TRANSLARNA 125 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

ATALUREN

から入手可能:

MEDISON PHARMA LTD

ATCコード:

M09AX03

医薬品形態:

GRANULES FOR ORAL SUSPENSION

構図:

ATALUREN 125 MG

投与経路:

PER OS

処方タイプ:

Required

製:

PTC THERAPEUTICS INTERNATIONAL LIMITED, IRELAND

治療領域:

ATALUREN

適応症:

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 testingבקשה לשינוי משטר מינון: 1/12/2020Renal impairmentSafety and efficacy of ataluren in patients with renal impairment has not been established. No dosage adjustment is required for patients with mild or moderate renal impairment. Treatment of patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease is not recommended (see sections 4.4 and 5.2).

承認日:

2020-07-31

製品の特徴

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