TRANSLARNA 250 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 250 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. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

تاريخ الترخيص:

2020-07-31

نشرة المعلومات

1
Translarna-125-250-1000-PIL-0723-V2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
TRANSLARNA 125 MG
TRANSLARNA 250 MG
TRANSLARNA 1000 MG
GRANULES FOR ORAL SUSPENSION
NAME AND QUANTITY OF ACTIVE INGREDIENTS
Translarna 125 mg
Each sachet of granules contains 125 mg of ataluren.
Translarna 250 mg
Each sachet of granules contains 250 mg of ataluren.
Translarna 1000 mg
Each sachet of granules contains 1000 mg of ataluren.
FOR INACTIVE INGREDIENTS IN THIS PRODUCT, see section 6 'ADDITIONAL
INFORMATION' in this
leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your 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 to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Translarna is intended for treating Duchenne muscular dystrophy caused
by a mutation in
the gene that allows normal muscle function. Duchenne disease is
caused by a problem in a
muscle protein called dystrophin. As a result, the muscles do not work
properly.
Translarna enables the production of normal dystrophin and in this way
helps muscles work
properly
.
This medicine is intended for patients with Duchenne muscular
dystrophy who have been
shown to carry a mutation in the dystrophin gene based on a genetic
test, are aged 2 years
or older, and are able to walk.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to ataluren or to any of the other
ingredients this medicine
contains, see section 6
‘
ADDITIONAL INFORMATION
’
.
•
You are receiving aminoglycoside antibiotics such as gentamicin,
tobramycin or
streptomycin by injection into a vein.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
•
If you have kidney problems, you must be under regular medical
sup

خصائص المنتج

1
Translarna-125-250-1000-SPC-0723-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).
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 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.
2
Translarna-125-250-1000-SPC-0723-V1
WEIGHT
RANGE
(KG)
NUMBER OF SACHETS
MORNING
MIDDAY
EVENING
125
MG
SACH
ETS
250
MG
SACHET
S
1000
MG
SACH