FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Danish: Hver tablet indeholder 50 mg riluzol og har “RPR 202” præget på den ene side af tabletten.
English: ALT levels should be measured more frequently in patients who develop elevated ALT levels.
Danish: ALAT bør undersøges oftere hos patienter, som viser ALAT stigning under behandling.
English: What Riluzole Zentiva is used for
Danish: Hvad Riluzol Zentiva anvendes til
English: 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.
Danish: 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.
English: Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Danish: Indlægsseddel: Information til brugeren Riluzol Zentiva 50 mg, filmovertrukne tabletter
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Riluzole is proposed to act by inhibiting glutamate processes.
Danish: Riluzol formodes at virke ved hæmning af glutamatprocessen.
English: The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Danish: Den mediane overlevelse nærmede sig 16,5 måneder mod 13,5 måneder for henholdsvis riluzol 100 mg/dag og placebo.
English: Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Danish: Riluzol Zentiva anvendes for at forlænge livet eller tiden indtil mekanisk ventilation hos patienter med amyotrofisk lateral sclerose (ALS).
English: 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.
Danish: I kliniske studier, fase III, udført på ALS patienter behandlet med riluzol, var de mest almindeligt rapporterede bivirkninger asteni, kvalme og abnorme leverfunktionstests.
English: Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Danish: Tabletten er kapselformet, hvid og mærket ”RPR 202” på den ene side.
English: In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Danish: Hos gravide rotter er der konstateret passage af 14C-riluzol over placenta til fostret.
English: You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Danish: Du kan køre bil og anvende værktøj og maskiner, når du tager Riluzol Zentiva, medmindre du føler dig svimmel eller omtåget.
English: 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.
Danish: 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.
English: 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).
Danish: Tilfælde af febril sygdom bør tilskynde lægen at kontrollere leukocyttallet og at afbryde riluzolbehandling i tilfælde af neutropeni (se pkt.
English: 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).
Danish: Riluzol Zentiva kan ikke anbefales til patienter med nedsat nyrefunktion, da der ikke er foretaget undersøgelser med gentagne doseringer hos denne patientgruppe (se pkt.
English: 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.
Danish: 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.
English: In dogs, haemolytic anaemia was observed.
Danish: Hæmolytisk anæmi blev observeret hos hunde.
English: In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole.
Danish: 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.
English: Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Danish: Kliniske undersøgelser har vist, at Riluzol Zentiva forlænger overlevelsen for patienter med ALS (se pkt.
English: Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Danish: Der er ikke udført undersøgelser med gentagne doseringer hos patienter med nedsat nyrefunktion (se pkt.
English: 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.
Danish: 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.
English: Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Danish: Vandfri calciumphosphat Mikrokrystallinsk cellulose Kolloid vandfri silica Magnesiumstearat Croscarmellosenatrium
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: - hvis du får nogen form for feber (forhøjet temperatur), da Riluzol Zentiva kan medføre nedsættelse af antallet af hvide blodlegemer.
English: Tracheostomy-free survival in patients treated with riluzole did not differ significantly from placebo.
Danish: Tracheostomi-fri overlevelse var ikke signifikant højere hos patienter behandlet med riluzol sammenlignet med placebo.
English: Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Danish: Uomdannet riluzol er hovedkomponenten i plasma og metaboliseres ekstensivt af CYP og efterfølgende glukuronidering.
English: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Danish: Kerne: vandfri calciumphosphat, mikrokrystallinsk cellulose, vandfri kolloid silica, magnesiumstearat, samt croscarmellosenatrium.
English: 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
Danish: 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
English: Each film-coated tablet contains 50 mg of riluzole.
Danish: En filmovertrukken tablet indeholder 50 mg riluzol.
English: Contents of the pack and other information What Riluzole Zentiva contains
Danish: Pakningsstørrelser og yderligere oplysninger Riluzol Zentiva indeholder:
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: Interstitial lung disease (see section 4.4)
Danish: Interstitiel lungesygdom (se pkt.
English: Riluzole Zentiva 50 mg film-coated tablets riluzole
Danish: Riluzol Zentiva 50 mg filmovertrukne tabletter riluzol
English: 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.
Danish: 4.1, var signifikant forlænget for de patienter, der havde fået riluzol sammenlignet med de patienter, som fik placebo.
English: In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Danish: In vitro studier med humane leverpræparationer viste, at CYP1A2 er det væsentlige isoenzym i riluzol-metabolismen.
English: 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.
Danish: - 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).
English: Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: anaemia allergic reactions inflammation of the pancreas (pancreatitis).
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) af Riluzol Zentiva er: - blodmangel - allergiske reaktioner - betændelse i bugspytkirtlen (pancreatitis)
English: Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Danish: Riluzol Zentiva er kontraindiceret under graviditeten (se pkt.
English: 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.
Danish: 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.
English: Other medicines and Riluzole Zentiva
Danish: Brug af anden medicin sammen med Riluzol Zentiva
English: 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).
Danish: Hos ældre (>70 år) bliver riluzols farmakokinetik ikke påvirket af gentagne doser (4,5 dages behandling med 50 mg riluzol to gange dagligt).
English: if you are pregnant or breast-feeding.
Danish: - hvis du er gravid eller ammer.
English: What Riluzole Zentiva is and what it is used for What you need to know before you take Riluzole Zentiva How to take Riluzole Zentiva Possible side effects
Danish: Det skal du vide, før du begynder at tage Riluzol Zentiva Sådan skal du tage Riluzol Zentiva Bivirkninger
English: Riluzole Zentiva 50 mg film-coated tablets
Danish: Riluzol Zentiva 50 mg filmovertrukne tabletter.
English: Method of administration
Danish: Administration Oral anvendelse
English: Safety and efficacy of Riluzole Zentiva has only been studied in ALS.
Danish: Sikkerhed og effekt af Riluzol Zentiva ved andre motor-neuronsygdomme end ALS er ikke undersøgt.
English: Riluzole Zentiva is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Danish: Riluzol Zentiva er kontraindiceret til ammende kvinder (se pkt.
English: How to take Riluzole Zentiva
Danish: Sådan skal du tage Riluzol Zentiva
English: Core
Danish: Hjerte
English: The active substance is riluzole.
Danish: Aktivt stof: Riluzol.
English: Coating
Danish: Amning
English: What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
Danish: Virkning og anvendelse Hvad Riluzol Zentiva er
English: What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
Danish: Kontakt lægen, før du tager Riluzol Zentiva: - hvis du har nogen form for leverproblemer: gulfarvning af huden eller det hvide i dine øjne
English: If you take more Riluzole Zentiva than you should
Danish: Hvis du har taget for mange Riluzol Zentiva
English: Nausea
Danish: Smerter
English: Cardiac disorders
Danish: Mave-tarm-kanalen Kvalme
English: PV-Hungary@zentiva.com
Danish: PV-Greece@zentiva.com
English: Inhalation use Blister (alu) 3 inhalers (3 x 30 doses) (multipack)
Danish: 3 inhalatorer (3 x 30 doser) (multipakning)
English: Strength Pharmaceutical form
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: Wash your hands
Danish: Vask hænder
English: Most of the following side effects are mild.
Danish: De fleste af følgende bivirkninger er milde.
English: Date of first authorisation: 17 september 2018
Danish: Dato for første markedsføringstilladelse: 17 september 2018
English: This leaflet was last revised in April 2019 Other sources of information
Danish: Denne indlægsseddel blev senest ændret i april 2019 Andre informationskilder
English: In this short period, a risk to the newborns/infants cannot be excluded.
Danish: I denne korte periode kan en risiko for nyfødte/spædbørn ikke udelukkes.
English: • Wash your hands thoroughly with soap and water.
Danish: • Vask hænderne grundigt med sæbe og vand.
English: *The number of doses administered refers only to tildrakizumab groups.
Danish: * Antallet af administrerede doser henviser kun til tildrakizumab-grupper.
English: Maximum concentration was reached at 6.2 days after injection.
Danish: Maksimal koncentration blev opnået 6,2 dage efter injektion.
English: **These patients were switched to placebo at week 28.
Danish: **Disse patienter skiftede til placebo ved uge 28.
English: Number of patients PASI 75a (%)
Danish: Antal patienter PASI 75a (%)
English: Do not warm in any other way.
Danish: Den må ikke opvarmes på nogen anden måde.
English: Collect all the materials you need
Danish: Find alle de ting frem, du skal bruge
English: Patients were 18 to 82 years old, with a mean age of 45.9.
Danish: Patienterne var mellem 18 og 82 år med en gennemsnitsalder på 45,9 år.
English: However, the physician should ensure appropriate follow-up of patients.
Danish: Lægen bør dog sikre relevant opfølgning af patienten.
English: Air bubbles may be present; there is no need to remove them.
Danish: Der kan være luftbobler i, men det er ikke nødvendigt at fjerne dem.
English: Important points to know
Danish: Vigtigt at vide
English: Week 12 (2 doses)*
Danish: Uge 12 (2 doser)*
English: Your doctor will decide for how long you need to take Ilumetri.
Danish: Din læge vil beslutte, hvor længe du skal tage Ilumetri.
English: One month after birth, the milk/serum ratio was ≤0.002.
Danish: En måned efter fødsel var mælk/serum forholdet ≤ 0,002.
English: Talk to your doctor about when you will have your injections and follow-up appointments.
Danish: Tal med lægen om, hvornår du skal have dine injektioner og opfølgende aftaler.
English: No data are available on the response to live or inactivated vaccines.
Danish: Der foreligger ingen data om respons på levende eller inaktiverede vacciner.
English: These include vaccines and immunosuppressants (medicines that affect the immune system).
Danish: Dette gælder også for vacciner og immunosuppressiva (medicin, der påvirker immunsystemet).
English: Maintenance of Response
Danish: Vedligeholdelse af respons
English: - If you currently have an infection or if you have long-term or repeated infections.
Danish: - hvis du har en infektion nu, eller hvis du får langvarige eller gentagne infektioner.
English: Interactions with cytochrome p450
Danish: Interaktioner med cytokrom p450
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment.
Danish: Det bør overvejes at stoppe behandling hos patienter, som ikke har vist respons efter 28 ugers behandling.
English: Baseline PGA score was marked or severe in 33.4% of patients.
Danish: PGA-scoren ved baseline var markant eller alvorlig hos 33,4 % af patienter.
English: The effects of this medicine in pregnant women are not known.
Danish: Virkningen af dette lægemiddel hos gravide kendes ikke.
English: If you feel the need, you can use a sticky plaster to cover the injection site.
Danish: Hvis du føler behov for det, kan du bruge et plaster til at dække injektionsstedet.
English: • Repeat the procedure with the second syringe in a different location of your skin if you are administering a dose of 200 mg.
Danish: • Gentag proceduren med den anden injektionssprøjte et andet sted på huden, hvis du administrerer en dosis på 200 mg.
English: Look out for infections and allergic reactions
Danish: Vær opmærksom på infektioner og allergiske reaktioner.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af tildrakizumab til gravide kvinder.
English: Common aIncluding nasopharyngitis.
Danish: Almindelig aInklusive nasopharyngitis.
English: 39.4c a Co-primary efficacy endpoint at week 12. b Non responder imputation for missing data.
Danish: 39,4c a Co-primær effektendepunkt i uge 12. b Non-respondent imputering for manglende data.
English: Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo.
Danish: Tre placebokontrollerede forsøg (et fase 2b og to fase 3) blev integreret for at evaluere sikkerheden af Ilumetri sammenlignet med placebo.
English: Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
Danish: Intravenøse doser på op til 10 mg/kg er blevet administreret sikkert i kliniske forsøg.
English: Proportion of Patients with PASI 90 response over time up to Week 64 (Full Analysis Set Part 3*)
Danish: Andel af patienter med PASI 90 respons over tid op til uge 64 (fuldt analysegrundlag Del 3*)
English: The effect of Ilumetri on human fertility has not been evaluated.
Danish: Effekten af Ilumetri på fertilitet hos mennesker er ikke blevet evalueret.
English: Very common side effects (may affect more than 1 in 10 people): - Upper respiratory infections
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer): - Infektioner i de øvre luftveje
English: c No imputation for missing data.
Danish: c Ingen imputering for manglende data.
English: • Read the Ilumetri Package Leaflet to learn more about your medicine.
Danish: • Læs Ilumetris indlægsseddel for at lære mere om din medicin.
English: You must look out for signs of these conditions while you are taking Ilumetri.
Danish: Du skal være opmærksom på tegn på sådanne tilstande, mens du tager Ilumetri.
English: Ilumetri has not been studied in these patient populations.
Danish: Ilumetri er ikke blevet undersøgt hos disse patientpopulationer.
English: - Choose a different location for the second injection.
Danish: - Vælg et nyt sted til den anden injektion.
English: o Do not touch this area again before giving the injection.
Danish: o Undlad at røre området igen, inden du giver injektionen.
English: Wait for 30 minutes (if stored in the refrigerator)
Danish: Vent i 30 minutter (hvis den opbevares i køleskabet
English: - If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs.
Danish: - hvis du har en infektion, som efter din læges vurdering er af betydning, for eksempel aktiv tuberkulose, der er en infektionssygdom, som primært påvirker lungerne.
English: Inspect the medicine
Danish: Kontrollér lægemidlet.
English: o DO NOT touch the blue plunger yet.
Danish: o Rør IKKE ved det blå stempel endnu.
English: Ilumetri can potentially cause serious side effects, including infections and allergic reactions.
Danish: Ilumetri kan muligvis forårsage alvorlige bivirkninger, herunder infektioner og allergiske reaktioner.
English: Maintenance and durability of PASI 90 Response.
Danish: Vedligeholdelse og varighed af PASI 90 respons.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Danish: Nogle patienter med indledningsvist delvist respons, kan efterfølgende få det bedre ved at fortsætte behandling ud over 28 uger.
English: - If you have recently had or plan to have a vaccination.
Danish: - hvis du er blevet vaccineret for nylig, eller hvis du planlægger at blive vaccineret.
English: • Take a carton pack out of the refrigerator and place the original and unopened carton pack on a clean and flat working surface.
Danish: • Tag en karton ud af køleskabet, og anbring den originale og uåbnede karton på en ren og flad arbejdsflade.
English: The median baseline PASI score ranged from 17.7 to 18.4 across treatment groups.
Danish: Den gennemsnitlige PASI-score ved baseline var fra 17,7 til 18,4 på tværs af behandlingsgrupper.
English: • Inspect Ilumetri visually for particulate matter and discoloration prior to administration.
Danish: • Kontrollér Ilumetri visuelt for partikler og misfarvning inden administration.
English: L-Histidine
Danish: L-histidin
English: Quality of Life/Patient-reported Outcomes
Danish: Livskvalitet/patientrapporterede resultater
English: a Long-term response in patients who were responders (had achieved at least PASI 75) to tildrakizumab at week 28. b No imputation for missing data.
Danish: a Langsigtet respons hos patienter, som var respondenter (havde opnået mindst PASI 75) på tildrakizumab i uge 28. b Ingen imputering for manglende data.
English: Take a pack from the refrigerator (if stored in the refrigerator)
Danish: Tag en pakke fra køleskabet (hvis den opbevares i køleskabet)