FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations).
Danish: De hyppigst rapporterede bivirkninger i løbet af de første 3 måneder i kontrollerede kliniske studier var hovedpine, øvre luftvejsinfektioner, nasopharyngitis, diarré, kvalme og hypertension (se tabel 6, bivirkninger baseret på alle studievarigheder).
English: Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): Tuberkulose som involvere hjerne og rygrad, meningitis.
English: Key secondary efficacy endpoints
Danish: Vigtige, sekundære effektmål
English: Key features Monotherapy Various csDMARDs
Danish: Hovedelementer Monoterapi Forskellige csDMARD
English: The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8.
Danish: Procentdelen af tofacitinib-behandlede patienter, der opnåede ACR20-, ACR50- og ACR70-respons i studierne ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start og ORAL Strategy vises i tabel 8.
English: XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Danish: XELJANZ bruges sammen med methotrexat til at behandle voksne patienter med aktiv psoriasisgigt.
English: Laboratory tests
Danish: Laboratorietests
English: Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Danish: Tofacitinib, alene eller kombineret med MTX, har vist forbedringer i fysisk funktion, målt ved HAQDI.
English: Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury.
Danish: Når behandling er begyndt, anbefales rutinemæssig monitorering af leverprøver og øjeblikkelig udredning af årsagerne til enhver forhøjelse af leverenzymer, så potentiel lægemiddelfremkaldt leverpåvirkning kan identificeres.
English: None b csDMARDs MTX MTX MTX None b
Danish: Ingen csDMARD MTX MTX MTX Ingen
English: The frequency of serious infection among tofacitinib-treated patients 65 years of age and older was higher than those under the age of 65 (4.8 per 100 patient-years versus 2.4 per 100 patient-years, respectively).
Danish: Hyppigheden af alvorlige infektioner blandt patienter på 65 år og ældre, der blev behandlet med tofacitinib, var højere end hos patienter under 65 år (henholdsvis 4,8 pr. 100 patientår versus 2,4 pr. 100 patientår).
English: Erythema Pruritus
Danish: Erytem Pruritus
English: This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.
Danish: Du har fået denne medicin af en speciallæge, som overvåger din behandling, og som ved, hvordan din sygdom skal behandles.
English: Pulmonary embolism
Danish: Pulmonal emboli
English: Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F.
Danish: Helbredsrelateret livskvalitet blev vurderet ved hjælp af SF-36v2-skemaet, og fatique blev vurderet ved hjælp af FACIT-F-skemaet.
English: Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Danish: De patienter, som blev randomiseret til adalimumab (aktiv kontrolarm), fik 40 mg subkutant hver anden uge i 12 måneder.
English: In post-marketing experience, cases of drug hypersensitivity associated with tofacitinib administration have been reported.
Danish: Der er efter markedsføring rapporteret om tilfælde af overfølsomhed forbundet med administration af tofacitinib.
English: • Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs).
Danish: • patienter med langvarig RA, som tidligere er blevet behandlet med to eller flere biologiske sygdomsmodificerende antireumatiske lægemidler (DMARDs).
English: In enzymatic assays, tofacitinib inhibits JAK1, JAK2, JAK3, and to a lesser extent TyK2.
Danish: I enzymatiske assays hæmmer tofacitinib JAK1, JAK2, JAK3 og i mindre grad TyK2.
English: They must not be crushed, split or chewed.
Danish: De må ikke knuses, deles eller tygges.
English: There is a higher rate of shingles in Japanese and Korean patients.
Danish: Helvedesild forekommer hyppigere hos japanske og koreanske patienter.
English: Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Danish: Patienterne skal behandles i overensstemmelse med de kliniske retningslinjer for hyperlipidæmi.
English: The possibility exists for tofacitinib to affect host defences against malignancies.
Danish: Det er muligt, at tofacitinib påvirker kroppens forsvarsmekanismer mod maligniteter.
English: If you are a woman of childbearing age, you should use effective birth control during treatment with XELJANZ and for at least 4 weeks after the last dose.
Danish: Hvis du er kvinde i den fødedygtige alder, skal du bruge sikker svangerskabsforebyggelse, mens du er i behandling med XELJANZ og i mindst 4 uger efter den sidste dosis.
English: • Pregnancy and lactation (see section 4.6).
Danish: • Graviditet og amning (se pkt.
English: Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Danish: Kvinder i den fertile alder skal rådes til at bruge effektiv prævention under behandling med tofacitinib og i mindst 4 uger efter den sidste dosis.
English: In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.
Danish: I induktions- og vedligeholdelsesstudierne på tværs af alle tofacitinib- og placebobehandlingsgrupperne, var de mest almindelige kategorier af alvorlige bivirkninger lidelser og infektioner i mave-tarm-kanalen, og den mest almindelige alvorlige bivirkning var forværring af UC.
English: Consultation with a healthcare professional with expertise in the treatment of TB is recommended to aid in the decision about whether initiating antituberculosis therapy is appropriate for an individual patient.
Danish: Det anbefales at inddrage en ekspert i behandling af TB i beslutningen om, hvorvidt det vil være hensigtsmæssigt at påbegynde tuberkulosebehandling hos en given patient.
English: The decision to use live vaccines prior to tofacitinib treatment should take into account the pre-existing immunosuppression in a given patient.
Danish: Beslutning om vaccination med levende vacciner før behandling med tofacitinib skal ske under hensyntagen til patientens eksisterende immunsupression.
English: Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of tofacitinib.
Danish: Patienterne skal evalueres og testes for latent eller aktiv infektion før administration af tofacitinib og i henhold til gældende retningslinjer under behandlingen.
English: Lymphocytes should be monitored at baseline and every 3 months thereafter.
Danish: Lymfocyttallet skal monitoreres ved baseline og derefter hver 3. måned.
English: Dose adjustment No dose adjustment is required when used in combination with MTX.
Danish: Dosisjustering Det er ikke nødvendigt at justere dosis, når det bruges i kombination med MTX.
English: Coadministration of tofacitinib with a high-fat meal resulted in no changes in AUC while Cmax was reduced by 32%.
Danish: Administration af tofacitinib i forbindelse med et måltid med højt fedtindhold resulterede ikke i ændring i AUC, men Cmax blev reduceret med 32 %.
English: Mean LDL cholesterol/HDL cholesterol ratios and Apolipoprotein B (ApoB)/ApoA1 ratios were essentially unchanged in tofacitinib-treated patients.
Danish: Gennemsnitsratioer for LDL-kolesterol:HDL-kolesterol og apolipoprotein B (ApoB):ApoA1 var stort set uændrede hos patienter, der blev behandlet med tofacitinib.
English: If drug-induced liver injury is suspected, the administration of tofacitinib should be interrupted until this diagnosis has been excluded.
Danish: Hvis der er mistanke om lægemiddelfremkaldt leverpåvirkning, skal behandlingen med tofacitinib afbrydes, indtil denne diagnose er udelukket.
English: XELJANZ 11 mg prolonged-release tablet contains sorbitol This medicine contains approximately 152 mg sorbitol in each prolonged-release tablet.
Danish: XELJANZ 11 mg depottablet indeholder sorbitol Dette lægemiddel indeholder cirka 152 mg sorbitol i hver depottablet.
English: Durability of clinical responses
Danish: Varighed af klinisk respons
English: Other findings at doses exceeding human exposures included effects on the hepatic and gastrointestinal systems.
Danish: Andre fund ved doser, der overstiger human eksponering, inkluderede virkninger på lever og mavetarmsystem.
English: For both studies, the primary endpoints were ACR20 response rate and change from baseline in HAQ-DI at month 3.
Danish: De primære effektmål i begge studier var ACR20-responsrate og ændring fra baseline i HAQ DI ved måned 3.
English: The efficacy and safety of tofacitinib were assessed in 6 randomised, double-blind, controlled multicentre studies in patients greater than 18 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria.
Danish: Tofacitinibs virkning og sikkerhed blev vurderet i 6 randomiserede, dobbeltblinde, kontrollerede multicenterstudier hos patienter over 18 år, som havde fået konstateret aktiv RA i henhold til kriterierne fra American College of Rheumatology (ACR).
English: The risks and benefits of treatment should be considered prior to initiating tofacitinib in patients:
Danish: Risici og fordele ved behandlingen skal overvejes, inden behandling med tofacitinib påbegyndes hos patienter:
English: Tell your doctor if you notice any breathing difficulties.
Danish: Fortæl det til lægen, hvis du får vejrtrækningsproblemer.
English: Tofacitinib has no or negligible influence on the ability to drive and use machines.
Danish: Tofacitinib påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: For pneumococcal polysaccharide vaccine the number of responders was as follows: 32% in patients receiving both tofacitinib and MTX; 62% for tofacitinib monotherapy; 62% for MTX monotherapy; and 77% for placebo.
Danish: For pneumokokpolysaccharidvaccine var antallet af respondenter følgende: 32 % for tofacitinib plus MTX, 62 % for tofacitinib-monoterapi, 62 % for MTX-monoterapi og 77 % for placebo.
English: Induction efficacy data (OCTAVE Induction 1 and OCTAVE Induction 2) The primary endpoint of OCTAVE Induction 1 and OCTAVE Induction 2 was the proportion of patients in remission at week 8, and the key secondary endpoint was the proportion of patients with improvement of endoscopic appearance of the mucosa at week 8.
Danish: Induktionseffektdata (OCTAVE Induction 1 og OCTAVE Induction 2 Det primære effektmål for OCTAVE Induction 1 og OCTAVE Induction 2 var andelen af patienter i remission ved uge 8, og det vigtige, sekundære effektmål var andelen af patienter med forbedring af endoskopisk udseende af slimhinden ved uge 8.
English: • fluconazole, ketoconazole, used to treat fungal infections
Danish: • fluconazol, ketoconazol, der bruges til at behandle svampeinfektioner
English: The proportion of patients achieving a DAS28 clinical remission (DAS28-4(ESR) < 2.6) in ORAL Step, ORAL Sync, and ORAL Standard is shown in Table 9.
Danish: Andelen af patienter, der opnåede DAS28 klinisk remission (DAS28-4(ESR) < 2,6) i Oral Step-, Oral Sync- og Oral Standard-studierne, vises i tabel 9.
English: The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Danish: Tofacitinibs farmakologiske aktivitet tilskrives modermolekylet.
English: TNF=tumour necrosis factor; N=number of patients in the analysis set.
Danish: TNF = Tumornekrosefaktor, N = Antallet af patienter i analysesættet.
English: If needed, your doctor may interrupt your XELJANZ treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).
Danish: Hvis det er nødvendigt, kan din læge afbryde behandlingen med XELJANZ i et stykke tid for at nedsætte risikoen for infektioner (lavt antal hvide blodlegemer) eller blodmangel (lavt antal røde blodlegemer).
English: Table 2: Low absolute neutrophil count Low absolute neutrophil count (ANC) (see section 4.4)
Danish: Tabel 2: Lavt absolut neutrofiltal Lavt absolut neutrofiltal (ANC) (se pkt.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomp likationer
English: Following oral administration of tofacitinib 11 mg prolonged-release tablet, peak plasma concentrations are reached at 4 hours and half-life is ~6 hours.
Danish: Efter oral administration af tofacitinib 11 mg depottabletter opnås de maksimale plasmakoncentrationer efter 4 timer og halveringstiden er ca. 6 timer.
English: Table 12: Proportion (%) of PsA patients who achieved clinical response and mean change from baseline in OPAL BROADEN and OPAL BEYOND studies Conventional synthetic DMARD inadequate responders a
Danish: Tabel 12: Andel (%) af patienter med PsA, som opnåede klinisk respons og gennemsnitlig ændring fra baseline i studierne OPAL BROADEN og OPAL BEYOND Konventionel syntetisk DMARD Patienter med utilstrækkeligt respons a (TNFi naive)
English: Included TNF Inhibitor naïve patients c.
Danish: Omfattede TNF-hæmmer-naive patienter c.
English: CYP3A & CYP2C19 Inhibitor Fluconazole
Danish: CYP3A- og CYP2C19-hæmmer Fluconazol
English: Combined use of tofacitinib with tacrolimus should be avoided
Danish: Samtidig anvendelse af tofacitinib og tacrolimus bør undgås
English: In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
Danish: I RA langtidssikkerhedspopulationen forblev stigninger i lipidparametre konsistente med, hvad der blev set i de kontrollerede kliniske studier.
English: Drug hypersensitivity* Angioedema* Urticaria*
Danish: Lægemiddeloverf ølsomhed* Angioødem* Urticaria
English: Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy.
Danish: Lipidparametre skal vurderes 8 uger efter behandlingsstart med tofacitinib.
English: Study V (O RAL Step)
Danish: Studie V (ORAL Step)
English: Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia.
Danish: Behandlingsafbrydelse kan være nødvendig for at håndtere dosisrelaterede afvigelser i laboratorietal inklusive lymfopeni, neutropeni og anæmi.
English: • Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Danish: • patienter med en ALC under 1,0 x109 celler/mm3 (se pkt.
English: If you forget to take XELJANZ
Danish: Hvis du har glemt at tage XELJANZ
English: • The website repository shall contain: o The educational material in digital format o The patient alert card in digital format
Danish: • Webstedets arkiv skal indeholde: o Uddannelsesmaterialet i digitalt format o Patientinformationskortet i digitalt format
English: Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Danish: Samtidig administration af ketoconazol og fluconazol øgede tofacitinibs Cmax, mens tacrolimus, ciclosporin og rifampicin nedsatte tofacitinibs Cmax.
English: Cases of opportunistic infections have been reported (see section 4.4).
Danish: Der er blevet rapporteret om tilfælde med opportunistiske infektioner (se pkt.
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Danish: Nominel p< 0,0001 for aktiv behandling versus placebo i måned 3.
English: If you stop taking XELJANZ You should not stop taking XELJANZ without discussing this with your doctor.
Danish: Hvis du holder op med at tage XELJANZ Du må ikke holde op med at tage XELJANZ uden først at diskutere det med lægen.
English: You may also be at higher risk of certain lung problems.
Danish: Der kan også være en større risiko for, at du får visse lungeproblemer.
English: Do not swallow the dessicant.
Danish: Undlad at synke tørremidlet.
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Danish: Samtidig administration af tofacitinib havde ikke nogen indvirkning på farmakokinetikken af orale kontraceptiva indeholdende levonorgestrel og ethinylestradiol hos frivillige raske kvinder.
English: The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Danish: Tofacitinibs virkning og sikkerhed blev vurderet i 2 randomiserede, dobbeltblinde, placebokontrollerede fase 3-studier hos voksne patienter med aktiv PsA (≥ 3 hævede og ≥ 3 ømme led).
English: The proportion of patients in both tofacitinib groups who had treatment failure was lower compared to placebo at each time point as early as week 8, the first time point where treatment failure was assessed, as shown in Figure 2.
Danish: Andelen af patienter i begge tofacitinib-grupper, der havde behandlingssvigt, var lavere sammenlignet med placebo ved hvert tidspunkt så tidligt som ved uge 8, det første tidspunkt, hvor behandlingssvigt blev vurderet, som vist på Figur 2.
English: In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
Danish: I hele behandlingsforløbet med tofacitinib var den generelle incidensrate for infektioner 60,3 hændelser pr. 100 patientår (der omfatter 49,4 % patienter; i alt 572 patienter).
English: *p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Danish: * p< 0,05, ** p< 0,001, *** p< 0,0001 versus placebo (versus MTX i ORAL Start studiet) ǂp<0,05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normale p-værdier uden justeringer for multiple sammenligninger)
English: The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Danish: Tofacitinibs sikkerhed og virkning hos børn i alderen fra 0 til under 18 år er endnu ikke klarlagt.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Danish: Tofacitinib 10 mg 2 gange dagligt er kontraindiceret til patienter, med et eller flere af følgende forhold:
English: Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
Danish: Patienter med alvorlig nedsat nyrefunktion skal forblive på en reduceret dosis, selv efter hæmodialyse (se pkt.
English: In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
Danish: I ORAL Scan og ORAL Start blev hæmning af progression af strukturel ledskade vurderet radiografisk og udtrykt som gennemsnitlig ændring fra baseline i mTSS og dets komponenter, erosionsscore og score for afsmalnet ledspalte (JSN), ved måned 6 og 12.
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Danish: Tofacitinib er et substrat for MDR1 in vitro, men ikke for brystkræft resistent protein (BCRP), OATP1B1/1B3 eller OCT1/2.
English: The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Danish: Tofacitinib metaboliseres primært af CYP3A4 og i mindre grad af CYP2C19.
English: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly (see section 4.4).
Danish: Da infektionsincidensen generelt er højere hos ældre mennesker, skal der udvises forsigtighed ved behandling af ældre (se pkt.
English: If you are not sure regarding any of the information provided above, please contact your doctor.
Danish: Hvis du er i tvivl om noget af ovenstående, skal du kontakte lægen.
English: Study VII (O RAL Strategy)
Danish: Studie VII (ORAL Strategy)
English: Combined use of tofacitinib with ciclosporine should be avoided
Danish: Samtidig anvendelse af tofacitinib og ciclosporin bør undgås
English: - The active substance is tofacitinib.
Danish: - Aktivt stof: tofacitinib.
English: The effect of tofacitinib on the development of lymphoma is uncertain.
Danish: Tofacitinibs indvirkning på udviklingen af lymfom er ukendt.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Danish: Behandlingen skal påbegyndes og superviseres af speciallæger med erfaring inden for diagnosticering og behandling af sygdomstilstande, som tofacitinib er indiceret til.
English: Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).
Danish: Samtidig administration af tofacitinib og potente CYP-induktorer (f.eks. rifampicin) kan medføre manglende eller nedsat klinisk respons (se figur 1).
English: The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Danish: Bivirkninger anført herunder er fra kliniske studier hos patienter med RA, PsA og UC og er klassificeret i henhold til systemorganklasse og hyppighed defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Results from population PK analysis in patients with active PsA or moderate to severe UC were consistent with those in patients with RA.
Danish: Resultaterne fra den farmakokinetiske populationsanalyse hos patienter med aktiv PsA eller moderat til svær UC var i overensstemmelse med de resultater, der sås hos patienter med RA.
English: Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
Danish: Der er rapporteret tilfælde af interstitiel lungesygdom (nogle med dødelig udgang) hos patienter, der er behandlet med tofacitinib i kliniske RA-studier og efter markedsføring, selv om det ikke er kendt, hvilken rolle Januskinase- (JAK-) inhibering har i disse tilfælde.
English: In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
Danish: I kliniske studier blev tofacitinib ikke evalueret hos patienter med kreatininclearance (estimeret ved Cockroft-Gault-ligningen) under 40 ml/min ved baseline (se pkt.