DEPALEPT SYRUP

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

VALPROIC ACID AS SODIUM

から入手可能:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATCコード:

N03AG01

医薬品形態:

SYRUP

構図:

VALPROIC ACID AS SODIUM 40 MG/ML ML

投与経路:

PER OS

処方タイプ:

Required

製:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

治療群:

VALPROIC ACID

治療領域:

VALPROIC ACID

適応症:

Generalized or partial epilepsy secondary generalized epilepsy and mixed forms of epilepsy.

承認日:

2023-07-31

情報リーフレット

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
Depalept syrup 200 mg/5 ml
Depalept 200 mg enteric-coated tablets
Depalept 500 mg enteric-coated tablets
Depalept syrup
Sodium Valproate 200 mg/5 ml
Depalept 200 mg
Enteric-coated tablets, each tablet contains:
Sodium Valproate 200 mg
Depalept 500 mg
Enteric-coated tablets, each tablet contains:
Sodium Valproate 500 mg
Inactive ingredients and allergens in the
preparation – see section 6 and section 2
“Important information about some of the
ingredients of the medicine”.
Read the entire leaflet carefully before using
the medicine. This leaflet contains concise
information about the medicine. If you have any
other questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others.
It may harm them even if it seems to you that their
medical condition is similar.
The medicine is not intended for children weighing
less than 17 kg.
Warning
DEPALEPT MAY SEVERELY HARM THE FETUS WHEN
taken during pregnancy
Neonates born to mothers who have taken
valproate during pregnancy are at an increased
risk of serious developmental disorders )mental
and physical( and behavioral disorders
)approximately 30-40% of cases( and/or
congenital malformations )approximately 11%
of cases(.
If you are a woman of childbearing age or if you
are pregnant, the doctor will prescribe valproate
for you only if other treatments are unsuitable.
Women of childbearing age should use
effective contraception while taking this
medicine. If despite using contraception you
become pregnant unintentionally, contact your
doctor immediately in order to discuss the
options for alternative therapy, if possible.
Do not stop using the medicine without
consulting the treating doctor, because your
condition may worsen.
In addition to the leaflet, the Depalept
preparation has a patient safety information card.
This card contains important safety information
tha

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Depalept 200 enteric coated tablets
Depalept 500 enteric coated tablets
Depalept Syrup
Depalept oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Depalept 200 enteric coated tablets_:
Sodium valproate
200 mg/tab
_Depalept 500 enteric coated tablets_:
Sodium valproate
500 mg/tab
_Depalept Syrup_:
Each 5 ml contains: Sodium Valproate
200 mg/5ml
_Depalept oral Solution_:
Each ml contains: Sodium Valproate
200 mg/1ml
This medicinal product contains sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Depalept 200 enteric coated tablets
Depalept 500 enteric coated tablets
Depalept Syrup
Depalept oral Solution
Patient safety information Card
The marketing of Depalept is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that the
patient should be aware of before and during treatment. Please explain
to the patient the need to review
the card before starting treatment.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Depalept is indicated for the treatment of generalized or partial
epilepsy secondary generalized
epilepsy and mixed forms of epilepsy.
4.2.
Posology and method of administration
In female children, female adolescents, women of childbearing
potential and pregnant women
Depalept 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 Section 4.6) and the benefit and risk should be
carefully reconsidered at regular
treatment reviews. Preferably Depalept should be prescribed as
monotherapy and at the lowest
effective dose, if possible as a prolonged release formulation. The
daily dose should be divided into
at least two single doses.
In view of the dosage strength this medicinal product is for use in
adults and children weighing o