TRANSLARNA 1000 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ATALUREN

متاح من:

MEDISON PHARMA LTD

ATC رمز:

M09AX03

الشكل الصيدلاني:

GRANULES FOR ORAL SUSPENSION

تركيب:

ATALUREN 1000 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PTC THERAPEUTICS INTERNATIONAL LIMITED, IRELAND

المجال العلاجي:

ATALUREN

الخصائص العلاجية:

Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Efficacy has not been demonstrated in non-ambulatory patients. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

تاريخ الترخيص:

2020-07-31

نشرة المعلومات

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_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ _
_ _
_ _
_ ןכדועמ(_
_ ןכדועמ(_
_ ןכדועמ(_
_.102.50_
_.102.50_
_.102.50_
_)_
_)_
_)_
_ _
_ _
_ _
______ ךיראת
51.51.51
________ םושירה רפסמו תילגנאב רישכת םש
01
/
00
-
34264
-
26
-
Translarna 125 mg 154
01
/
00
-
34266
-
27
-
Translarna 250 mg 154
01
/
00
-
34267
-
28
-
Translarna 1000 mg 154
___ םושירה לעב םש
__
מ"עב המראפ ןוסידמ
_____
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
CLINICAL EFFICACY AND
SAFETY
The mean change in timed function tests
from baseline to Week 48 was better in
the ataluren 10-, 10-, 20-mg/kg arm than
placebo in time to run/walk 10 meters
(better by 1.
4
seconds), time to climb 4
stairs (better by 2.4 seconds), and time to
descend 4 stairs (better by 1.6 seconds),
Figure 3.
The mean change in timed
function tests from baseline to
Week 48 was better in the
ataluren 10-, 10-, 20-mg/kg arm
than placebo in time to run/walk
10 meters (better by 1.5seconds),
time to climb 4 stairs (better by
2.4 seconds), and time to descend
4 stairs (better by 1.6 seconds),
Figure 3.
_ _

خصائص المنتج

Translarna-125-250-1000-SPC-0620-V1
Physician's Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
Translarna 125 mg
Translarna 250 mg
Translarna 1000 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Translarna 125 mg, granules for oral suspension.
Each sachet contains 125 mg ataluren.
Translarna 250 mg, granules for oral suspension.
Each sachet contains 250 mg ataluren.
Translarna 1000 mg, granules for oral suspension.
Each sachet contains 1000 mg ataluren.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Translarna is indicated for the treatment of Duchenne muscular
dystrophy resulting from a
nonsense mutation in the dystrophin gene, in ambulatory patients aged
2 years and older (see
section 5.1). Efficacy has not been demonstrated in non-ambulatory
patients.
The presence of a nonsense mutation in the dystrophin gene should be
determined by genetic
testing (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION_ _
Treatment with Translarna should only be initiated by specialist
physicians with experience in
the management of Duchenne/Becker muscular dystrophy.
Posology
Ataluren should be administered orally every day in 3 doses.
The first dose should be taken in the morning, the second at midday,
and the third in the
evening. Recommended dosing intervals are 6 hours between morning and
midday doses,
6 hours between midday and evening doses, and 12 hours between the
evening dose and the
first dose on the next day.
The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg
body weight at midday,
and 20 mg/kg body weight in the evening (for a total daily dose of 40
mg/kg body weight).
Translarna-125-250-1000-SPC-0620-V1
Translarna is available in sachets of 125 mg, 250 mg or 1000 mg. The
table below provides
information on which sachet strength(s) to use in the preparation of
the recommended dose by
body weight range.
WEIGHT
RANGE
(KG)
NUMBER OF SACHETS
MORNING