natgillin/translations-raw huggingface dataset:
HAQ-DI-responsraten (respons defineres som et fald fra baseline på ≥ 0,35) ved måned 3 i studierne OPAL BROADEN og OPAL BEYOND var på hhv. 53 % og 50 % hos patienter, som fik tofacitinib 5 mg 2 gange dagligt, hhv. 31 % og 28 % hos patienter, som fik placebo, og 53 % hos patienter, som fik adalimumab 40 mg subkutant en gang hver anden uge (kun OPAL BROADEN).
in studies OPAL BROADEN and OPAL BEYOND was 53% and 50%, respectively in patients receiving tofacitinib 5 mg twice daily, 31% and 28%, respectively in patients receiving placebo, and 53% in patients receiving adalimumab 40 mg subcutaneously once every 2 weeks (OPAL BROADEN only).
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.
ORAL Step: Patienter med utilstrækkeligt respons på TNF
NA ORAL Step: TNF Inhibitor Inadequate Responders
• Uddannelsesmateriale til læger • Informationsmateriale til patienter
• Physician educational material
Patienter, som fik tofacitinib 5 mg to gange dagligt, havde en større forbedring (p< 0,05) fra baseline i fysisk funktion sammenlignet med placebo ved måned 3 (se tabel 13).
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Almene symptomer og reaktioner på administrati onsstedet
General disorders and administration site conditions
Det anbefales ikke at initiere behandling hos patienter med et absolut neutrofiltal (ANC) under 1,0x109 celler/l.
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Udseende og pakningsstørrelser XELJANZ 5 mg filmovertrukne tabletter er hvide og runde.
What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
dagligt i OCTAVE Open opnåede 53 % (154/293) patienter klinisk respons, og 14 % (42/293) patienter opnåede remission.
After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission.
Det anbefales ikke at initiere behandling hos patienter med et absolut lymfocyttal (ALC) under 0,75x x109 celler/l.
It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm3.
TNFi Patienter med utilstrækkeligt responsb
TNFi Inadequate Respondersb
N Måned 3
N Month 3
Bakteriel pneumoni Encephalitis Atypisk mykobakteriel infektion
Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
ændring fra baseline i Dactylitis Severity Score, ACR20/50/70 = American College of Rheumatology ≥20 %, 50 %, 70 % forbedring, csDMARD = konventionelt syntetisk sygdomsmodificerende antireumatisk lægemiddel, N = antal randomiserede og behandlede patienter, IR = ikke relevant, da data fra placebobehandling ikke er tilgængelige ud over måned 3 på grund af placebo overført til tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg 2 gange dagligt, s,c.
70% improvement; csDMARD=conventional synthetic disease-modifying antirheumatic drug; N=number of randomised and treated patients; NA=Not applicable, as data for placebo treatment is not available beyond month 3 due to placebo advanced to tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor; PASI=Psoriasis Area and
Ikke relevant ORAL Start: MTX-naive
NA ORAL Start: MTX-naïve
ORAL Strategy: Patienter med utilstrækkeligt respons på MTX
ORAL Strategy: MTX Inadequate Responders
monoklonale 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.
Forkortelser: BSA = legemsoverfladeareal, ΔLEI = ændring fra baseline i Leeds Enthesitis Index, ΔDSS =
Abbreviations: BSA=body surface area; ΔLEI=change from baseline in Leeds Enthesitis Index; ΔDSS=change from baseline in Dactylitis Severity Score; ACR20/50/70=American College of Rheumatology ≥ 20%, 50%,
Kreatininclearance Dosisjustering
Creatinine Clearance
Patienter, som fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, oplevede signifikant større forbedringer fra baseline sammenlignet med placebogruppen inden for alle 8 områder samt i scorerne for fysisk helbred og psykisk helbred ved måned 3 i ORAL Solo, ORAL Scan og ORAL Step.
Patients receiving either 5 or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step.
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede betydeligt større forbedringer fra baseline i begge skemaer sammenlignet med placebogruppen i ORAL Sync, ORAL Standard og ORAL Scan.
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
ORAL Scan: Patienter med utilstrækkeligt respons på MTX
NA ORAL Scan: MTX Inadequate Responders
Det anbefales ikke at initiere behandling med tofacitinib hos patienter med ANC under 1,0 x109 celler/l.
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Tofacitinib 5 mg 2 gange dagligt + DMARD(s)
Tofacitinib 5 mg Twice Daily + DMARD(s)
Placebo + DMARD N= 158
Placebo + DMARD(s) N=158
Bekræftet ALC til under 0,75 x109 celler/l var forbundet med en øget incidens af alvorlige infektioner
Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
ACR50 Måned 3 Måned 6
ACR50 Month 3 Month 6
Tag ikke XELJANZ: - hvis du er allergisk over for tofacitinib eller et af de øvrige indholdsstoffer i XELJANZ (angivet i afsnit 6).
Do not take XELJANZ: - if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6) - if you have a severe infection such as bloodstream infection or active tuberculosis - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, udviste en signifikant større forbedring i fysisk funktion sammenlignet med placebogruppen så tidligt som uge 2 i ORAL Solo og ORAL Sync.
Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync.
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.
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.
ACR20 Måned 3 Måned 6 Måned 12
ACR20 Month 3 Month 6 Month 12
I kontrollerede kliniske fase 3-studier med tofacitinib-monoterapi var infektionsraten over 03 måneder 16,2 % (100 patienter) i gruppen med 5 mg 2 gange dagligt (i alt 616 patienter), 17,9 % (115 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 642 patienter) og 18,9 % (23 patienter) i placebogruppen (i alt 122 patienter).
In controlled Phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Pneumoni Influenza Herpes zoster Urinvejsinfek -tion
Pneumonia Influenza Herpes zoster Urinary tract infection Sinusitis Bronchitis Nasopharyngitis Pharyngitis
d. Opretholdt kortikosteroidfri remission blev defineret som værende i remission uden at tage kortikosterioider i mindst 4 uger før besøget i både uge 24 og 52.
d. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least
Tofacitinib 5 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebob (CI)
Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI)
Neutrofiler Behandling med tofacitinib var forbundet med en øget incidens af neutropeni (under 2,0 x109 celler/l)
Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
Ikke almindelig ≥ 1/1.000 til
≥1/1,000 to
Tofacitinib 5 mg To gange dagligt Tofacitinib 10 mg To gange dagligt Placebo
Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo
Opretholdelse af klinisk respons blev defineret ud fra en reduktion i induktionsstudiets (OCTAVE Induction 1, OCTAVE Induction 2) baseline Mayo-score på ≥ 3 point og ≥ 30 %, med en ledsagende reduktion i subscoren for rektal blødning på ≥ 1 point eller en subscore for rektal blødning på 0 eller 1.
Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
= subkutant, TNFi = tumornekrosefaktorinhibitor; PASI=Psoriasis Area and Severity indeks, PASI75 = ≥ 75 % forbedring i PASI.
Severity index; PASI75=≥ 75% improvement in PASI.
ACR70 Måned 3 Måned 6
ACR70 Month 3 Month 6
Cmax
AUC Cmax
Tofacitinib 10 mg To gange dagligt Placebo
Tofacitinib 10 mg Twice Daily Placebo
Tofacitinib 10 mg 2 gange dagligt N= 368 Gennemsnit (SD)a
Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a
N=59 for placebo, N=65 for tofacitinib 5 mg to gange dagligt, N=55 for tofacitinib 10 mg to gange dagligt.
4 weeks prior to the visit at both week 24 and week 52. f. N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Hver 5 mg filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 5 mg tofacitinib.
Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Samtidig administration af potente CYP3A4
Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended.
Tofacitinib 5 mg 2 gange dagligt + MTX N= 277 Gennemsnit (SD)a
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
Hver 10 mg filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 10 mg tofacitinib.
Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Forhøjet blodkreatinin Forhøjet blodkolesterol Forhøjet lavdensitetslipoprotein
Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 5 MG BLISTERKORT
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
Tofacitinib 10 mg To gange dagligt N=476
Tofacitinib 10 mg Twice Daily N=476
Tofacitinib 5 mg 2 gange dagligt N=384
Tofacitinib 5 mg Twice Daily N=384
Placebo Tofacitinib 5 mg 2 gange dagligt
Placebo Tofacitinib 5 mg Twice Daily
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 10 MG BLISTERKORT
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
Tofacitinib 10 mg 2 gange dagligt + MTX N= 290 Gennemsnit (SD)a
Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a
ACR20 Måned 3 Måned 6
ACR20 Month 3 Month 6
Tofacitinib 5 mg 2 gange dagligt N= 344 Gennemsnit (SD)a
Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a
Normalisering af endoskopisk udseende af slimhindenc
Normalization of endoscopic appearance of the mucosac
Tabel 14: Kliniske fase 3-studier med tofacitinib i doser på 5 mg og 10 mg to gange dagligt hos patienter med UC OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
I kontrollerede fase 3-studier med tofacitinib og baggrundsDMARD var infektionsraten over 0-3 måneder 21,3 % (207 patienter) i gruppen med 5 mg 2 gange dagligt (i alt 973 patienter), 21,8 % (211 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 969 patienter) og 18,4 % (103 patienter) i placebogruppen (i alt 559 patienter).
In controlled Phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients).
LÆGEMIDLETS NAVN XELJANZ 5 mg filmovertrukne tabletter XELJANZ 10 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
Tabel 4: Dosisjustering ved nedsat leverfunktion Nedsat leverfunktion
Table 4: Dose Adjustment for Hepatic Impairment Hepatic
Co-primære effektmålc
Co-primary efficacy endpointsc
PASI75g Måned 3 Måned 6 Måned 12
PASI75g Month 3
Remissiona Med tidligere svigt af TNF-hæmmer Uden tidligere svigt af TNF-hæmmerb Forbedring af endoskopisk udseende af slimhindenc Med tidligere svigt af TNF-hæmmer Uden tidligere svigt af TNF-hæmmerb TNF = Tumornekrosefaktor, N = Antallet af patienter i analysesættet.
With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Tofacitinib 10 mg To gange dagligt N=197
Tofacitinib 10 mg Twice Daily N=197
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg tofacitinib (som tofacitinibcitrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Tofacitinib 5 mg To gange dagligt N=198
Tofacitinib 5 mg Twice Daily N=198
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. b. Vigtigt, sekundært effektmål: Forbedring af endoskopisk udseende af slimhinden blev defineret som en
a. Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
I de kontrollerede kliniske RA-studier sås i de puljede grupper af patienter, der fik 5 eller 10 mg 2 gange dagligt, et bekræftet fald i ALC til under 0,50 x109 celler/l hos 0,3 % af patienterne og et bekræftet fald i ALC til mellem 0,50 og 0,75 x109 celler/l hos 1,9 % af patienterne.
In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Tofacitinib 5 mg 2 gange dagligt monoterapi N= 241
Tofacitinib 5 mg Twice Daily Monotherapy N=241
Udslæt
Impairment
Pneumocystis jirovecii-pneumoni Pneumokokpneumoni
Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Tofacitinib 10 mg To gange dagligt N=429
Tofacitinib 10 mg Twice Daily N=429
Tofacitinibs dosis skal reduceres til 5 mg to gange dagligt hos patienter, der får 10 mg to gange dagligt.
a Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg tofacitinib (som tofacitinibcitrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
SD = Standardafvigelse b
TNFi Inadequate Responders b
Placebo Tofacitinib 10 mg To gange dagligt
Placebo Tofacitinib 10 mg Twice Daily
Måned 6: ACR20 mTSS DAS284(ESR)<
ACR20 mTSS DAS284(ESR)<2.6 Month 3:
Tofacitinib 10 mg 2 gange dagligt + DMARD N= 315
Tofacitinib 10 mg Twice Daily + DMARD(s) N=315
Tofacitinib 5 mg 2 gange dagligt + MTX
Tofacitinib 5 mg Twice Daily + MTX
Tofacitinib 10 mg 2 gange dagligt monoterapi N= 243
Tofacitinib 10 mg Twice Daily Monotherapy N=243
Tofacitinib 5 mg 2 gange dagligt + MTX N=376
Tofacitinib 5 mg Twice Daily + MTX N=376
Tofacitinib 10 mg 2 gange dagligt Gennemsnitlig forskel fra MTXd (CI)
Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI)
Tofacitinib 5 mg 2 gange dagligt Gennemsnitlig forskel fra MTXd (CI)
Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL 10 MG BEHOLDERENS INDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING
• Din læge kan beslutte at forlænge den indledende behandling på 10 mg to gange dagligt med yderligere 8 uger (16 uger i alt) efterfulgt af 5 mg to gange dagligt.
• Your doctor may decide to extend the initial 10 mg twice a day treatment by an additional
Cytomegalovirusinfektion
Viral infection
Tidspunkt for skift fra placebo til 5 mg eller 10 mg tofacitinib 2 gange dagligt
Time of mandatory placebo rescue to tofacitinib 5 or 10 mg twice daily
Tofacitinib 10 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebob (CI)
Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
MTX-IR
mTSS
Måned 6 *p <0,05, ***p<0,0001 versus placebo, s.c.=subkutant, N=antal forsøgspersoner analyseret
*p <0.05, ***p<0.0001 versus placebo, SC=subcutaneous, QOW=every other week, N=number of subjects analysed, DAS28=Disease Activity Scale 28 joints, ESR=Erythrocyte Sedimentation Rate.
ORAL Standard: MTX
ORAL Standard: MTX Inadequate Responders
Tofacitinib 10 mg 2 gange dagligt + MTX N= 309
Tofacitinib 10 mg Twice Daily + MTX N=309
LÆGEMIDLETS NAVN XELJANZ 10 mg tabletter tofacitinib
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL 5 MG BEHOLDERENS INDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1178/003 56 filmovertrukne tabletter EU/1/17/1178/004 182 filmovertrukne tabletter EU/1/17/1178/014 112 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
I de kontrollerede kliniske RA-studier sås i de puljede grupper af patienter, der fik 5 eller 10 mg 2 gange dagligt, et bekræftet fald i ANC til under 1,0 x109 celler/l hos 0,08 % af patienterne.
In the controlled RA clinical studies, confirmed decreases in ANC below 1,000 cells/mm3 occurred in 0.08% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1178/007 56 filmovertrukne tabletter EU/1/17/1178/008 112 filmovertrukne tabletter EU/1/17/1178/009 182 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
Tofacitinib 2 gange dagligt + MTX
Tofacitinib Twice Daily + MTX
Tofacitinib 10 mg 2 gange dagligt + MTX
Tofacitinib 10 mg Twice Daily + MTX
Tofacitinib 10 mg 2 gange dagligt + MTX N= 134
Tofacitinib 10 mg Twice Daily + MTX N=134
Tofacitinib 5 mg 2 gange dagligt + MTX N= 316
Tofacitinib 5 mg Twice Daily + MTX N=316
Forbedring af endoskopisk udseende af slimhinderne b
Improvement of endoscopic appearance of the mucosab
Tofacitinib 5 mg 2 gange dagligt + MTX N= 133
Tofacitinib 5 mg Twice Daily + MTX N=133
LÆGEMIDLETS NAVN XELJANZ 5 mg tabletter tofacitinib
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
• Psoriasisgigt
• wheezing
Tofacitinib 5 mg 2 gange dagligt + DMARD N= 312
Tofacitinib 5 mg Twice Daily + DMARD(s) N=312
Med tidligere svigt af TNFhæmmer
Prior TNFi failure Prior corticosteroid failure
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1178/005 60 filmovertrukne tabletter EU/1/17/1178/006 180 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Opretholdt kortikosteroidfri remission blev defineret som værende i remission uden at tage kortikosterioider i mindst 4 uger før besøget i både uge 24 og 52.
e. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least
Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
a. Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Included TNF Inhibitor naïve patients.
Tabel 3: Lav hæmoglobinværdi
Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Brug af anden medicin sammen med XELJANZ Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
LÆGEMIDLETS NAVN XELJANZ 5 mg filmovertrukne tabletter tofacitinib
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets tofacitinib
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1178/001 60 filmovertrukne tabletter EU/1/17/1178/002 180 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Tofacitinib som monoterapi 5 mg 2 gange dagligt N= 370
Tofacitinib 5 mg Twice Daily Monotherapy N=370
LÆGEMIDLETS NAVN XELJANZ 10 mg filmovertrukne tabletter tofacitinib
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg film-coated tablets tofacitinib
Kvinder i den fertile alder skal rådes til at bruge effektiv prævention under behandling med tofacitinib
Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Tofacitinib som monoterapi 10 mg 2 gange dagligt N= 394
Tofacitinib 10 mg Twice Daily Monotherapy N=394