FrancophonIA/ELRC3.0 huggingface dataset:
English: Confirmed increases in liver enzymes greater than 3 times the upper limit of normal (3x ULN) were uncommonly observed in RA patients.
Maltese: Żidiet ikkonfermati fl-enzimi tal-fwied aktar minn 3 darbiet il-limitu massimu tan-normal (3x ULN) kienu osservati b'mod mhux komuni f'pazjenti b'RA.
English: *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.
Maltese: 0001 kontra l-plaċebo, SC=taħt il-ġilda, QOW=kull ġimagħtejn, N=numru ta' individwi analizzati, DAS28=Skala tal-Attività tal-Mard 28 ġog, ESR=Rata ta' Sedimentazzjoni tal-Eritroċiti.
English: If lab value confirmed by repeat testing within 7 days, dosing should be discontinued.
Maltese: Jekk il-valur tal-laboratorju jiġi kkonfermat minn ittestjar ripetut fi żmien 7 ijiem, id-dożaġġ għandu jitwaqqaf.
English: Secondary effects from immunosuppression, such as bacterial and viral infections and lymphoma were observed at clinically relevant doses.
Maltese: Effetti sekondarji millimmunosuppressjoni, bħall-infezzjonijiet batterjali u virali u limfoma kienu osservati f'dożi klinikament rilevanti.
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Maltese: Inkisbet sinifikanza statistika globalment f'p≤ 0.05 skont il-proċedura ta' ttestjar pass 'l isfel speċifikata minn qabel.
English: As early as week 2, the earliest scheduled study visit, and at each visit thereafter, significant differences were observed between tofacitinib 10 mg twice daily and placebo in the change from baseline in rectal bleeding and stool frequency, and partial Mayo score.
Maltese: Sa minn ġimgħa 2, l-iktar vista ta' studju skedata kmieni, u f'kull vista wara din, ġew osservati differenzi sinifikanti bejn tofacitinib 10 mg darbtejn kuljum u l-plaċebo fil-bidla mil-linja bażi filfsada mir-rektum u fil-frekwenza tal-ippurgar, u punteġġ Mayo parzjali.
English: Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS) and mental component summary (MCS) scores, and in all 8 domains of the SF-36 in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Maltese: Riżultati relatati mas-saħħa u mal-kwalità tal-ħajja Tofacitinib 10 mg darbtejn kuljum wera titjib ikbar mil-linja bażi meta mqabbel mal-plaċebo filpunteġġi tas-sommarju tal-komponent fiżiku (PCS, physical component summary) u s-sommarju talkomponent mentali (MCS, mental component summary), u fit-8 dominji kollha tas-SF-36 fl-istudji ta' induzzjoni (OCTAVE Induzzjoni 1, OCTAVE Induzzjoni 2).
English: ORAL Solo and ORAL Sync.
Maltese: II (ORAL Sync)
English: The overall incidence rate of infections with tofacitinib in the long-term safety all exposure population (total 4,867 patients) was 46.1 patients with events per 100 patient-years (43.8 and 47.2 patients with events for 5 mg and 10 mg twice daily, respectively).
Maltese: Ir-rata ta' inċidenza ġenerali tal-infezzjonijiet b'tofacitinib fil-popolazzjoni tas-sigurtà fit-tul b'esponiment sħiħ (total 4,867 pazjent) kien ta' 46.1 pazjent b'avvenimenti għal kull 100 sena talpazjent (43.8 u 47.
English: Tofacitinib 5 mg twice daily + MTX N=133
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX N=133
English: 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
Maltese: EU/1/17/1178/007 56 pillola miksija b'rita EU/1/17/1178/008 112-il pillola miksija b'rita EU/1/17/1178/009 182 pillola miksija b'rita
English: Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000): infezzjoni fid-demm (sepsis), tuberkulożi mxerrda li tinvolvi l-għadam u organi oħrajn, infezzjonijiet oħrajn mhux tas-soltu, infezzjonijiet filġogi.
English: Tofacitinib impaired female fertility but not male fertility in rats (see section 5.3).
Maltese: Tofacitinib indebbolixxa l-fertilità tan-nisa iżda mhux il-fertilità tal-irġiel fil-firien (ara sezzjoni 5.3).
English: Tofacitinib 5 mg twice daily + MTX N=316
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX N=316
English: Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
Maltese: Il-kura b'tofacitinib kienet assoċjata ma' żieda fl-inċidenza ta' elevazzjoni fl-enzimi tal-fwied f'xi pazjenti (ara sezzjoni 4.8 testijiet tal-enzimi tal-fwied).
English: Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets.
Maltese: Folji tal-fojl tal-aluminju/fojl tal-aluminju inforrati bil-PVC ta' dożi uniċi li fihom 14-il pillola miksija b'rita.
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Maltese: Kien hemm inċidenza ogħla ta' avvenimenti avversi għall-kombinazzjoni ta' tofacitinib ma' MTX kontra tofacitinib bħala monoterapija fil-provi kliniċi ta' RA.
English: XELJANZ 10 mg film-coated tablets XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Maltese: XELJANZ 10 mg pilloli miksija b'rita XELJANZ 10 mg pillola miksija b'rita għandha dehra blu u tonda.
English: 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
Maltese: EU/1/17/1178/003 56 pillola miksija b'rita EU/1/17/1178/004 182 pillola miksija b'rita EU/1/17/1178/014 112-il pillola miksija b'rita
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.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): infezzjoni fil-pulmun (pulmonite u bronkite), ħruq ta' Sant' Antnin (herpes zoster), infezzjonijiet tal-imnieħer, tal-gerżuma jew tal-passaġġ tan-nifs (nasofariniġite), influwenza, sinusite, infezzjoni fil-bużżieqa tal-awrina (ċistite), uġigħ fil-griżmejn (fariniġite), żieda fl-enzimi tal-muskoli fid-demm (sinjali ta' problemi tal-muskoli), uġigħ ta' stonku (żaqq) (li tista' tkun infammazzjoni tar-rita tal-istonku), rimettar, dijarea, tħossok imdardar (dardir), indiġestjoni, tfekkik tal-ġogi, għadd baxx taċ-ċelluli ħomor tad-demm (anemija), deni, għeja, nefħa fissaqajn u fl-idejn, uġigħ ta' ras, pressjoni għolja tad-demm, sogħla, raxx.
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.
Maltese: Tofacitinib 11 mg pilloli li jerħu l-mediċina bil-mod darba kuljum urew ekwivalenza farmakokinetika (AUC u Cmax) għal tofacitinib 5 mg pilloli miksija b'rita darbtejn kuljum.
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.
Maltese: Għal tnaqqis persisenti (2 valuri sekwenzjali f'din il-medda wara ttestjar ta' rutina) f'din il-firxa, id-dożaġġ ta' tofacitinib 11 mg li jerħi l-mediċina bil-mod għandu jiġi interrott sakemm l-ANC ikun akbar minn 1,000.
English: • chest tightness
Maltese: • infafet tal-ġilda
English: Hepatic steatosis Hepatic enzyme increased T ransaminases increased Liver function test abnormal Gamma glutamyltransferase increased
Maltese: Żieda fl-enzima tal-fwied Żieda fittransaminases Test tal-funzjoni tal-fwied mhux normali
English: Tofacitinib 5 mg twice daily Tofacitinib 10 mg twice daily placebo
Maltese: Tofacitinib 5 mg darbtejn kuljum Tofacitinib 10 mg darbtejn kuljum plaċebo
English: Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
Maltese: Tofacitinib f'kombinament ma' methotrexate (MTX) huwa indikat għall-kura ta' artrite rewmatika (RA) attiva moderata sa severa f'pazjenti adulti li rrispondew b'mod inadegwat għal, jew li huma intolleranti għal waħda jew aktar mill-mediċini antirewmatiċi li jimmodifikaw il-marda.
English: In the controlled portion of the RA phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: Fil-parti kkontrollata tal-istudju ta' RA ta' monoterapija tal-fażi 3 (0-3 xhur) (studju I, ara sezzjoni 5.1), l-elevazzjonijiet fl-ALT akbar minn 3x ULN kienu osservati f'1.65%, 0.41%, u 0% talpazjenti li jirċievu l-plaċebo, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Maltese: EU/1/17/1178/005 60 pillola miksija b'rita EU/1/17/1178/006 180 pillola miksija b'rita
English: In the subgroup of patients with prior TNF inhibitor failure, the observed treatment difference from placebo was numerically greater for tofacitinib 10 mg twice daily than tofacitinib 5 mg twice daily by 9.7 to 16.7 percentage points across the primary and key secondary endpoints.
Maltese: Fissottogrupp ta' pazjenti b'falliment fil-passat ta' inibitur ta' TNF, id-differenza fil-kura osservata millplaċebo kienet numerikament ikbar għal tofacitinib 10 mg darbtejn kuljum milli tofacitinib 5 mg darbtejn kuljum b'9.7 sa 16.7 punti perċentwali fost il-punti tat-tmiem primarji u sekondarji ewlenin.
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).
Maltese: Id-doża totali ta' kuljum ta' tofacitinib għandha titnaqqas bin-nofs f'pazjenti li jirċievu inibituri qawwija ta' ċikotromu P450 (CYP) 3A4 (eż., ketoconazole) u f'pazjenti li jirċievu prodott mediċinali konkomitanti 1 jew aktar li jirriżulta f'inibizzjoni moderata ta' CYP3A4 kif ukoll inibizzjoni qawwija ta' CYP2C19 (eż, fluconazole) (ara sezzjoni 4.5).
English: Tofacitinib was not carcinogenic in mice at exposures up to 38 or 19 times the clinical exposure level at 5 mg or 10 mg twice daily.
Maltese: Tofacitinib ma kienx karċinoġeniku fil-ġrieden f'esponimenti sa 38 jew 19-il darba tal-livell tal-esponiment kliniku b'5 mg jew 10 mg darbtejn kuljum.
English: Each pack contains 56, 112, or 182 film-coated tablets.
Maltese: Kull pakkett fih 56, 112, jew 182 pillola miksija b'rita.
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Maltese: 001; †p<0.05 għal tofacitinib kontra l-plaċebo.
English: For patients (total 1,750) on monotherapy, the rates were 48.9 and 41.9 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Maltese: Għallpazjenti (total 1,750) fuq il-monoterapija, ir-rati kienu ta' 48.9 u 41.9 pazjent b'avvenimenti għal kull 100 sena tal-pazjent għal 5 mg u 10 mg darbtejn kuljum, rispettivament.
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).
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): tuberkulożi, infezzjoni fil-kliewi, infezzjoni fil-ġilda, herpes simplex jew ħżieża (herpes orali), għadd baxx taċ-ċelluli bojod tad-demm, żieda fl-enzimi tal-fwied (sinjali ta' problemi tal-fwied), żieda fil-kreatinina tad-demm (sinjal possibbli ta' problemi fil-kliewi), żieda fil-kolesterol (inkluż żieda fl-LDL), żieda fil-piż, deidrazzjoni, tensjoni fil-muskoli, uġigħ fil-muskoli u fil-ġogi, tendonite, nefħa fil-ġogi, tfekkik tal-ġogi, sensazzjonijiet mhux normali, irqad ħażin, konġestjoni tas-sinus, qtugħ ta' nifs jew diffikultà sabiex tieħu nifs, ħmura tal-ġilda, ħakk, fwied xaħmi, infjammazzjoni bl-uġigħ ta' spazji żgħar fir-rita (divertikulite), infezzjonijiet virali, infezzjonijiet virali li jaffetwaw l-imsaren, xi tipi ta' kanċers talġilda (tat-tipi mhux tal-melanoma).
English: o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and/or when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19 inhibitors, effects on pregnancy and foetus, use in breast-feeding, effect on vaccination efficacy and the use of live/attenuated vaccines.
Maltese: o Li l-kura b'XELJANZ tista' żżid ir-riskju ta' infezzjonijiet u tal-kanċer tal-ġilda mhux melanoma o Li l-pazjenti għandhom javżaw lill-professjonisti tas-saħħa jekk ikunu qed jippjanaw li jirċievu xi tilqima jew li jinqabdu tqal o Sinjali jew sintomi tat-tħassib dwar is-sikurezza li ġej u/jew meta l-pazjenti għandhom ifittxu l-attenzjoni minn HCPL: infezzjonijiet, riattivazzjoni tal-herpes zoster, kanċer talġilda mhux melanoma, żidiet fit-transaminase u potenzjal għal ħsara fil-fwied ikkaġunata mill-mediċini, perforazzjoni gastrointestinali, mard tal-pulmun interstizjali, immunosoppressjoni miżjuda meta jintuża flimkien ma' bijoloġiċi u immunosoppressanti inkluż aġenti li jneħħu limfoċita B, riskju miżjud ta' avvenimenti avversi meta XELJANZ jingħata flimkien ma' MTX, esponiment miżjud għal XELJANZ meta jingħata flimkien ma' inibituri ta' CYP3A4 u CYP2C19, effetti fuq it-tqala u l-fetu, użu matul it-treddigħ, effett fuq l-effikaċja tat-tilqima u l-użu ta' tilqim ħaj/attenwat.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Maltese: Għandu jiġi kkunsidrat l-effett addittiv ta' prodotti mogħtija flimkien li fihom sorbitol (jew fructose) u t-teħid fid-dieta ta' sorbitol (jew fructose).
English: 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.
Maltese: tal-pazjenti u għal ALC bejn 500 u 750 ċellula/mm 3 f'1.9 % tal-pazjenti għad-dożi ta' 5 mg darbtejn kuljum u 10 mg darbtejn kuljum ikkombinati.
English: • Pregnancy and lactation (see section 4.6).
Maltese: • Tqala u treddigħ (ara sezzjoni 4.6)
English: NMSCs have been reported in patients treated with tofacitinib.
Maltese: Kienu rrapportati NMSCs f'pazjenti kkurati b'tofacitinib.
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Maltese: Kull pillola miksija b'rita fiha tofacitinib citrate, ekwivalenti għal 5 mg tofacitinib.
English: Furthermore, at month 12 of study OCTAVE Open, 74% (48/65) of patients who achieved remission at the end of study OCTAVE Sustain on either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily remained in remission while receiving tofacitinib 5 mg twice daily.
Maltese: Barra minn hekk, f'xahar 12 tal-Istudju OCTAVE Miftuħ, 74% (48/65) tal-pazjenti li kisbu remissjoni fl-aħħar tal-Istudju OCTAVE Sostenn fuq jew tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum baqgħu f'remissjoni waqt li kienu qed jirċievu tofacitinib 5 mg darbtejn kuljum.
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:
Maltese: Id-doża totali ta' kuljum ta' tofacitinib għandha titnaqqas bin-nofs f'pazjenti li jirċievu inibituri qawwija ta' ċikotromu P450 (CYP) 3A4 (eż., ketoconazole) u f'pazjenti li jirċievu prodott mediċinali konkomitanti 1 jew aktar li jirriżulta f'inibizzjoni moderata ta' CYP3A4 kif ukoll inibizzjoni qawwija ta' CYP2C19 (eż, fluconazole) (ara sezzjoni 4.5) kif ġej:
English: Table 4: Dose adjustment for hepatic impairment Hepatic impairment category
Maltese: Tabella 4: Aġġustament tad-doża għal indeboliment tal-fwied Kategorija ta' indeboliment tal-fwied
English: Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Maltese: L-għoti flimkien ma' ketoconazole u fluconazole żied is-Cmax ta' tofacitinib, filwaqt li tacrolimus, ciclosporine u rifampicin naqqsu s-Cmax ta' tofacitinib.
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Maltese: Kull pillola miksija b'rita fiha tofacitinib citrate, ekwivalenti għal 10 mg tofacitinib.
English: 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
Maltese: Tabella 15 Proporzjon ta' pazjenti li ssodisfaw il-punti tat-tmiem tal-effikaċja f'ġimgħa 8 (OCTAVE studju ta' induzzjoni 1 u OCTAVE studju ta' induzzjoni 2) OCTAVE studju ta' induzzjoni 1 Qari tal-endoskopija ċentrali
English: 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 mg or 10 mg (plus MTX) twice daily respectively, (both significant versus placebo plus MTX).
Maltese: Fil-grupp tal-plaċebo kif ukoll ta' MTX, 78% tal-pazjenti ma esperjenzaw l-ebda progress radjugrafiku (bidla f'mTSS ta' inqas minn jew daqs 0.5) f'xahar 6 meta mqabbla ma' 89% u 87% tal-pazjenti kkurati b'tofacitinib ta' 5 jew ta' 10 mg (kif ukoll MTX) darbtejn kuljum rispettivament, (kemm sinfikanti kontra l-plaċebo kif ukoll ta' MTX).
English: In the 6-month and 24-month, controlled clinical studies, the rate of serious infections in the 5 mg twice daily tofacitinib monotherapy group was 1.7 patients with events per 100 patient-years.
Maltese: Fl-istudji kliniċi kkontrollati ta' 6 xhur u 24 xahar, ir-rata ta' infezzjonijiet serji fil-grupp ta' monoterapija ta' tofacitinib ta' 5 mg darbtejn kuljum kienet ta' 1.7 pazjent b'avvenimenti għal kull 100 sena tal-pazjent.
English: Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Maltese: Kull pillola fiha 10 mg ta' tofacitinib (bħala tofacitinib citrate).
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.
Maltese: Għal tnaqqis persistenti (2 valuri sekwenzali f'din il-medda wara ttestjar ta' rutina) f'din il-medda, id-dożaġġ ta' tofacitinib 11 mg li jerħi l-mediċina bil-mod għandu jiġi interrott sakemm l-ALC ikun aktar minn 750.
English: Patients who completed 8 weeks in 1 of the induction studies and achieved clinical response were re-randomised into OCTAVE Sustain; 179 out of 593 (30.2%) patients were in remission at baseline of OCTAVE Sustain.
Maltese: Il-pazjenti li temmew 8 ġimgħat f'1 mill-istudji ta' induzzjoni u li kisbu rispons kliniku ġew randomizzati mill-ġdid f'OCTAVE Sostenn; 179 minn 593 (30.
English: Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Maltese: Rispons inadegwat għal mill-inqas inibitur TNF 1 (TNFi) minħabba nuqqas ta' effikaċja u/jew intollerabilità.
English: - Each 10 mg film-coated tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Maltese: - Kull 10 mg pillola miksija b'rita fiha 10 mg ta' tofacitinib (bħala tofacitinib citrate).
English: Treatment failure was defined as an increase in Mayo score of ≥ 3 points from maintenance study baseline, accompanied by an increase in rectal bleeding subscore by ≥ 1 point, and an increase of endoscopic subscore of ≥ 1 point yielding an absolute endoscopic subscore of ≥ 2 after a minimum treatment of 8 weeks in the study.
Maltese: Il-falliment tal-kura ġie definit bħala żieda fil-punteġġ Mayo ta' ≥ 3 punti mil-linja bażi tal-istudju ta' manteniment, akkumpanjata minn żieda fis-sottoputneġġ tal-fsada mir-rektum b'≥punt 1, u żieda tassottopunteġġ endoskopiku ta' ≥punt 1 li rriżultat f'sottopunteġġ endoskopiku assolut ta' ≥ 2 wara kura minima ta' 8 ġimgħat fl-istudju.
English: Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
Maltese: Limfoma u kanċers oħrajn (bħal kanċer tal-pulmun, tas-sider, melanoma, kanċer tal-prostata u kanċer pankreatiku), ġew irrappurtati f'pazjenti kkurati b'XELJANZ.
English: o Contact details of the prescriber
Maltese: o Dettalji ta' kuntatt tal-preskrivent
English: • antibiotics such as rifampicin, used to treat bacterial infections
Maltese: • antibijotiċi bħal rifampicin, użati sabiex jikkuraw infezzjonijiet batterjali
English: In ORAL Scan, tofacitinib 10 mg twice daily plus background MTX resulted in significantly greater inhibition of the progression of structural damage compared to placebo plus MTX at months 6 and 12.
Maltese: F'ORAL Scan, tofacitinib ta' 10 mg darbtejn kuljum kif ukoll MTX fl-isfond irriżulta f'inibizzjoni statistikament akbar tal-progress tal-ħsara strutturali meta mqabbel mal-plaċebo kif ukoll MTX f'xhur 6 u 12.
English: Treatment groups (randomisation ratio)
Maltese: Gruppi ta' kura (proporzjon ta' randomizzazzjoni)
English: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Maltese: L-analiżi PK tal-popolazzjoni f'pazjenti b'RA tindika li l-esponiment sistemiku (AUC) ta' tofacitinib fl-estremi tal-piż tal-ġisem (40 kg, 140 kg) kienu simili (f'medda ta' 5%) għal dak ta' pazjent ta' 70 kg. Pazjenti anzjani ta' 80 sena kienu stmati li għandhom anqas minn 5% AUC ogħla relattiv maletà medja ta' 55 sena.
English: ACR20 mT SS DAS284(ESR)<2.6 Month 3:
Maltese: Xahar 6: ACR20 mTSS DAS284(ESR)
English: Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
Maltese: Tofacitinib jista' jingħata bħala monoterapija f'każ ta' intolleranza għal MTX jew meta kura b'MTX mhijiex xierqa (ara sezzjonijiet 4.4 u 4.5).