Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
VALPROIC ACID; VALPROIC ACID AS SODIUM
SANOFI ISRAEL LTD
N03AG01
TABLETS PROLONGED RELEASE
VALPROIC ACID 145 MG; VALPROIC ACID AS SODIUM 333 MG
PER OS
Required
SANOFI S.P.A., ITALY
VALPROIC ACID
Epilepsy:Treatment of generalized or partial epilepsy secondary epilepsy and mixed forms of epilepsy. Bipolar disorders: Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to valproic acid for acute mania.
2020-06-30
.كبيبط لبق نم ةيفاضإ ةراشتسإ كل مدقت .كبيبط عم كلذ نع يثدحتت نأ لبق كب ةديدش ةروطخل نيضرعم تاورپلاڤ ـب نجلوع يتاوللا تاهملأ اودلو نيذلا عضرلا نإ كهجوي .ةريطخ ةقاعإ ىلإ يدؤت دق يتلا ومنلا يف لكاشملو ةيقلخ تاهوشت ثودحل ثيحب ،عرصلا وأ بطقلا يئانث بارطضلإا جلاع يف ةربخ وذ يئاصخأ ىلإ كبيبط نأ يئاصخلأا ناكمإب .ةركبم ةلحرم يف ةليدب جلاع تارايخ مييقت ناكملإاب نوكي ردق ضفخ متي نأو ناكملإا ردق ةسلس كلمح ةريسم نوكت يكل لئاسو ةدع ذختي .كنينج ىلعو كيلع ةروطخ يأ عاطتسملا ونورك تپلاپيد نم كب صاخلا يئاودلا رادقملا رييغت ررقي نأ يئاصخلأا نأش نم 500 ونورك تپلاپيد ـب جلاعلا فقوي وأ ،رخآ ءاود ىلإ كلوحي نأ وأ غلم 500 .رقتسم كضرم نأ نم دكأتلا لجأ نم كلذ - ً لاماح يحبصت نأ لبق ةليوط ةرتف غلم كيلوفلا ضمح .لمحلل نيططخت امدنع كيلوفلا ضمح لوانت نع كبيبط يلأسإ ةدوجوملا ركبم ضاهجلإو يرقفلا دومعلا قاقشنلإ ةماعلا ةروطخلا للقي نأ نكمي ةيقلخ تاهوشت ثودحل ةروطخلا للقي نأ حجرملا ريغ نم ،كلذ عم .لمح لك يف .تاورپلاڤ لامعتسلإ ةبوسنملا :ةيسيئر لئاسر ،كلذب كبيبط كاصوأ اذإ لاإ ،غلم 500 ونورك تپلاپيد لوانت نع يفقوتت لا ● بيبطلا عم يثدحتت نأ لبق كب ةصاخلا لمحلا عنم لئاسو لامعتسإ نع يفقوتت لا ● ضفخ متيو كتلاح ىلع ةرطيسلا نامض لجأ نم جمانرب ةيوس امكدامتعإ لبقو ،كعيض Izlasiet visu dokumentu
1 DEPA-PO-500MG-26.0 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS DEPALEPT CHRONO 500 MG Patient safety information card and guide The marketing of Depalept Chrono is subject to a risk management plan (RMP) including a 'Patient card', 'patient guide', 'Healthcare professionals guide' and 'Physician Checklist' in the frame of Pregnancy Prevention Program. The 'Patient card' and the 'Patient guide' emphasize important safety information on the risk of congenital malformations and neuro-development disorders that the female patients should be aware of before and during treatment. Please explain to the patient the need to review the card and the guide before starting treatment and discuss the Physician Checklist at intiation of treatment and at least annually . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Depalept Chrono 500 mg 1 divisible prolonged-release tablet contains 333 mg of sodium valproate and 145 mg valproic acid (equivalent to a total of 500 mg sodium valproate). Excipients with known effect: Contains 47.21 mg sodium per prolonged-release tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Depalept Chrono 500 mg: Oblong, practically white, scored film-coated tablets The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Epilepsy: Treatment of generalized or partial epilepsy secondary epilepsy and mixed forms of epilepsy. 2 Bipolar disorders: Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to valproic acid for acute mania. _ _ 4.2 Posology and method of administration Notes When switching from previous (non-prolonged-release) dosage forms to Depalept chrono, care must be taken to ensure adequate serum levels of valproic acid. In female children, female adolescents, women of childbearing potential and pregnant women Depalept chrono should be initiated and supervised b Izlasiet visu dokumentu