natgillin/translations-raw huggingface dataset:
Der har været rapporteret om tilfælde af interstitiel lungesygdom hos patienter i behandling med riluzol, hvoraf nogle var alvorlige (se afsnit 4.8).
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8).
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.
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.
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.
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.
På grund af risikoen for hepatitis skal serum-aminotransferaser, inklusive ALAT, måles før og under behandling med riluzol.
Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole.
Hvis du er under 18 år, anbefales det ikke, at du tager Riluzol Zentiva, da der ikke er nogen information tilgængelig for denne patientgruppe.
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.
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.
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.
Tabletterne er pakket i matte PVC/aluminium blisterkort.
Tablets are packaged in opaque pvc/aluminium blister cards.
Med udgangspunkt i de farmakokinetiske undersøgelser, er der ingen særlige anvisninger for brug af Riluzol Zentiva i denne patientgruppe.
Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population.
Du må ikke tage Riluzol Zentiva, hvis du er gravid eller ammer, eller har mistanke om, at du er gravid.
You MUST NOT take Riluzole Zentiva if you are or think you may be pregnant, or if you are breast-feeding.
Denne metabolit konjugeres hurtigt med glukuronsyre til O- og N- glukuronider.
This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
This leaflet was last approved in {MM/YYYY}.
Det aktive indholdsstof i Riluzol Zentiva er riluzol, som virker på nervesystemet.
The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Der er intet bevis for, at Riluzol Zentiva udviser terapeutisk effekt på den motoriske funktion, på lungefunktion, facikulationer, muskelstyrke og motoriske symptomer.
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Der er ingen kliniske studier, der har vurderet interaktion mellem riluzol og andre lægemidler.
There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products.
Neurologiske og psykiatriske symptomer, akut toxisk encefalopati med feberdøs, koma og methæmoglobinæmi er blevet observeret i enkelte tilfælde.
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
(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.
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.
Klinisk erfaring med riluzol mangler hos gravide.
Clinical experience with riluzole in pregnant women is lacking.
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.
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.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PVC/ALUMINIUM BLISTER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Riluzolbehandling bør afbrydes, hvis ALAT værdierne stiger til 5 gange øvre normalværdi.
Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Riluzol Zentiva er ikke vist at være effektiv i behandlingen af de sene stadier af ALS.
Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Riluzol Zentiva anbefales ikke til pædiatriske patienter, pga. manglende data vedrørende riluzols sikkerhed og virkning ved neurodegenerative sygdomme hos børn og unge.
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.
- hvis du får hoste eller besvær med at trække vejret, da dette kan være tegn på en lungesygdom (som hedder interstitiel lungesygdom).
if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
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
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
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.
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.
Anafylaktoid reaktion, angioødem
Anaphylactoid reaction, angioedema
MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Hos patienter behandlet med riluzol 100 mg/dag var overlevelsen signifikant forlænget sammenlignet med patienter, som fik placebo.
In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
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.
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.
Forhøjede baselineværdier af adskillige leverfunktionsprøver (især forhøjet bilirubin) bør udelukke brugen af riluzol (se pkt.
Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8).
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).
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.
Diarré, abdominalsmerter, opkastning
Diarrhoea, abdominal pain, vomiting
Leversygdom eller baseline-værdier af aminotransferaser på mere end 3 gange øvre normalgrænse.
Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.
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.
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
Riluzol Zentiva anvendes til patienter med amyotrofisk lateral sclerose (ALS).
Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
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.
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.
Abnorme leverfunktionstests
Abnormal liver function tests
(≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til
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).
Hovedpine, svimmelhed, oral paræstesi og døsighed
Headache, dizziness, oral paraesthesia, somnolence
Riluzol Zentiva fås i en pakning med 28, 56, 98, 112 eller 168 tabletter til oral anvendelse.
Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Den primære metaboliske vej for riluzol er initial oxidation af CYP1A2 fremstillende N-hydroxyriluzol (RPR112512) riluzols aktive hovedmetabolit.
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Alvorlig neutropeni (se pkt.
Severe neutropenia (see section 4.4)
Den mediane overlevelse var 17,7 måneder for riluzol-gruppen mod 14,9 måneder for placebo-gruppen.
The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Hvis du har taget for mange tabletter, skal du straks kontakte din læge eller skadestue.
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Hvis du har glemt at tage Riluzol Zentiva
If you forget to take Riluzole Zentiva
Efter indgift af en enkelt peroral dosis riluzol på 50 mg stiger AUC 1,7 gange hos patienter med mild kronisk nedsat leverfunktion og ca. 3 gange hos patienter med moderat kronisk nedsat leverfunktion.
The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
Hver tablet indeholder 50 mg riluzol og har “RPR 202” præget på den ene side af tabletten.
Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
ALAT bør undersøges oftere hos patienter, som viser ALAT stigning under behandling.
ALT levels should be measured more frequently in patients who develop elevated ALT levels.
Hvad Riluzol Zentiva anvendes til
What Riluzole Zentiva is used for
Hos rotter nedsatte riluzol frekvensen af graviditet og antallet af fostre ved doser, der var mindst to gange den dosis, som mennesker får under behandling.
In rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least twice the systemic exposure of humans given clinical therapy.
Indlægsseddel: Information til brugeren Riluzol Zentiva 50 mg, filmovertrukne tabletter
Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Riluzol formodes at virke ved hæmning af glutamatprocessen.
Riluzole is proposed to act by inhibiting glutamate processes.
Den mediane overlevelse nærmede sig 16,5 måneder mod 13,5 måneder for henholdsvis riluzol 100 mg/dag og placebo.
The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Riluzol Zentiva anvendes for at forlænge livet eller tiden indtil mekanisk ventilation hos patienter med amyotrofisk lateral sclerose (ALS).
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
I kliniske studier, fase III, udført på ALS patienter behandlet med riluzol, var de mest almindeligt rapporterede bivirkninger asteni, kvalme og abnorme leverfunktionstests.
In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests.
Tabletten er kapselformet, hvid og mærket ”RPR 202” på den ene side.
Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Hos gravide rotter er der konstateret passage af 14C-riluzol over placenta til fostret.
In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Du kan køre bil og anvende værktøj og maskiner, når du tager Riluzol Zentiva, medmindre du føler dig svimmel eller omtåget.
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
I en dosis-virkningsundersøgelse blev 959 patienter med ALS randomiseret til en af fire behandlingsgrupper: Riluzol 50, 100, 200 mg/dag eller placebo, og de blev fulgt i 18 måneder.
In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
Tilfælde af febril sygdom bør tilskynde lægen at kontrollere leukocyttallet og at afbryde riluzolbehandling i tilfælde af neutropeni (se pkt.
The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia (see section 4.8).
Riluzol Zentiva kan ikke anbefales til patienter med nedsat nyrefunktion, da der ikke er foretaget undersøgelser med gentagne doseringer hos denne patientgruppe (se pkt.
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).
Riluzols farmakokinetik er undersøgt hos raske mandlige frivillige efter peroral enkeltdosering af 25 til 300 mg og efter gentagen oral dosering af 25 til 100 mg to gange dagligt.
The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Hæmolytisk anæmi blev observeret hos hunde.
In dogs, haemolytic anaemia was observed.
In vitro studier med anvendelse af human lever mikrosomale præparationer antyder, at CYP1A2 er det principielle isoenzym involveret i den initiale oxidative metabolisme af riluzol.
In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole.
Kliniske undersøgelser har vist, at Riluzol Zentiva forlænger overlevelsen for patienter med ALS (se pkt.
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Der er ikke udført undersøgelser med gentagne doseringer hos patienter med nedsat nyrefunktion (se pkt.
Studies at repeated doses have not been conducted in patients with impaired renal function (see section
I et dobbelt-blindt placebokontrolleret studie, der var designet til at undersøge effekt og sikkerhed hos japanske patienter, blev 204 patienter randomiseret til enten 100 mg riluzol/dag (50 mg 2 gange daglig) eller placebo.
In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Vandfri calciumphosphat Mikrokrystallinsk cellulose Kolloid vandfri silica Magnesiumstearat Croscarmellosenatrium
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Ved gentagen indgift (10 dages behandling med 50 mg riluzol to gange dagligt) fordobles akkumulationen af uomdannet riluzol i plasma, og steady state nås på mindre end 5 dage.
With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days.
I en klinisk undersøgelse blev 155 patienter randomiseret til enten riluzol 100 mg/dag (50 mg bid) eller placebo, og de blev fulgt i 12 til 21 måneder.
In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
- hvis du får nogen form for feber (forhøjet temperatur), da Riluzol Zentiva kan medføre nedsættelse af antallet af hvide blodlegemer.
IMPORTANT Tell your doctor immediately if you experience any fever (increase in temperature) because Riluzole Zentiva may cause a decrease in the number of white blood cells.
Tracheostomi-fri overlevelse var ikke signifikant højere hos patienter behandlet med riluzol sammenlignet med placebo.
Tracheostomy-free survival in patients treated with riluzole did not differ significantly from placebo.
Uomdannet riluzol er hovedkomponenten i plasma og metaboliseres ekstensivt af CYP og efterfølgende glukuronidering.
Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Kerne: vandfri calciumphosphat, mikrokrystallinsk cellulose, vandfri kolloid silica, magnesiumstearat, samt croscarmellosenatrium.
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) af Riluzol Zentiva er: svimmelhed prikken i munden opkastning søvnighed hurtigere hjerterytme diarré hovedpine mavesmerter smerter
Common side effects (may affect up to 1 in 10 people) of Riluzole Zentiva are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
En filmovertrukken tablet indeholder 50 mg riluzol.
Each film-coated tablet contains 50 mg of riluzole.
Pakningsstørrelser og yderligere oplysninger Riluzol Zentiva indeholder:
Contents of the pack and other information What Riluzole Zentiva contains
Resultaterne viste lavere eksponering af riluzol i den japanske gruppe (Cmax 0,85 [90 % CI 0,68-1,08] og AUCinf 0,88 [90 % CI 0,69-1,13]) og lignende eksponering for metabolitten.
A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer) af Riluzol Zentiva er: - træthed - kvalme - forføjet niveau af nogle enzymer (aminotransferaser) i blodet.
Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Interstitiel lungesygdom (se pkt.
Interstitial lung disease (see section 4.4)
Riluzol Zentiva 50 mg filmovertrukne tabletter riluzol
Riluzole Zentiva 50 mg film-coated tablets riluzole
4.1, var signifikant forlænget for de patienter, der havde fået riluzol sammenlignet med de patienter, som fik placebo.
Survival, as defined in the second paragraph of section 4.1, was significantly extended for patients who received riluzole as compared to patients who received placebo.
In vitro studier med humane leverpræparationer viste, at CYP1A2 er det væsentlige isoenzym i riluzol-metabolismen.
In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
- hvis du får nogen af følgende symptomer: Gulfarvning af huden eller det hvide i øjnene (gulsot), kløe over hele kroppen, kvalme eller kaster op, da dette kan være tegn på leverbetændelse (hepatitis).
if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking Riluzole Zentiva to make sure that this does not occur.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) af Riluzol Zentiva er: - blodmangel - allergiske reaktioner - betændelse i bugspytkirtlen (pancreatitis)
Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: anaemia allergic reactions inflammation of the pancreas (pancreatitis).
Riluzol Zentiva er kontraindiceret under graviditeten (se pkt.
Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Efter indgift af en enkelt peroral dosis på 50 mg riluzol er der ikke fundet signifikante forskelle i de farmakokinetiske parametre målt hos patienter med moderat eller svær kronisk nedsat nyrefunktion (creatininclearence mellem 10 og 50 ml/min) sammenlignet med raske frivillige.
There is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Brug af anden medicin sammen med Riluzol Zentiva
Other medicines and Riluzole Zentiva
Hos ældre (>70 år) bliver riluzols farmakokinetik ikke påvirket af gentagne doser (4,5 dages behandling med 50 mg riluzol to gange dagligt).
The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
- hvis du er gravid eller ammer.
if you are pregnant or breast-feeding.