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TRANSLARNA Granules for oral suspension (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Translarna 125 mg granules for oral suspension. Translarna 250 mg granules for oral suspension. Translarna 1000 mg granules for oral suspension.

2. Qualitative and quantitative composition

<u>Translarna 125 mg granules for oral suspension:</u> Each sachet contains 125 mg ataluren. <u>Translarna 250 mg granules for oral suspension:</u> Each sachet contains 250 mg ataluren. <u>Translarna 1000 ...

3. Pharmaceutical form

Granules for oral suspension. White to off-white granules.

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 ...

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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).

4.4. Special warnings and precautions for use

Patients who do not have a nonsense mutation Patients must have a nonsense mutation in the dystrophin gene as part of their underlying disease state, as determined by genetic testing. Patients who do not ...

4.5. Interaction with other medicinal products and other forms of interaction

Aminoglycosides Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3). ...

4.6. Pregnancy and lactation

Pregnancy There are no adequate data from the use of ataluren in pregnant women. Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3). ...

4.7. Effects on ability to drive and use machines

The effect of ataluren on driving, on cycling, or on using machines has not been tested. Patients who experience dizziness should use caution when driving, cycling or using machines.

4.8. Undesirable effects

Summary of the safety profile The safety profile of ataluren is based on pooled data from two randomised, double-blind, 48-week placebo-controlled studies conducted in a total of 232 male patients with ...

4.9. Overdose

Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea. No serious adverse reactions were observed ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system ATC code: M09AX03 Mechanism of action A nonsense mutation in DNA results in a premature stop codon within an mRNA. This ...

5.2. Pharmacokinetic properties

Administration of ataluren on a body weight-adjusted basis (mg/kg) resulted in similar steady-state exposures (AUC) among children and adolescents with nmDMD over a broad range of body weights. Although ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity. A standard package of reproduction toxicity studies was available. No effects ...

6.1. List of excipients

Polydextrose (E1200) Macrogol Poloxamer Mannitol (E421) Crospovidone Hydroxyethyl cellulose Artificial vanilla flavour: maltodextrin, artificial flavours and propylene glycol. Silica, colloidal anhydrous ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years. Each prepared dose is best administered immediately after preparation. The prepared dose should be discarded if not consumed within 24 hours of preparation if kept refrigerated (2–8°C), or within ...

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after dilution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (colouring and polyester/foil bond), aluminium foil (moisture barrier), adhesive (polyurethane class), ...

6.6. Special precautions for disposal and other handling

Sachets should only be opened at the time of dose preparation. The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice), or 3 tablespoons of semi-solid ...

7. Marketing authorization holder

PTC Therapeutics International Limited, 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

8. Marketing authorization number(s)

Translarna 125 mg granules for oral suspension: EU/1/13/902/001 Translarna 250 mg granules for oral suspension: EU/1/13/902/002 Translarna 1000 mg granules for oral suspension: EU/1/13/902/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31 July 2014 Date of latest renewal: 23 July 2020

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