DEPAKINE 5.764gm/100ml syrup

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

SANOFI-SYNTHELABO FRANCE

Dosage:

5.764 gm/100ml

Pharmaceutical form:

syrup

Units in package:

125 ml

Manufactured by:

GLOBAL NAPI

Authorization date:

1997-01-28

Patient Information leaflet

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® 57.64 MG/ML SYRUP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium valproate ............. 57.64 mg For 1 ml.
Excipients with known effect: sucrose, sorbitol, sodium,
parahydroxybenzoates.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM Syrup.
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 that meet 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 effective dose.
The daily dose should be di

Summary of Product characteristics

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