FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Danish: Effekten af disse stigninger i lipidparametre på kardiovaskulær morbiditet og mortalitet er ikke blevet fastlagt.
English: Olumiant can be used alone or together with some other medicines, such as methotrexate.
Danish: Olumiant kan anvendes alene eller sammen med visse andre lægemidler som f.eks. methotrexat.
English: There was no clear relationship between decreases in neutrophil counts and the occurrence of serious infections.
Danish: Der var ingen klar sammenhæng mellem fald i neutrofiltal og forekomst af alvorlige infektioner.
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Danish: Estimat af hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100).
English: These could be symptoms of tuberculosis (an infectious disease of the lungs).
Danish: Dette kan være tegn på tuberkulose (en infektionssygdom i lungerne).
English: Most cases of hepatic transaminase elevations were asymptomatic and transient.
Danish: De fleste tilfælde af forhøjede leveraminotransferaser var asymptomatiske og forbigående.
English: All patients on background MTX
Danish: Alle patienter på baggrunds-MTX
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA37
Danish: Farmakoterapeutisk klassifikation: Selektive immunsuppressiva, ATC-kode: L04AA37
English: Of these, 2166 rheumatoid arthritis patients were exposed to Olumiant for at least one year.
Danish: Af disse blev 2.166 patienter med reumatoid artritis eksponeret for Olumiant i mindst ét år.
English: See section 4.2 for dose recommendations.
Danish: 4.2 for at anbefalinger vedrørende dosering.
English: Including data from a long-term extension study, remission and low disease activity rates were maintained for at least 2 years.
Danish: Efter inklusion af data fra et længerevarende forlængelsesstudie blev raterne for remission og lav sygdomsaktivitet opretholdt i mindst 2 år.
English: Baricitinib was teratogenic in rats and rabbits.
Danish: Baricitinib var teratogent hos rotter og kaniner.
English: Administration with meals was not associated with a clinically relevant effect on exposure.
Danish: Administration i forbindelse med måltider var ikke forbundet med en klinisk relevant effekt på eksponeringen.
English: • That Olumiant is contraindicated in pregnancy as pre-clinical data showed reduced foetal growth and malformations.
Danish: • Olumiant er kontraindiceret under graviditet, da præ-kliniske data har vist reduceret føtal vækst og misdannelser.
English: Olumiant should not be given to patients with active TB.
Danish: Olumiant må ikke gives til patienter med aktiv TB.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogent potentiale.
English: No relevant differences regarding efficacy and safety were observed in subgroups defined by types of concomitant DMARDs used in combination with baricitinib.
Danish: Der blev ikke observeret nogen relevante forskelle i effekt og sikkerhed i undergrupper defineret ud fra type af samtidig DMARD anvendt i kombination med baricitinib.
English: To help you remember to take Olumiant, you may find it easier to take it at the same time every day.
Danish: Det kan måske være lettere for dig at huske at tage Olumiant, hvis du tager det på samme tidspunkt hver dag.
English: • Radiographic progression (mTSS)
Danish: • Radiologisk progression (mTSS)
English: The patient alert card shall contain the following key messages:
Danish: Patientkortet skal indeholde følgende hovedbudskaber:
English: Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.
Danish: Den kliniske erfaring er meget begrænset hos patienter ≥ 75 år, og hos disse patienter er en startdosis på 2 mg passende.
English: Transporters
Danish: Transportører
English: Remission and low disease activity
Danish: Remission og lav sygdomsaktivitet
English: Your doctor may check for levels of fat in the blood, such as cholesterol, while you are taking Olumiant.
Danish: Lægen kan kontrollere niveauet af fedt i dit blod, såsom dit kolesteroltal, mens du tager Olumiant.
English: No data are available on the response to vaccination with live vaccines in patients receiving baricitinib.
Danish: Der foreligger ingen data om respons på vaccination med levende vacciner hos patienter, som får baricitinib.
English: Food intake led to a decreased exposure by up to 14 %, a decrease in Cmax by up to 18 % and delayed tmax by 0.5 hours.
Danish: Indtagelse af mad førte til en reduktion i eksponering på op til 14 %, et fald i Cmax på op til 18 % og en forsinkelse af tmax på 0,5 timer.
English: Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90 % of the administered dose is expected to be eliminated within 24 hours.
Danish: Farmakokinetiske data ved en enkeltdosis på 40 mg hos raske frivillige indikerer, at mere end 90 % af den administrerede dosis kan forventes at være elimineret inden for 24 timer.
English: • Low disease activity and remission (SDAI)
Danish: • Lav sygdomsaktivitet og remission (SDAI)
English: On background cDMARDs5
Danish: På baggrunds-cDMARDs5
English: Rare cases of lymphoproliferative disorders have been reported.
Danish: Sjældne tilfælde af lymfoproliferative tilstande er blevet rapporteret.
English: There are no adequate data from the use of baricitinib in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af baricitinib til gravide kvinder.
English: The rate of serious infections with Olumiant (1.1 %) was similar to placebo (1.2 %).
Danish: Hyppigheden af alvorlige infektioner med Olumiant (1,1 %) svarede til placebo (1,2 %).
English: Olumiant treatment should not be resumed until the infection resolves.
Danish: Behandling med Olumiant må ikke genoptages, før infektionen er gået over.
English: • Do not take Olumiant if you are pregnant or suspect you may be pregnant.
Danish: • Tag ikke Olumiant, hvis du er gravid eller har mistanke om, at du kan være gravid:
English: Most infections were mild to moderate in severity.
Danish: De fleste infektioner var lette til moderate i sværhedsgrad.
English: Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.
Danish: Herpes zoster blev rapporteret hyppigere hos patienter ≥ 65 år, som tidligere har været i behandling med både biologiske og konventionelle DMARDs.
English: Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity.
Danish: Enkeltdoser på op til 40 mg og flere doser på op til 20 mg daglig i 10 dage er blevet administreret i kliniske studier uden dosisbegrænsende toksicitet.
English: • cellulose, microcrystalline
Danish: • cellulose, mikrokrystallinsk
English: Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.
Danish: Der blev observeret stabile responsrater, og ACR20-/50-/70-responserne blev opretholdt i mindst 2 år, herunder i det længerevarende forlængelsesstudie.
English: A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure.
Danish: I alt 3.464 patienter blev behandlet med Olumiant i kliniske studier vedrørende reumatoid artritis, og det repræsenterede 4.214 patientårs eksponering.
English: Mean volume of distribution following intravenous infusion administration was 76 L, indicating distribution of baricitinib into tissues.
Danish: Det gennemsnitlige fordelingsvolumen efter intravenøs infusion var 76 l, hvilket indikerer fordeling af baricitinib ind i væv.
English: • That the patient may need to have their cholesterol level checked during treatment
Danish: • At det kan være nødvendigt, at patienten får kontrolleret kolesteroltallet under behandlingen.
English: Adverse events were comparable to those seen at lower doses and no specific toxicities were identified.
Danish: Bivirkningerne var sammenlignelige med de bivirkninger, der blev set ved lavere doser, og der blev ikke identificeret nogen specifikke toksiske virkninger.
English: Greater rates of remission compared to placebo were observed as early as week 4.
Danish: Der blev observeret højere remissionsrater sammenlignet med placebo så tidligt som i uge 4.
English: Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Danish: Behandling med Olumiant 4 mg resulterede i en statistisk signifikant hæmning af progression af strukturel ledskade (tabel 5).
English: The main objectives of the programme are to make the prescribers aware of the risks associated with the product's use, and to highlight specific risk minimisation measures to be performed before and during the treatment with Olumiant.
Danish: Hovedformålet med programmet er at gøre de ordinerende læger opmærksomme på de risici, der er forbundet med anvendelse af præparatet, og at fremhæve bestemte risikominimeringsforanstaltninger, der skal opfyldes før og under behandlingen med Olumiant.
English: QR code to be included+ www.olumiant.eu
Danish: QR-kode skal indsættes + www.olumiant.eu
English: • That Olumiant increases the potential risk of infections.
Danish: • Olumiant øger den potentielle risiko for infektioner.
English: Olumiant is contraindicated during pregnancy (see section 4.3).
Danish: Olumiant er kontraindiceret under graviditet (se pkt.
English: The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib.
Danish: De kliniske data er ikke tilstrækkelige til at vurdere den potentielle incidens af maligniteter efter eksponering for baricitinib.
English: Infections reported with Olumiant treatment included Herpes zoster.
Danish: Infektioner rapporteret i forbindelse med behandling med Olumiant omfattede også herpes zoster.
English: RA-BUILD cDMARD-IR patients
Danish: RA-BUILD cDMARD-IR patienter
English: • That the Patient Alert Card should be carried by the patient at any time and to share it with other healthcare professionals involved in their treatment.
Danish: • At patienten til enhver tid skal have patientkortet med sig, og at patienten skal vise det til andre sundhedspersoner, der er involveret i hans/hendes behandling.
English: Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Danish: Baricitinib er en selektiv og reversibel hæmmer af Janus-kinase (JAK) 1 og JAK2.
English: As of 01 July 2019, 114 VTEs have been reported in 102 cases from post-marketing reports.
Danish: Fra 1. juli 2019 var der efter markedsføring rapporteret om 114 VTE' i 102 tilfælde.
English: Opportunistic infections related to demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure.
Danish: Opportunistiske infektioner relateret til demodicose (skab) blev observeret hos hunde ved eksponeringer på ca. 7 gange eksponeringen hos mennesker.
English: Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Danish: Immunmodulerende lægemidler kan øge risikoen for maligniteter, herunder lymfom.
English: Moreover, recurrent DVT and subsequent PE observed September 2018 in patient who continued treatment with baricitinib after the first DVT also confirm possible relationship between use of baricitinib and occurrence of VTE.
Danish: Desuden bekræfter observationer i september 2018 af tilbagevendende DVT og efterfølgende PE hos patienter, som fortsatte behandling med baricitinib efter første DVT, også at der er en mulig sammenhæng mellem brug af baricitinib og forekomsten af VTE.
English: Animal studies indicate that baricitinib may have an adverse effect on bone development in utero at higher dosages.
Danish: Dyrestudier indikerer, at baricitinib kan have en skadelig virkning på knogleudviklingen in utero ved højere doser.
English: From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Danish: Ud af de 316 bivirkninger, der indgik i review fra post-marketing rapporter, var udslæt (n=95) den hyppigst rapporterede bivirkning.
English: The majority of patients who lost their low disease activity or remission status after dose reduction could regain disease control after the dose was returned to 4 mg.
Danish: Størstedelen af de patienter, der mistede deres status med lav sygdomsaktivitet eller remission efter dosisreduktion, kunne genvinde sygdomskontrol, efter at dosis igen var sat op til 4 mg.
English: Patients who discontinued or received rescue therapy were considered as non-responders thereafter.
Danish: Patienter, der fik seponeret behandlingen eller fik nødbehandling, blev herefter anset for at være ikke-responderende.
English: A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding.
Danish: En risiko hos nyfødte/spædbørn kan ikke udelukkes, og Olumiant bør ikke anvendes under amning.
English: For Olumiant, the most common serious infections were herpes zoster, and cellulitis.
Danish: For Olumiant var de hyppigste alvorlige infektioner herpes zoster og cellulitis.
English: • A painful skin rash with blisters.
Danish: • et smertefuldt hududslæt med blærer.
English: You and your doctor should decide if you will breast-feed or use Olumiant.
Danish: Du og lægen skal sammen afgøre, om du skal amme eller tage Olumiant.
English: Inhibition of IL-6 induced STAT3 phosphorylation
Danish: Hæmning af IL-6-induceret fosforylering af STAT3
English: Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
Danish: Patienter med hepatitis B-overflade-antistof og hepatitis B-kerne-antistof, men uden hepatitis B-overflade-antigen kunne også deltage; sådanne patienter bør monitoreres for ekspression af hepatitis B-virus (HBV)-DNA.
English: No adverse foetal effects were observed at exposures 2 times the human exposure based on AUC.
Danish: Der blev ikke observeret nogen føtale virkninger ved eksponeringer på 2 gange eksponeringen hos mennesker baseret på AUC.
English: Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score
Danish: Forkortelser: QD = én gang daglig, Q2W = én gang hver anden uge, s.c. = subkutant, ACR = American College of Rheumatology, SDAI = Simplified Disease Activity Index, HAQ-DI = Health Assessment Questionnaire-Disability Index, mTSS = modified Total Sharp Score.
English: In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F).
Danish: I alle studier rapporterede de patienter, der blev behandlet med Olumiant, forbedringer i patientrapporteret livskvalitet målt ved Short Form (36) Health Survey (SF-36) Physical Component Score og træthed målt ved Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale.
English: Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly reduced, without actual loss of renal function or the occurrence of renal adverse events.
Danish: Derfor kan estimater for den glomerulære filtrationshastighed baseret på serum-kreatinin være lettere reducerede uden en reel forringelse af nyrefunktionen eller forekomst af negative renale virkninger.
English: Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Danish: Før behandling med Olumiant påbegyndes, anbefales det, at patienterne bringes a jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering.
English: Inform your doctor immediately if you get symptoms of infection, such as:
Danish: Fortæl straks lægen, hvis du får symptomer på en infektion, f.eks.:
English: This could be a sign of a herpes zoster infection.
Danish: Dette kan være et tegn på herpes zosterinfektion.
English: Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted.
Danish: Baricitinib kan være en klinisk relevant hæmmer af OCT1, men der er på nuværende tidspunkt ingen kendte selektive OCT1-substrater, for hvilke klinisk signifikante interaktioner kan forudsiges.
English: Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was observed in the therapeutic dose range.
Danish: Efter oral administration af baricitinib blev der observeret en dosisproportional stigning i den systemiske eksponering i det terapeutiske dosisinterval.
English: In female rats there were decreased numbers of corpora lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine survival of the embryos.
Danish: Hos hunrotter var der et nedsat antal corpora lutea og implantationssteder, et øget præ-implantationstab og/eller negative virkninger på embryoernes intrauterine overlevelse.
English: • A cough that won't go away, night sweats, and weight loss.
Danish: • hoste, der ikke vil gå over, nattesved og vægttab.
English: Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Danish: Patienter med dokumenteret aktiv hepatitis B- eller C-infektion blev ekskluderet fra kliniske studier.
English: Potential for baricitinib to affect the pharmacokinetics of other medicinal products
Danish: Baricitinibs potentiale til at påvirke farmakokinetikken af andre lægemidler
English: These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.
Danish: Disse virkninger kan medføre, at det bliver lettere at udføre normale dagligdags aktiviteter og kan derved forbedre den helbredsrelaterede livskvalitet hos patienter med leddegigt.
English: Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.
Danish: Baricitinib modulerer disse signalveje ved delvist at hæmme den enzymatiske aktivitet af JAK1 og JAK2 og dermed reducere fosforyleringen og aktiveringen af STATs.
English: In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.
Danish: I et klinisk farmakologisk studie blev ca. 75 % af den administrerede dosis udskilt i urinen, mens ca. 20 % af dosis blev udskilt i fæces.
English: • Use effective contraception while taking Olumiant (and for 1 week after, if you stop treatment).
Danish: • Brug sikker prævention, mens du tager Olumiant (og i mindst 1 uge efter, hvis du har stoppet behandlingen).
English: By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints.
Danish: Ved at nedsætte aktiviteten af dette enzym hjælper Olumiant med at mindske smerter, stivhed og hævelse i og omkring leddene samt træthed og hjælper med at bremse skader på knogler og brusk i leddene.
English: Monitoring Guidance
Danish: Monitoreringsvejledning
English: Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
Danish: Kombination med biologiske DMARDs eller andre Janus-kinase (JAK)-hæmmere anbefales ikke, da en risiko for additiv immunsuppression ikke kan udelukkes.
English: Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Danish: Olumiant virker ved at nedsætte aktiviteten af et enzym i kroppen, der kaldes ‘Janus-kinase', som er forbundet med inflammation.
English: Absolute Neutrophil Count (ANC)
Danish: Absolut neutrofiltal (ANC)
English: Patients who develop adverse reactions should receive appropriate treatment.
Danish: Patienter, der udvikler bivirkninger, skal have relevant behandling.
English: You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
Danish: Du skal fortælle det til lægen, hvis du bliver gravid, da Olumiant ikke må anvendes under graviditet.
English: Treatment should be temporarily interrupted if drug-induced liver injury is suspected
Danish: Behandlingen bør afbrydes midlertidigt, hvis der er mistanke om lægemiddelinduceret leverskade.
English: • titanium dioxide (E171)
Danish: • titandioxid (E 171)
English: • That Olumiant should not be taken while pregnant and that women should inform their doctor should they become (or wish to become) pregnant
Danish: • At Olumiant ikke må anvendes under graviditet, og at kvinder skal fortælle deres læge, hvis de bliver (eller planlægger at blive) gravide.
English: BEACON (24 weeks)
Danish: BEACON (24 uger)
English: Decreases in red blood cell parameters were observed in mice, rats and dogs at exposures approximately 6 to 36 times the human exposure.
Danish: Fald i parametre for røde blodceller blev observeret hos mus, rotter og hunde ved eksponeringer på ca. 6-36 gange eksponeringen hos mennesker.
English: The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min.
Danish: Den anbefalede dosis er 2 mg én gang daglig hos patienter med kreatininclearance 30-60 ml/min.
English: b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
Danish: b Sammensat term (eczema herpeticum, herpes simplex, oftalmisk herpes simplex, oral herpes).
English: If you stop taking Olumiant Do not stop taking Olumiant unless your doctor tells you to stop taking it.
Danish: Du må ikke stoppe med at tage Olumiant, medmindre lægen fortæller dig, at du skal stoppe med at tage det.
English: Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Danish: I den intracellulære signalvej fosforylerer og aktiverer JAKs signaltransduktorer og aktivatorer af transskription (STATs), hvilket aktiverer genekspression inde i cellen.
English: The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections (see section 4.2).
Danish: Risiciene og fordelene ved Olumiant-behandling skal nøje overvejes forud for indledning af behandling hos patienter med aktive, kroniske eller tilbagevendende infektioner (se pkt.
English: Since there were no effects on spermatogenesis (as assessed by histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of these female effects.
Danish: Da der ikke var nogen indvirkning på spermatogenesen (vurderet ved histopatologi) eller sæd/sperma-endepunkter hos hanrotter, var den nedsatte samlede parringsevne sandsynligvis et resultat af virkningerne på hunrotter.
English: Immunosuppressive medicinal products
Danish: Immunsupprimerende lægemidler
English: If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.
Danish: Hvis der opstår en alvorlig allergisk eller anafylaktisk reaktion, skal behandling med baricitinib straks seponeres.