FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
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: For recommended modifications based on ANC, see section 4.2.
Maltese: Għal modifikazzjonijiet irrakkomandati abbażi tal-ANC, ara sezzjoni 4.2.
English: ≥1/100 to <1/10
Maltese: ≥1/100 sa
English: c. Normalization of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
Maltese: In-normalizzazzjoni tad-dehra endoskopika tal-mukuża ġiet definita bħala sottopunteġġ endoskopiku Mayo ta' 0.
English: After 8 weeks on tofacitinib 10 mg twice daily in OCTAVE Open, remission was achieved in 35% (20/58) patients who received tofacitinib 5 mg twice daily in OCTAVE Sustain and 40% (40/99) patients with dose interruption in OCTAVE Sustain.
Maltese: Wara 8 ġimgħat fuq tofacitinib 10 mg darbtejn kuljum f'OCTAVE Miftuħ, ir-remissjoni nkisbet f'35% (20/58) tal-pazjenti li rċivew tofacitinib 5 mg darbtejn kuljum f'OCTAVE Sostenn u 40% (40/99) tal-pazjenti b'interruzzjoni fid doża f'OCTAVE Sostenn.
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Maltese: * p≤0.05 nominali; ** p<0.001 nominali; *** p<0.0001 nominali għal kura attiva kontra plaċebo f'Xahar 3.
English: Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Maltese: Herpes simplex Gastroenterite virali
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: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż
English: NA ORAL Scan: MTX Inadequate Responders
Maltese: NA ORAL Scan: Pazjenti li Rrispondew b'mod Inadegwat għal MTX
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 sections 4.4 and 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 sezzjonijiet 4.4 u 4.5) kif ġej:
English: Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins (IL-2, -4, -6, -7, -9, -15, -21) and type I and type II interferons, which will result in modulation of the immune and inflammatory response.
Maltese: b'selettività funzjonali fuq riċetturi taċ-ċitokina li jissenjalaw permezz ta' pari ta' JAK2. Linbibizzjoni ta' JAK1 u JAK3 permess ta' tofacitinib tattenwa s-senjalar tal-interleukins (IL-2, -4, -6,7, -9, -15, -21) u interferons tat-tip I u tat-tip II, li jirriżultaw fl-modulazzjoni tar-rispons immuni u infjammatorju.
English: • antibiotics such as clarithromycin and rifampicin, used to treat bacterial infections
Maltese: • antibijotiċi bħal clarithromycin u rifampicin, użati sabiex jikkuraw infezzjonijiet batterjali
English: Subjects with mild (creatinine clearance 50-80 mL/min), moderate (creatinine clearance 30-49 mL/min), and severe (creatinine clearance < 30 mL/min) renal impairment had 37%, 43% and 123% higher AUC, respectively, compared to subjects with normal renal function (see section 4.2).
Maltese: Individwi b'indeboliment ħafif (tneħħija tal-kreatinina 50-80 mL/min), moderat (tneħħija tal kreatinina 30-49 mL/min), u sever (tneħħija tal-kreatinina < 30 mL/min) tal-kliewi kellhom 37%, 43%
English: 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).
Maltese: Fażi 3 b'DMARDs fl-isfond, ir-rati ta' infezzjoni fuq 0-3 xhur fil-grupp ta' tofacitinib kif ukoll DMARD ta' 5 mg darbtejn kuljum (total 973 pazjent) u ta' 10 mg darbtejn kuljum (total 969 pazjent) kienu ta' 21.3% (207 pazjenti) u 21.8% (211-il pazjent), rispettivament, meta mqabbla ma' 18.4% (103 pazjenti) fil-grupp tal-plaċebo kif ukoll DMARD (total 559 pazjent).
English: NA ORAL Sync: DMARD Inadequate Responders
Maltese: NA ORAL Sync: Pazjenti li Rrispondew b'mod Inadegwat għal DMARD
English: ACR70 Month 3 Month 6
Maltese: ACR70 Xahar 3 Xahar 6
English: 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).
Maltese: ≥ 0.35) f'xahar 3 fi studji OPAL BROADEN u OPAL BEYOND kien 53% u 50%, rispettivament f'pazjenti li rċivew tofacitinib 5 mg darbtejn kuljum, 31% u 28%, rispettivament f'pazjenti li rċivew ilplaċebo, u 53% f'pazjenti li rċivew adalimumab 40 mg taħt il-ġilda darba kull ġimagħtejn (OPAL
English: 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.
Maltese: Fl-istudji kliniċi kkontrollati dwar RA, tnaqqis ikkonfermat fl-ANC taħt 1,000 ċellula/mm3 seħħ f'0.08% tal-pazjenti għad-dożi ta' 5 mg darbtejn kuljum u 10 mg darbtejn kuljum ikkombinati.
English: The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Maltese: tofacitinib hija attribwita għall-molekula oriġinali.
English: In OPAL BROADEN, Minimal Disease Activity (MDA) response was achieved by 26.2%, 25.5% and 6.7% of tofacitinib 5 mg BID, adalimumab and placebo treated patients, respectively (tofacitinib 5 mg BID treatment difference from placebo 19.5% [95% CI: 9.9, 29.1]) at month 3.
Maltese: 6.7% tal-pazjenti kkurati b'tofacitinib 5 mg BID, adalimumab u plaċebo, rispettivament (differenza filkura ta' tofacitinib 5 mg BID minn plaċebo 19.5% [95% CI: 9.9, 29.1]) f'xahar 3. F'OPAL BEYOND,
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 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: Tofacitinib 10 mg Twice Daily + DMARD(s) N=315
Maltese: Tofacitinib 10 mg Darbtejn Kuljum + DMARD(s) N=315
English: The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases in systemic exposure.
Maltese: Il-PK ta' tofacitinib huwa kkaratterizzat minn assorbiment ta' malajr (konċentrazzjonijiet massimi fil plażma jintlaħqu fi żmien 0.5-siegħa), eliminazzjoni ta' malajr (half-life ta' ~3 sigħat) u żidiet proporzjonali mad-doża fl-esponiment sistemiku.
English: Tofacitinib 10 mg Twice Daily N=197
Maltese: Tofacitinib 10 mg Darbtejn Kuljum N=197
English: Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years.
Maltese: 70 kg. Pazjenti anzjani ta' 80 sena kienu stmati li għandhom anqas minn 5% AUC ogħla relattiv maletà medja ta' 55 sena.
English: Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI)
Maltese: Tofacitinib 10 mg Darbtejn Kuljum Differenza Medja minn MTXd (CI)
English: In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in PCS and MCS scores, and in all 8 domains of the SF-36 at week 24 and week 52.
Maltese: Fl-istudju ta' manteniment (OCTAVE Sustain), tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum wera manteniment ikbar ta' titjib meta mqabbel mal-plaċebo fil-punteġġi PCS u MCS, u fit-8 dominji kollha tas-SF-36
English: In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
Maltese: F'kuntrast mat tnaqqis osservat wara d-doża għal żmien qasir, l-għadd taċ-ċelluli natural killer CD16/56+ urew żieda medja ta' 73% mil-linja bażi.
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, normalization 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 fil linja 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: Noneb csDMARDs MTX MTX MTX Noneb
Maltese: MTX MTX MTX L-ebdab
English: Tofacitinib binds predominantly to albumin and does not appear to bind to α1-acid glycoprotein.
Maltese: Tofacitinib jintrabat b'mod predominanti mal-albumina u ma jidhirx li jintrabat ma' α1-acid glikoproteina.
English: Tofacitinib 5 mg Twice Daily Monotherapy N=241
Maltese: Tofacitinib 5 mg Monoterapija Darbtejn Kuljum N=241
English: Tofacitinib 5 mg Twice Daily + DMARD(s) N=312
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + DMARD(s) N=312
English: MTX-IR MTX-IR TNFi-IR MTX-naïvea MTX-IR
Maltese: MTX-IR MTX-IR TNFi-IR Mingħajr esperjenza ta' MTX
English: Coadministered Drug
Maltese: TAL-PRODOTT MEDIĊINALI
English: Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Maltese: Monitoraġġ tal-lipidi Il-kura b'tofacitinib kienet assoċjata ma' żidiet fil-parametri tal-lipidi bħal kolesterol totali, kolesterol tal-lipoproteina ta' densità baxxa (LDL), u kolesterol tal-lipoproteina ta' densità għolja (HDL).
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: Steady state concentrations are achieved in 24-48 hours with negligible accumulation after twice daily administration.
Maltese: 24-48 siegħa b'akkumulazzjoni negliġibbli wara għoti ta' darbtejn kuljum.
English: Tofacitinib 5 mg Twice Daily N=384
Maltese: Tofacitinib 5 mg Darbtejn Kuljum N=384
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 irrakkomandat 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 tat tumur, interleukin-17, interleukin-12/interleukin-23, anti-integrini, u immunosoppressanti kimiċi b'saħħithom li jinkludu azathioprine, mercaptopurine, ciclosporine, u tacrolimus.
English: - Keep this leaflet.
Maltese: Bojod, Suwed u Asjatiċi.
English: Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Maltese: Kull 5 mg pillola miksija b'rita fiha tofacitinib citrate, ekwivalenti għal 5 mg tofacitinib.
English: 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).
Maltese: Artrite psorjatika Tofacitinib f'kombinament ma' MTX huwa indikat għall-kura ta' artrite psorjatika (PsA) attiva f'pazjenti adulti li rrispondew b'mod inadegwat għal, jew li kienu intolleranti għal terapija b'mediċina antirewmatika li timmodifika marda preċedenti (disease-modifying antirheumatic drug, DMARD) (ara sezzjoni 5.1).
English: Tofacitinib 5 mg Twice Daily N=198
Maltese: Tofacitinib 5 mg Darbtejn Kuljum N=198
English: Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
Maltese: Tofacitinib 5 mg Darbtejn Kuljum Differenza Medja minn MTXd (CI)
English: b.Antimalarials were allowed.
Maltese: Il-mediċini kontra l-malarja kienu permessi.
English: Maximum effects were generally observed within 6 weeks.
Maltese: effetti massimi kienu ġeneralment osservati fi żmien 6 ġimgħat.
English: 4 weeks prior to the visit at both week 24 and week 52.
Maltese: f'ġimgħa 24 u f'ġimgħa 52.
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: Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post marketing reports.
Maltese: Emboliżmu pulmonari Ġie osservat emboliżmu pulmonari (PE) f'pazjenti li ħadu tofacitinib fil-provi kliniċi u f'rapporti ta'
English: ACR20 mTSS DAS284(ESR)<2.6 Month 3:
Maltese: Xahar 6: ACR20 mTSS DAS284(ESR)
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 għall-kura attiva kontra plaċebo f'xahar 3.
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 tal fwied u 30% eliminazzjoni tal-kliewi tal-mediċina oriġinali.
English: Tofacitinib 5 mg Twice Daily + MTX N=376
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + MTX N=376
English: X-Ray TNFi-IR Monotherapy, Active comparator (MTX),
Maltese: X-Ray TNFi-IR Monoterapij a,
English: Musculoskeletal pain
Maltese: Uġigħ muskoluskeletal i
English: Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Maltese: Tofacitinib twaqqaf u l pazjent irkupra wara l-kura b'dożi standard ta' mediċina antivirali.
English: c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Maltese: c Inkisbet sinifikanza statistika globalment f'p≤ 0.05 skont il-proċedura ta' ttestjar pass 'l isfel speċifikata minn qabel.
English: Over the course of ORAL Strategy, responses with tofacitinib 5 mg twice daily + MTX were numerically similar compared to adalimumab 40 mg + MTX and both were numerically higher than tofacitinib 5 mg twice daily.
Maltese: Matul ORAL Strategy, ir-rispons b'tofacitinib 5 mg darbtejn kuljum + MTX kien numerikament simili meta mqabbel ma' adalimumab 40 mg + MTX u t-tnejn kienu numerikament ogħla minn tofacitinib
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 bl influwenza u vaċċini polysaccharide pnewmokokkali f'pazjenti li jirċievu tofacitinib 10 mg darbtejn kuljum fit-tul.
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using XELJANZ 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 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
Maltese: • Il-kard ta' twissija tal-pazjent għandu jkun fiha l-messaġġi ewlenin li ġejjin: o Messaġġ ta' twissija għall-HCPs li jkunu qed jikkuraw il-pazjent fi kwalunkwe ħin, inkluż f'kundizzjonijiet ta' emerġenza, li l-pazjent ikun qed juża XELJANZ 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 meta l-pazjenti għandhom ifittxu l-attenzjoni minn HCPL: infezzjonijiet, riattivazzjoni tal-herpes zoster, kanċer tal-ġilda mhux melanoma, żidiet fit-transaminase u potenzjal għal ħsara fil-fwied ikkaġunata millmediċini, 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,
English: Local Endoscopy Read
Maltese: Qari tal-Endoskopija Lokali
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall galactose, defiċjenza fil-Lapp lactase jew li għandhom problemi fl-assorbiment ta' glucose-galactose m'għandhomx jingħataw dan il-prodott mediċinali.
English: Tofacitinib 5 mg Twice Daily + DMARD(s)
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + DMARD(s)
English: Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Maltese: Kull 10 mg pillola miksija b'rita fiha tofacitinib citrate, ekwivalenti għal 10 mg tofacitinib.
English: You may also be at higher risk of certain lung problems.
Maltese: Tista' tkun f'riskju ogħla ta' ċerti problemi tal-fwied.
English: 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
Maltese: ACR20/50/70= Kulleġġ Amerikan tar-Rewmatoloġija ≥ 20%, 50%, titjib ta' 70%; csDMARD= mediċina antirewmatika li timmodifika l-marda sintetika konvenzjonali; N=numru ta' pazjenti li ntgħażlu b'mod każwali u kkurati; NA= Mhux applikabbli, peress li dejta għal kura bil-plaċebo mhijiex disponibbli wara xahar 3 minħabba plaċebo avvanzat għal tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum; SC q2w=taħt il-ġilda darba kull ġimagħtejn; TNFi= inibitur tal-fattur tan-nekrożi tat-tumur; PASI=Indiċi tal-Parti u tas-Severità tal-Psorjasi; PASI75=≥ 75% titjib fil-PASI.
English: Tofacitinib 5 mg Twice Daily Monotherapy N=370
Maltese: Tofacitinib 5 mg Monoterapija Darbtejn Kuljum N=370
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Maltese: Pfizer Europe MA EEIG (bħala lowgo tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq)
English: XELJANZ 5 mg film-coated tablets
Maltese: XELJANZ 5 mg pilloli tofacitinib
English: Subjects with mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had 3%, and 65% higher AUC, respectively, compared to subjects with normal hepatic function.
Maltese: Individwi b'indeboliment ħafif (Child Pugh A) u moderat (Child Pugh B) tal-fwied kellhom 3%, u
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: • with a history of a serious or an opportunistic infection,
Maltese: • b'infezzjonijiet rikorrenti, • bi storja ta' infezzjoni serja jew opportunistika,
English: Treatment groups (Randomisation ratio)
Maltese: Gruppi ta' kura (Proporzjon ta' randomizzazzjoni)
English: Tofacitinib 10 mg Twice Daily + MTX N=309
Maltese: Tofacitinib 10 mg Darbtejn Kuljum + MTX N=309