FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire Disability Index; N=total number of patients in the statistical analysis; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor.
Maltese: HAQ-DI= Indiċi ta' Diżabilità ibbażat fuq Kwestjonarju ta' Valutazzjoni tas-Saħħa; N=numru totali ta' pazjenti fl-analiżi statistika;
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.
Maltese: Fl-istudju ta' manteniment randomizzat ta' 52 ġimgħa tal-fażi 3, il-proporzjon ta' pazjenti b'infezzjonijiet kien 35.9% (71 pazjent) fil-grupp ta' 5 mg darbtejn kuljum u 39.8% (78 pazjent) fil-grupp ta' tofacitinib 10 mg darbtejn kuljum, meta mqabbel ma' 24.2% (48 pazjent) fil-grupp tal-plaċebo.
English: Tofacitinib 5 mg twice daily + MTX N=376
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX N=376
English: When given at a dose of 5 mg twice daily, tofacitinib plus MTX exhibited similar effects on mean progression of structural damage (not statistically significant).
Maltese: Meta mogħtija doża ta' 5 mg darbtejn kuljum, tofacitinib kif ukoll MTX wera effetti simili fuq il-progress medju ta' ħsara strutturali (mhux statistikament sinifikanti).
English: Pneumonia Influenza Herpes zoster Urinary tract infection Sinusitis Bronchitis Nasopharyngitis Pharyngitis
Maltese: Pulmonite Influwenza Herpes zoster Infezzjoni flapparat talawrina
English: Pyrexia Oedema peripheral Fatigue
Maltese: Deni Edema periferali
English: Tofacitinib was administered as monotherapy (i.e., without concomitant use of biologics and immunosuppressants) for UC.
Maltese: Tofacitinib ingħata bħala monoterapija (jiġifieri, mingħajr użu konkomitanti ta' bijoloġiċi u immunosoppressanti) għal UC.
English: Tofacitinib 10 mg twice daily + MTX N=309
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX N=309
English: Tofacitinib 10 mg twice daily monotherapy N=394
Maltese: Tofacitinib 10 mg darbtejn kuljum monoterapija N=394
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Maltese: p<0.0001 nominali għal kura attiva kontra plaċebo f'Xahar 3.
English: ALC less than 500
Maltese: ALC anqas minn 500
English: Table 18: Proportion of patients meeting primary and key secondary efficacy endpoints at week 52 by TNF inhibitor therapy subgroup (OCTAVE sustain, central endoscopy read)
Maltese: Tabella 18 Proporzjon ta' pazjenti li ssodisfaw il-punti tat-tmiem tal-effikaċja primarja u sekondarja ewlenin f'ġimgħa 52 minn sottogrupp ta' terapija b'inibitur ta' TNF (OCTAVE sostenn, qari tal-endoskopija ċentrali) Punt tat-tmiem
English: Key features Monotherapy Various csDMARDs
Maltese: Monoterapija csDMA RDs varji
English: The most common serious adverse reactions were serious infections (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi komuni serji kienu infezzjonijiet serji (ara sezzjoni 4.4).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għallgalactose, defiċjenza fil-lactase totali jew li għandhom problemi fl-assorbiment ta' glucose-galactose m'għandhomx jingħataw dan il-prodott mediċinali.
English: • Mean LDL cholesterol increased by 15% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 16% in the tofacitinib 5 mg twice daily arm and 19% in the tofacitinib 10 mg twice daily arm at month 24.
Maltese: • Il-kolesterol tal-LDL medju żdied bi 15% fil-fergħa ta' tofacitinib 5 mg darbtejn kuljum u 20% filfergħa ta' tofacitinib 10 mg darbtejn kuljum f'xahar 12, u żdied b'16% fil-fergħa ta' tofacitinib 5 mg darbtejn kuljum u 19% fil-fergħa ta' tofacitinib 10 mg darbtejn kuljum f'xahar 24.
English: The tablets are provided in blisters containing 14 tablets.
Maltese: Il-pilloli huma pprovduti f'folji li fihom 14-il pillola.
English: An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Maltese: Ġiet osservata relazzjoni lineari approssimattiva bejn il-piż tal-ġisem u lvolum tad-distribuzzjoni, li rriżultat f'konċentrazzjonijiet massimi (Cmax) u minimi (Cmin) f'pazjenti eħfef.
English: Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Maltese: Potenzjal għal prodotti mediċinali oħrajn sabiex jinfluwenzaw il-farmakokinetika (PK) ta' tofacitinib
English: Population DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTX-naïve a
Maltese: • It-tabib tiegħek jista' jiddeċiedi li jwaqqaf XELJANZ jekk XELJANZ ma jaħdimx għalik fi żmien 16-il ġimgħa.
English: The most common serious infections reported with tofacitinib were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Maltese: L-aktar infezzjonijiet serji komuni rrappurtati b'tofacitinib kienu pnewmonja, ċellulite, herpes zoster, infezzjoni fil-passaġġ urinarju, divertikulite, u appendiċite.
English: Gastritis Dyspepsia
Maltese: Konġestjoni tassinus
English: In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm3 occurred in 1.3% of patients and for ALC between 500 and 750 cells/mm3 in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Maltese: Fil-popolazzjoni tas-sigurtà fit-tul ta' RA, tnaqqis ikkonfermat fl-ALC taħt 500 ċellula/mm 3 seħħ f'1.3% tal-pazjenti u għal ALC bejn 500 u 750 ċellula/mm 3 fi 8.4 % tal-pazjenti għad-dożi ta' 5 mg darbtejn kuljum u 10 mg darbtejn kuljum ikkombinati.
English: Leukopenia Lymphopenia Neutropenia
Maltese: Lewkopenija Limfopenija Newtropenija
English: In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
Maltese: Fi studji mhux kliniċi, kienu osservati effetti fuq is-sistemi immunitarji u ematopojetiċi li kienu attribwiti għall-propjetajiet farmakoloġiċi (inibizzjoni JAK) ta' tofacitinib.
English: Tofacitinib 5 mg twice daily monotherapy N=370
Maltese: Tofacitinib 5 mg monoterapija darbtejn kuljum N=370
English: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Maltese: Peress li tofacitinib huwa metabolizzat minn CYP3A4, x'aktarx li jkun hemm interazzjoni ma' prodotti mediċinali li jinibixxu jew jinduċu CYP3A4.
English: Tofacitinib 5 mg twice daily + MTX Mean difference from placebob (CI)
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX Medja ta' differenza millplaċebo b (CI)
English: In study OPAL BROADEN, the progression of structural joint damage was assessed radiographically utilising the van der Heijde modified Total Sharp Score (mTSS) and the proportion of patients with radiographic progression (mTSS increase from baseline greater than 0.5) was assessed at month 12.
Maltese: Fl-istudju OPAL BROADEN, il-progressjoni ta' ħsara strutturali tal-ġogi kienet ivvalutata b'mod radjugrafiku permezz tal-bidla fil-punteġġ totali Sharp (mTSS) ta' van der Heijde u l-proporzjon ta' pazjenti bi progressjoni radjugrafika (żieda fl-mTSS mil-linja bażi ta' aktar minn 0.5) ġie vvalutat f'xahar 12.
English: Each prolonged-release tablet contains tofacitinib citrate, equivalent to 11 mg tofacitinib.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha tofacitinib citrate, ekwivalenti għal 11 mg tofacitinib.
English: Clearance mechanisms for tofacitinib are approximately 70% hepatic metabolism and 30% renal excretion of the parent drug.
Maltese: Il-mekkaniżmi ta' tneħħija għal tofacitinib kienu ta' bejn wieħed u ieħor 70% tal-metaboliżmu talfwied u 30% eliminazzjoni tal-kliewi tal-mediċina oriġinali.
English: Tofacitinib 10 mg twice daily + DMARD(s) ORAL Sync: DMARD inadequate responders
Maltese: Tofacitinib 10 mg darbtejn kuljum + DMARD(s) ORAL Sync: persuni li ma rrispondewx b'mod adegwat għal DMARD N=147
English: The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.
Maltese: L-aktar infezzjonijiet komuni li rriżultaw fit-twaqqif tat-terapija kienu herpes zoster u pulmonite.
English: p<0.0001 for tofacitinib 10 mg twice daily versus placebo.
Maltese: 0001 għal tofacitinib 10 mg darbtejn kuljum kontra l-plaċebo.
English: Following long-term treatment (median duration of tofacitinib treatment of approximately 5 years), CD4+ and CD8+ counts showed median reductions of 28% and 27%, respectively, from baseline.
Maltese: Wara l-kura fit-tul (tul ta' żmien medju tal-kura b'tofacitinib ta' bejn wieħed u ieħor 5 snin), l-għadd ta' CD4+ u CD8+ urew tnaqqis medju ta' 28% u 27%, rispettivament, mil-linja bażi.
English: In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg film-coated tablets 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).
Maltese: Fi studji kliniċi kkontrollati tal-fażi 3, ir-rati ta' infezzjoni fuq 0-3 xhur fil-gruppi ta' monoterapija ta' tofacitinib ta' 5 mg darbtejn kuljum (total 616-il pazjent) u ta' 10 mg darbtejn kuljum (total 642 pazjent) kienu ta' 16.2% (100 pazjent) u 17.9% (115-il pazjent), rispettivament, meta mqabbla ma' 18.9% (23 pazjent) fil-grupp tal-plaċebo (total 122 pazjent).
English: Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to > 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD).
Maltese: Studju PsA-I (OPAL BROADEN) evalwa 422 pazjent li kellhom rispons inadegwat preċedenti (minħabba nuqqas ta' effikaċja jew intolleranza) għal csDMARD (MTX għal 92.7% tal-pazjenti);
English: • Mean HDL cholesterol increased by 17% in the tofacitinib 5 mg twice daily arm and 18% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 19% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 24.
Maltese: • Il-kolesterol tal-HDL medju żdied bi 17% fil-fergħa ta' tofacitinib 5 mg darbtejn kuljum u 18% fil-fergħa ta' tofacitinib 10 mg darbtejn kuljum f'xahar 12 u żdied b'19% fil-fergħa ta' tofacitinib 5 mg darbtejn kuljum u 20% fil-fergħa ta' tofacitinib 10 mg darbtejn kuljum f'xahar 24.
English: Tofacitinib 5 mg twice daily + DMARD(s)
Maltese: Tofacitinib 5 mg darbtejn kuljum + DMARD(s)
English: Table 11: LS Mean change from baseline in HAQ-DI at month 3 Placebo + MTX
Maltese: Tabella 11: LS bidla medja mil-linja bażi f'HAQ-DI f'xahar 3 Plaċebo + MTX
English: Table 11: LS mean change from baseline in HAQ-DI at month 3 Placebo + MTX
Maltese: Tabella 11: LS Bidla medja mil-linja bażi f'HAQ-DI f'xahar 3 Plaċebo + MTX
English: Patients receiving tofacitinib 5 mg 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).
Maltese: Il-pazjenti li kienu qed jirċievu tofacitinib ta' 5 jew ta' 10 mg darbtejn kuljum urew titjib statistikament akbar mil-linja bażi fil-funzjonament fiżiku meta mqabbla mal-plaċebo f'xahar 3 (studji ORAL Solo, ORAL Sync, ORAL Standard, u ORAL Step) u f'xahar 6 (studji ORAL Sync u ORAL Standard).
English: 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, 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.
Maltese: Tofacitinib ma ġiex studjat u l-użu tiegħu għandu jiġi evitat f'kombinament ma' bijoloġiċi bħal antagonisti ta' TNF, antagonisti ta' interleukin (IL)-1R, antagonisti ta' IL-6R, antikorpi monoklonali kontra CD20, modulaturi selettivi ta' aktar minn stimulu wieħed u immunosuppressanti qawwija bħal azathioprine, 6-mercaptopurine, ciclosporine u tacrolimus minħabba l-possibbiltà ta' żieda flimmunosuppressjoni u żieda fir-riskju tal-infezzjoni.
English: Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement from baseline compared to placebo in the SF-36v2 physical functioning domain, the SF-36v2 physical component summary score, and FACIT-F scores at month 3 in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Maltese: Il-pazjenti li rċivew tofacitinib 5 mg darbtejn kuljum urew titjib aktar mil-linja bażi meta mqabbel mal-plaċebo fid-dominju talfunzjonament fiżiku SF-36v2, il-punteġġ tas-sommarju tal-komponent fiżiku SF-36v2 u l-punteġġi FACIT-F f'xahar 3 fi studji OPAL BROADEN and OPAL BEYOND (p≤ 0.05 nominali).
English: • who have resided or travelled in areas of endemic mycoses,
Maltese: • li għexu jew ivvjaġġaw lejn postijiet ta' mikożiji endemiċi,
English: It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Maltese: Fl-istudji kliniċi kkontrollati dwar RA, tnaqqis ikkonfermat fl-ANC taħt 1,000 ċellula/mm
English: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).
Maltese: Tofacitinib huwa indikat għall-kura ta' pazjenti adulti b'kolite ulċerattiva (UC, ulcerative colitis) attiva moderata sa severa li kellhom rispons inadegwat, rispons mitluf, jew li kienu intolleranti jew għal terapija konvenzjonali jew għal aġent bijoloġiku (ara sezzjoni 5.1).
English: 28 prolonged-release tablets 91 prolonged-release tablets
Maltese: 28 pillola li terħi l-mediċina bil-mod 91 pillola li terħi l-mediċina bil-mod
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.
Maltese: XELJANZ mhuwiex rakkomandat għall-użu ma' mediċini li jdgħajfu lis-sistema immuni, li jinkludu 'l hekk imsejħa terapiji bijoloġiċi (antikorpi) immirati, bħal dawk li jinibixxu l-fattur tan-nekrożi tattumur, interleukin-17, interleukin-12/interleukin-23, anti-integrini, u immunosoppressanti kimiċi b'saħħithom li jinkludu azathioprine, mercaptopurine, ciclosporine, u tacrolimus.
English: A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalisation of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
Maltese: Proporzjon ikbar b'mod konsiderevoli ta' pazjenti fiż-żewġ gruppi ta' kura b'tofacitinib 5 mg darbtejn kuljum u tofacitinib 10 mg darbtejn kuljum kisbu l-punti tat-tmiem li ġejjin f'ġimgħa 52 meta mqabbel mal-plaċebo: remissjoni, titjib tad-dehra endoskopika tal-mukuża, normalizzazzjoni tad-dehra endoskopika tal-mukuża, manteniment tar-rispons kliniku, remissjoni fost pazjenti f'remissjoni fillinja bażi, u remissjoni mingħajr kortikosterojdi sostnuta kemm f'ġimgħa 24 kif ukoll f'ġimgħa 52 fost pazjenti f'remissjoni fil-linja bażi, kif muri f'Tabella 17
English: ORAL Scan: MTX inadequate responders
Maltese: NA ORAL Scan: Pazjenti li rrispondew b'mod inadegwat għal MTX
English: At month 12, 96% and 98% of patients receiving tofacitinib 5 mg twice daily, and adalimumab 40 mg subcutaneously every 2 weeks, respectively, did not have radiographic progression (mTSS increase from baseline less than or equal to 0.5).
Maltese: F'xahar 12, 12, 96% u 98% tal-pazjenti li rċivew tofacitinib 5 mg darbtejn kuljum, u adalimumab 40 mg taħt il-ġilda kull ġimagħtejn, rispettivament, ma kellhomx progressjoni radjugrafika (żieda fl-mTSS mil-linja bażi ta' inqas minn jew daqs 0.5).
English: Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Maltese: Informazzjoni għall-pazjent XELJANZ 5 mg pilloli miksija b'rita XELJANZ 10 mg pilloli miksija b'rita tofacitinib
English: The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni waqt l-ewwel 3 xhur fi provi kliniċi kkontrollati kienu wġigħ ta' ras, infezzjonijiet fl-apparat respiratorju ta' fuq, nasofariniġite, dijarea, dardir u pressjoni għolja (ara Tabella 6, Reazzjonijiet Avversi tal-Mediċina [ADRs] abbażi tat-tul ta' żmien totali tal-istudji kollha).
English: In the RA phase 3 monotherapy study (0-24 months) (study VI, see section 5.1), ALT elevations greater than 3x ULN were observed in 7.1%, 3.0%, and 3.0% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: Fl-istudju ta' monoterapija tal-fażi 3 dwar RA (0-24 xhur) (studju VI, ara sezzjoni 5.1), lelevazzjonijiet fl-ALT akbar minn 3x ULN kienu osservati f'7.1%, 3.0%, u 3.0% tal-pazjenti li jirċievu MTX, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: The clinical significance of this is unknown, however, similar results were obtained in a separate vaccine study with influenza and pneumococcal polysaccharide vaccines in patients receiving long-term tofacitinib 10 mg twice daily.
Maltese: Is-sinifikat kliniku ta' dan mhuwiex magħruf, madankollu, inkisbu riżultati simili fi studju separat tal-vaċċin blinfluwenza u vaċċini polysaccharide pnewmokokkali f'pazjenti li jirċievu tofacitinib 10 mg darbtejn kuljum fit-tul.
English: Benign thymomas were observed in female rats at 187 or 94 times the clinical exposure level at 5 mg or 10 mg twice daily.
Maltese: Tijmomi beninni kienu osservati fil-firien nisa f'187 jew 94 darba tal-livell tal-esponiment kliniku b'5 mg jew 10 mg darbtejn kuljum.
English: Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Maltese: Ir-remissjoni ġiet definita bħala remissjoni klinika (punteġġ Mayo ≤ 2 blebda sottopunteġġ individwali > 1) u sottopunteġġ tal-fsada mir-rektum ta' 0.
English: Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Maltese: Fatturi ta' riskju addizzjonali li għandhom jiġu kkunsidrati meta jiġi ddeterminat ir-riskju tal-pazjent għal PE huma età akbar, obeżità, status tat-tipjip, u immobilizzazzjoni.
English: CARTON FOR 11 MG BLISTER PACK
Maltese: KARTUNA GĦAL 11 MG PAKKETT BIL-FOLJI
English: Tofacitinib 10 mg twice daily monotherapy N=243
Maltese: Tofacitinib 10 mg monoterapija darbtejn kuljum N=243
English: XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Maltese: XELJANZ jintuża flimkien ma' methotrexate biex jikkura pazjenti adulti b'artrite psorjatika attiva.
English: - Each 5 mg film-coated tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Maltese: - Kull 5 mg pillola miksija b'rita fiha 5 mg ta' tofacitinib (bħala tofacitinib citrate).
English: ACR20 Month 3 Month 6 Month 12
Maltese: Xahar 3 Xahar 6 Xahar 12
English: Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Maltese: Tofacitinib twaqqaf u lpazjent irkupra wara l-kura b'dożi standard ta' mediċina antivirali.
English: Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
Maltese: Il-pazjenti li jippreżentaw b'sinjali u b'sintomi addominali fil-bidu għandhom jiġu evalwati minnufih għal identifikazzjoni bikrija ta' perforazzjoni gastrointestinali.
English: • The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening and maintenance of the patient o Vaccination course to be completed before treatment o A specific reference to the fact that the patient has been informed and understands that tofacitinib is contraindicated during pregnancy and breast-feeding and women of childbearing potential should use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose o That the benefit risk of tofacitinib should be discussed with the patient, and the patient alert card should be given to and discussed with the patient o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
Maltese: • Il-Lista ta' kontroll tal-preskrivent għandu jkun fiha l-messaġġi ewlenin li ġejjin: o Lista ta' testijiet li għandhom jitwettqu waqt l-iskinjar inizjali u ż-żamma tal-pazjent o Kors ta' tilqim li għandu jitlesta qabel il-kura o Referenza speċifika għall-fatt li l-pazjent ġie infurmat u jifhem li tofacitinib m'għandux jintuża waqt it-tqala u t-treddigħ u nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effetiv waqt il-kura b'toficitinib u għal tal-inqas 4 ġimgħat wara l-aħħar doża o Li l-benefiċċju riskju ta' tofacitinib għandu jiġi diskuss mal-pazjent, u l-kard ta' twissija tal-pazjent għandha tingħata lil u tiġi diskussa mal-pazjent o Komorbiditajiet rilevanti li għalihom tiġi avżata l-kawtela meta jingħata XELJANZ u kundizzjonijiet li fihom m'għandux jingħata XELJANZ o Lista ta' medikazzjonijiet konkomitanti li mhumiex kompatibbli ma' kura b'XELJANZ o Il-bżonn ta' diskussjoni mal-pazjenti dwar ir-riskji assoċjati mal-użu ta' XELJANZ, speċfikament fir-rigward ta' infezzjonijiet, herpes zoster, tuberkulożi (TB) u infezzjonijiet opportunistiċi oħra, malinni, perforazzjonijiet gastrointestinali, mard tal-pulmun interstizjali, u anormalitajiet tal-laboratorju o Il-bżonn ta' monitoraġġ għal kwalunkwe sinjal u sintomu u anormalità tal-laboratorju għal identifikazzjoni bikrija tar-riskji msemmija hawn fuq.
English: Tofacitinib 10 mg twice daily + MTX N=134
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX N=134
English: In the controlled portion of the RA phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: II-IV, ara sezzjoni 5.1), l-elevazzjonijiet fl-ALT akbar minn 3x ULN kienu osservati f'0.9%, 1.24% u 1.14% talpazjenti li jirċievu l-plaċebo, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.