FrancophonIA/ELRC3.0 huggingface dataset:
English: Tofacitinib dose should be reduced to 5 mg film-coated tablet once daily in patients receiving 11 mg prolonged-release tablet once daily.
Danish: Tofacitinibs dosis skal reduceres til 5 mg filmovertrukken tablet én gang dagligt hos patienter, der får 11 mg depottablet én gang dagligt.
English: 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.
Danish: 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.
English: 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.
Danish: I PsA II-studiet (OPAL BEYOND) vurderedes 394 patienter, som var blevet seponeret fra en TNFhæmmer på grund af manglende virkning eller intolerans.
English: The extent of decrease in MTX exposure does not warrant modifications to the individualised dosing of MTX.
Danish: Det er ikke nødvendigt at justere dosis af MTX pga. nedsat eksponering for MTX.
English: Tofacitinib impaired female fertility but not male fertility in rats (see section 5.3).
Danish: Tofacitinib påvirkede hunrotters, men ikke hanrotters fertilitet (se pkt.
English: 6 months 2 years
Danish: 6 måneder 1 år
English: Film coat cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
Danish: Tabletovertrækket celluloseacetat hydroxypropylcellulose (E463) hypromellose (E464) titandioxid (E171) triacetin (E1518) rød jernoxid (E172)
English: 30 or 90 prolonged-release tablets.
Danish: eller 90 depottabletter.
English: Hepatic impairment
Danish: Hovedpine Paræstesi
English: It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Danish: Det anbefales ikke at initiere behandling hos patienter med et absolut neutrofiltal (ANC) under 1,0x10
English: Lab value (cells/mm
Danish: Laboratorieværdi (x10 9 celler/l)
English: Inadequate response to at least 1 csDMARD due to lack of efficacy and/or intolerability.
Danish: Utilstrækkelig respons på mindst 1 csDMARD på grund af manglende effekt og/eller intolerans.
English: 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, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus.
Danish: Det frarådes, at XELJANZ bruges sammen med lægemidler, der undertrykker immunforsvaret, herunder såkaldte målrettede biologiske behandlinger (antistoffer), som dem, der hæmmer tumornekrose-faktorer, interleukin-17, interleukin-12/interleukin-23, anti-integriner og stærke kemiske lægemidler, der undertrykker immunforsvaret, herunder azathioprin, mercaptopurin, ciclosporin og tacrolimus.
English: Month 6 ORAL Standard: MTX inadequate responders Tofacitinib 5 mg twice daily + MTX
Danish: Måned 6 ORAL Standard: Patienter med utilstrækkeligt respons på MTX Tofacitinib 5 mg 2 gange dagligt + MTX
English: Patients treated with tofacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Danish: Risikofaktorer (f.eks. hypertension, hyperlipidæmi) for patienter, som behandles med tofacitinib, skal håndteres som en integreret del af patientbehandlingen.
English: Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
Danish: Behandling med tofacitinib var forbundet med en øget forekomst af forhøjede leverenzymer hos nogle patienter (se pkt.
English: Tel: 1800 633 363 (toll free)
Danish: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
English: Warnings and precautions Talk to your doctor or pharmacist before taking XELJANZ: - if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired - if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system) - if you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager XELJANZ: - hvis du tror, du har en infektion eller har symptomer på en infektion såsom feber, svedtendens, kuldegysninger, muskelsmerter, hoste, åndenød, slimdannelse eller ændring i slim, vægttab, varm eller rød eller smertefuld hud eller sår på kroppen, synkebesvær eller smerter, når du synker, diarré eller mavesmerter, brændende fornemmelse, når du lader vandet, eller lader vandet hyppigere end normalt, udtalt træthed.
English: Co-primary efficacy endpoints c
Danish: Co-primære effektmål
English: Improvement of endoscopic appearance of the mucosa
Danish: Forbedring af endoskopisk udseende af slimhinden
English: Tofacitinib exposure is increased when coadministered with potent inhibitors of CYP3A4 (e.g., ketoconazole) or when administration of one or more concomitant medicinal products results in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) (see section 4.2).
Danish: Eksponeringen for tofacitinib øges, når det gives samtidigt med potente CYP3A4-hæmmere (fx ketoconazol), eller når administration af et eller flere samtidige lægemidler resulterer i både moderat hæmning af CYP3A4 og potent hæmning af CYP2C19 (fx fluconazol) (se pkt.
English: XELJANZ 5 mg film-coated tablet - The active substance is tofacitinib.
Danish: XELJANZ 5 mg filmovertrukket tablet - Aktivt stof: tofacitinib.
English: Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in physical functioning compared to placebo at month 3 (studies ORAL Solo, ORAL Sync, ORAL Standard, and ORAL Step) and month 6 (studies ORAL Sync and ORAL Standard).
Danish: Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, udviste en signifikant forbedring fra baseline i fysisk funktion sammenlignet med placebogruppen ved måned 3 (studierne ORAL Solo, ORAL Sync, ORAL Standard og ORAL Step) og måned 6 (studierne ORAL Sync og ORAL Standard).
English: Do not crush, split or chew.
Danish: Må ikke knuses, deles eller tygges.
English: CARTON FOR 11 MG BLISTER PACK
Danish: KARTON TIL 11 MG BLISTERPAKNING
English: Tofacitinib 11 mg prolonged-release tablets once daily has demonstrated pharmacokinetic equivalence (AUC and Cmax) to tofacitinib 5 mg film-coated tablets twice daily.
Danish: Tofacitimib 11 mg depottabletter én gang dagligt har vist sig at være farmakokinetisk svarende til tofacitinib 5 filmovertrukne tabletter to gange dagligt (AUC og Cmax).
English: In the MTX group, 70% of patients experienced no radiographic progression at month 6 compared to 83% and 90% of patients treated with tofacitinib 5 or 10 mg twice daily respectively, both significant versus MTX.
Danish: I MTX-gruppen havde 70 % af patienterne ikke radiografisk progression ved måned 6 sammenlignet med 83 % og 90 % af de patienter, der fik hhv. 5 mg og 10 mg tofacitinib 2 gange dagligt.
English: XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
Danish: XELJANZ 10 mg filmovertrukket tablet - Aktivt stof: tofacitinib.
English: For persistent (2 sequential values in this range on routine testing) decreases in this range, tofacitinib 11 mg prolonged-release dosing should be interrupted until ANC is greater than 1,000.
Danish: Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen med 11 mg tofacitinib som depottablet afbrydes, indtil ANC er over 1,0.
English: For persistent (2 sequential values in this range on routine testing) decreases in this range, dosing should be reduced or interrupted until ANC is greater than 1,000.
Danish: Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen reduceres eller afbrydes, indtil ANC er over 1,0.
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted until ALC is greater than 750.
Danish: Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen reduceres eller afbrydes, indtil ALC er over 0,75.
English: Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Danish: Andre lægemidlers indvirkning på tofacitinibs farmakokinetik (PK)
English: Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Danish: Utilstrækkelig respons på mindst 1 TNFi på grund af manglende effekt og/eller intolerans.
English: There is a higher rate of infections in patients aged 65 years and older.
Danish: Patienter på 65 år og derover får oftere infektioner.
English: Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins (IL-2, -4, -6, -7, -9, -15, -21) and type I and type II interferons, which will result in modulation of the immune and inflammatory response.
Danish: I humane celler hæmmer tofacitinib fortrinsvist signalering gennem heterodimere cytokinreceptorer, som er forbundet med JAK3 og/eller JAK1, med funktionel selektivitet for cytokinreceptorer, som signalerer via JAK2-par. Hæmning af JAK1 og JAK3 med tofacitinib dæmper signalering af interleukiner (IL-2, -4, -6, -7, -9, -15, -21) og type I- og type IIinterferoner, hvilket vil medføre modulering af immun- og inflammationsresponset.
English: N ORAL Step: TNF Inhibitor inadequate responders Tofacitinib 5 mg twice daily + MTX
Danish: Tid ORAL Step: Patienter med utilstrækkeligt respons på TNF Inhibitor Tofacitinib 5 mg 2 gange dagligt + MTX
English: 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 (including increased LDL), weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, joint sprain, 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).
Danish: 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 (herunder førhøjet LDL), vægtstigning, væskemangel, forstrækning af muskler, muskel- og ledsmerter, senebetændelse, hævede led, forstrækning af 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).
English: AST elevations greater than 3x ULN were observed in < 1.0% in both the tofacitinib 5 mg and 10 mg twice daily groups.
Danish: ASAT-stigning > 3 x ULN blev observeret hos <1,0 % både ved 5 mg og 10 mg tofacitinib 2 gange dagligt.
English: ORAL Standard: MTX inadequate responders
Danish: ORAL Standard: Patienter med utilstrækkeligt respons på MTX
English: Patients treated with tofacitinib 11 mg prolonged-release tablets once daily may be switched to tofacitinib 5 mg film-coated tablets twice daily on the day following the last dose of tofacitinib 11 mg prolonged-release tablets.
Danish: Patienter, som behandles med tofacitinib 11 mg depottabletter én gang dagligt, kan skifte til tofacitinib 5 mg filmovertrukne tabletter to gange dagligt på dagen efter indtagelse af sidste dosis tofacitinib 11 mg depottabletter.
English: NA ORAL Step: TNF Inhibitor inadequate responders
Danish: ORAL Step: Patienter med utilstrækkeligt respons på TNF
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med XELJANZ Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm
Danish: Det anbefales ikke at initiere behandling hos patienter med et absolut lymfocyttal (ALC) under 0,75x x10
English: 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 section 4.5).
Danish: 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.4.5).
English: The recommended dose is 5 mg administered twice daily.
Danish: Den anbefalede dosis er 5 mg 2 gange dagligt.
English: Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): lungeinfektion (lungebetændelse og bronkitis), helvedesild (herpes zoster), infektioner i næse, hals eller luftrør (forkølelse), influenza, bihulebetændelse, urinvejsinfektion (blærebetændelse), ondt i halsen (svælgkatar), forhøjede muskelenzymer i blodet (tegn på muskelproblemer), mavesmerter (som kan skyldes betændelse i mavens slimhinde), opkastning, diarré, kvalme, fordøjelsesbesvær, lavt antal røde blodlegemer (blodmangel, anæmi), feber, udmattelse (træthedsfornemmelse), hævede fødder og hænder, hovedpine, forhøjet blodtryk (hypertension), hoste, udslæt.
English: Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Danish: Utilstrækkeligt respons på mindst én TNF-hæmmer (TNFi) på grund af manglende effekt og/eller intolerans.
English: Tofacitinib 5 mg twice daily + DMARD(s)
Danish: Tofacitinib 5 mg 2 gange dagligt + DMARD(s)
English: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Danish: Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
English: Normalisation of endoscopic appearance of the mucosa c
Danish: Forbedring af endoskopisk udseende af slimhinden c
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, inden du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter.
English: DAS284(ESR)<2.6 Month 3:
Danish: DAS284(ESR)< 2,
English: ANC less than 500
Danish: ANC < 0,50
English: 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 section 4.5) as follows:
Danish: 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.
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, tofacitinib 11 mg prolonged-release dosing should be interrupted until ALC is greater than 750.
Danish: Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen med 11 mg tofacitinib depottablet afbrydes, indtil ALC er over 0,75.
English: Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
Danish: Forhøjet lavdensitetsli po-protein Vægtstignin
English: - Each 5 mg film-coated tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Danish: - Hver 5 mg filmovertrukken tablet indeholder 5 mg tofacitinib (som tofacitinibcitrat).
English: As a precautionary measure, the use of tofacitinib during breast-feeding is contraindicated (see section 4.3).
Danish: Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under amning (se pkt.
English: • blood in the stool
Danish: • Har haft blodpropper i venerne
English: MT X-IR
Danish: MTX-IR
English: Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Danish: Primært effektmål: Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
English: In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Danish: I de langvarige RA-forlængelsesstudier med baggrunds-DMARD blev ALAT-stigning > 3 x ULN observeret hos hhv. 1,8 % og 1,6 % af de patienter, der fik henholdsvis tofacitinib 5 mg og 10 mg 2 gange dagligt.
English: Hypertension
Danish: Dehydrering
English: Tofacitinib 5 mg twice daily Tofacitinib 10 mg twice daily placebo
Danish: Tofacitinib 5 mg to gange dagligt Tofacitinib 10 mg to gange dagligt placebo
English: LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING
Danish: ETIKET TIL 5 MG BEHOLDERENS INDRE EMBALLAGE
English: Meningitis cryptococcal Mycobacteriu m avium complex infection
Danish: Tuberkulose i centralnerves ystemet, Kryptokokme ningitis, Mycobacteriu m aviumkompleks infektion
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of
Danish: Remission blev defineret som klinisk remission (en samlet Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
English: Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily (see section 4.2).
Danish: Tofacitinibs dosis skal reduceres til 5 mg én gang dagligt hos patienter, der får 5 mg to gange dagligt (se pkt.
English: Table 10: Radiographic changes at months 6 and 12
Danish: Tabel 10: Radiografiske ændringer ved 6 og 12 måneder ORAL Scan: Patienter med utilstrækkelig respons på MTX
English: ACR20 mT SS DAS284(ESR)<2.6 Month 3:
Danish: ACR20 mTSS DAS284(ESR)
English: Table 4: Dose adjustment for hepatic impairment Hepatic impairment category
Danish: Tabel 4: Dosisjustering ved nedsat leverfunktion Nedsat leverfunktionkategori
English: Tofacitinib 10 mg twice daily placebo
Danish: Tofacitinib 10 mg to gange dagligt placebo
English: Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Danish: Nekrotiserend e fasciitis Bakteriæmi Stafylokokba kteriæmi Pneumocystis jiroveciipneumoni Pneumokokpn eu-moni Bakteriel pneumoni Encephalitis Atypisk mykobakteriel infektion Cytomegalovi rus-infektion Bakteriel artrit
English: In OPAL BEYOND, MDA was achieved by 22.9% and 14.5% of tofacitinib 5 mg BID and placebo treated patients, respectively, however tofacitinib 5 mg BID did not achieve nominal statistical significance (treatment difference from placebo 8.4% [95% CI: -1.0, 17.8] at month 3).
Danish: Dog havde patienter, som fik tofacitinib 5 mg 2 gange dagligt, ikke et nominelt statistisk signifikant respons (behandlingsforskel fra placebo 8,4 % [95 % CI: -1,0; 17,8]) ved måned 3).
English: It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Danish: Det anbefales ikke at initiere behandling med tofacitinib hos patienter med ANC under 1,0 x10
English: XELJANZ 5 mg tablets tofacitinib
Danish: XELJANZ 5 mg tabletter tofacitinib
English: Ulcerative colitis is an inflammatory disease of the large bowel.
Danish: Blødende tyktarmsbetændelse er en betændelsessygdom i tyktarmen.
English: Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
Danish: Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede signifikant større forbedringer fra baseline i træthed sammenlignet med placebo i alle 5 studier.
English: XELJANZ 10 mg tablets tofacitinib
Danish: XELJANZ 10 mg tabletter tofacitinib
English: CARTON FOR 10 MG BLISTER PACK
Danish: KARTON TIL 10 MG BLISTERKORT
English: Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 12 months.
Danish: De patienter, som blev randomiseret til tofacitinib, fik 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt i 12 måneder.
English: In these studies, AST elevations greater than 3x ULN were observed in 0.72%, 0.5% and 0.31% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Danish: I disse studier blev der observeret stigning i ASAT > 3 x ULN hos 0,72 %, 0,5 % og 0,31 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
English: In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C.
Danish: I kliniske studier blev tofacitinib ikke evalueret hos forsøgspersoner med svært nedsat (Child Pugh C) leverfunktion (se pkt.
English: Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months.
Danish: De patienter, som blev randomiseret til tofacitinib, fik 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt i 6 måneder.
English: ΔLEIf Month 3 Month 6 Month 12
Danish: ΔDSS Måned 3 Måned 6 Måned 12