البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ATALUREN
MEDISON PHARMA LTD
M09AX03
GRANULES FOR ORAL SUSPENSION
ATALUREN 250 MG
PER OS
Required
PTC THERAPEUTICS INTERNATIONAL LIMITED, IRELAND
ATALUREN
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.
2020-07-31
_ _ _ _ _ _ _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. _ _ اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة