INOVELON 100 MG TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RUFINAMIDE

متاح من:

EISAI ISRAEL LTD., ISRAEL

ATC رمز:

N03AF03

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

RUFINAMIDE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EISAI MANUFACTURING LIMITED, UK

المجال العلاجي:

RUFINAMIDE

الخصائص العلاجية:

Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 1 year of age and older.

تاريخ الترخيص:

2016-01-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) 1986
This medicine is to be supplied by physician’s
prescription only
INOVELON 100 MG, FILM COATED TABLETS
INOVELON 200 MG, FILM COATED TABLETS
INOVELON 400 MG, FILM COATED TABLETS
COMPOSITION
ACTIVE INGREDIENTS:
Rufinamide 100 mg
Rufinamide 200 mg
Rufinamide 400 mg
For
the list
of
Inactive ingredients:
See section
“Additional information”.
READ THE ENTIRE LEAFLET
CAREFULLY BEFORE YOU
START
USING THIS MEDICINE.
This leaflet
contains
essential information about this medicine. If you have
any further questions,
refer to the physician or the
pharmacist.
This medicine has been prescribed to treat
your
illness. Do not pass it on to others. It may harm them,
even if it seems to you that their illness is similar.
INOVELON contains Rufinamide; this medicine belongs
to the class of anti-epileptic medicines used for the
treatment
of
epileptic seizures related to Lennox–
Gastaut syndrome.
Lennox–Gastaut
syndrome is characterized by recurrent
severe seizures appearing in different variations.
WHAT IS THIS MEDICINE INTENDED FOR?
INOVELON is administered as an addition to the treatment of
seizures related to Lennox–Gastaut
syndrome in patients
above the age of 4 years.
THERAPEUTIC GROUP: anti-convulsant
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You
are
sensitive
(allergic)
to
the
active
ingredient
Rufinamide or to other derivatives of the Triazole group or
to any of the other ingredients that this medicine contains
(please see 'Additional Information')
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE USING INOVELON, TELL YOUR PHYSICIAN IF:
• You suffer or have previously suffered from problems with
liver function. Since there is little information regarding the
use of INOVELON in people with liver diseases, the physician
may increase the dose more slowly. In severe cases, the
physician may decide that treatment with INOVELON is not
suitable for you.
• You or any of your family members suffer from a congenital

خصائص المنتج

PRESCRIBING INFORMATION
1.
NAME OF THE
MEDICINAL PRODUCT
INOVELON 100 MG TABLETS
INOVELON 200 MG TABLETS
INOVELON 400 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg rufinamide.
Excipients with known effect: 20 mg lactose monohydrate/film coated
tablet.
Each film-coated tablet contains 200 mg rufinamide.
Excipients with known effect: 40 mg lactose monohydrate/film coated
tablet.
Each film-coated tablet contains 400 mg rufinamide.
Excipients with known effect: 80 mg lactose monohydrate/film coated
tablet.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, ‘ovaloid’, slightly convex and scored on both sides.
INOVELON 100 MG TABLETS is embossed ‘Є261’ on one side and blank
on the other side
INOVELON 200 MG TABLETS is embossed ‘Є262’ on one side and blank
on the other side
INOVELON 400 MG TABLETS is embossed ‘Є263’ on one side and blank
on the other side
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INOVELON TABLETS is indicated as adjunctive therapy in the treatment
of seizures
associated with Lennox-Gastaut syndrome in patients 1 year of age and
older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with INOVELON TABLETS should be initiated by a physician
specialised in
paediatrics or neurology with experience in the treatment of epilepsy.
Posology
_USE IN CHILDREN FROM ONE YEAR TO LESS THAN FOUR YEARS OF AGE _
_ _
_Patients not receiving valproic acid (as sodium):_
Treatment should be initiated at a dose of 10 mg/kg/day administered
in two equally
divided doses separated by approximately 12 hours. According to
clinical response and
tolerability, the dose may be increased by up to 10 mg/kg/day every
third day to a target
dose of 45 mg/kg/day administered in two equally divided doses
separated by
approximately 12 hours. For this patient population, the maximum
recommended dose is
45 mg/kg/day.
Patients receiving _valproic acid_ (as sodium):
As valpro