FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH(s) should provide within the risk management plan educational material for prescribers and patients.
Danish: Indehaverne af markedsføringstilladelse skal sammen med risikostyringsplanen udlevere en informationsmaterialepakke til ordinerende læger og patienter.
English: For products without an RMP, a RMP should be submitted.
Danish: For produkter uden risikostyringsplan skal en sådan forelægges.
English: The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP.
Danish: Indehaverne af markedsføringstilladelse udsender den vedtagne direkte meddelelse til sundhedspersoner, der koordineres med de nationale kompetente myndigheder i henhold til handlingsplanen, som er vedtaget af CHMP.
English: EMA/460814/2013 EMEA/H/C/002542
Danish: Den 26. juli 2013 EMA/460814/2013 EMEA/H/C/002542
English: The applicant requested a re-examination of the opinion.
Danish: Ansøgeren anmodede om fornyet overvejelse af udtalelsen.
English: It was to be available as tablets (5 mg).
Danish: Det var hensigten, at det skulle leveres som tabletter (5 mg).
English: It was not clear that these risks could be managed successfully in medical practice.
Danish: Det var ikke klart, om disse risici kunne håndteres tilfredsstillende i klinisk praksis.
English: The company that applied for authorisation is Pfizer Limited.
Danish: Den virksomhed, der ansøgte om tilladelse, er Pfizer Limited.
English: What were the CHMP's main concerns that led to the refusal?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder, der førte til afslaget?
English: Outcome of re-examination
Danish: Resultat af den fornyede overvejelse
English: The CHMP refusal was confirmed after re-examination.
Danish: CHMP's afslag blev bekræftet efter fornyet overvejelse.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The effects of Xeljanz were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Xeljanz blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Biological DMARDs are medicines that target specific proteins in the immune system.
Danish: Biologiske DMARD er lægemidler, der er rettet mod bestemte proteiner i immunsystemet.
English: What is Xeljanz?
Danish: Hvad er Xeljanz?
English: The company will consider future requests for compassionate use on an individual basis in accordance with local regulations.
Danish: Fremtidige anmodninger om anvendelse med særlig udleveringstilladelse vil virksomheden vurdere enkeltvis i henhold til de lokale bestemmelser.
English: The company informed the CHMP that patients receiving tofacitinib in clinical trials will continue to receive it as planned.
Danish: Virksomheden har til CHMP oplyst, at de patienter, der får tofacitinib i kliniske undersøgelser, vil fortsætte dermed som planlagt.
English: What did the company present to support its application?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen?
English: They are produced by a method known as ‘recombinant DNA technology': they are made by cells that have received a gene (DNA) that makes them able to produce the medicine.
Danish: De fremstilles ved “rekombinant DNA-teknologi”: De produceres af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere lægemidlet.
English: Refusal of the marketing authorisation for Xeljanz (tofacitinib)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Xeljanz (tofacitinib)
English: The CHMP had major concerns about the overall safety profile of Xeljanz.
Danish: CHMP's hovedbetænkeligheder vedrørte den overordnede sikkerhedsprofil for Xeljanz.
English: Xeljanz is a medicine that contains the active substance tofacitinib.
Danish: Xeljanz er et lægemiddel, der indeholder det aktive stof tofacitinib.
English: The company initially presented the results of five main studies of safety and effectiveness involving over 3,300 patients with rheumatoid arthritis.
Danish: Virksomheden fremlagde først resultaterne af fem hovedundersøgelser af virkning og sikkerhed, hvor der deltog over 3 300 patienter med leddegigt.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
English: These studies compared Xeljanz (in a dose of 5 or 10 mg twice daily) with placebo (a dummy treatment), either alone or as an addition to other background medicines (DMARDs).
Danish: I undersøgelserne blev Xeljanz (5 eller 10 mg to gange dagligt) sammenlignet med placebo (en virkningsløs behandling), enten alene eller som supplement til baggrundsbehandling med andre lægemidler (DMARD).
English: What was Xeljanz expected to be used for?
Danish: Hvad forventedes Xeljanz anvendt til?
English: However, the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful.
Danish: Undersøgelserne var imidlertid ikke tilstrækkelige til entydigt at påvise en reduktion i sygdomsaktivitet og beskadigelse af ledstrukturen, navnlig ved den lavere 5 mg dosis af Xeljanz og hos den målpopulation af patienter, hos hvem behandling med mindst to andre DMARD havde slået fejl.
English: It was to be used in patients in whom treatment with at least one other medicine known as a biological disease-modifying antirheumatic drug (biological DMARD1), had been unsuccessful either because patients were unable to tolerate treatment due to side effects, or because they did not respond adequately.
Danish: Det skulle anvendes hos patienter, der var blevet behandlet med mindst et andet lægemiddel af typen biologiske sygdomsmodificerende antireumatiske lægemidler (biologiske DMARD1), og hos hvem denne behandling havde slået fejl, enten fordi patienterne ikke tålte behandlingen på grund af bivirkninger, eller fordi behandlingen ikke virkede tilfredsstillende.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 25 July 2013.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 25. juli 2013 afslaget på ansøgningen om markedsføringstilladelse.
English: In April 2013, the Committee considered that, taken together, the data from the five main studies showed that treatment with Xeljanz resulted in an improvement in the signs and symptoms of rheumatoid arthritis and the physical function of patients.
Danish: I april 2013 fandt udvalget, at dataene fra de fem hovedundersøgelser viste, at behandling med Xeljanz gav bedring i tegn og symptomer på leddegigt og i patienternes fysiske funktion.
English: These safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood.
Danish: Sikkerhedsproblemerne bestod desuden i risiko for andre svære bivirkninger, herunder visse kræfttyper, tarmperforation, leverbeskadigelse og problemer med øget indhold af fedtstoffer (lipider) i blodet.
English: By blocking the enzymes, tofacitinib is expected to reduce the inflammation and other symptoms of the disease.
Danish: Fordi tofacitinib blokerer disse enzymer, forventedes det at mindske inflammationen og de øvrige symptomer på sygdommen.
English: On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis.
Danish: Den 25. april 2013 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Xeljanz, der var bestemt til behandling af leddegigt (rheumatoid arthritis).
English: There were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.
Danish: Der var vigtige uafklarede problemer i form af risiko for alvorlige infektioner af den type, der var iagttaget med tofacitinib, og som hænger sammen med lægemidlets immunundertrykkende virkning.
English: Therefore, in April 2013 the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: I april 2013 fandt CHMP derfor, at fordelene ved Xeljanz ikke opvejede risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
English: Xeljanz was expected to be used in the treatment of moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Danish: Xeljanz forventedes anvendt til behandling af moderat til svær aktiv leddegigt (rheumatoid arthritis, en sygdom i immunsystemet, der medfører beskadigelse og inflammation af leddene).
English: How is Xeljanz expected to work?
Danish: Hvordan forventes Xeljanz at virke?
English: At re-examination in July 2013 the company proposed to remove claims of an effect on structural damage from the indication.
Danish: Ved den fornyede overvejelse i juli 2013 foreslog virksomheden at ophøre med at hævde, at lægemidlet virkede på beskadigelse af ledstrukturen.
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Danish: Disse enzymer spiller en vigtig rolle i inflammationsprocessen og i den beskadigelse af leddene, der finder sted ved leddegigt.
English: The active substance in Xeljanz, tofacitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Danish: Det aktive stof i Xeljanz, tofacitinib, er et immunundertrykkende lægemiddel (et lægemiddel, der nedsætter immunsystemets aktivitet), som virker ved at blokere virkningen af enzymer af typen Januskinaser.
English: The main measures of effectiveness were changes in patient scores for signs and symptoms of disease, physical function of the patient, structural damage to joints and disease activity; these were measured after 3 or 6 months, depending on the study.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i patienternes score for sygdomstegn og -symptomer, deres fysiske funktion, beskadigelse af ledstrukturen og sygdomsaktivitet.
English: However, the lack of robust evidence on prevention of structural damage with Xeljanz in the proposed dose and population still contributed to the Committee's view that the benefits of treatment did not outweigh significant and unresolved concerns about safety.
Danish: Der manglede imidlertid stadig håndfast bevis for, at Xeljanz forebygger beskadigelse af ledstrukturen ved den ansøgte dosis og til den ansøgte patientgruppe.
English: 30 months.
Danish: 30 måneder.
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: You may need medical treatment.
Danish: Du har muligvis brug for medicinsk behandling.
English: Do not freeze.
Danish: Må ikke fryses.
English: Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014
Danish: Dato for første markedsføringstilladelse: 30 juni 2009 Dato for seneste fornyelse: 11 april 2014
English: For use by one person only
Danish: Må kun anvendes af én person
English: All patients recovered without complications.
Danish: Alle patienterne restituerede uden komplikationer.
English: Then take your next dose as usual the following day.
Danish: Tag herefter den næste dosis som sædvanligt den følgende dag.
English: Using the wrong medicine could cause severe harm.
Danish: Brug af forkert medicin kan medføre alvorlig skade.
English: The mean duration of diabetes was 12.8 years.
Danish: Gennemsnitsvarigheden af diabetes var 12,8 år.
English: The relevance for humans is likely to be low but cannot be completely excluded.
Danish: Relevansen af dette for mennesker er højst sandsynligt lav, men kan ikke udelukkes helt.
English: The duration of observation was a minimum of 3.5 years and up to a maximum of 5 years.
Danish: Observationsvarigheden var mindst 3,5 år op til maksimalt 5 år.
English: This usually goes away over time.
Danish: Forsvinder som regel med tiden.
English: These may include:
Danish: Disse kan inkludere:
English: Please consult your doctor for further information on this topic.
Danish: Spørg din læge for yderligere information om dette emne.
English: You can give yourself the injection at any time of the day, regardless of meals.
Danish: Du kan give dig selv injektionen når som helst i løbet af dagen, uafhængigt af et måltid.
English: It also ensures that the dosing is accurate.
Danish: Det sikrer endvidere, at doseringen er nøjagtig.
English: This is normal and does not affect your dose.
Danish: Dette er normalt og har ingen indflydelse på din dosis.
English: Time from randomisation (months)
Danish: Tid efter randomisering (måneder)
English: These reactions have usually been mild.
Danish: Reaktionerne var i reglen milde.
English: Important information
Danish: Vigtig information
English: Increased lipase*
Danish: Forhøjet lipase*
English: After first use: 1 month.
Danish: Efter ibrugtagning: 1 måned.
English: Contact your doctor if you have any questions or concerns.
Danish: Kontakt din læge, hvis du har spørgsmål eller er bekymret.
English: This reduction was observed within the first two weeks of treatment.
Danish: Denne reduktion blev observeret inden for de første to behandlingsuger.
English: Do not change your dose unless your doctor has told you to.
Danish: Du må ikke ændre din dosis, medmindre lægen har bedt dig om det.
English: Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Danish: Inden du anvender pennen for første gang, vil din læge eller sygeplejerske vise dig, hvordan den bruges.
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Danish: • som monoterapi, når metformin anses for uhensigtsmæssigt på grund af intolerance eller kontraindikationer
English: • in addition to other medicinal products for the treatment of diabetes.
Danish: • som supplement til andre lægemidler til behandling af diabetes.
English: This indicates the pen is defective and you must use a new one.
Danish: Dette indikerer, at pennen er defekt, og du skal bruge en ny.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsstudier er udelukkende blevet udført hos voksne.
English: Very rare
Danish: Meget sjælden
English: Stop taking Victoza and contact a doctor immediately if you notice any of the following serious side effects:
Danish: Stop med at tage Victoza og kontakt straks en læge, hvis du bemærker nogen af følgende alvorlige bivirkninger:
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af overdosis bør der initieres passende understøttende behandling baseret på patientens kliniske tegn og symptomer.
English: Liraglutide should therefore be used with caution in these patients.
Danish: Liraglutid skal derfor anvendes med forsigtighed til disse patienter.
English: Always use a new needle for each injection.
Danish: Brug altid en ny nål til hver injektion.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: On average, 8.6% of patients developed antibodies.
Danish: Gennemsnitligt udviklede 8,6% af patienterne antistoffer.
English: ATC code: A10BJ02
Danish: ATC-kode: A10BJ02
English: The estimated hazard ratio was consistently below 1 for all 3 MACE components.
Danish: Den estimerede hazard-ratio var konstant under 1 for alle 3 MACE-komponenter.
English: Then follow the instructions below:
Danish: Følg herefter nedenstående vejledning:
English: MedDRA system organ classes
Danish: MedDRA systemorganklasser
English: 2 IU a According to the individualised recommendation by the investigator at the previous visit, for example depending on whether the patient has experienced hypoglycaemia.
Danish: 2 IE a Jævnfør investigators individuelle anbefalinger ved det foregående besøg, f.eks. afhængigt af om patienten har haft hypoglykæmi.
English: However, it is preferable that Victoza is injected around the same time of the day, when the most convenient time of the day has been chosen.
Danish: Det er dog at foretrække, at Victoza injiceres på omtrent samme tidspunkt hver dag, når det bedst egnede tidspunkt er valgt.
English: Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Danish: Din læge vil fortælle dig, hvordan du kan behandle lavt blodsukker, og hvad du skal gøre, hvis du bemærker et eller flere af disse advarselssignaler.
English: Caring for your pen
Danish: Vedligeholdelse af din pen
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: 1 pen 2 pens 3 pens 5 pens 10 pens
Danish: 1 pen 2 penne 3 penne 5 penne 10 penne
English: If your pen is already in use, go to ‘Select your dose', step H.
Danish: Hvis din pen allerede er i brug, så gå direkte til ‘Valg af dosis', trin H.
English: EXP Discard pen 1 month after first use.
Danish: EXP Pennen skal bortskaffes 1 måned efter første anvendelse.
English: More frequent blood testing to determine the ability of your blood to clot may be required.
Danish: Hyppigere blodprøver til at bestemme blodets evne til at størkne kan være nødvendigt.
English: Ethnic origin
Danish: Etnisk oprindelse
English: You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional.
Danish: Du skal kun fordele din dosis mellem din nuværende pen og en ny pen, hvis du har fået træning eller vejledning af sundhedspersonalet.
English: It also slows food passage through your stomach and can help prevent heart disease.
Danish: Det gør også, at maden passerer langsommere gennem maven og kan være med til at forhindre hjertesygdom.
English: No interaction study has been performed.
Danish: Der er ikke udført interaktionsundersøgelser.
English: Summary of the safety profile
Danish: Opsummering af sikkerhedsprofilen
English: These reactions usually diminish within a few days or weeks on continued treatment.
Danish: Bivirkningerne mindskes som regel inden for få dages eller ugers kontinuerlig behandling.
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Danish: Pankreatitis kan være en alvorlig, eventuelt livstruende tilstand.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP tilslutter sig PRAC's videnskabelige konklusioner.
English: • if you have or have had a disease of the pancreas.
Danish: • hvis du har eller har haft en sygdom i bugspytkirtlen (pankreas).
English: The injection site and timing can be changed without dose adjustment.
Danish: Injektionssted og -tidspunkt kan ændres uden dosisjustering.
English: Increased amylase* * From controlled phase 3b and 4 clinical trials only where they were measured.
Danish: Forhøjet amylase* *Fra kontrollerede fase 3b og 4 kliniske studier, hvor kun disse blev målt.
English: Primary endpoint - MACE Components of MACE:
Danish: Primært endepunkt- MACE Komponenter af MACE:
English: • Do not try to repair your pen or pull it apart.
Danish: • Forsøg ikke at reparere pennen eller skille den ad.
English: It is important to avoid dehydration by drinking plenty of fluids.
Danish: Det er vigtigt at undgå dehydrering ved at drikke rigeligt med væske.
English: Patients with an event (%)
Danish: Patienter med en hændelse (%)
English: Split your dose into two injections:
Danish: Opdeling af dosis i to injektioner:
English: Liraglutide did not reduce the plaque size of already established plaques.
Danish: Liraglutid reducerede ikke plaque-størrelsen ved allerede etablerede plaques.
English: Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pennen og æsken efter 'EXP'.
English: After at least one week, the dose should be increased to 1.2 mg.
Danish: Efter mindst én uge skal dosis øges til 1,2 mg.
English: Victoza is given as an injection under the skin (subcutaneous).
Danish: Victoza gives som en injektion under huden (subkutant).
English: Headache and nasopharyngitis were also common.
Danish: Hovedpine og nasopharyngitis var ligeledes almindelige.
English: Your doctor may reduce your dose of these medicines before you start using Victoza.
Danish: Din læge kan sætte din dosis af disse lægemidler ned, før du begynder at bruge Victoza.
English: Do not use the cartridge scale to measure how much liraglutide to inject - it is not accurate enough.
Danish: Brug ikke cylinderampulskalaen til at måle, hvor meget liraglutid der skal injiceres - den er ikke tilstrækkelig nøjagtig.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Avoid driving or using machines if you experience signs of hypoglycaemia.
Danish: Undgå at køre bil eller betjene maskiner, hvis du oplever tegn på hypoglykæmi.
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Danish: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Danmark
English: This is to make sure that you get your full dose.
Danish: På denne måde sikrer du, at du får den fulde dosis.
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Danish: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Danmark
English: Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Danish: Klar og farveløs eller næsten farveløs, isotonisk opløsning; pH=8,15.
English: Pancreatitis (including necrotising pancreatitis)
Danish: Pankreatitis (inklusive nekrotiserende pankreatitis)
English: • Hypoglycaemia (low blood sugar).
Danish: • Hypoglykæmi (lavt blodsukker).
English: If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
Danish: Hvis du får disse symptomer, skal du straks søge lægehjælp og informere din læge hurtigst muligt.
English: It is not an insulin and should therefore not be used as a substitute for insulin.
Danish: Det er ikke et insulin og kan derfor ikke bruges som en erstatning for insulin.
English: No other treatment-related tumours have been found.
Danish: Der er ikke konstateret øvrige behandlingsrelaterede tumorer.
English: Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials.
Danish: Hyppighederne for alle hændelser er beregnet på basis af deres forekomst i kliniske fase 3a-forsøg.
English: Patients (%) achieving
Danish: Patienter (%) der opnåede