DEPAKINE 200mg enteric coated tab.

البلد: مصر

اللغة: الإنجليزية

المصدر: EDA (Egyptian Drug Authority)

متاح من:

SANOFI-SYNTHELABO FRANCE

جرعة:

200 mg

الشكل الصيدلاني:

enteric coated tablet

الوحدات في الحزمة:

10 tablets

المصنعة من قبل:

GLOBAL NAPI

تاريخ الترخيص:

1997-01-28

نشرة المعلومات

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

خصائص المنتج

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