FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 07 May 2012 Date of latest renewal: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: 7. maj 2012 Dato for seneste fornyelse: 09. januar 2017
English: See sections 4.3, 4.4 and 5.2
Danish: 4.3, 4.4 og 5.2.
English: ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.
Danish: I de første 3 måneder bør ALAT måles hver måned, resten af det første år hver 3. måned, og derefter periodevis.
English: The mode of action is unclear.
Danish: Virkningsmekanismen er uklar.
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Danish: U kabelovny 130 102 37 Prag 10 Tjekkiet
English: Patients should be warned to report any febrile illness to their physicians.
Danish: Patienterne bør indskærpes, at enhver febril sygdom skal rapporteres til deres læge.
English: The volume of distribution of riluzole is about 245 ± 69 L (3.4 L/kg).
Danish: Distributionsvolumen for riluzol er ca. 245 ± 69 l (3,4 l/kg).
English: Riluzole Zentiva
Danish: Riluzol Zentiva
English: If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Danish: Hvis du oplever noget af ovenstående, eller hvis du føler dig usikker, så fortæl det til din læge, som vil beslutte, hvad der skal gøres.
English: Intensive testing in seven other standard in vitro or in vivo assays did not show any genotoxic potential of the metabolite.
Danish: Intensiv testning i syv andre standard in vitro eller in vivo forsøg viste ikke noget genotoksisk potentiale for metabolitten.
English: The overall urinary excretion accounts for about 90% of the dose.
Danish: Den samlede udskillelse i urinen udgør ca. 90 % af dosis.
English: No malformations were seen in animal reproductive studies.
Danish: Der blev ikke observeret misdannelser i dyrereproduktionsstudierne.
English: Very common Common
Danish: Meget almindelige
English: Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Danish: Få mere information hos din læge om ALS og hvorfor du får denne medicin
English: Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or operate machinery if these symptoms occur.
Danish: Patienter bør advares om muligheden for at opleve svimmelhed eller vertigo, og de bør opfordres til ikke at køre bil eller betjene maskiner, hvis disse symptomer opstår.
English: The tablets are film-coated, capsule-shaped and white.
Danish: Tabletterne er filmovertrukne, kapselformede og hvide.
English: Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
Danish: Din læge kan ønske at tage blodprøver for at kontrollere antallet af hvide blodlegemer, som er vigtige for at kunne bekæmpe infektioner.
English: Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
Danish: Overlevelse er defineret som patienter, der var i live uden at være intuberet for mekanisk ventilation og uden trakeostomi.
English: It is not known whether riluzole is excreted in human milk.
Danish: Det vides ikke, om riluzol udskilles i human mælk.
English: Only 2% of a riluzole dose was recovered unchanged in the urine.
Danish: Kun 2 % af en riluzol dosis blev genfundet uomdannet i urinen
English: Riluzole is eliminated mainly in the urine.
Danish: Riluzol udskilles hovedsagelig i urinen.
English: The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Danish: Hastigheden og graden af absorption reduceres, når riluzol gives med fedtholdige måltider (fald i Cmax på 44 %, fald af AUC på 17 %).
English: Patients who are pregnant or breast-feeding.
Danish: Patienter, som er gravide eller ammer.
English: Study data indicate that Asian patients may be more susceptible to liver function test abnormalities3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Danish: Data fra studier indikerer, at asiatiske patienter kan være mere udsatte for unormale leverfunktionstests - 3,2 % (194/5995) af asiatiske patienter mod 1,8 % (100/5641) af patienter med kaukasisk afstamning.
English: Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Danish: Riluzol er ca. 97 % proteinbundet og bindes hovedsageligt til serumalbumin og lipoproteiner.
English: Riluzole is extensively distributed throughout the body and has been shown to cross the blood brain barrier.
Danish: Riluzol fordeles i hele kroppen og har vist sig at passere blod-hjernebarrieren.
English: The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours).
Danish: Anbefalet daglig dosis for voksne og ældre er 100 mg (50 mg hver 12. time).
English: Standard tests for genotoxicity performed with riluzole were negative.
Danish: Standardtests for genotoxicitet udført med riluzol var negative.
English: If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking Riluzole Zentiva.
Danish: Hvis du har mistanke om, du er gravid, eller hvis du overvejer at amme, skal du spørge din læge til råds, før du tager Riluzol Zentiva.
English: Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent.
Danish: Plasmaniveauerne stiger lineært med dosis, og den farmakokinetiske profil er dosis-uafhængig.
English: In the majority of the reported cases, symptoms resolved after medicinal product discontinuation and symptomatic treatment.
Danish: I de fleste af de rapporterede tilfælde forsvandt symptomerne efter seponering af lægemidlet og ved behandling af symptomerne.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Danish: Farmakoterapeutisk klassifikation: Centralnervesystemet, øvrige lægemidler, ATC kode: N07XX02
English: Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring within 60 to 90 minutes (Cmax=173 ± 72 (sd) ng/ml).
Danish: Riluzol absorberes hurtigt efter peroral administration med maksimal plasmakoncentration efter 60 til 90 minutter (Cmax = 173 ± 72 (SD) ng/ml).
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
Danish: Overtræk: hypromellose, macrogol 6000 og titandioxid (E171).
English: Although the pathogenesis of ALS is not completely elucidated, it is suggested that glutamate (the primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the disease.
Danish: Skønt patogenesen ved ALS ikke er helt belyst, er der dog en formodning om, at glutaminat (den primære excitatoriske neurotransmitter i centralnervesystemet) spiller en stor rolle for celledød ved sygdommen.
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Danish: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne Frankrig
English: All these findings were noted at doses which were 2-10 times higher than the human dose of 100 mg/day.
Danish: De nævnte fund blev observeret ved doser 2-10 gange højere end den humane dosis på 100 mg/dag.
English: In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of treated compared to control female rats.
Danish: I en enkelt toksicitetsundersøgelse blev fravær af corporar lutea observeret ved en højere incidens i ovarier fra behandlede rotter sammenlignet med kontrolgruppe.
English: Each package contains 28, 56, 98, 112 or 168 tablets.
Danish: Hver pakning indeholder 28, 56, 98, 112 eller 168 tabletter.
English: Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
Danish: Derfor bør Riluzol Zentiva ikke bruges til patienter med andre former af motor-neuronsygdomme.
English: Riluzole Zentiva stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Danish: Riluzol Zentiva forhindrer frigivelsen af glutamat og dette kan hjælpe med at forebygge, at nerveceller bliver ødelagt.
English: Riluzole did not show any carcinogenicity potential in either rats or mice.
Danish: Riluzol viser ingen tegn på carcinogene egenskaber hverken i mus eller rotter.
English: On the basis of these data, and taking into consideration the negative studies on the carcinogenesis of riluzole in the mouse and rat, the genotoxic effect of this metabolite is not considered to be of relevance in humans.
Danish: På basis af disse resultater og de negative forsøg af riluzols carcinogenese på mus og rotter taget i betragtning anses den genotoksiske effekt af denne metabolit for værende uden relevans for mennesker.
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Danish: ALS er en form for motor-neuronsygdom, hvor angreb på de nerveceller, der er ansvarlige for at sende instruktioner til musklerne, fører til muskelsvaghed, muskeltab og lammelse.
English: Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Danish: Behandling med Riluzol Zentiva bør kun iværksættes af speciallæger med erfaring i behandling af motor-neuronsygdomme.
English: The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord.
Danish: Ødelæggelsen af nervecellerne i motor-neuronsygdomme kan skyldes for meget glutamat (et kemisk stof) i hjernen og rygmarven.
English: Reductions in red blood cell parameters and/or alterations in liver parameters were noted inconsistently in subacute and chronic toxicity studies in rats and monkeys.
Danish: Inkonsistente reduktioner i det røde blodbillede og/eller ændringer i leverparametrene blev observeret i de subakutte og kroniske toksicitetsundersøgelser hos rotter og aber.
English: The metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged riluzole.
Danish: Metabolitterne, som identificeres i urinen, er tre fenolderivater, et ureido-derivat og uomdannet riluzol.
English: In lactating rats, 14C-riluzole was detected in milk.
Danish: Hos diegivende rotter blev 14C-riluzol detekteret i mælken.
English: Tests on the major active metabolite of riluzole gave positive results in two in vitro tests.
Danish: Tests af riluzols væsentligste aktive metabolit gav positive resultater i to in vitro og in vivo tests.
English: 56 film-coated tablets 28 film-coated tablets 98 film-coated tablets 112 film-coated tablets 168 film-coated tablets
Danish: 56 filmovertrukne tabletter 28 filmovertrukne tabletter 98 filmovertrukne tabletter 112 filmovertrukne tabletter 168 filmovertrukne tabletter
English: There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN.
Danish: Der er ingen erfaring med dosisreduktion eller re-eksposition hos patienter, som har udviklet ALAT stigning til 5 gange normalværdien.
English: Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8).
Danish: Der har været rapporteret om tilfælde af interstitiel lungesygdom hos patienter i behandling med riluzol, hvoraf nogle var alvorlige (se afsnit 4.8).
English: In this study, the efficacy was assessed on inability to walk alone, loss of upper limb function, tracheostomy, need for artificial ventilation, gastric tube feeding or death.
Danish: I dette studie blev effekten målt på manglende evne til at gå alene, tab af funktionsevne i de øvre lemmer, tracheostomi, behov for kunstig ventilering, fødeindtagelse gennem sonde eller død.
English: Meta-analysis including this study and those described above showed a less striking effect on survival for riluzole as compared to placebo although the differences remained statistically significant.
Danish: Meta-analyser, der inkluderede dette studie og de ovenfor nævnte, viste en mindre tydelig effekt på overlevelse i riluzol-gruppen sammenlignet med placebo, selvom forskellene forblev statistisk signifikante.
English: Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole.
Danish: På grund af risikoen for hepatitis skal serum-aminotransferaser, inklusive ALAT, måles før og under behandling med riluzol.
English: If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is no information available in this population.
Danish: Hvis du er under 18 år, anbefales det ikke, at du tager Riluzol Zentiva, da der ikke er nogen information tilgængelig for denne patientgruppe.
English: The effect of riluzole 50 mg/day was not statistically significant compared to placebo and the effect of 200 mg/day was essentially comparable to that of 100 mg/day.
Danish: Effekten af riluzol 50 mg/dag var ikke signifikant forskellig fra placebo, og effekten af 200 mg/dag var i al væsentlighed sammenlignelig med 100 mg/dag.
English: Tablets are packaged in opaque pvc/aluminium blister cards.
Danish: Tabletterne er pakket i matte PVC/aluminium blisterkort.
English: Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population.
Danish: Med udgangspunkt i de farmakokinetiske undersøgelser, er der ingen særlige anvisninger for brug af Riluzol Zentiva i denne patientgruppe.
English: You MUST NOT take Riluzole Zentiva if you are or think you may be pregnant, or if you are breast-feeding.
Danish: Du må ikke tage Riluzol Zentiva, hvis du er gravid eller ammer, eller har mistanke om, at du er gravid.
English: This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Danish: Denne metabolit konjugeres hurtigt med glukuronsyre til O- og N- glukuronider.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Danish: Det aktive indholdsstof i Riluzol Zentiva er riluzol, som virker på nervesystemet.
English: There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Danish: Der er intet bevis for, at Riluzol Zentiva udviser terapeutisk effekt på den motoriske funktion, på lungefunktion, facikulationer, muskelstyrke og motoriske symptomer.
English: There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products.
Danish: Der er ingen kliniske studier, der har vurderet interaktion mellem riluzol og andre lægemidler.
English: Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
Danish: Neurologiske og psykiatriske symptomer, akut toxisk encefalopati med feberdøs, koma og methæmoglobinæmi er blevet observeret i enkelte tilfælde.
English: Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Danish: (f.eks. caffein, diclofac, diazepam, nicergolin, clomepramin, imipramin, fluvoxamin, phenacetin, theophyllin, amitriptylin, og quinoloner) kan potentielt nedsætte riluzols eliminations-hastighed, hvorimod stoffer, der fremmer CYP1A2 (f.eks. cigaretrygning, grillmad, rifampicin og omeprazol) kan øge eliminationshastigheden af riluzol.
English: Clinical experience with riluzole in pregnant women is lacking.
Danish: Klinisk erfaring med riluzol mangler hos gravide.
English: In a parallel group study designed to assess the efficacy and safety of riluzole in patients at a late stage of the disease, survival time and motor function under riluzole did not differ significantly from that of placebo.
Danish: I en parallel-gruppeundersøgelse designet til at bestemme effekten og sikkerheden af riluzol hos patienter i et sent stadium af sygdommen afveg overlevelse og motorisk funktion under riluzolbehandling ikke signifikant fra placebo.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PVC/ALUMINIUM BLISTER
English: Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Danish: Riluzolbehandling bør afbrydes, hvis ALAT værdierne stiger til 5 gange øvre normalværdi.
English: Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Danish: Riluzol Zentiva er ikke vist at være effektiv i behandlingen af de sene stadier af ALS.
English: Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Danish: Riluzol Zentiva anbefales ikke til pædiatriske patienter, pga. manglende data vedrørende riluzols sikkerhed og virkning ved neurodegenerative sygdomme hos børn og unge.
English: if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
Danish: - hvis du får hoste eller besvær med at trække vejret, da dette kan være tegn på en lungesygdom (som hedder interstitiel lungesygdom).
English: EU/1/12/768/001 - 56 film-coated tablets EU/1/12/768/002 - 28 film-coated tablets EU/1/12/768/003 - 98 film-coated tablets EU/1/12/768/004 - 112 film-coated tablets EU/1/12/768/005 - 168 film-coated tablets
Danish: EU/1/12/768/001 - 56 filmovertrukne tabletter EU/1/12/768/002 - 28 filmovertrukne tabletter EU/1/12/768/003 - 98 filmovertrukne tabletter EU/1/12/768/004 - 112 filmovertrukne tabletter EU/1/12/768/005 - 168 filmovertrukne tabletter
English: Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Danish: Øget alanin aminotransferase i de første tre måneder efter påbegyndt behandling med riluzol; det var oftest forbigående og niveauet vendte tilbage til under dobbelt ULN efter 2 til 6 måneder ved fortsat behandling.
English: Anaphylactoid reaction, angioedema
Danish: Anafylaktoid reaktion, angioødem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
Danish: Hos patienter behandlet med riluzol 100 mg/dag var overlevelsen signifikant forlænget sammenlignet med patienter, som fik placebo.
English: If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Danish: Hvis der opstår respiratoriske symptomer som tør hoste og/eller dyspnø, bør der tages et røntgenbillede af brystkassen, og ved tegn på eventuelle interstitielle lungesygdomme (f.eks. bilaterale diffuse lungeinfiltrater) bør behandling med riluzol seponeres øjeblikkeligt.
English: Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8).
Danish: Forhøjede baselineværdier af adskillige leverfunktionsprøver (især forhøjet bilirubin) bør udelukke brugen af riluzol (se pkt.
English: Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Danish: Fertilitetsstudier hos rotter viste en mindre forringelse af reproduktionsevne og fertilitet ved doser på 15 mg/kg/dag (hvilket er højere end den terapeutiske dosis).
English: Diarrhoea, abdominal pain, vomiting
Danish: Diarré, abdominalsmerter, opkastning
English: Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.
Danish: Leversygdom eller baseline-værdier af aminotransferaser på mere end 3 gange øvre normalgrænse.
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Danish: Hos patienter fra kliniske studier (n=20) hvor ALAT var forøget til mere end 5 gange ULN, blev behandlingen stoppet, og niveauet faldt til mindre end 2 gange ULN, i de fleste tilfælde inden for 2-4 måneder (se pkt.
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Danish: Riluzol Zentiva anvendes til patienter med amyotrofisk lateral sclerose (ALS).
English: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Danish: Riluzol bør gives med forsigtighed til patienter med anamnestisk patologisk leverfunktion eller til patienter med let forhøjede værdier af serum-aminotransferaser (ALAT, ASAT op til 3 gange de øvre normalværdier) bilirubin og/eller gamma-glutamyl transferase (GGT) niveauer.
English: Abnormal liver function tests
Danish: Abnorme leverfunktionstests
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til
English: Headache, dizziness, oral paraesthesia, somnolence
Danish: Hovedpine, svimmelhed, oral paræstesi og døsighed
English: Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Danish: Riluzol Zentiva fås i en pakning med 28, 56, 98, 112 eller 168 tabletter til oral anvendelse.
English: The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Danish: Den primære metaboliske vej for riluzol er initial oxidation af CYP1A2 fremstillende N-hydroxyriluzol (RPR112512) riluzols aktive hovedmetabolit.
English: Severe neutropenia (see section 4.4)
Danish: Alvorlig neutropeni (se pkt.
English: The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Danish: Den mediane overlevelse var 17,7 måneder for riluzol-gruppen mod 14,9 måneder for placebo-gruppen.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Danish: Hvis du har taget for mange tabletter, skal du straks kontakte din læge eller skadestue.
English: If you forget to take Riluzole Zentiva
Danish: Hvis du har glemt at tage Riluzol Zentiva