Verenigde Staten - Engels - NLM (National Library of Medicine)

edw pharma, inc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - tiglutik is indicated for the treatment of amyotrophic lateral sclerosis (als). tiglutik is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)]. risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of tiglutik during pregnancy. data animal data oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. the mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (rhdd, 100 mg) on a mg/m2 basis. when riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. the no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the rhdd on a mg/m2 basis. maternal toxicity was observed at the highest dose tested in rat and rabbit. when riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. the mid dose, a no-effect dose for pre- and postnatal developmental toxicity, is approximately equal to the rhdd on a mg/m2 basis. risk summary there are no data on the presence of riluzole in human milk, the effects on the breastfed infant, or the effects on milk production. riluzole or its metabolites have been detected in milk of lactating rat. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tiglutik and any potential adverse effects on the breastfed infant from tiglutik or from the underlying maternal condition. in rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see nonclinical toxicology (13.1)]. safety and effectiveness in pediatric patients have not been established. in clinical studies of riluzole, 30% of patients were 65 years and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients with mild [child-pugh's (cp) score a] or moderate (cp score b) hepatic impairment had increases in auc, compared to patients with normal hepatic function. thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of tiglutik is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [see clinical pharmacology (12.3)]. japanese patients are more likely to have higher riluzole concentrations. consequently, the risk of adverse reactions may be greater in japanese patients [see clinical pharmacology (12.3)].

Australië - Engels - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - riluzole -

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - riluzole 50mg - film coated tablet - 50 mg - active: riluzole 50mg excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium hypromellose macrogol 6000 magnesium stearate microcrystalline cellulose titanium dioxide - riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (als).

Europese Unie - Spaans - EMA (European Medicines Agency)

zentiva k.s. - el riluzol - la esclerosis lateral amiotrófica - otras drogas del sistema nervioso - riluzole zentiva está indicado para prolongar la vida o el tiempo de ventilación mecánica para pacientes con esclerosis lateral amiotrófica (ela). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. la supervivencia fue definido como pacientes que estaban vivos, no intubados para la ventilación mecánica y la traqueotomía libre. no hay ninguna evidencia de que el riluzole zentiva ejerce un efecto terapéutico sobre la función motora, la función pulmonar, fasciculaciones, la fuerza muscular y los síntomas motores. riluzole zentiva no ha sido demostrado ser eficaz en las etapas finales de la ela. la seguridad y la eficacia de riluzole zentiva sólo ha sido estudiado en la ela. por lo tanto, riluzole zentiva no debe ser utilizado en pacientes con cualquier otra forma de motor-enfermedad de la neurona.

Taiwan - Chinees - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

吉帝藥品股份有限公司 台中市北屯區綏遠路二段216之5號6樓、216號地下一層 (16647167) - riluzole - 膜衣錠 - riluzole (9200037100) mg - riluzole - 肌萎縮脊髓側索硬化症（ＡＭＹＯＴＲＯＰＨＩＣ　ＬＡＴＥＲＡＬ　ＳＣＬＥＲＯＳＩＳ，ＡＬＳ）。

Europese Unie - Portugees - EMA (European Medicines Agency)

zentiva k.s. - riluzol - esclerose lateral amiotrófica - outros medicamentos do sistema nervoso - riluzole zentiva está indicado para prolongar a vida ou o tempo para ventilação mecânica para pacientes com esclerose lateral amiotrófica (als). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. a sobrevivência foi definido como pacientes que estavam vivos, e não entubado para ventilação mecânica e traqueostomia-livre. não há nenhuma evidência de que riluzol zentiva exerce um efeito terapêutico no motor de função, função pulmonar, fasciculações, a força muscular e sintomas motores. riluzol zentiva não foi mostrado para ser eficaz em fases tardias da als. a segurança e a eficácia do riluzol zentiva só tem sido estudado em als. portanto, o riluzol zentiva não deve ser utilizado em pacientes com qualquer outra forma de motor-doença do neurônio.

Frankrijk - Frans - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

zambon spa - riluzole 50 - film - pour un film orodispersible > riluzole 50,00 mg - la substance active contenue dans emylif est le riluzole qui agit sur le système nerveux.emylif est prescrit chez les patients adultes atteints de sclérose latérale amyotrophique (sla).la sla est une forme de maladie du motoneurone qui affecte les cellules nerveuses responsables de l’envoi d’instructions aux muscles, ce qui entraîne une faiblesse musculaire, une atrophie musculaire et une paralysie.la destruction des cellules nerveuses dans les maladies du motoneurone peut être provoquée par une quantité trop importante de glutamate (un messager chimique) dans le cerveau et la moelle épinière. emylif bloque la libération de glutamate, ce qui peut contribuer à empêcher la destruction des cellules nerveuses.veuillez consulter votre médecin pour des informations complémentaires sur la sla et les raisons pour lesquelles ce médicament vous a été prescrit.

Ierland - Engels - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - riluzole - film coated tablet - 50 milligram

Europese Unie - Sloveens - EMA (European Medicines Agency)

zentiva k.s. - riluzola - amiotrofična lateralna skleroza - druga zdravila na živčnem sistemu - zdravilo riluzole zentiva je indicirano, da podaljša življenjsko dobo ali čas do mehanskega prezračevanja pri bolnikih z amiotrofično lateralno sklerozo (als). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. preživetje je bil opredeljen kot bolniki, ki so bili živi, ne intubated za mehansko prezračevanje in tracheotomy-brezplačno. ni dokazov, da riluzola zentiva privlačnost terapevtski učinek na motor funkcija, delovanje pljuč, fascikulacijama, mišične moči in motorične simptome. riluzola zentiva ne bi bilo dokazano, da so učinkovite v poznih fazah als. varnost in učinkovitost riluzola zentiva je samo študiral v als. zato, riluzola zentiva ne sme uporabljati pri bolnikih s katero koli drugo obliko motornih-neurone bolezni.

Europese Unie - Italiaans - EMA (European Medicines Agency)

zentiva k.s. - riluzolo - sclerosi laterale amiotrofica - altri farmaci sul sistema nervoso - riluzolo zentiva è indicato per estendere la vita o il tempo alla ventilazione meccanica per i pazienti con sclerosi laterale amiotrofica (sla). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. la sopravvivenza è stata definita come pazienti che erano vivi, non intubato per la ventilazione meccanica e la tracheotomia-libero. non vi è alcuna prova che il riluzolo zentiva esercita un effetto terapeutico sulla funzione motoria, la funzione polmonare, fascicolazioni, la forza muscolare e sintomi motori. riluzolo zentiva non è stato dimostrato di essere efficace nelle fasi tardive della sla. la sicurezza e l'efficacia di riluzolo zentiva è stata studiata solo in als. pertanto, il riluzolo zentiva non deve essere usato in pazienti con qualsiasi altra forma di motore-la malattia del neurone.