا نادقف ىلإ كلذ يدؤي دقو مظتني نل _ نم دكأتلاو ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ لامعتسإ زوجي لا_ _ تنك نإ تاراظنلا عضوب مق .ءاودلا اهيف لمعتست ةرم لك يف يئاودلا رادقملا_ _.كلذل ةجاحب_ _ وأ بيبطلا رشتسإ ،ءاودلا لامعتسإب قلعتت ةيفاضإ ةلئسأ كيدل ترفوت اذإ_ _.يلديصلا_ _ةيبناجلا ضارعلأا )4_ Baca dokumen lengkapnya
AZO API JUL 22 V5 1. NAME OF THE MEDICINAL PRODUCT Azopt 1% ophthalmic suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide. Excipient with known effect: Each ml of suspension contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azopt 1% is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology When used as monotherapy or adjunctive therapy, the dose is one drop of Azopt 1% in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. _Special populations _ _ _ _Elderly population _ No dose adjustment in elderly patients is necessary. _Hepatic and renal impairment _ Azopt 1% has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. Azopt 1% has not been studied in patients with severe renal impairment (creatinine clearance ˂ 30 ml/min) or in AZO API JUL 22 V5 patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, Azopt 1% is therefore contra-indicated in such patients (see also section 4.3). _Paediatric population _ The safety and efficacy of Azopt 1% in infants, children and adolescents aged 0 to 17 years have not been established. Currently available data are described in sections 4.8 and 5.1. Azopt 1% is not recommended for use in infants, children and adolescents. Method of administration _ _ For ocular use. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the systemic absorption Baca dokumen lengkapnya