TEGLUTIK 5 MGML ORAL SUSPENSION

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

RILUZOLE

Fáanlegur frá:

MEGAPHARM LTD

ATC númer:

N07XX02

Lyfjaform:

SUSPENSION

Samsetning:

RILUZOLE 5 MG / 1 ML

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

ITALFARMACO S.A., SPAIN

Lækningarsvæði:

RILUZOLE

Ábendingar:

TEGLUTIK 5 mg/ml oral suspension is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).

Leyfisdagur:

2017-02-14

Upplýsingar fylgiseðill

.كعضو ةبقارمل برشلل ق
ّ
لعم للم/غلم ٥ كيتولچيت كلوانت ءانثأ
ةينيتور
·
نأ نكمم ضارعلأا هذه
ّ
نلأ ،سفنتلا يف تابوعص نم وأ لاعس نم
يناعت تنك
.)
ّ
يللاخلا نيتئرلا ضرم ىعد
ُ
ي يذلا( نيتئرلا يف ضرم ىلإ ريش
ُ
ت
ة
ّ
يفاضإ ة
ّ
يبناج ضارعأ
دحاو لمعتسم نم رثكأ ىدل رهظت ة
ّ
يبناج ضارعأ – ادج ةعئاش ة
ّ
يبناج ضارعأ
:ةرشع نم
قاهرإ
ضرملاب روعش
مدلا يف )نيملأا تلاقان( دبكلا تاميزنإ
تايوتسم يف عافترا
:١٠٠ نيب نم نيلمعتسم ١٠-١ ىدل رهظت
ةيبناج ضارعأ – ةعئاش ة
ّ
يبناج ضارعأ
راود
مفلا يف زخو وأ ردخ
تاؤيقت
ساعن
بلقلا ةريتو يف عافترا
لاهسإ
عاد
ُ
ص
نطب ملأ
ملأ
:١,٠٠٠ نيب نم نيلمعتسم ١٠-١ ىدل رهظت
ضارعأ – ةعئاش ريغ ة
ّ
يبناج ضارعأ
مد رقف
ي
ّ
سسحت لعف در
سايركنبلا باهتلا
،لوزولير صارقأ نم ربكأ ةعرسب هصاصتما
متي لوزولير برشلا ق
ّ
لعم نأ ىلإ ا
ً
رظن
تايوتسم يف عافتراو لاهسلإا ،راودلا
،قاهرلإا يف فيفخ عافترا لوصح نكمملا نم
.مدلا يف )نيملأا تلاقان( دبكلا تاميزنإ
ضارعأ نم تيناع اذإ وأ ة
ّ
يبناجلا ضارعلأا دحأ مقافت اذإ ،يبناج
ضرع رهظ اذإ
.بيبطلا ةراشتسا كيلعف ،ةرشنلا يف
ةروكذم ريغ ة
ّ
يبناج
:ة
ّ
يبناجلا ضارعلأا نع غيلبتلا
طبارلا ىلع طغضلا للاخ نم ة
ّ
يبناج ضارعأ نع ة
ّ
حصلا ةرازو غيلبت نكمملا نم
يف ةيسيئرلا ةحفصلا ىلع دوجوملا
"ةيودلأاب جلاع ةجيتن ة
ّ
يبناج ضارعأ نع

Vara einkenni

Page
1
of
10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TEGLUTIK 5 MG/ML ORAL SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral suspension contains 5 mg of riluzole
Excipients with known effects: 1 ml of oral suspension contains 400 mg
of sorbitol E420
(equivalent to 571.43 mg of liquid sorbitol (70%w/w).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Slightly brown, opaque homogeneous suspension after being manually
shaken.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TEGLUTIK 5 MG/ML ORAL SUSPENSION is indicated to extend life or the
time to
mechanical ventilation for patients with amyotrophic lateral sclerosis
(ALS).
Clinical trials have demonstrated that riluzole 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 TEGLUTIK 5 MG/ML ORAL SUSPENSION exerts a
therapeutic
effect on motor function, lung function, fasciculations, muscle
strength and motor symptoms.
TEGLUTIK 5 MG/ML ORAL SUSPENSION has not been shown to be effective in
the late
stages of ALS.
Safety and efficacy of TEGLUTIK 5 MG/ML ORAL SUSPENSION has only been
studied in
ALS. Therefore, TEGLUTIK 5 MG/ML ORAL SUSPENSION should not be used in
patients
with any other form of motor neurone disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with TEGLUTIK 5 MG/ML ORAL SUSPENSION should only be
initiated by
specialist physicians with experience in the management of motor
neurone diseases.
Posology
The recommended daily dose in adults or elderly is 100 mg (50 mg every
12 hours). No
significant increased benefit can be expected from higher daily doses.
Page
2
of
10
It is recommended to assume 10 ml two times a day of the suspension
(i.e. 10 ml corresponds to
50 mg of Riluzole).
Special populations
_Paediatric population_
:
TEGLUTIK 5 MG/ML ORAL SUSPENSION is not recommended for use in
paediatric
population, due to a la