INOVELON

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Rufinamide 200mg

Предлага се от:

Eisai New Zealand Limited

дозиране:

200 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Rufinamide 200mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry pink 00F44042 Sodium laurilsulfate

Вид предписание :

Prescription

Терапевтични показания:

INOVELON is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, PA/Al/PVC/Al-polyamide-aluminium foil-polyvinylchloride/aluminium foil - 10 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PA/Al/PVC/Al-polyamide-aluminium foil-polyvinylchloride/aluminium foil - 30 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PA/Al/PVC/Al-polyamide-aluminium foil-polyvinylchloride/aluminium foil - 50 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PA/Al/PVC/Al-polyamide-aluminium foil-polyvinylchloride/aluminium foil - 60 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PA/Al/PVC/Al-polyamide-aluminium foil-polyvinylchloride/aluminium foil - 100 tablets - 48 months from date of manufacture stored at or below 30°C

Дата Оторизация:

2019-09-18

Листовка

Eisai New Zealand Ltd.
Version 1
1
INOVELON

RUFINAMIDE FILM-COATED TABLETS
_(ru-fin-a-mide) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Inovelon.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT INOVELON IS
USED FOR
Inovelon is used with other
medicines to treat seizures
associated with Lennox-Gastaut
syndrome in adults, adolescents
and children from 4 years of
age.
Lennox-Gastaut syndrome is the
name given to a group of severe
epilepsies in which you may
experience repeated seizures of
various types.
Inovelon has been given to you
by your doctor to reduce the
number of your seizures or fits.
It contains the active ingredient
rufinamide. Rufinamide belongs
to a group of medicines called
anti epileptics.
It works by reducing the number
of fits that you have.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
INOVELON
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:

Rufinamide, the active
ingredient, or to any of the
other ingredients listed at the
end of this leaflet under
Product Description
INOVELON TABLETS CONTAIN
LACTOSE.
If you have been told by your
doctor that you have intolerance
to some sugars, tell your doctor
before taking Inovelon.
Some of the symptoms of an
allergic reaction may include:

shortness of breath

wheezing or difficulty
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching or hives on the
skin

Данни за продукта

Inovelon Data Sheet Version 1.0
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
INOVELON 100 mg, 200 mg and 400 mg film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INOVELON 100 mg film coated tablet contains 100 mg rufinamide.
Each INOVELON 200 mg film coated tablet contains 200 mg rufinamide.
Each INOVELON 400 mg film coated tablet contains 400 mg rufinamide.
Excipients with known effects:
Each 100 mg film coated tablet contains 20 mg lactose monohydrate.
Each 200 mg film coated tablet contains 40 mg lactose monohydrate.
Each 400 mg film coated tablet contains 80 mg lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
INOVELON 100 mg film coated tablets: Pink, oval, slightly convex,
scored on both sides,
embossed ‘Є261’ on one side and blank on the other side. The
tablet can be divided into
equal doses.
INOVELON 200 mg film coated tablets: Pink, oval, slightly convex,
scored on both sides,
embossed ‘Є262’ on one side and blank on the other side. The
tablet can be divided into
equal doses.
INOVELON 400 mg film coated tablets: Pink, oval, slightly convex,
scored on both sides,
embossed ‘Є263’ on one side and blank on the other side. The
tablet can be divided into
equal doses.
Inovelon Data Sheet Version 1.0
Page 2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
INOVELON is indicated as adjunctive therapy in the treatment of
seizures associated with
Lennox Gastaut syndrome in patients 4 years of age and older.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with INOVELON should be initiated by a physician specialised
in paediatrics or
neurology with experience in the treatment of epilepsy.
INOVELON should be taken twice daily in two equally divided doses, one
in the morning
and one in the evening.
USE IN CHILDREN FOUR YEARS OF AGE OR OLDER AND LESS THAN 30 KG
_Patients not receiving valproate: _
Treatment should be initiated at a total daily dose of 200 mg.
According to clinical response
and tolerability, the total daily