natgillin/translations-raw huggingface dataset:
Patienter skal overvåges nøje for udvikling af symptomer på TB, herunder også patienter som blev testet negative for latent TB-infektion, før behandlingen begyndte. 
Patients should be closely monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Studie I (ORAL Solo) 
Study I (ORAL Solo)
• Det centraliserede websted skal indeholde: o Uddannelsesmaterialet i digitalt format o Patientinformationskortet i digitalt format 
• The centralised website shall contain: o The educational material in digital format o The patient alert card in digital format
Tabel 10: Radiografiske ændringer ved 6 og 12 måneder ORAL Scan: Patienter med utilstrækkelig respons på MTX 
Table 10: Radiographic Changes at Months 6 and 12 ORAL Scan: MTX Inadequate Responders
Pædiatrisk population 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.
HDPE-beholdere med silicagel som tørremiddel og børnesikre låg indeholdende 60 eller 180 filmovertrukne tabletter. 
HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
Måned 6: mTSS ACR70 
Month 6: mTSS ACR70
Traumer, forgiftninger og behandlings komplikatio ner 
Injury, poisoning and procedural complications
Tofacitinib er et substrat for MDR1 in vitro, men ikke for brystkræft resistent protein (BCRP), OATP1B1/1B3 eller OCT1/2 og er ikke en hæmmer af MDR1, OATP1B1/1B3, OCT2, OAT1/3 eller MRP ved klinisk relevante koncentrationer. 
In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
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).
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)
Tofacitinib 10 mg 2 gange daglig 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:
Alvorlige infektioner kan forekomme oftere hos personer, der også tager kortikosteroider (fx prednison). 
Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
CYP-induktor Rifampicin 
CYP Rifampicin
≤3 ugentlige doser (MTX-naive). 
a. ≤3 weekly doses (MTX-naïve).
Tuberkulose Diverticulitis Pyelonephritis Cellulitis Herpes simplex Viral gastroenteritis Virusinfektion 
Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Generelt er der færre bivirkninger, når XELJANZ bliver brugt alene til behandling af leddegigt. 
In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis.
Samtidig anvendelse af tofacitinib og tacrolimus bør undgås 
Combined use of Tofacitinib with Tacrolimus should be avoided
Måned 3 Måned 6 (forsøgspersoner på placebo med < 20 % forbedring af antal hævede og ømme led skiftede til tofacitinib ved måned 3) 
Month 3 Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Samtidig administration af tofacitinib og potente CYP-induktorer (fx 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).
Tabel 11: Gennemsnitlig ændring (LS) fra baseline i HAQ-DI ved 3 måneder Placebo + MTX 
Table 11: LS Mean Change from Baseline in HAQ-DI at Month 3 Placebo + MTX
Tabel 9: Antal (%) forsøgspersoner, der opnåede DAS28-4(ESR) <2,6 remission ved 3 og 6 måneder 
Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Ingen dosisjustering 
No Dose Adjustment
Skema over bivirkninger 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 
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).
Tofacitinib er ikke en hæmmer eller inducer af CYPerne (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4) og ikke en hæmmer af UGTerne (UGT1A1, UGT1A4, UGT1A6, UGT1A9, og UGT2B7). 
Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
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 responsa (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
OCTAVE Induction 2-studiet Central endoskopivurdering Lokal endoskopivurdering 
OCTAVE Induction Study 2 Central Endoscopy Read
Opbevares i den originale beholder og/eller blister for at beskytte mod fugt. 
Store in the original, bottle and/or blister, in order to protect from moisture.
Dissemineret TB Nekrotiserende fasciitis 
Urosepsis Disseminated TB Necrotizing fasciitis
Samtidig anvendelse af tofacitinib og ciclosporin bør undgås 
Combined use of Tofacitinib with Ciclosporine should be avoided
Ved baseline havde 80,7 % og 49,2 % af patienterne hhv. enthesitis og dactylitis. 
At baseline, 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Der var ingen bekræftede fald i ANC til under 0,50 x109 celler/l i nogen af behandlingsgrupperne. 
There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group.
Kun til oral anvendelse 
For oral use.
XELJANZ 5 mg film-coated tablet indeholder cirka 59 mg lactose og XELJANZ 10 mg filmovertrukket tablet indeholder ca. 119 mg lactose i hver tablet. 
XELJANZ 5 mg film-coated tablet contains approximately 59 mg lactose in each tablet and XELJANZ 10 mg film-coated tablet contains approximately 119 mg lactose in each tablet.
Tofacitinib skal bruges med forsigtighed hos patienter, som kan have en højere risiko for gastrointestinal perforation (fx patienter med en anamnese med diverticulitis, patienter i samtidig behandling med kortikosteroider og/eller non-steroide anti-inflammatoriske lægemidler). 
Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis, patients with concomitant use of corticosteroids and/or nonsteroidal anti-inflammatory drugs).
Røntgen TNFi-IR Monoterap i, aktiv komparator (MTX), røntgen 
X-Ray TNFi-IR Monotherapy, Active comparator (MTX),
De co-primære effektmål var følgende: gennemsnitlig ændring fra baseline i mTSS, procent forsøgspersoner, der opnåede ACR20- eller ACR70-respons, gennemsnitlig ændring fra baseline i HAQ-DI, procent forsøgspersoner, der opnåede DAS28-4(ESR) < 2,6 (remission). 
c. Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
Mindste kvadraters gennemsnitlige ændring fra baseline i HAQ-DI Konventionel syntetisk DMARD Patienter med utilstrækkeligt responsa (TNFi naive) 
Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
mTSSc Baseline Måned 6 
Baseline Month 6
Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA 
Placebo Placebo Placebo Placebo Placebo MTX
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 x109 celler/l, eller patienter, der blev behandlet med 10 mg to gange dagligt, kan have øget risiko for herpes zoster (se pkt. 
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).
Samtidig administration af ketoconazol og fluconazol øgedetofacitinibs 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.
Huller i mavesækken eller tarmene opstår oftest hos patienter, som også tager non-steroide antiinflammatoriske lægemidler (NSAID) eller kortikosteroider (fx prednison). 
Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
Hævede led Tendonitis 
Joint swelling Tendonitis
g. N=101 for placebo, N=101 for tofacitinib 5 mg to gange dagligt, N=87 for tofacitinib 10 mg to gange dagligt. 
g. N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
croscarmellosenatrium, magnesiumstearat, hypromellose 6cP (E464), titandioxid (E171), 
croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide
XELJANZ kan bruges sammen med methotrexat eller sommetider alene ved behandling af leddegigt. 
XELJANZ may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis.
DAS284(ESR)< 2,6 Måned 3: 
DAS284(ESR)<2.6 Month 3:
6 måneder 2 år 
2 years 6 months 2 years
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 118,88 mg lactose. 
Each film-coated tablet contains 118.88 mg of lactose.
I alle studier havde patienter, der blev behandlet med 5 mg eller 10 mg tofacitinib 2 gange dagligt, statistisk signifikante ACR20-, ACR50- og ACR70-responsrater ved måned 3 og måned 6 versus placebogruppen (eller versus MTX i ORAL Start). 
In all studies, patients treated with either 5 or 10 mg twice daily tofacitinib had statistically significant ACR20, ACR50 and ACR70 response rates at month 3 and month 6 versus placebo (or versus MTX in ORAL Start) treated patients.
- De andre ingredienser er mikrokrystallinsk cellulose, lactosemonohydrat (se afsnit 2), croscarmellosenatrium, magnesiumstearat, hypromellose 6 cP (E464), titanoxid (E171), macrogol 3350, triacetin (E1518), Indigotin (indigocarmin) (E132), og Brilliant Blue FCF (E133). 
- The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTXnaivea 
MTX-IR MTX-IR TNFi-IR MTX-naïvea MTX-IR
I kontrollerede kliniske studier med RA-patienter, der startede med tofacitinib 10 mg 2 gange dagligt eller placebo, var antallet af respondenter på influenzavaccine ens i de 2 grupper: tofacitinib (57 %) og placebo (62 %). 
In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Eksponeringen for tofacitinib nedsættes, når det administreres samtidigt med potente CYP-induktorer (fx rifampicin). 
Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
Respons for fysisk funktion og helbredsrelaterede resultater 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.
Sjælden ≥ 1/10.000 til 
≥1/10,000 to
NA ORAL Sync: Patienter med utilstrækkeligt respons på DMARD 
NA ORAL Sync: DMARD Inadequate Responders
Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under graviditet (se pkt. 
As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section
Bivirkningsfrekvensen var højere for kombinationen tofacitinib plus MTX end for XELJANZ som monoterapi i kliniske RA-studier. 
There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Kortikosteroidfri remission hos patienter, der tager kortikosteroider ved baseline a,g 
Corticosteroidfree remission among patients taking corticosteroids at baselinea,g
182 filmovertrukne tabletter 
182 film-coated tablets
Lokal endoskopivurdering 
Local Endoscopy Read
Dyslipidæmi Hyperlipidæmi Dehydrering 
Dyslipidaemia Hyperlipidaemia Dehydration
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 56 filmovertrukne tabletter 
PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
Der er gennemført et kontrolleret studie hos RA-patienter, som fik baggrunds-MTX, og som blev immuniseret med en levende svækket virusvaccine (Zostavax®) 2 til 3 uger før, de begyndte 12 ugers behandling med 5 mg tofacitinib 2 gange dagligt eller placebo. 
A controlled study was conducted in patients with RA on background MTX immunised with a live attenuated virus vaccine (Zostavax®) 2 to 3 weeks before initiating a 12-week treatment with tofacitinib 5 mg twice daily or placebo.
Tidligere immunosuppressivasvigt 
Prior immunosuppressant failure
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 59,44 mg lactose. 
Each film-coated tablet contains 59.44 mg of lactose.
Tuberkulose i centralnervesyst emet, 
Tuberculosis of central nervous system
Tabel 17: Andel af patienter, der opfylder effektmål ved uge 52 (OCTAVE Sustain) Central endoskopivurdering 
Table 17: Proportion of Patients Meeting Efficacy Endpoints at Week 52 (OCTAVE Sustain) Central Endoscopy Read
Tabel 5: Dosisjustering ved nedsat nyrefunktion Nedsat nyrefunktion 
Table 5: Dose Adjustment for Renal Impairment Renal
I monoterapigruppen med 10 mg tofacitinib 2 gange dagligt var forekomsten 1,6 patienter med hændelser pr. 100 patientår, 0 patienter med hændelser pr. 100 patientår for placebogruppen, og 1,9 patienter med hændelser pr. 100 patientår for MTX-gruppen. 
In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patientyears, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
mTSS = modificeret total Sharp-score, ACR20 (70) = American College of Rheumatology ≥ 20 % (≥ 70 %) forbedring, DAS28 = Disease Activity Score 28 led, ESR = erytrocytsedimentationshastighed, HAQ-DI = Health Assessment Questionnaire Disability Index, DMARD = sygdomsmodificerende antireumatisk lægemiddel, IR = utilstrækkeligt respons, csDMARD = konventionel syntetisk DMARD, TNFi = tumornekrosefaktorhæmmer, ADA = adalimumab, MTX = methotrexat. 
DAS28=Disease Activity Score 28 joints, ESR=Erythrocyte Sedimentation Rate, HAQ-DI=Health Assessment Questionnaire Disability Index, DMARD=disease-modifying antirheumatic drug, IR=inadequate responder, csDMARD=conventional synthetic DMARD, TNFi=tumour necrosis factor inhibitor, NA=not applicable, ADA=adalimumab, MTX=methotrexate.
Angioødem* Urticaria 
Drug hypersensitivity* Angioedema* Urticaria*
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, normalization 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.
Tofacitinibs samlede daglige dosis skal reduceres til halvdelen hos patienter, der får kraftige hæmmere af cytochrom P450 (CYP) 3A4 (f.eks. ketoconazol) og hos patienter, der får ét eller flere samtidige lægemidler, der både resulterer i moderat hæmning af CYP3A4 samt kraftig hæmning af CYPSC19 (f.eks. fluconazol) (se pkt. 
Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see sections 4.4 and 4.5) as follows:
Metabolism e og ernæring 
Metabolism and nutrition disorders
Ikke relevant Ikke relevant p<0,0001, tofacitinib versus placebo + MTX, LS = beregnet ved mindste kvadraters metode, N = antal patienter, HAQ-DI = Health Assessment Questionnaire Disability Index 
*** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Mycobacterium avium-kompleks infektion 
Meningitis cryptococcal Mycobacterium avium complex infection
Tabel 6: Bivirkninger 
Table 6: Adverse Drug Reactions
Almindelig ≥ 1/100 til 
≥1/100 to <1/10
Τηλ: +357 22 817690 
(CYPRUS BRANCH) Τηλ: +357 22 817690
INFORMATION I BRAILLESKRIFT XELJANZ 5 mg 
INFORMATION IN BRAILLE XELJANZ 5 mg
INFORMATION I BRAILLESKRIFT XELJANZ 10 mg 
INFORMATION IN BRAILLE XELJANZ 10 mg
• Tjeklisten til ordinerende læger skal indeholde følgende nøgleinformation: o Lister med tests, som skal udføres i forbindelse med den intiale screening af patienten o Hvilke vaccinationer, der skal gennemføres før behandling o Relevante samtidige sygdomme, hvor der tilrådes forsigtighed ved administration af XELJANZ, og tilstande, hvor Xeljanz ikke bør administreres o Liste over lægemidler, som ikke bør anvendes sammen med XELJANZ-behandling o Nødvendigheden af at diskutere risici ved XELJANZ-behandling med patienterne, særligt med hensyn til infektioner, herpes zoster, tuberkulose (TB) og andre opportunistiske infektioner, malignitet, gastrointestinal perforation, interstitiel lungesygdom og afvigelser i laboratorietal. 
• The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening of the patient o Vaccination course to be completed before treatment o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
XELJANZ 10 mg filmovertrukne tabletter er blå og runde. 
XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Opretholdelse af klinisk responsd 
Maintenance of clinical responsed
Fysisk funktion og helbredsrelateret livskvalitet 
Physical function response and health-related outcomes
N=antal forsøgspersoner analyseret, ACR20/50/70=American College of Rheumatology ≥ 20, 50, 70 % forbedring; MTX=methotrexat. 
QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70%
KVALITATIV OG KVANTITATIV SAMMENSÆTNING XELJANZ 5 mg filmovertrukne tabletter 
QUALITATIVE AND QUANTITATIVE COMPOSITION XELJANZ 5 mg film-coated tablets
Det anbefales ikke at initiere eller fortsætte behandling med tofacitinib hos patienter med et bekræftet lymfocyttal under 0,75 x109 celler/l. 
It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3.
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): tuberkulose, nyrebetændelse, betændelse i huden, herpes simplex eller forkølelsessår (oral herpes), lavt antal hvide blodlegemer, forhøjede leverenzymer i blodet (tegn på leverproblemer), forhøjet blodkreatinin (tegn på mulige nyreproblemer), forhøjet kolesterol, vægtstigning, væskemangel, forstrækning af muskler, muskel- og ledsmerter, senebetændelse, hævede led, føleforstyrrelser, dårlig søvn, tilstoppede bihuler, åndenød eller vejrtrækningsbesvær, hudrødme, kløe, fedtlever, smertefuld betændelse i de små udposninger i tarmen (diverculitis), virusinfektioner, virusinfektioner, der påvirker mave-tarm-kanalen, visse typer hudkræft (ikke-melanom typer). 
Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
d Opnået statistisk signifikans globalt ved p≤ 0,05 iht. 
c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
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
Benigne, maligne og uspecificere de tumorer (inkl. 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 and 10 mg Twice Daily Doses in Patients with RA
Baggrundsmedicin Ingen b csDMARD MTX MTX MTX Ingen b 
Noneb csDMARDs MTX MTX MTX Noneb
Klinisk responsd 
Clinical responsed