DEPALEPT CHRONO 500 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VALPROIC ACID; VALPROIC ACID AS SODIUM

متاح من:

SANOFI - AVENTIS ISRAEL LTD

ATC رمز:

N03AG01

الشكل الصيدلاني:

TABLETS PROLONGED RELEASE

تركيب:

VALPROIC ACID 145 MG; VALPROIC ACID AS SODIUM 333 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

SANOFI WINTHROP INDUSTRIE, FRANCE

المجال العلاجي:

VALPROIC ACID

الخصائص العلاجية:

Treatment of generalized or partial epilepsy secondary epilepsy and mixed forms of epilepsy. Bipolar disorders: Treatment and/or prevention of acute manic episodes in the context of bipolar disorders.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

GUIDE FOR HEALTHCARE PROFESSIONALS
INFORMATION ON THE RISKS OF VALPROATE
(DEPALEPT CHRONO) USE IN FEMALE
PATIENTS AND PREGNANT WOMEN.
CONTRACEPTION AND PREGNANCY
PREVENTION
This guide is a mandatory part of the Depalept Chrono Marketing
Authorization as an additional measure to
minimize
the
risk
of
congenital
malformations
and
neuro-developmental
disorders
and
improve
the
benefit/risk ratio of Depalept Chrono. The purpose of this guide is
therefore to ensure that healthcare
professionals who prescribe Depalept Chrono and patients who use
Depalept Chrono are aware of and
understand the specific safety requirements concerning the use of
Depalept Chrono.
The objective of this guide is to prevent Depalept Chrono exposure
during pregnancy. The types of risks in
children exposed to Depalept Chrono during pregnancy are the same
regardless of the indication in which
Depalept Chrono was prescribed. The risk minimization measures
described in this guide therefore apply to
the use of Depalept Chrono in any indication.
READ THIS GUIDE CAREFULLY BEFORE PRESCRIBING DEPALEPT CHRONO TO FEMALE
PATIENTS. THIS
GUIDE IS PART OF THE DEPALEPT CHRONO PREGNANCY PREVENTION PROGRAM AND
SHOULD BE USED
ALONG WITH THE PATIENT GUIDE, THE PATIENT CARD AND PHYSICIAN
CHECKLIST.
KEEP A COPY OF THE CHECKLIST ONCE IT HAS BEEN COMPLETED.
It is recommended that you keep an electronic version in the
patient’s file.
Give the Patient Guide to every patient treated with Depalept Chrono.
It can be found at MOH (Ministry of
Health) site. For further information about Depalept Chrono, read the
prescribing information completely
before prescribing Depalept Chrono.
1
CONTENT
1.
INFORMATION ON CONGENITAL MALFORMATIONS AND DEVELOPMENTAL
DISORDERS
......................................................................................................
3
•
Congenital malformations
..........................................................................
3
•
Developmental disorders
...........................................................................
3
2

خصائص المنتج

1
_ _
_ _
February 2021 Version DEPA-PO-500MG-19.0
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 treatement 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
2
EPILEPSY:
Treatment of generalized or partial epilepsy secondary epilepsy and
mixed forms of
epilepsy.
BIPOLAR DISORDERS:
Treatment and/or prevention of acute manic episodes in the context of
bipolar disorders.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IN FEMALE CHILDREN, FEMALE ADOLESCENTS, WOMEN OF CHILDBEARING
POTENTIAL AND PREGNANT WOMEN
Depalept chrono should be initiated and supervised by a specialist
experienced in the management of
epilepsy or bipolar disorder. Treatment should only be initiated if
other treatments are ineffective or
not tolerated (see Section 4.3, 4.4 and Section 4.6) and the benefit
and risk should be carefully
reconsidered at regula