FrancophonIA/ELRC3.0 huggingface dataset:
English: • antibiotics such as rifampicin, used to treat bacterial infections
Danish: • antibiotika, såsom rifampicin, der bruges til at behandle bakterie-infektioner
English: Ciclosporine
Danish: Ciclosporin
English: Secondary effects from immunosuppression, such as bacterial and viral infections and lymphoma were observed at clinically relevant doses.
Danish: Sekundære virkninger af immunsuppression såsom bakterielle og virale infektioner samt lymfom blev observeret ved klinisk relevante doser.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2),
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, lactosemonohydrat (se afsnit 2),
English: Tell your doctor if you notice any painful blisters on your skin.
Danish: Fortæl det til lægen, hvis du får smertefulde blærer på huden.
English: Tofacitinib dose should be reduced a
Danish: Tofacitinib-dosen bør reduceres
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other medicinal products utilising a non-deformable prolonged-release formulation.
Danish: Der er indberettet sjældne tilfælde af obstruktive symptomer hos patienter med kendte strikturer i forbindelse med indtagelse af andre lægemidler, der benytter sig af en ikke-deformerbar depotformulering.
English: CYP Inducer Rifampicin
Danish: CYP-induktor Rifampicin
English: Pharmacokinetics in patients
Danish: Farmakokinetik hos patienter
English: RA and PsA patients have an increased risk for cardiovascular disorders.
Danish: RA- og PsA-patienter har større risiko for kardiovaskulær sygdom.
English: Try to take your tablet (one 11 mg prolonged-release tablet) at the same time each day, e.g., morning or evening.
Danish: Sørg for at tage tabletten (én 11 mg depottablet) på samme tidspunkt hver dag, for eksempel morgen eller aften.
English: Steady state concentrations are achieved in 24-48 hours with negligible accumulation after twice daily administration.
Danish: Steady state-koncentrationer opnås i løbet af 24-48 timer med ubetydelig akkumulering efter administration 2 gange dagligt.
English: If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment.
Danish: Hvis de tages sammen med XELJANZ, kan de forårsage en ændring af niveauet af XELJANZ i kroppen, og det kan være nødvendigt at justere dosis af XELJANZ.
English: All metabolites have been observed in animal species and are predicted to have less than 10-fold potency than tofacitinib for JAK1/3 inhibition.
Danish: Alle metabolitter er blevet observeret i dyrearter og forventes at have en potens, der er 10 gange mindre end tofacitinibs JAK1/3-hæmning.
English: • Use of combined hormonal contraceptives or hormone replacement therapy
Danish: • Brug af kombinerede hormonelle antikontraceptiva eller hormonerstatningsbehandling
English: Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52.
Danish: Opretholdt kortikosteroidfri remission blev defineret som værende i remission uden at tage kortikosterioider i mindst 4 uger før besøget i både uge 24 og 52.
English: • Inherited coagulation disorder
Danish: • Arvelige koagulationsforstyrrelser
English: Changes in mean HAQ-DI and DAS28-4(ESR) were maintained in both tofacitinib treatment groups through to the end of the studies.
Danish: Ændringer i gennemsnitlig HAQ-DI og DAS28-4(ESR) blev opretholdt frem til afslutning af studierne i begge tofacitinib-grupper.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende sværhedsgrad.
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Danish: Behandlingseffekt indtrådte hurtig (så tidligt som uge 2 i studierne ORAL Solo, ORAL Sync og ORAL Step), og effekten blev stadig bedre i takt med behandlingsvarigheden.
English: ≤3 weekly doses (MTX-naïve).
Danish: ≤3 ugentlige doser (MTX-naive).
English: In a human radiolabelled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
Danish: I et humant studie med radioaktivt mærket tofacitinib tegnede uomdannet aktivt stof sig for mere end 65 % af den samlede cirkulerende radioaktivitet, og de resterende 35 % blev tilskrevet 8 metabolitter, som hver især tegnede sig for mindre end 8 % af den samlede radioaktivitet.
English: Patients with latent TB, who test positive, should be treated with standard antimycobacterial therapy before administering tofacitinib.
Danish: Patienter med latent TB, som testes positive, skal behandles standardmæssigt med antimykobakteriel terapi, før tofacitinib administreres.
English: At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Danish: Efter 12 måneder i OCTAVE Open opnåede henholdsvis 52 % (25/48) og 45 % (37/83) af disse patienter remission.
English: Table 9: Number (%) of subjects achieving DAS28-4(ESR) < 2.6 remission at months 3 and 6
Danish: Tabel 9: Antal (%) forsøgspersoner, der opnåede DAS28-4(ESR) <2,6 remission ved 3 og 6 måneder
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0) 1 52 11 400
Danish: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: All these lymphocyte subset changes returned toward baseline after temporary discontinuation of treatment.
Danish: Alle disse ændringer i undergrupper af lymfocytter vendte tilbage mod baseline-værdier efter midlertidig behandlingsafbrydelse.
English: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Danish: En farmakokinetisk populationsanalyse hos RA-patienter peger på, at den systemiske eksponering (AUC) for tofacitinib ved yderpunkterne for kropsvægt (40 kg, 140 kg) stort set er den samme (inden for 5 %) som for en patient på 70 kg.
English: Changes from baseline in HAQ-DI in studies ORAL Standard, ORAL Step and ORAL Sync are shown in Table 11.
Danish: Ændringer i HAQ-DI i forhold til baseline i studierne ORAL Standard, Oral Step og ORAL Sync vises i Tabel 11.
English: In patients with RA, treatment up to 6 months with tofacitinib was associated with dose-dependent reductions of circulating CD16/56+ natural killer (NK) cells, with estimated maximum reductions occurring at approximately 8-10 weeks after initiation of therapy.
Danish: Hos RA-patienter var behandling med tofacitinib i op til 6 måneder forbundet med dosisafhængig reduktion af cirkulerende CD16/56+ naturlige dræberceller (NK) med anslået maksimal reduktion ca. 8-10 uger efter behandlingsstart.
English: • For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day.
Danish: • For patienter, der tidligere har taget biologiske lægemidler til behandling af blødende tyktarmsbetændelse (såsom de lægemidler, der blokerer aktiviteten af tumornekrosefaktor i kroppen), og hvis disse lægemidler ikke virkede, kan lægen beslutte at fortsætte med at give dig 10 mg to gange dagligt.
English: The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8).
Danish: Risikoen for opportunistiske infektioner er højere i Asien (se pkt.
English: • If maintaining XELJANZ 5 mg twice a day did not work for you, your doctor may decide to increase the dose to 10 mg twice a day.
Danish: • Hvis vedligeholdelse med XELJANZ 5 mg to gange dagligt ikke virkede for dig, kan din læge beslutte at øge dosis til 10 mg to gange dagligt.
English: Concomitant stable doses of oral aminosalicylates and corticosteroids (prednisone or equivalent daily dose up to 25 mg) were permitted with taper of corticosteroids to discontinuation mandated within 15 weeks of entering the maintenance study.
Danish: Samtidige, stabile doser med orale aminosalicylater og kortikosteroider (prednison eller tilsvarende daglig dosis op til 25 mg) var tilladt med nedtrapning af kortikosteroider til obligatorisk seponering inden for 15 uger fra inklusionen i vedligeholdelsesstudiet.
English: The enzymatic activity of CYP enzymes is reduced in RA patients due to chronic inflammation.
Danish: Aktiviteten af CYP-enzymer er nedsat hos RA-patienter pga. kronisk inflammation.
English: Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Danish: Ændringerne i niveauerne af totalserum IgG, IgM og IgA i løbet af 6 måneders behandling med tofacitinib hos RA-patienter var små og ikke dosisafhængige og svarende til dem, der blev set med placebo, hvilket indikerer fravær af systemisk humoral suppression.
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tofacitinib.
Danish: Patienterne skal overvåges nøje for udvikling af symptomer på infektion under og efter behandling med tofacitinib.
English: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Danish: Mindst én konventionel behandling var mislykkedes for de inkluderede patienter, herunder kortikosteroider, immunomodulatorer og/eller en TNF-hæmmer.
English: Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years.
Danish: Det blev estimeret, at AUC er mindre end 5 % større hos ældre patienter på 80 år i forhold til gennemsnitsalderen på 55 år.
English: Table 13: Change from baseline in HAQ-DI in PsA studies OPAL BROADEN and OPAL BEYOND
Danish: Tabel 13: Ændring fra baseline i HAQ-DI i PsA-studierne OPAL BROADEN og OPAL BEYOND
English: Your doctor should perform blood tests before you start taking XELJANZ, and after 4 to 8 weeks of treatment and then every 3 months, to determine if you have a low white blood cell (neutrophil or lymphocyte) count, or a low red blood cell count (anaemia).
Danish: Din læge vil tage blodprøver, før du begynder at tage XELJANZ, efter 4 til 8 ugers behandling og derefter hver 3. måned for at se, om du har et lavt antal hvide blodlegemer (neutrofiler eller lymfocytter) eller et lavt antal røde blodlegemer (blodmangel, anæmi).
English: Following a single dose of 10 mg, mean AUC in subjects with ESRD based on concentrations measured on a non-dialysis day was approximately 40% (90% confidence intervals: 1.5-95%) higher compared to subjects with normal renal function.
Danish: Efter en enkelt dosis på 10 mg var det gennemsnitlige AUC hos forsøgspersoner med ESRD, baseret på koncentrationer målt på ikkedialysedage, cirka 40 % (90 % konfidensinterval: 1,5-95 %) større end hos forsøgspersoner med normal nyrefunktion.
English: Patients who completed 8 weeks in 1 of the induction studies and achieved clinical response were re-randomised into OCTAVE Sustain; 179 out of 593 (30.2%) patients were in remission at baseline of OCTAVE Sustain.
Danish: Patienter, der fuldførte 8 uger i ét af induktionsstudierne og opnåede klinisk respons, blev randomiseret igen til OCTAVE Sustain; 179 ud af 593 (30,2 %) patienter var i remission ved baseline for OCTAVE Sustain.
English: • Heart failure
Danish: • Hjerteinsufficiens
English: Tofacitinib 11 mg prolonged-release tablets must be taken whole in order to ensure the entire dose is delivered correctly.
Danish: Tofacitinib 11 mg depottabletter skal tages hele for at sikre, at den samlede dosis indgives korrekt.
English: The impact of tofacitinib on chronic viral hepatitis reactivation is unknown.
Danish: Tofacitinibs indvirkning på reaktivering af kronisk viral hepatitis kendes ikke.
English: • with a history of a serious or an opportunistic infection,
Danish: • som har en alvorlig eller opportunistisk infektion i anamnesen
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Danish: Hver pakning indeholder 56, 112 eller 182 tabletter og hver flaske indeholder 60 eller 180 tabletter.
English: The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib.
Danish: Andelen af patienter, der seponerede behandlingen pga. bivirkninger i løbet af de første 3 måneder i dobbeltblinde placebo- eller MTX-kontrollerede studier, var 3,8 % for patienter, der tog tofacitinib.
English: If live zoster vaccine is administered; it should only be administered to patients with a known history of chickenpox or those that are seropositive for varicella zoster virus (VZV).
Danish: Hvis levende zoster-vaccine administreres, bør det kun gives til patienter med kendt anamnese med skoldkopper eller til patienter, der er seropositive over for varicella zoster-virus (VZV).
English: Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
Danish: Forsigtighed anbefales også hos patienter med kronisk lungesygdom i anamnesen, da de kan være mere disponerede for infektioner.
English: Changes in CRP observed with tofacitinib treatment do not reverse fully within 2 weeks after discontinuation, indicating a longer duration of pharmacodynamic activity compared to the half-life.
Danish: De ændringer i CRP, der blev observeret ved behandling med tofacitinib, reverserede ikke helt inden for 2 uger efter seponering, hvilket antyder, at den farmakodynamiske aktivitet varer længere end svarende til halveringstiden.
English: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Danish: Da tofacitinib omsættes af CYP3A4, er interaktion med lægemidler, der hæmmer eller inducerer CYP3A4, sandsynlig.
English: For patients who have difficulties swallowing, tofacitinib tablets may be crushed and taken with water.
Danish: Til patienter, som har svært ved at synke, kan tofacitinib tabletter knuses og indtages sammen med vand.
English: Ulcerative colitis
Danish: Ulcerativ colitis
English: Following long-term treatment (median duration of tofacitinib treatment of approximately 5 years), CD4+ and CD8+ counts showed median reductions of 28% and 27%, respectively, from baseline.
Danish: Efter langtidsbehandling (den mediane behandlingsvarighed med tofacitinib var cirka 5 år) viste CD4+- og CD8+-tallene mediane reduktioner på henholdsvis 28 % og 27 % i forhold til baseline.
English: No evidence of stereo conversion in human samples was detected.
Danish: Der er ikke registreret evidens for stereokonvertering i humane prøver.
English: In patients treated with tofacitinib, the incidence of herpes zoster appears to be increased in:
Danish: Blandt patienter, der blev behandlet med tofacitinib, synes risikoen for herpes zoster at være højere hos:
English: Treatment with tofacitinib resulted in significant improvements in some signs and symptoms of PsA, as assessed by the ACR20 response criteria compared to placebo at month 3.
Danish: Behandling med tofacitinib resulterede i signifikante forbedringer af visse PsA-tegn og symptomer, vurderet i henhold til ACR20 kriterierne sammenlignet med placebo ved måned 3.
English: - if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
Danish: - hvis du har høj risiko for at udvikle hudkræft, kan din læge anbefale, at du får huden undersøgt med jævne mellemrum, mens du tager Xeljanz.
English: Particular consideration should be given to patients with longstanding RA who have previously received two or more biological DMARDs.
Danish: Det bør særligt overvejes hos patienter, som har haft RA i længere tid, og som tidligere er blevet behandlet med to eller flere biologiske DMARDs.
English: In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
Danish: I modsætning til det observerede fald efter korttidsbehandling viste CD16/56+-NK-celletallet en median stigning på 73 % fra baseline.
English: mTSSc Baseline Month 6 Month 12
Danish: mTSS Baseline Måned 6 Måned 12
English: Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
Danish: Lægen bør tjekke dit kolesteroltal 8 uger efter, du er begyndt at tage XELJANZ.
English: RA patients have an increased risk for cardiovascular disorders.
Danish: RA-patienter har større risiko for kardiovaskulær sygdom.
English: The most common serious adverse reactions were serious infections (see section 4.4).
Danish: De hyppigste alvorlige bivirkninger var alvorlige infektioner (se pkt.
English: The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
Danish: Anvendelsen af tofacitinib i kombination med fosfodiesterase-4-hæmmere er ikke blevet undersøgt i kliniske studier med tofacitinib.
English: In the entire treatment experience with tofacitinib, the most commonly reported infection was nasopharyngitis, occurring in 18.2% of patients (211 patients).
Danish: I hele behandlingsforløbet med tofacitinib var den mest almindeligt indberettede infektion nasofaryngit, som 18,2 % af patienterne oplevede (211 patienter).
English: Antituberculosis therapy should also be considered prior to administration of tofacitinib in patients who test negative for TB but who have a past history of latent or active TB and where an adequate course of treatment cannot be confirmed; or those who test negative but who have risk factors for TB infection.
Danish: Tuberkulosebehandling skal også overvejes inden administration af tofacitinib hos patienter, som testes negative for TB, men som har en anamnese med latent eller aktiv TB, og hvor et passende behandlingsforløb ikke kan bekræftes, samt hos patienter, der testes negative, men som har risikofaktorer for TB-infektion.
English: Prior to initiating tofacitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Danish: Før initiering af tofacitinib anbefales det, at patienten er ajour med alle vaccinationer i overensstemmelse med gældende retningslinjer.
English: Study duration
Danish: Studiets varighed
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandlingen skal påbegyndes og superviseres af speciallæger med erfaring inden for diagnosticering og behandling af reumatoid artrit.
English: At baseline, 79.9% and 56.2% of patients had enthesitis and dactylitis, respectively.
Danish: Ved baseline havde 79,9 % og 56,2 % af patienterne hhv. enthesitis og dactylitis.
English: The European Medicines Agency has deferred the obligation to submit results of studies with tofacitinib in one or more subsets of the paediatric population in juvenile idiopathic arthritis and in ulcerative colitis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med tofacitinib i en eller flere undergrupper af den pædiatriske population med juvenil idiopatisk artrit og med ulcerativ colitis (se pkt.
English: Confirmed increases in liver enzymes greater than 3 times the upper limit of normal (3x ULN) were uncommonly observed in RA patients.
Danish: Bekræftede stigninger i leverenzymer til mere end 3 gange øvre normalgrænse (3 x ULN) var ikke en almindelig observation hos RA-patienter.
English: The clinical significance of this is unknown, however, similar results were obtained in a separate vaccine study with influenza and pneumococcal polysaccharide vaccines in patients receiving long-term tofacitinib 10 mg twice daily.
Danish: Den kliniske relevans af dette kendes ikke, men der blev opnået lignende resultater i et særskilt vaccinestudie med influenza- og pneumokokpolysaccharidvacciner hos patienter, der fik langtidsbehandling med 10 mg tofacitinib 2 gange dagligt.
English: Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib.
Danish: Det er ikke sandsynligt, at hæmmere af CYP2C19 alene eller af P-glykoprotein vil ændre tofacitinibs farmakokinetik signifikant.
English: Caution should be exercised when considering initiation of tofacitinib treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST), particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
Danish: Der skal udvises forsigtighed, når initiering af tofacitinib overvejes hos patienter med forhøjet alanin-aminotransferase (ALAT) eller aspartat-aminotransferase (ASAT), specielt hvis behandlingen initieres i kombination med potentielt levertoksiske lægemidler såsom MTX.
English: Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Danish: Der er rapporteret gastrointestinale perforationer i kliniske studier, selv om det ikke vides, hvilken rolle JAK-hæmning spiller ved disse hændelser.
English: Each pack contains 28 or 91 prolonged-release tablets.
Danish: Hver pakning indeholder 28 eller 91 depottabletter.
English: Do not take a double dose to make up for a forgotten 11 mg prolonged-release tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt 11 mg depottablet.
English: In study OPAL BROADEN, the progression of structural joint damage was assessed radiographically utilising the van der Heijde modified Total Sharp Score (mTSS) and the proportion of patients with radiographic progression (mTSS increase from baseline greater than 0.5) was assessed at month 12.
Danish: I OPAL BROADEN-studiet blev progression af strukturel ledskade vurderet radiografisk ved hjælp af van der Heijde modified Total Sharp Score (mTSS), og procentdelen af patienter med radiografisk progression (mTSS-stigning fra baseline på mere end 0,5) blev vurderet ved måned 12.
English: The risks and benefits of tofacitinib treatment should be considered prior to initiating therapy in patients with current or a history of malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing tofacitinib in patients who develop a malignancy.
Danish: Risici og fordele ved behandling med tofacitinib skal overvejes, inden behandlingen påbegyndes hos patienter med nuværende malignitet eller malignitet i anamnesen bortset fra vellykket behandling af non-melanom hudkræft (NMSC), og hvis man overvejer at fortsætte behandlingen med tofacitinib hos patienter, der udvikler en malignitet.
English: After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Danish: Efter behandlingsstart med tofacitinib hos RA-patienter blev der observeret et hurtigt fald i serumC-reaktivt protein (CRP), som blev opretholdt under behandlingen.
English: You should not receive XELJANZ if your white blood cell (neutrophil or lymphocyte) count or red blood cell count is too low.
Danish: Du bør ikke tage XELJANZ, hvis antallet af hvide blodlegemer (neutrofiler eller lymfocytter) eller røde blodlegemer er for lavt.
English: • Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
Danish: • Tidligere venøs tromboemboli, enten dyb venetrombose eller lungeemboli