natgillin/translations-raw huggingface dataset:
Pneumoni Influenza Herpes zoster Urinvejsinf ek-tion Sinuitis Bronkitis Nasofaryng itis 
Pneumonia Influenza Herpes zoster Urinary tract infection Sinusitis Bronchitis Nasopharyngitis Pharyngitis
XELJANZ 11 mg depottabletter bruges til at behandle voksne patienter med moderat til svær, aktiv leddegigt, en langvarig sygdom som hovedsagelig giver smerter og hævede led. 
XELJANZ11 mg prolonged-release tablets are used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints.
Klinisk respons blev defineret som en reduktion af Mayscoren i forhold til baseline på ≥ 3 point og ≥ 30 %, med en ledsagende reduktion af subscoren for rektal blødning på ≥ 1 point eller en absolut subscore for rektal blødning på 0 eller 1. 
Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
I ORAL Standard og ORAL Scan blev de gennemsnitlige forbedringer i begge skemaer opretholdt til måned 12 hos patienter, der blev behandlet med tofacitinib. 
In ORAL Standard and ORAL Scan, mean improvements in both scales were maintained to 12 months in tofacitinib-treated patients.
Patienter, der oplever en reduktion i respons på tofacitinib 5 mg to gange daglig vedligeholdelsesbehandling, kan have fordel af en øgning til tofacitinib 10 mg indgivet to gange dagligt. 
Patients who experience a decrease in response on tofacitinib 5 mg twice daily maintenance therapy may benefit from an increase to tofacitinib 10 mg administered twice daily.
Tabel 15: Andelen af patienter, der opfylder effektmål ved uge 8 (OCTAVE Induction 1studiet og OCTAVE Induction 2-studiet) OCTAVE Induction 1-studiet Central endoskopivurdering Lokal endoskopivurdering 
Table 15: Proportion of patients meeting efficacy endpoints at week 8 (OCTAVE induction study 1 and OCTAVE induction study 2) OCTAVE induction study 1 Central endoscopy read
- 11 mg depottabletterne findes som blisterkort med 7 depottabletter. 
- The 11 mg prolonged-release tablets are provided in blisters containing 7 prolonged-release tablets.
Pyreksi Perifert ødem Træthed 
Pyrexia Oedema peripheral Fatigue
Når ANC er over 1,0, genoptages behandlingen som det er klinisk relevant. 
When ANC is greater than 1,000, treatment should be resumed as clinically appropriate.
Forhøjet blodkreatini 
Blood creatine phosphokinase increased
Tabel 7: Kliniske fase 3-studier med tofacitinib i doser på 5 mg og 10 mg 2 gange dagligt hos RA-patienter 
Table 7: Phase 3 clinical trials of tofacitinib 5 mg and 10 mg twice daily doses in patients with RA
Hos patienter (i alt 1.750) på monoterapi var forekomsten henholdsvis 48,9 og 41,9 patienter med hændelser pr. 100 patientår for 5 mg og 10 mg 2 gange dagligt. 
For patients (total 1,750) on monotherapy, the rates were 48.9 and 41.9 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Patienter med nytilkomne abdominale symptomer skal straks evalueres mhp. 
Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
XELJANZ 11 mg depottabletter kan også tages alene i de tilfælde, hvor behandling med methotrexat ikke tåles eller ikke tilrådes. 
XELJANZ 11 mg prolonged-release tablets can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.
XELJANZ indeholder: 
What XELJANZ contains
En signifikant større andel af patienter i begge behandlingsgrupper, tofacitinib 5 mg to gange dagligt og tofacitinib 10 mg to gange dagligt, opnåede de følgende effektmål ved uge 52 sammenlignet med placebo: remission, forbedring af endoskopisk udseende af slimhinden, normalisering af endoskopisk udseende af slimhinden, opretholdelse af klinisk respons, remission hos patienter i remission ved baseline og opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline, som vist i Tabel 17. 
A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalisation of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
Tofacitinib 10 mg 2 gange dagligt + DMARD(s) ORAL Sync: Patienter med utilstrækkeligt respons på DMARD 
Tofacitinib 10 mg twice daily + DMARD(s) ORAL Sync: DMARD inadequate responders
Blisterkort af aluminiumsfolie/aluminiumsfolie med PVC-bagside med 7 depottabletter. 
Aluminium foil/PVC backed aluminium foil blisters containing 7 prolonged-release tablets.
Indigotin (indigocarmin) (E132) (kun i 10 mg styrke) Brilliant Blue FCF (E133) (kun i 10 mg styrke) 
FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) (10 mg strength only) FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133) (10 mg strength only)
Patienter, der fik tofacitinib 5 mg 2 gange dagligt, opnåede en større forbedring i fysisk funktion fra baseline sammenlignet med placebo i SF-36v2, i den sammenlagte SF36v2-score og i FACIT-F-score ved måned 3 i OPAL BROADEN- og OPAL BEYOND (nominel p< 0,05). 
Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement from baseline compared to placebo in the SF-36v2 physical functioning domain, the SF-36v2 physical component summary score, and FACIT-F scores at month 3 in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Det anbefales ikke at initiere eller fortsætte behandling med tofacitinib hos patienter med et bekræftet lymfocyttal under 0,75 x10 
It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm
Kreatininclearance Dosisjustering ved nedsat nyrefunktion for tabletter af forskellig styrke 
Dose adjustment in renal impairment for different strength tablets
Den anbefalede dosis er én 11 mg depottablet én gang dagligt. 
The recommended dose is one 11 mg prolonged-release tablet administered once daily.
Hos patienter (i alt 3.117), der fik baggrundsDMARD, var incidensen henholdsvis 41,0 og 50,3 patienter med hændelser pr. 100 patientår for 5 mg og 10 mg 2 gange dagligt. 
For patients (total 3,117) on background DMARDs, the rates were 41.0 and 50.3 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
I PsA I-studiet (OPAL BROADEN) vurderedes 422 patienter, som tidligere havde haft utilstrækkelig respons (på grund af manglende effekt eller intolerans) på en csDMARD (MTX for 92,7% af patienterne). 
Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to > 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD).
I de randomiserede 8-ugers fase 2/3-induktionsstudier var andelen af patienter med infektioner 21,1 % (198 patienter) i gruppen med tofacitinib 10 mg to gange dagligt sammenlignet med 15,2 % (43 patienter) i placebogruppen. 
In the randomised 8-week Phase 2/3 induction studies, the proportions of patients with infections were 21.1% (198 patients) in the tofacitinib 10 mg twice daily group compared to 15.2% (43 patients) in the placebo group.
I vedligeholdelsesstudiet (OCTAVE Sustain), udviste tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg to gange dagligt en større forbedringsopretholdelse sammenlignet med placebo i PCS- og MCS-scorerne og i alle 8 domæner af SF-36 ved uge 24 og uge 52. 
In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in PCS and MCS scores, and in all 8 domains of the SF-36 at week 24 and week 52.
Før behandling med tofacitinib påbegyndes, skal screening for viral hepatitis udføres i overensstemmelse med kliniske retningslinjer. 
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with tofacitinib.
Cellulitis Herpes simplex Viral gastroenteriti s 
T uberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
p<0,0001 for tofacitinib 5 mg to gange dagligt versus placebo. 
p<0.0001 for tofacitinib 5 mg twice daily versus placebo.
XELJANZ bruges sammen med methotrexat, når den forudgående behandling af leddegigt ikke har været tilstrækkelig eller ikke tåles. 
XELJANZ is used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated.
Tabel 18: Andel af patienter, der opfylder primære og vigtige, sekundære effektmål ved uge 52 efter TNF-hæmmer-behandlingsundergruppe (OCTAVE Sustain, central endoskopivurdering) 
Table 18: Proportion of patients meeting primary and key secondary efficacy endpoints at week 52 by TNF inhibitor therapy subgroup (OCTAVE sustain, central endoscopy read)
I ORAL Standard og ORAL Scan blev de gennemsnitlige forbedringer i FACIT-F opretholdt til måned 12 hos patienter, der fik tofacitinib. 
In ORAL Standard and ORAL Scan, mean FACIT-F improvements were maintained to 12 months in tofacitinib-treated patients.
Måned 6: 
Month 6:
Måned 3 Måned 6 Måned 12 Måned 24 
Month 3 Month 6 Month 12 Month 24
I vedligeholdelsesstudiet (OCTAVE Sustain), påviste tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg to gange dagligt en større forbedringsopretholdelse sammenlignet med placebo i den samlede score og alle 4 domænescorer for IBDQ ved uge 24 og uge 52. 
In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in the total and all 4 domain scores of the IBDQ at week 24 and week 52.
- XELJANZ 11 mg depottabletter er lyserøde og ovale. 
- XELJANZ 11 mg prolonged-release tablet is pink and oval in appearance.
Du må ikke tage XELJANZ, hvis du er gravid. 
XELJANZ must not be used during pregnancy.
Forbedring af endoskopisk visning af slimhinderne Normalisering af endoskopisk udseende af slimhinden Klinisk responsd 
Improvement of endoscopic appearance of the mucosab Normalisation of endoscopic appearance of the mucosac Clinical responsed
Der blev observeret benigne tymomer hos hunrotter ved 187 eller 94 gange det kliniske eksponeringsniveau på 5 mg eller 10 mg to gange dagligt. 
Benign thymomas were observed in female rats at 187 or 94 times the clinical exposure level at 5 mg or 10 mg twice daily.
p<0,0001 for tofacitinib 10 mg to gange dagligt versus placebo. 
p<0.0001 for tofacitinib 10 mg twice daily versus placebo.
Det frarådes, at XELJANZ bruges sammen med lægemidler, der undertrykker immunforsvaret, herunder såkaldte målrettede biologiske behandlinger (antistoffer), som dem, der hæmmer tumornekrose-faktorer og stærke kemiske lægemidler, der undertrykker immunforsvaret, herunder azathioprin, mercaptopurin, ciclosporin og tacrolimus. 
XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus.
Utilstrækkeligt respons på mindst én konventionelt syntetisk DMARD (csDMARD) på grund af manglende effekt og/eller intolerans. 
Inadequate response to at least one conventional synthetic DMARD (csDMARD) due to lack of efficacy and/or intolerability.
Indlægsseddel: Information til patienten XELJANZ 11 mg depottabletter tofacitinib 
Package leaflet: Information for the patient XELJANZ 11 mg prolonged-release tablets tofacitinib
XELJANZ 11 mg depottabletter bruges sammen med methotrexat, når den forudgående behandling af leddegigt ikke har været tilstrækkelig eller ikke tåles. 
XELJANZ 11 mg prolonged-release tablets are used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated.
Indlægsseddel: Information til patienten XELJANZ 5 mg filmovertrukne tabletter XELJANZ 10 mg filmovertrukne tabletter tofacitinib 
Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Tidligere TNFi-svigt Tidligere kortikosteroid-svigt Tidligere immunosuppressivasvigt 
Prior TNFi failure Prior corticosteroid failure
Psoriasisgigt • Den anbefalede dosis er 5 mg 2 gange dagligt. 
Psoriatic arthritis • The recommended dose is 5 mg twice a day.
XELJANZ 10 mg filmovertrukne tabletter XELJANZ 10 mg filmovertrukne tabletter er blå og runde. 
XELJANZ 10 mg film-coated tablets XELJANZ 10 mg film-coated tablet is blue and round in appearance.
5.1), var i alt 608 RA-patienter 65 år og ældre, inklusive 85 patienter, der var 75 år og derover. 
Of the 4,271 patients who enrolled in RA studies I-VI (see section 5.1), a total of 608 RA patients were 65 years of age and older, including 85 patients 75 years and older.
• Gennemsnitligt steg LDL-kolesterol med 15 % i armen, der fik 5 mg tofacitinib 2 gange dagligt, og med 20 % i armen, der fik 10 mg tofacitinib 2 gange dagligt, ved måned 12 og med 16 % i armen, der fik 5 mg tofacitinib 2 gange dagligt, og med 19 % i armen, der fik 10 mg tofacitinib 2 gange dagligt, ved måned 24. 
• Mean LDL cholesterol increased by 15% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 16% in the tofacitinib 5 mg twice daily arm and 19% in the tofacitinib 10 mg twice daily arm at month 24.
Andel af patienter, der opfylder primære og vigtige, sekundære effektmål ved uge 8 efter TNF-hæmmer-behandlingsundergrupper (OCTAVE Induction 1-studiet og OCTAVE Induction 2-studiet, central endoskopivurdering) OCTAVE Induction 1-studiet 
Proportion of patients meeting primary and key secondary efficacy endpoints at week 8 by TNF inhibitor therapy subgroups (OCTAVE induction study 1 and OCTAVE induction study 2, central endoscopy read) OCTAVE induction study 1
Tofacitinib er ikke blevet undersøgt og bør ikke anvendes i kombination med biologiske lægemidler såsom TNF-antagonister, interleukin (IL)-1R-antagonister, IL-6R-antagonister, anti-CD20monoklonale antistoffer, selektive co-stimuleringsmodulatorer og potente immunsuppressiva såsom azathioprin, 6-mercaptopurin, ciclosporin og tacrolimus på grund af muligheden for øget immunsuppressionen og øget risiko for infektion. 
Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
• Gennemsnitligt steg HDL-kolesterol med 17 % i armen, der fik 5 mg tofacitinib 2 gange dagligt, og med 18 % i armen, der fik 10 mg tofacitinib 2 gange dagligt, ved måned 12 og med 19 % i armen, der fik 5 mg tofacitinib 2 gange dagligt, og med 20 % i armen, der fik 10 mg 2 gange dagligt, ved måned 24. 
• Mean HDL cholesterol increased by 17% in the tofacitinib 5 mg twice daily arm and 18% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 19% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 24.
XELJANZ 5 mg filmovertrukne tabletter XELJANZ 5 mg filmovertrukne tabletter er hvide og runde. 
XELJANZ 5 mg film-coated tablets XELJANZ 5 mg film-coated tablet is white and round in appearance.
Tofacitinib i kombination med methotrexat (MTX) er indiceret til behandling af moderat til svær aktiv reumatoid artrit (RA) hos voksne patienter, som har haft utilstrækkeligt respons på, eller som ikke har tolereret behandling med et eller flere sygdomsmodificerende antireumatiske lægemidler (DMARDs). 
Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
Tofacitinib er ikke blevet undersøgt og bør ikke anvendes i kombination med biologiske lægemidler såsom TNF-antagonister, interleukin (IL)-1R-antagonister, IL-6R-antagonister, anti-CD20monoklonale antistoffer, IL-17 antagonister, IL-12/IL-23 antagonister, anti-integriner, selektive costimuleringsmodulatorer og potente immunsuppressiva såsom azathioprin, 6-mercaptopurin, ciclosporin og tacrolimus på grund af muligheden for øget immunsuppressionen og øget risiko for infektion. 
Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Tofacitinib i kombination med MTX er indiceret til behandling af aktiv psoriasisartrit (PsA) hos voksne patienter, som har haft utilstrækkeligt respons på, eller som ikke har tolereret behandling med et tidligere sygdomsmodificerende antireumatisk lægemiddel (DMARD) (se pkt. 
Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).
Tegn på allergiske reaktioner (hyppighed ”sjælden”) inkluderer - trykken for brystet 
Signs of allergic reactions (unknown) include
Sådan skal du tage XELJANZ 
How to take XELJANZ
Behandling med tofacitinib var forbundet med en dosisafhængig stigning i antallet af Bceller. 
Treatment with tofacitinib was associated with dose-dependent increases in B cell counts.
Behandlingsafbrydelse og seponering 
Dose interruption and discontinuation
Måned 3 ORAL Sync: Patienter med utilstrækkeligt respons på DMARD Tofacitinib 5 mg 2 gange dagligt 
Month 3 ORAL Sync: DMARD inadequate responders Tofacitinib 5 mg twice daily
Virkningen kan genoprettes efter 8 uger med en behandling på 10 mg to gange dagligt (se pkt. 
Efficacy may be regained by 8 weeks of 10 mg twice daily therapy (see section 5.1).
Måned 3: 
Month 3:
I begge undergrupper af patienter med eller uden tidligere svigt af TNF-hæmmer, opnåede en større andel af patienter, der blev behandlet med enten tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg to gange dagligt, de følgende effektmål ved uge 52 for OCTAVE Sustain sammenlignet med placebo: remission, forbedring af endoskopisk udseende af slimhinden, eller opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline (Tabel 
In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, or sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline (Table 18).
Hvis en patient udvikler en alvorlig infektion, skal behandlingen med tofacitinib afbrydes, indtil infektionen er bragt under kontrol. 
Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Patienter behandlet med tofacitinib, som er japanske eller koreanske, eller patienter, som har haft RA længe, og som tidligere har fået to eller flere biologiske DMARSs eller patienter med ALC under 1,0 x10 
Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
For patienter, der får tofacitinib 10 mg to gange dagligt, skal doseringen reduceres til tofacitinib 5 mg to gange dagligt. 
For patients receiving tofacitinib 10 mg twice daily, dosing should be reduced to tofacitinib 5 mg twice daily.
I placebo plus MTX-gruppen havde 78 % af patienterne ikke radiografisk progression (mTSSændringer mindre eller lig 0,5) ved måned 6 sammenlignet med henholdsvis 89 % og 87 % af de patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt (plus MTX). 
In the placebo plus MTX group, 78% of patients experienced no radiographic progression (mTSS change less than or equal to 0.5) at month 6 compared to 89% and 87% of patients treated with tofacitinib 5 or 10 mg (plus MTX) twice daily respectively, (both significant versus placebo plus MTX).
Tofacitinibs dosis skal reduceres til 5 mg filmovertrukken tablet én gang dagligt hos patienter, der får 11 mg depottablet én gang dagligt. 
Tofacitinib dose should be reduced to 5 mg film-coated tablet once daily in patients receiving 11 mg prolonged-release tablet once daily.
I det randomiserede 52-ugers fase 3-vedligeholdelsesstudie var andelen af patienter med infektioner 35,9 % (71 patienter) i gruppen med tofacitinib 5 mg to gange dagligt og 39,8 % (78 patienter) i gruppen med tofacitinib 10 mg to gange dagligt, sammenlignet med 24,2 % (48 patienter) i placebogruppen. 
In the randomised 52-week phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group.
I PsA II-studiet (OPAL BEYOND) vurderedes 394 patienter, som var blevet seponeret fra en TNFhæmmer på grund af manglende virkning eller intolerans. 
Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD.
Det er ikke nødvendigt at justere dosis af MTX pga. nedsat eksponering for MTX. 
The extent of decrease in MTX exposure does not warrant modifications to the individualised dosing of MTX.
Tofacitinib påvirkede hunrotters, men ikke hanrotters fertilitet (se pkt. 
Tofacitinib impaired female fertility but not male fertility in rats (see section 5.3).
6 måneder 1 år 
6 months 2 years
Tabletovertrækket celluloseacetat hydroxypropylcellulose (E463) hypromellose (E464) titandioxid (E171) triacetin (E1518) rød jernoxid (E172) 
Film coat cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
eller 90 depottabletter. 
30 or 90 prolonged-release tablets.
Hovedpine Paræstesi 
Hepatic impairment
Det anbefales ikke at initiere behandling hos patienter med et absolut neutrofiltal (ANC) under 1,0x10 
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Laboratorieværdi (x10 9 celler/l) 
Lab value (cells/mm
Utilstrækkelig respons på mindst 1 csDMARD på grund af manglende effekt og/eller intolerans. 
Inadequate response to at least 1 csDMARD due to lack of efficacy and/or intolerability.