FrancophonIA/ELRC3.0 huggingface dataset:
English: Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
Danish: Janus-kinaser (JAKs) er enzymer, der transducerer intracellulære signaler fra celleoverfladereceptorer for en række cytokiner og vækstfaktorer, som er involveret i hæmatopoiese, inflammation og immunfunktion.
English: • Fever, wounds, feeling more tired than usual, or dental problems.
Danish: • feber, sår, usædvanlig træthed eller tandproblemer.
English: In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.
Danish: 43,1 % (95 % CI: 34,0 %, 52,8 %) af patienterne opnåede tilfredsstillende IgG-immunresponser på tetanusvaccination.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for baricitinib er CHMP nået frem til følgende videnskabelige konklusioner:
English: Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate.
Danish: Patienter, der var hepatitis C-antistof-positive, men negative for hepatitis C-virus-RNA, kunne deltage.
English: The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.
Danish: Prodrugget leflunomid omdannes hurtigt til teriflunomid, der er en svag OAT3hæmmer, og som derfor kan lede til øget baricitinib-eksponering.
English: Radiographic Changes
Danish: Radiologiske forandringer
English: • The purpose and use of the Patient Alert Card
Danish: • Formål og anvendelse af Patientkortet.
English: The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development.
Danish: JAK/STAT-signalvejen er vist at være involveret i celleadhæsion og cellepolaritet, hvilket kan påvirke den tidlige embryonale udvikling.
English: If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.
Danish: Hvis HBV-DNA påvises, bør en specialist i leversygdomme konsulteres for at afgøre, om det er nødvendigt at afbryde behandlingen.
English: In controlled studies, for up to 16 weeks, the following rates were observed for Olumiant vs. placebo:
Danish: I kontrollerede studier blev der over de første 16 uger observeret følgende forekomster for Olumiant vs. placebo:
English: • That Olumiant use should be stopped in case of herpes zoster or any other infection that doesn't respond to standard treatment until the event resolves.
Danish: • Behandlingen med Olumiant skal afbrydes i tilfælde af herpes zoster eller ved enhver anden infektion, der ikke responderer på standardbehandling, indtil symptomerne forsvinder.
English: Baricitinib was detected in the milk of lactating rats.
Danish: Baricitinib blev påvist i mælken hos diegivende rotter.
English: Following oral administration, baricitinib is rapidly absorbed with a median tmax of approximately 1 hour (range 0.5 - 3.0 h) and an absolute bioavailability of approximately 79 % (CV = 3.94 %).
Danish: Efter oral administration absorberes baricitinib hurtigt med en median-tmax på ca. 1 time (interval 0,5-3,0 time) og en absolut biotilgængelighed på ca. 79 % (CV = 3,94 %).
English: Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Danish: Behandling med baricitinib var forbundet med dosisafhængige stigninger i lipidparametre, herunder totalkolesterol, triglycerider, LDL-kolesterol og HDL-kolesterol.
English: Improvements were seen as early as Week 1 and, in studies RA-BEGIN and RA-BEAM, this was maintained for up to 52 weeks.
Danish: Der blev set forbedring så tidligt som i uge 1, og i studierne RA-BEGIN og RA-BEAM blev denne opretholdt frem til uge 52.
English: Swelling of the face, Urticaria
Danish: Hævelse i ansigtet Urticaria
English: In a pre- and postnatal development study, decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, respectively, the human exposure.
Danish: I et studie af præ- og postnatal udvikling blev der observeret nedsat vægt hos afkommet og nedsat postnatal overlevelse ved eksponeringer på henholdsvis 4 og 21 gange eksponeringen hos mennesker.
English: You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk.
Danish: Du må ikke tage Olumiant, mens du ammer, da det ikke vides, om det går over i mælken.
English: RA-BEACON TNF-IR patients
Danish: RA-BEACON TNF-IR patienter
English: Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation.
Danish: Olumiant skal anvendes med forsigtighed til patienter med kendte risici for DVT/PE, såsom alder, overvægt, anamnese med DVT/PE eller patienter som gennemgår operation og immobilisering.
English: Combination with biologic DMARDs or other JAK inhibitors has not been studied.
Danish: Kombination med biologiske DMARDs eller andre JAK-hæmmere er ikke blevet undersøgt.
English: Olumiant 2 mg film-coated tablets EU/1/16/1170/001
Danish: Olumiant 2 mg filmovertrukne tabletter EU/1/16/1170/001
English: A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections.
Danish: En dosis på 2 mg én gang daglig er passende til f.eks. patienter ≥ 75 år og kan være passende til patienter med kroniske eller tilbagevendende infektioner i anamnesen.
English: Olumiant has no or negligible influence on the ability to drive and use machines.
Danish: Olumiant påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If a planned pregnancy is considered, Olumiant treatment should be stopped.
Danish: Hvis graviditet planlægges, skal behandling med Olumiant ophøre.
English: The efficacy and safety of Olumiant once daily was assessed in 4 Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis diagnosed according to the ACR/EULAR 2010 criteria (see Table 3).
Danish: Virkningen og sikkerheden af Olumiant én gang daglig blev vurderet i 4 randomiserede, dobbeltblinde fase 3-multicenterstudier hos patienter med moderat til svær aktiv reumatoid artritis diagnosticeret i henhold til ACR/EULAR 2010-kriterierne (se tabel 3).
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for symptomer på bivirkninger.
English: • That Olumiant use is associated with hyperlipidaemia; prescribers should monitor the patient's lipid parameters and manage the hyperlipidaemia, if detected.
Danish: • Anvendelse af Olumiant er forbundet med hyperlipidæmi; ordinerende læge skal monitorere patientens lipidparametre og korrigere hyperlipidæmi, hvis den påvises.
English: In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and > 400 nM, respectively.
Danish: I analyser af de enkelte enzymer hæmmede baricitinib aktiviteten af JAK1, JAK2, tyrosinkinase 2 og JAK3 med IC50værdier på henholdsvis 5,9, 5,7, 53 og > 400 nM.
English: Summary of key outcome measures
Danish: Oversigt over mål for nøgleresultater
English: An imbalance in reports of VTE with 0% (EAIR of 0,0) for placebo vs. 0,53% (EAIR of 1,3) for baricitinib 4-mg was noted in placebo-controlled trials.
Danish: En ubalance i rapportering af VTE med 0% (EAIR på 0,0) for placebo vs. 0,53% (EAIR på 1,3) for baricitinib 4 mg blev rapporteret i placebokontrollerede studier.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Olumiant therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Olumiant seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: For the total population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0 % (95 % CI: 58.4 %, 76.2 %) of the patients.
Danish: For totalpopulationen resulterede pneumokokvaccination i tilfredsstillende IgGimmunresponser hos 68,0 % (95 % CI: 58,4 %, 76,2 %) af patienterne.
English: * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN)
Danish: *p ≤ 0,05, **p ≤ 0,01, ***p ≤ 0,001 vs. placebo (vs. MTX for studie RA-BEGIN).
English: Decreases in lymphocytes, eosinophils and basophils as well as lymphoid depletion in organs/tissues of the immune system were observed in mice, rats and dogs.
Danish: Der blev observeret fald i antallet af lymfocytter, eosinofiler og basofiler såvel som lymfoid depletion i immunsystemets organer/væv hos mus, rotter og hunde.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Olumiant in one or more subsets of the paediatric population in chronic idiopathic arthritis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Olumiant i en eller flere undergrupper af den pædiatriske population med kronisk idiopatisk artritis (se pkt.
English: In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).
Danish: I klinisk farmakologiske studier var der ingen klinisk relevante effekter på eksponeringen, når baricitinib blev administreret sammen med digoxin (Pgp-substrat) eller methotrexat (substrat for flere transportører).
English: In placebo-controlled trials in which MTX was not required, 501 subjects randomized to baricitinib 2 mg or 4 mg received MTX as background therapy, and 303 received conventional DMARDs other than MTX (approximately half with MTX and half without).
Danish: I placebo-kontrollerede forsøg, hvor MTX ikke var påkrævet, fik 501 forsøgspersoner, der var randomiseret til baricitinib 2 mg eller 4 mg, MTX som basisbehandling, og 303 fik andre konventionelle DMARDs end MTX (ca. halvdelen med MTX og halvdelen uden).
English: The PK of baricitinib is linear with respect to time.
Danish: Farmakokinetikken af baricitinib er lineær med hensyn til tid.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see section 5.3).
Danish: Foreliggende farmakodynamiske/toksikologiske data hos dyr har vist, at baricitinib udskilles i mælk (se pkt.
English: 14 film-coated tablets 28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 35 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 84 x 1 filmovertrukne tabletter
English: Each tablet contains 2 or 4 milligrams of baricitinib.
Danish: Hver tablet indeholder 2 eller 4 milligram baricitinib.
English: In patients with rheumatoid arthritis, decreases in serum C-reactive protein (CRP) were observed as early as 1 week after starting treatment with Olumiant and were maintained throughout dosing.
Danish: Hos patienter med reumatoid artritis blev der observeret fald i serumniveauet af C-reaktivt protein (CRP) så tidligt som 1 uge efter opstart af Olumiant, og det blev opretholdt gennem hele doseringsperioden.
English: The effect of Olumiant on progression of structural joint damage was evaluated radiographically in studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Danish: Effekten af Olumiant på progression af strukturel ledskade blev evalueret radiologisk i RA-BEGIN-, RA-BEAM- og RA-BUILD-studierne og bestemt ved brug af modified Total Sharp Score (mTSS) og dets komponenter, erosionsscore og score for afsmalnet ledspalte.
English: • magnesium stearate
Danish: • magnesiumstearat
English: In a long-term extension study, patients from Studies RA-BEAM, RA-BUILD and RA-BEACON who achieved sustained low disease activity or remission (CDAI ≤ 10) after at least 15 months of treatment with Olumiant 4 mg once daily were re-randomized 1:1 in a double-blind manner to continue 4 mg once daily or reduce dose to 2 mg once daily.
Danish: I et længerevarende forlængelsesstudie blev de patienter fra RA-BEAM, RA-BUILD og RA-BEACON, der opnåede vedvarende lav sygdomsaktivitet eller remission (CDAI ≤ 10) efter mindst 15 måneders behandling med Olumiant 4 mg én gang daglig, randomiseret på ny i forholdet 1:1 på dobbeltblindet vis til at fortsætte med 4 mg én gang daglig eller få reduceret dosis til 2 mg én gang daglig.
English: Weight increased Creatine phosphokinase increased >5 x ULNc a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection).
Danish: Vægtstigning Kreatinkinase > 5 x ULNc a Sammensat term (akut sinuitis, epiglottitis, laryngitis, nasofaryngitis, orofaryngeale smerter, faryngitis, faryngotonsillitis, rhinitis, sinuitis, tonsillitis, tracheitis, infektion i øvre luftveje).
English: Vaccine study
Danish: Vaccinationsstudie
English: Talk to your doctor or pharmacist before and during treatment with Olumiant if you: - have an infection, or if you often get infections.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet før og under behandlingen med Olumiant, hvis du: - har en infektion, eller hvis du ofte får infektioner.
English: On the basis of the scientific conclusions for baricitinib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing baricitinib is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for baricitinib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder baricitinib, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: • That treatment with Olumiant may increase the risk of infections, and viral reactivation.
Danish: • At behandling med Olumiant kan øge risikoen for infektioner samt viral reaktivering.
English: Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis (see section 5.3).
Danish: Dyrestudier antyder, at behandling med baricitinib har potentiale til at nedsætte fertiliteten hos kvinder, mens de er i behandling, mens der ikke var nogen indvirkning på spermatogenesen hos hanner (se pkt.
English: Keep this information with you and share it with other healthcare professionals involved in your medical care or treatment.
Danish: Hav altid patientkortet med dig og vis det til andre læger og øvrigt sundhedspersonale, der er involveret i dine helbredsundersøgelser eller i din behandling.
English: Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as undergoing biotransformation.
Danish: Metabolisering af baricitinib medieres af CYP3A4, med mindre end 10 % af dosis identificeret som blivende biotransformeret.
English: In treatment-naïve patients, the combination of Olumiant with potentially hepatotoxic medicinal products, such as methotrexate, resulted in increased frequency of these elevations.
Danish: Hos tidligere ubehandlede patienter resulterede kombination af Olumiant og potentielt hepatotoksiske lægemidler, f.eks. methotrexat, i en øget hyppighed af disse stigninger.
English: Absolute Lymphocyte Count (ALC)
Danish: Absolut lymfocyttal (ALC)
English: Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.
Danish: Samtidig brug af OAT3-hæmmerne ibuprofen og diclofenac kan medføre øget eksponering for baricitinib, men deres potentiale for hæmning af OAT3 er imidlertid svagere sammenlignet med probenecid, og klinisk relevant interaktion forventes derfor ikke.
English: The MAH shall ensure that, in each Member State where Olumiant is marketed, all healthcare professionals who are expected to prescribe Olumiant are provided with the physician educational material, which should contain:
Danish: I hvert medlemsland, hvor Olumiant markedsføres, skal MAH sikre sig, at alle læger, som forventes at ordinere Olumiant, har undervisningsmaterialet til rådighed.
English: Data from clinical studies shows that the incidence rate of urticaria and face oedema is higher in the baricitinib 4 mg arm [urticarial: 0.60; face oedema: 0.89] compared to placebo arm [urticarial: 0.29; face oedema:0.29].
Danish: Data fra kliniske studier viser, at incidensraten for urticaria og ansigtsødem er højere i armen med baricitinib 4 mg [urticariel: 0,60; ansigtsødem: 0,89] sammenlignet med placeboarmen [urticariel: 0,29; ansigtsødem: 0,29].
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandling skal indledes af læger med erfaring i diagnosticering og behandling af reumatoid artritis.
English: Haemoglobin (Hb)
Danish: Hæmoglobin (Hb)
English: This document contains important information you should be aware of before and during treatment with Olumiant.
Danish: Dette patientkort indeholder vigtige oplysninger, som du skal være opmærksom på før og under behandling med Olumiant.
English: In a clinical pharmacology study, baricitinib was excreted predominately as the unchanged active substance in urine (69 %) and faeces (15 %) and only 4 minor oxidative metabolites were identified (3 in urine; 1 in faeces) constituting approximately 5 % and 1 % of the dose, respectively.
Danish: I et klinisk farmakologisk studie blev baricitinib overvejende udskilt som det uomdannede aktive stof i urinen (69 %) og fæces (15 %), og der blev kun identificeret 4 underordnede oxidative metabolitter (3 i urinen, 1 i fæces), som udgjorde henholdsvis ca. 5 % og 1 % af dosis.
English: You should use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after the last Olumiant treatment.
Danish: Du skal bruge sikker prævention for at undgå at blive gravid under behandlingen med Olumiant og i mindst én uge efter den sidste dosis Olumiant.
English: RA-BEGIN (52 weeks)
Danish: RA-BEGIN (52 uger)
English: Cmax and AUC at steady state are 1.4- and 2.0-fold higher, respectively, in subjects with rheumatoid arthritis compared to healthy subjects.
Danish: Cmax og AUC ved steady state er henholdsvis 1,4 og 2,0 gange højere hos forsøgspersoner med reumatoid artritis sammenlignet med raske forsøgspersoner.
English: In particular, tell your doctor or pharmacist before taking Olumiant if you are taking: - probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood.
Danish: Før du begynder at tage Olumiant, er det særligt vigtigt at fortælle lægen eller apotekspersonalet, hvis du tager: - probenecid (mod urinsyregigt), da denne medicin kan øge niveauet af Olumiant i blodet.
English: The RA-BEGIN Study in MTX-naïve patients is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs (section 4.1).
Danish: RA-BEGIN-studiet hos methotrexat (MTX)-naïve patienter er understøttende for målgruppen af patienter med et utilstrækkeligt respons (IR) eller intolerance overfor andre DMARDs (pkt.
English: Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Danish: Analyser af scorer for erosion og afsmalnet ledspalte stemte overens med de samlede scorer.
English: Please remove this portion of the patient leaflet and keep it with you.
Danish: Klip nedenstående del af indlægssedlen af og hav den med dig.
English: Baricitinib induced a mean increase in serum creatinine levels of 3.8 µmol/L after two weeks of treatment, as compared to placebo, which remained stable thereafter during up to 104 weeks of treatment.
Danish: Baricitinib inducerede en gennemsnitlig stigning i serum-kreatinin på 3,8 µmol/l efter 2 ugers behandling sammenlignet med placebo, og stigningen forblev herefter stabil under op til 104 ugers behandling.
English: Statistically significant pain reduction was seen as early as Week 1 and in studies RA-BEGIN and RA-BEAM this was maintained for up to 52 weeks.
Danish: Der blev set en statistisk signifikant reduktion af smerter så tidligt som i uge 1, og i studierne RA-BEGIN og RA-BEAM blev denne opretholdt frem til uge 52.
English: Six placebo-controlled studies were integrated (997 patients on 4 mg once daily and 1070 patients on placebo) to evaluate the safety of Olumiant in comparison to placebo for up to 16 weeks after treatment initiation.
Danish: Seks placebokontrollerede studier blev puljet (997 patienter fik 4 mg én gang daglig, og 1.070 patienter fik placebo) for at vurdere sikkerheden af Olumiant sammenlignet med placebo i op til 16 uger efter påbegyndt behandling.
English: The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric population (see section 4.2).
Danish: Sikkerheden, virkningen og farmakokinetikken af baricitinib er endnu ikke klarlagt hos en pædiatrisk population (se pkt.
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.
Danish: Dyb venetrombose (DVT) og lungeemboli (PE) er blevet rapporteret hos patienter der behandles med baricitinib.
English: In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported.
Danish: Efter markedsføring er der rapporteret om tilfælde af lægemiddeloverfølsomhed forbundet med administration af baricitinib.
English: The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis.
Danish: Risikoen for lymfocytose er øget hos ældre patienter med reumatoid artritis.
English: A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see section 5.1).
Danish: En dosis på 2 mg én gang daglig kan også overvejes til patienter, der har opnået vedvarende kontrol af sygdomsaktivitet med 4 mg én gang daglig og er egnede til nedtrapning af dosis (se pkt.
English: This may be due to inhibition of creatinine secretion by baricitinib in the renal tubules.
Danish: Dette kan skyldes, at baricitinib hæmmer udskillelsen af kreatinin i de renale tubuli.
English: Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.
Danish: Anvendelse af levende, svækkede vacciner under eller umiddelbart før behandling med Olumiant anbefales ikke.
English: Neutropaenia <1 x 109 cells/Lc
Danish: Neutropeni < 1 x 109 celler/lc
English: If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, Olumiant should be temporarily interrupted until this diagnosis is excluded.
Danish: Hvis der observeres stigning i ALAT- eller ASAT under den rutinemæssige kontrol af patienterne, og der er mistanke om lægemiddelinduceret leverskade, skal behandlingen med Olumiant afbrydes midlertidigt, indtil denne diagnose er udelukket.