国家: 以色列
语言: 英文
来源: Ministry of Health
FINGOLIMOD AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L04AA27
HARD CAPSULE
FINGOLIMOD AS HYDROCHLORIDE 0.5 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
FINGOLIMOD
FINGOLIMOD
Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis ( MS ) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
2016-03-31
ةيئاودلا ةعرجلا لوانت لبق بلقلل يئابرهكلا طيطختلا صحف ∙ ةيئاودلا ةعرجلا لوانت دعب ةعاس لك مدلا طغضو ضبنلا صوحف ∙ ةيئاودلا ةعرجلا لوانت نم تاعاس 6 دعب بلقلل يئابرهكلا طيطختلا صحف ∙ جلاعلا نع فقوتلا .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي نسحت أرط ولو ىتح ،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا نع فقوتلا زوجي لا .ةيحصلا كتلاح ىلع رظنأ ـ مقافتتو دوعت دق ددعتملا بلصتلا ضارعأ نإف ،ءاودلا لوانت نع تفقوت اذإ ةرقف يف »اينيليﭼ نع فقوتلا دعب ددعتملا بلصتلا ضرم يف ديدش مقافت« دنبلا .ةيبناجلا ضارعلأا ةعرجلا نم دكأتلاو ءاودلا عبﺎط صيخشت بجي ! ةمتعلا يف ةيودلأا لوﺎﻨتت لا . ءاود ﺎهيف لوﺎﻨتت ةرم لك يف ةيئاودلا . كلذ رملأا مزل اذإ ةيبطلا تارﺎظﻨلا عض وأ بيبطلا رشتسإ ،ءاودلا لﺎمعتسإ لوح ةيفﺎضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا ةيبنﺎجلا ضارعلأا )4 .نيلمعتسملا ضعب دنع ةيبناج ً اضارعأ ببسي دق اينيليﭼ لامعتسإ نإ ،ءاود لكب امك .اهنم ً ايأ يناعت لاأ زئاجلا نم ،ةيبناجلا ضارعلأا ةمئاق نم شهدنت لا :لمشت ،ةيدج ةيبنﺎج ً ﺎضارعأ ﺎيﻨيليﭼ ببسي دق ءدب دﻨع )bradyarrythmia وأ bradycardia( ءيطب بلق مظن ∙ ﺎيﻨيليﭼ كلوﺎﻨت ةيئاودلا ةعرجلا كلوانت دعب ةصاخ ،كبلق مظن ؤطابت ىلإ يدؤت نأ اينيليﭼ ناكمإب اذإ ىفشتسم برقأ يف ئراوطلا ةفرغ ىلإ وأ كبيبط ىلإ ً اروف هجوت .ىلو 阅读完整的文件
GIL API NOV23 V 10.1 Page 1 of 22 USPI Aug.2023, EU SmPC Dec.2022 PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Gilenya 0.5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GILENYA is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. For the full list of excipients, see section 12. 3 PHARMACEUTICAL FORM Hard capsule. Hard capsules with a white opaque body and bright yellow opaque cap; radial imprint in black ink “FTY 0.5 mg” on the cap and 2 radial bands imprinted on the capsule body with yellow ink. Fingolimod hydrochloride is a white to almost white crystalline powder. PATIENT/CAREGIVER GUIDE AND PREGNANCY REMINDER CARD The marketing of Gilenya 0.5 mg is subject to a risk management plan (RMP) including a 'Patient/Caregiver guide' and a 'Pregnancy reminder card'. These materials emphasize important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review these materials before starting treatment. PHYSICIAN'S CHECKLIST This product is marketed with a 'physician's checklist' providing important safety information. Please ensure you are familiar with this material as it contains important safety information. 4 THERAPEUTIC INDICATIONS Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. 5 DOSAGE AND ADMINISTRATION GENERAL TARGET POPULATION The recommended dose of Gilenya is one 0.5 mg capsule taken orally once daily, which can be taken with or without food. If a dose is missed, treatment should be continued with the next dose as planned. Before initiating treatment with Gilenya, a recent complete blood count (CBC) (i.e. within 6 months or after discontinuation of prior therapy) should be available. Assessments of CBC are also recommended periodically during treatment, at month 阅读完整的文件