natgillin/translations-raw huggingface dataset:
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. 
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.
Der er rapporteret gastrointestinale perforationer i kliniske studier, selv om det ikke vides, hvilken rolle JAK-hæmning spiller ved disse hændelser. 
Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Hver pakning indeholder 28 eller 91 depottabletter. 
Each pack contains 28 or 91 prolonged-release tablets.
Du må ikke tage en dobbeltdosis som erstatning for en glemt 11 mg depottablet. 
Do not take a double dose to make up for a forgotten 11 mg prolonged-release tablet.
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. 
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.
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. 
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.
Efter behandlingsstart med tofacitinib hos RA-patienter blev der observeret et hurtigt fald i serumC-reaktivt protein (CRP), som blev opretholdt under behandlingen. 
After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Du bør ikke tage XELJANZ, hvis antallet af hvide blodlegemer (neutrofiler eller lymfocytter) eller røde blodlegemer er for lavt. 
You should not receive XELJANZ if your white blood cell (neutrophil or lymphocyte) count or red blood cell count is too low.
• Tidligere venøs tromboemboli, enten dyb venetrombose eller lungeemboli 
• Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
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). 
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).
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): Tuberkulose som involvere hjerne og rygrad, meningitis. 
Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Vigtige, sekundære effektmål 
Key secondary efficacy endpoints
Hovedelementer Monoterapi Forskellige csDMARD 
Key features Monotherapy Various csDMARDs
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. 
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.
XELJANZ bruges sammen med methotrexat til at behandle voksne patienter med aktiv psoriasisgigt. 
XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Laboratorietests 
Laboratory tests
Tofacitinib, alene eller kombineret med MTX, har vist forbedringer i fysisk funktion, målt ved HAQDI. 
Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
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. 
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.
Ingen csDMARD MTX MTX MTX Ingen 
None b csDMARDs MTX MTX MTX None b
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). 
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).
Erytem Pruritus 
Erythema Pruritus
Du har fået denne medicin af en speciallæge, som overvåger din behandling, og som ved, hvordan din sygdom skal behandles. 
This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.
Pulmonal emboli 
Pulmonary embolism
Helbredsrelateret livskvalitet blev vurderet ved hjælp af SF-36v2-skemaet, og fatique blev vurderet ved hjælp af FACIT-F-skemaet. 
Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F.
De patienter, som blev randomiseret til adalimumab (aktiv kontrolarm), fik 40 mg subkutant hver anden uge i 12 måneder. 
Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Der er efter markedsføring rapporteret om tilfælde af overfølsomhed forbundet med administration af tofacitinib. 
In post-marketing experience, cases of drug hypersensitivity associated with tofacitinib administration have been reported.
• patienter med langvarig RA, som tidligere er blevet behandlet med to eller flere biologiske sygdomsmodificerende antireumatiske lægemidler (DMARDs). 
• Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs).
I enzymatiske assays hæmmer tofacitinib JAK1, JAK2, JAK3 og i mindre grad TyK2. 
In enzymatic assays, tofacitinib inhibits JAK1, JAK2, JAK3, and to a lesser extent TyK2.
De må ikke knuses, deles eller tygges. 
They must not be crushed, split or chewed.
Helvedesild forekommer hyppigere hos japanske og koreanske patienter. 
There is a higher rate of shingles in Japanese and Korean patients.
Patienterne skal behandles i overensstemmelse med de kliniske retningslinjer for hyperlipidæmi. 
Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Det er muligt, at tofacitinib påvirker kroppens forsvarsmekanismer mod maligniteter. 
The possibility exists for tofacitinib to affect host defences against malignancies.
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. 
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.
• Graviditet og amning (se pkt. 
• Pregnancy and lactation (see section 4.6).
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. 
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.
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. 
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.
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. 
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.
Beslutning om vaccination med levende vacciner før behandling med tofacitinib skal ske under hensyntagen til patientens eksisterende immunsupression. 
The decision to use live vaccines prior to tofacitinib treatment should take into account the pre-existing immunosuppression in a given patient.
Patienterne skal evalueres og testes for latent eller aktiv infektion før administration af tofacitinib og i henhold til gældende retningslinjer under behandlingen. 
Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of tofacitinib.
Lymfocyttallet skal monitoreres ved baseline og derefter hver 3. måned. 
Lymphocytes should be monitored at baseline and every 3 months thereafter.
Dosisjustering Det er ikke nødvendigt at justere dosis, når det bruges i kombination med MTX. 
Dose adjustment No dose adjustment is required when used in combination with MTX.
Administration af tofacitinib i forbindelse med et måltid med højt fedtindhold resulterede ikke i ændring i AUC, men Cmax blev reduceret med 32 %. 
Coadministration of tofacitinib with a high-fat meal resulted in no changes in AUC while Cmax was reduced by 32%.
Gennemsnitsratioer for LDL-kolesterol:HDL-kolesterol og apolipoprotein B (ApoB):ApoA1 var stort set uændrede hos patienter, der blev behandlet med tofacitinib. 
Mean LDL cholesterol/HDL cholesterol ratios and Apolipoprotein B (ApoB)/ApoA1 ratios were essentially unchanged in tofacitinib-treated patients.
Hvis der er mistanke om lægemiddelfremkaldt leverpåvirkning, skal behandlingen med tofacitinib afbrydes, indtil denne diagnose er udelukket. 
If drug-induced liver injury is suspected, the administration of tofacitinib should be interrupted until this diagnosis has been excluded.
XELJANZ 11 mg depottablet indeholder sorbitol Dette lægemiddel indeholder cirka 152 mg sorbitol i hver depottablet. 
XELJANZ 11 mg prolonged-release tablet contains sorbitol This medicine contains approximately 152 mg sorbitol in each prolonged-release tablet.
Varighed af klinisk respons 
Durability of clinical responses
Andre fund ved doser, der overstiger human eksponering, inkluderede virkninger på lever og mavetarmsystem. 
Other findings at doses exceeding human exposures included effects on the hepatic and gastrointestinal systems.
De primære effektmål i begge studier var ACR20-responsrate og ændring fra baseline i HAQ DI ved måned 3. 
For both studies, the primary endpoints were ACR20 response rate and change from baseline in HAQ-DI at month 3.
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). 
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.
Risici og fordele ved behandlingen skal overvejes, inden behandling med tofacitinib påbegyndes hos patienter: 
The risks and benefits of treatment should be considered prior to initiating tofacitinib in patients:
Fortæl det til lægen, hvis du får vejrtrækningsproblemer. 
Tell your doctor if you notice any breathing difficulties.
Tofacitinib påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Tofacitinib has no or negligible influence on the ability to drive and use machines.
For pneumokokpolysaccharidvaccine var antallet af respondenter følgende: 32 % for tofacitinib plus MTX, 62 % for tofacitinib-monoterapi, 62 % for MTX-monoterapi og 77 % for placebo. 
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.
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. 
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.
• fluconazol, ketoconazol, der bruges til at behandle svampeinfektioner 
• fluconazole, ketoconazole, used to treat fungal infections
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. 
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.
Tofacitinibs farmakologiske aktivitet tilskrives modermolekylet. 
The pharmacologic activity of tofacitinib is attributed to the parent molecule.
TNF = Tumornekrosefaktor, N = Antallet af patienter i analysesættet. 
TNF=tumour necrosis factor; N=number of patients in the analysis set.
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). 
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).
Tabel 2: Lavt absolut neutrofiltal Lavt absolut neutrofiltal (ANC) (se pkt. 
Table 2: Low absolute neutrophil count Low absolute neutrophil count (ANC) (see section 4.4)
Traumer, forgiftninger og behandlingskomp likationer 
Injury, poisoning and procedural complications
Efter oral administration af tofacitinib 11 mg depottabletter opnås de maksimale plasmakoncentrationer efter 4 timer og halveringstiden er ca. 6 timer. 
Following oral administration of tofacitinib 11 mg prolonged-release tablet, peak plasma concentrations are reached at 4 hours and half-life is ~6 hours.
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) 
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
Omfattede TNF-hæmmer-naive patienter c. 
Included TNF Inhibitor naïve patients c.
CYP3A- og CYP2C19-hæmmer Fluconazol 
CYP3A & CYP2C19 Inhibitor Fluconazole
Samtidig anvendelse af tofacitinib og tacrolimus bør undgås 
Combined use of tofacitinib with tacrolimus should be avoided
I RA langtidssikkerhedspopulationen forblev stigninger i lipidparametre konsistente med, hvad der blev set i de kontrollerede kliniske studier. 
In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
Lægemiddeloverf ølsomhed* Angioødem* Urticaria 
Drug hypersensitivity* Angioedema* Urticaria*
Lipidparametre skal vurderes 8 uger efter behandlingsstart med tofacitinib. 
Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy.
Behandlingsafbrydelse kan være nødvendig for at håndtere dosisrelaterede afvigelser i laboratorietal inklusive lymfopeni, neutropeni og anæmi. 
Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia.
• patienter med en ALC under 1,0 x109 celler/mm3 (se pkt. 
• Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Hvis du har glemt at tage XELJANZ 
If you forget to take XELJANZ
• Webstedets arkiv skal indeholde: o Uddannelsesmaterialet i digitalt format o Patientinformationskortet i digitalt format 
• The website repository shall contain: o The educational material in digital format o The patient alert card in digital format
Samtidig administration af ketoconazol og fluconazol øgede tofacitinibs Cmax, mens tacrolimus, ciclosporin og rifampicin nedsatte tofacitinibs Cmax. 
Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Der er blevet rapporteret om tilfælde med opportunistiske infektioner (se pkt. 
Cases of opportunistic infections have been reported (see section 4.4).
Nominel p< 0,0001 for aktiv behandling versus placebo i måned 3. 
Nominal p<0.0001 for active treatment versus placebo at month 3.
Hvis du holder op med at tage XELJANZ Du må ikke holde op med at tage XELJANZ uden først at diskutere det med lægen. 
If you stop taking XELJANZ You should not stop taking XELJANZ without discussing this with your doctor.
Der kan også være en større risiko for, at du får visse lungeproblemer. 
You may also be at higher risk of certain lung problems.
Undlad at synke tørremidlet. 
Do not swallow the dessicant.
Samtidig administration af tofacitinib havde ikke nogen indvirkning på farmakokinetikken af orale kontraceptiva indeholdende levonorgestrel og ethinylestradiol hos frivillige raske kvinder. 
Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
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). 
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).
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. 
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.
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). 
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).
* 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) 
*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)
Tofacitinibs sikkerhed og virkning hos børn i alderen fra 0 til under 18 år er endnu ikke klarlagt. 
The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Tofacitinib 10 mg 2 gange dagligt er kontraindiceret til patienter, med et eller flere af følgende forhold: 
Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Patienter med alvorlig nedsat nyrefunktion skal forblive på en reduceret dosis, selv efter hæmodialyse (se pkt. 
Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
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. 
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.
Tofacitinib er et substrat for MDR1 in vitro, men ikke for brystkræft resistent protein (BCRP), OATP1B1/1B3 eller OCT1/2. 
In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Tofacitinib metaboliseres primært af CYP3A4 og i mindre grad af CYP2C19. 
The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Da infektionsincidensen generelt er højere hos ældre mennesker, skal der udvises forsigtighed ved behandling af ældre (se pkt. 
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).
Hvis du er i tvivl om noget af ovenstående, skal du kontakte lægen. 
If you are not sure regarding any of the information provided above, please contact your doctor.
Samtidig anvendelse af tofacitinib og ciclosporin bør undgås 
Combined use of tofacitinib with ciclosporine should be avoided
- Aktivt stof: tofacitinib. 
- The active substance is tofacitinib.
Tofacitinibs indvirkning på udviklingen af lymfom er ukendt. 
The effect of tofacitinib on the development of lymphoma is uncertain.
Behandlingen skal påbegyndes og superviseres af speciallæger med erfaring inden for diagnosticering og behandling af sygdomstilstande, som tofacitinib er indiceret til. 
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Samtidig administration af tofacitinib og potente CYP-induktorer (f.eks. rifampicin) kan medføre manglende eller nedsat klinisk respons (se figur 1). 
Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).