Land: Israël
Taal: Engels
Bron: Ministry of Health
ATALUREN
MEDISON PHARMA LTD
M09AX03
GRANULES FOR ORAL SUSPENSION
ATALUREN 1000 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. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.
2020-07-31
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 Lees het volledige document
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 Lees het volledige document