Country: মিশর
ভাষা: ইংরেজি
সূত্র: EDA (Egyptian Drug Authority)
SANOFI-SYNTHELABO FRANCE
200 mg
enteric coated tablet
10 tablets
GLOBAL NAPI
1997-01-28
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT DEPAKINE 200 MG GASTRO-RESISTANT TABLETS. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium valproate ..........................................................................................200 mg for one tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM :Gastro-resistant tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS IN ADULTS: either as single-agent therapy, or in combination with another antiepileptic treatment: • Treatment of generalized epilepsy: clonic, tonic, tonic-clonic, absence, myoclonic and atonic seizures, and Lennox-Gastaut syndrome. • Treatment of partial epilepsy: partial seizures with or without secondary generalization. IN CHILDREN: either as single-agent therapy, or in combination with another antiepileptic treatment: • Treatment of generalized epilepsy: clonic, tonic, tonic-clonic, absence, myoclonic and atonic seizures, and Lennox-Gastaut syndrome. • Treatment of partial epilepsy: partial seizures with or without secondary generalization. IN CHILDREN:• Prevention of recurrence of seizures after one or more febrile convulsions, meeting the criteria for complicated febrile convulsions, when intermittent benzodiazepine prophylaxis has failed. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Female children, female adolescents, women of childbearing potential and pregnant _ _women_ DEPAKINE should be initiated and supervised by a specialist experienced in the management of epilepsy. Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews. Preferably DEPAKINE should be prescribed as monotherapy and at the lowest effecti সম্পূর্ণ নথি পড়ুন
1 GUIDE FOR HEALTHCARE PROFESSIONALS INFORMATION ON THE RISKS OF VALPROATE ( _DEPAKINE_ _®_ ) USE IN FEMALE PATIENTS AND PREGNANT WOMEN. CONTRACEPTION AND PREGNANCY PREVENTION Read this booklet carefully before any prescription of valproate to female patients. This booklet is a risk minimization measure part of the valproate Pregnancy Prevention Program aimed at minimizing pregnancy exposure during treatment with valproate. Information about valproate use can also be found on-line at www.sanofi.com.eg 2 CONTENT PURPOSE OF THIS GUIDE EXECUTIVE SUMMARY 1. INFORMATION ON CONGENITAL MALFORMATIONS AND DEVELOPMENTAL DISORDERS Congenital malformations Developmental disorders 2. THE ROLE OF DIFFERENT HEALTH-CARE PROFESSIONALS (HCPS) 3. CONDITIONS OF VALPROATE PRESCRIPTION: PREGNANCY PREVENTION PROGRAM 4. TREATMENT OF FEMALE PATIENTS WITH VALPROATE Female patient – first prescription Women of childbearing potential who are not planning a pregnancy Women of childbearing potential who are planning a pregnancy Women with an unplanned pregnancy 5. SWITCHING OR DISCONTINUING VALPROATE Patients with epilepsy 3 PURPOSE OF THIS GUIDE This Guide for healthcare professionals (HCPs) is an educational tool part of the VALPROATE PREGNANCY PREVENTION PROGRAM , which targets both healthcare professionals and patients. Its objective is to provide information about the teratogenic risks associated with the use of valproate during pregnancy, the actions necessary to minimize the risks to your patients, and to ensure your patient has an adequate level of understanding of the risk. It provides up-to-date information about the risks of CONGENITAL MALFORMATIONS and NEURO- DEVELOPMENTAL DISORDERS in children exposed to valproate during pregnancy. The nature of the risks for children exposed to valproate during pregnancy are the same irrespective of the indication for which valproate has been prescribed. Therefore, the risk minimization measures described in this Guide apply to the use of valproate regardless of th সম্পূর্ণ নথি পড়ুন