Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Riluzole
Zentiva k.s.
N07XX02
riluzole
Other nervous system drugs
Amyotrophic Lateral Sclerosis
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.
Revision: 13
Authorised
2012-05-07
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Riluzole Zentiva 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases. Posology The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses. Special populations _Renal impairment_ Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4). _Elderly_ Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population. 3 _Hepatic impairment_ See sections 4.3, 4.4 and 5.2 _Paediatric population _ Riluzole Zentiva is not recommended for use paediat Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Riluzole Zentiva 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases. Posology The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses. Special populations _Renal impairment_ Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4). _Elderly_ Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population. 3 _Hepatic impairment_ See sections 4.3, 4.4 and 5.2 _Paediatric population _ Riluzole Zentiva is not recommended for use paediat Przeczytaj cały dokument