RILUTEK

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

RILUZOLE

Доступна с:

SANOFI ISRAEL LTD

код АТС:

N07XX02

Фармацевтическая форма:

FILM COATED TABLETS

состав:

RILUZOLE 50 MG

Администрация маршрут:

PER OS

Тип рецепта:

Required

Производитель:

SANOFI WINTHROP INDUSTRIE, FRANCE

Терапевтическая группа:

RILUZOLE

Терапевтические области:

RILUZOLE

Терапевтические показания :

Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).

Дата Авторизация:

2022-06-30

тонкая брошюра

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with
a doctor’s prescription only
RILUTEK 50 MG FILM COATED TABLETS
Active ingredient: Riluzole 50 mg
Inactive and allergenic ingredients in the preparation:
see section 6 “Further information” and section
2 “Important information regarding some of the
ingredients of the medicine”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the
medicine.
If you have further questions, refer to the doctor or
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 preparation is intended for the treatment of adults,
from the age of 18 years.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment of ALS (amyotrophic lateral sclerosis) –
a motor neuron disease.
ALS is a type of neuronal disease that impairs transfer of
information from the nerves to the muscles, which leads
to weakness, muscle impairment and paralysis.
THERAPEUTIC GROUP: The substance acts on the central
nervous system.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are SENSITIVE (ALLERGIC) to the active ingredient
or any of the additional ingredients contained in the
medicine (see section 6 “Further Information”).
You are suffering from a LIVER DISEASE or from an
increase in blood level of enzymes associated with
liver function (transaminases).
You are PREGNANT or BREASTFEEDING.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Do not use the medicine without consulting a doctor
before commencing treatment:
∙ If you are suffering from lIVER PROBLEMS: yellowing
of the skin or the white part of the eyes (jaundice),
itching all over the body, feeling sick or being sick.
∙ If your KIDNEYS are not functioning well.
∙ If you have any FEVER: it can be due to low white
blood cell count, which

Характеристики продукта

Rilutek-SPC-15.0
1
1.
NAME OF THE MEDICINAL PRODUCT
RILUTEK 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of riluzole
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The tablets are capsule-shaped, white and engraved with “RPR 202”
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RILUTEK is indicated to extend life or the time to mechanical
ventilation for patients with
amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that RILUTEK extends survival for
patients with ALS (see section
5.1). Survival was defined as patients who were alive, not intubated
for mechanical ventilation and
tracheotomy-free.
There is no evidence that RILUTEK exerts a therapeutic effect on motor
function, lung function,
fasciculations, muscle strength and motor symptoms. RILUTEK has not
been shown to be effective in
the late stages of ALS.
Safety and efficacy of RILUTEK has only been studied in ALS.
Therefore, RILUTEK should not be
used in patients with any other form of motor neurone disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with RILUTEK should only be initiated by specialist
physicians with experience in the
management of motor neurone diseases.
Posology
The recommended daily dose in adults or older people is 100 mg (50 mg
every 12 hours).
No significant increased benefit can be expected from higher daily
doses.
Rilutek tablets should be taken at least an hour before, or two hours
after a meal to avoid a food related
decrease in biovailability.
Special populations
_Impaired renal function _
RILUTEK is not recommended for use in patients with impaired renal
function, as studies at repeated
doses have not been conducted in this population (see section 4.4).
_Older people _
2
Based on pharmacokinetic data, there are no special instructions for
the use of RILUTEK in this
population.
_Impaired hepatic function_
See sections 4.3, 4.4 and 5.2.
_ _
_Paediatric population _
RILUTEK i