natgillin/translations-raw huggingface dataset:
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.
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.
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.
Måned 6 ORAL Standard: Patienter med utilstrækkeligt respons på MTX Tofacitinib 5 mg 2 gange dagligt + MTX
Month 6 ORAL Standard: MTX inadequate responders Tofacitinib 5 mg twice daily + MTX
Risikofaktorer (f.eks. hypertension, hyperlipidæmi) for patienter, som behandles med tofacitinib, skal håndteres som en integreret del af patientbehandlingen.
Patients treated with tofacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Behandling med tofacitinib var forbundet med en øget forekomst af forhøjede leverenzymer hos nogle patienter (se pkt.
Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
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.
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.
Co-primære effektmål
Co-primary efficacy endpoints c
Forbedring af endoskopisk udseende af slimhinden
Improvement of endoscopic appearance of the mucosa
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.
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).
XELJANZ 5 mg filmovertrukket tablet - Aktivt stof: tofacitinib.
XELJANZ 5 mg film-coated tablet - The active substance is tofacitinib.
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).
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).
Må ikke knuses, deles eller tygges.
Do not crush, split or chew.
KARTON TIL 11 MG BLISTERPAKNING
CARTON FOR 11 MG BLISTER PACK
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).
Tofacitinib 11 mg prolonged-release tablets once daily has demonstrated pharmacokinetic equivalence (AUC and Cmax) to tofacitinib 5 mg film-coated tablets twice daily.
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.
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.
XELJANZ 10 mg filmovertrukket tablet - Aktivt stof: tofacitinib.
XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
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.
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.
Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen reduceres eller afbrydes, indtil ANC er over 1,0.
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.
Ved vedvarende fald (2 sekventielle målinger i dette interval ved rutinemåling) skal behandlingen reduceres eller afbrydes, indtil ALC er over 0,75.
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.
Andre lægemidlers indvirkning på tofacitinibs farmakokinetik (PK)
Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Utilstrækkelig respons på mindst 1 TNFi på grund af manglende effekt og/eller intolerans.
Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Patienter på 65 år og derover får oftere infektioner.
There is a higher rate of infections in patients aged 65 years and older.
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.
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.
Tid ORAL Step: Patienter med utilstrækkeligt respons på TNF Inhibitor Tofacitinib 5 mg 2 gange dagligt + MTX
N ORAL Step: TNF Inhibitor inadequate responders Tofacitinib 5 mg twice daily + MTX
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).
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).
ASAT-stigning > 3 x ULN blev observeret hos <1,0 % både ved 5 mg og 10 mg tofacitinib 2 gange dagligt.
AST elevations greater than 3x ULN were observed in < 1.0% in both the tofacitinib 5 mg and 10 mg twice daily groups.
ORAL Standard: Patienter med utilstrækkeligt respons på MTX
ORAL Standard: MTX inadequate responders
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.
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.
ORAL Step: Patienter med utilstrækkeligt respons på TNF
NA ORAL Step: TNF Inhibitor inadequate responders
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Det anbefales ikke at initiere behandling hos patienter med et absolut lymfocyttal (ALC) under 0,75x x10
It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm
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).
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).
Den anbefalede dosis er 5 mg 2 gange dagligt.
The recommended dose is 5 mg administered twice daily.
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.
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.
Utilstrækkeligt respons på mindst én TNF-hæmmer (TNFi) på grund af manglende effekt og/eller intolerans.
Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Tofacitinib 5 mg 2 gange dagligt + DMARD(s)
Tofacitinib 5 mg twice daily + DMARD(s)
Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Forbedring af endoskopisk udseende af slimhinden c
Normalisation of endoscopic appearance of the mucosa c
Kontakt lægen, inden du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
DAS284(ESR)< 2,
DAS284(ESR)<2.6 Month 3:
ANC < 0,50
ANC less than 500
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 section 4.5) as follows:
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.
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.
Forhøjet lavdensitetsli po-protein Vægtstignin
Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
- Hver 5 mg filmovertrukken tablet indeholder 5 mg tofacitinib (som tofacitinibcitrat).
- Each 5 mg film-coated tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under amning (se pkt.
As a precautionary measure, the use of tofacitinib during breast-feeding is contraindicated (see section 4.3).
• Har haft blodpropper i venerne
• blood in the stool
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.
Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
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.
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.
Dehydrering
Hypertension
Tofacitinib 5 mg to gange dagligt Tofacitinib 10 mg to gange dagligt placebo
Tofacitinib 5 mg twice daily Tofacitinib 10 mg twice daily placebo
ETIKET TIL 5 MG BEHOLDERENS INDRE EMBALLAGE
LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING
Tuberkulose i centralnerves ystemet, Kryptokokme ningitis, Mycobacteriu m aviumkompleks infektion
Meningitis cryptococcal Mycobacteriu m avium complex infection
Remission blev defineret som klinisk remission (en samlet Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of
Tofacitinibs dosis skal reduceres til 5 mg én gang dagligt hos patienter, der får 5 mg to gange dagligt (se pkt.
Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily (see section 4.2).
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
ACR20 mTSS DAS284(ESR)
ACR20 mT SS DAS284(ESR)<2.6 Month 3:
Tabel 4: Dosisjustering ved nedsat leverfunktion Nedsat leverfunktionkategori
Table 4: Dose adjustment for hepatic impairment Hepatic impairment category
Tofacitinib 10 mg to gange dagligt placebo
Tofacitinib 10 mg twice daily placebo