natgillin/translations-raw huggingface dataset:
• som har en alvorlig eller opportunistisk infektion i anamnesen
• with a history of a serious or an opportunistic infection,
Hver pakning indeholder 56, 112 eller 182 tabletter og hver flaske indeholder 60 eller 180 tabletter.
Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
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.
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.
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).
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).
Forsigtighed anbefales også hos patienter med kronisk lungesygdom i anamnesen, da de kan være mere disponerede for infektioner.
Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
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.
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.
Da tofacitinib omsættes af CYP3A4, er interaktion med lægemidler, der hæmmer eller inducerer CYP3A4, sandsynlig.
Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Til patienter, som har svært ved at synke, kan tofacitinib tabletter knuses og indtages sammen med vand.
For patients who have difficulties swallowing, tofacitinib tablets may be crushed and taken with water.
Ulcerativ colitis
Ulcerative colitis
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.
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.
Der er ikke registreret evidens for stereokonvertering i humane prøver.
No evidence of stereo conversion in human samples was detected.
Blandt patienter, der blev behandlet med tofacitinib, synes risikoen for herpes zoster at være højere hos:
In patients treated with tofacitinib, the incidence of herpes zoster appears to be increased in:
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.
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.
- 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.
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
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.
Particular consideration should be given to patients with longstanding RA who have previously received two or more biological DMARDs.
I modsætning til det observerede fald efter korttidsbehandling viste CD16/56+-NK-celletallet en median stigning på 73 % fra baseline.
In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
mTSS Baseline Måned 6 Måned 12
mTSSc Baseline Month 6 Month 12
Lægen bør tjekke dit kolesteroltal 8 uger efter, du er begyndt at tage XELJANZ.
Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
RA-patienter har større risiko for kardiovaskulær sygdom.
RA patients have an increased risk for cardiovascular disorders.
De hyppigste alvorlige bivirkninger var alvorlige infektioner (se pkt.
The most common serious adverse reactions were serious infections (see section 4.4).
Anvendelsen af tofacitinib i kombination med fosfodiesterase-4-hæmmere er ikke blevet undersøgt i kliniske studier med tofacitinib.
The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
I hele behandlingsforløbet med tofacitinib var den mest almindeligt indberettede infektion nasofaryngit, som 18,2 % af patienterne oplevede (211 patienter).
In the entire treatment experience with tofacitinib, the most commonly reported infection was nasopharyngitis, occurring in 18.2% of patients (211 patients).
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.
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.
Før initiering af tofacitinib anbefales det, at patienten er ajour med alle vaccinationer i overensstemmelse med gældende retningslinjer.
Prior to initiating tofacitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Studiets varighed
Study duration
Behandlingen skal påbegyndes og superviseres af speciallæger med erfaring inden for diagnosticering og behandling af reumatoid artrit.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Ved baseline havde 79,9 % og 56,2 % af patienterne hhv. enthesitis og dactylitis.
At baseline, 79.9% and 56.2% of patients had enthesitis and dactylitis, respectively.
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.
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).
Bekræftede stigninger i leverenzymer til mere end 3 gange øvre normalgrænse (3 x ULN) var ikke en almindelig observation hos RA-patienter.
Confirmed increases in liver enzymes greater than 3 times the upper limit of normal (3x ULN) were uncommonly observed in RA patients.
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.
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.
Det er ikke sandsynligt, at hæmmere af CYP2C19 alene eller af P-glykoprotein vil ændre tofacitinibs farmakokinetik signifikant.
Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib.
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