Riluzole Zentiva
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
22-11-2022
Valmisteyhteenveto
(SPC)
22-11-2022
Julkisesta arviointikertomuksesta
(PAR)
23-05-2012
Aktiivinen ainesosa:
Riluzole
Saatavilla:
Zentiva k.s.
ATC-koodi:
N07XX02
INN (Kansainvälinen yleisnimi):
riluzole
Terapeuttinen ryhmä:
Other nervous system drugs
Terapeuttinen alue:
Amyotrophic Lateral Sclerosis
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 13
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2012-05-07
Pakkausseloste
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
Lue koko asiakirja
Valmisteyhteenveto
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
Lue koko asiakirja
