FrancophonIA/ELRC3.0 huggingface dataset:
English: In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
Maltese: Fl-esperjenza bil-kura kollha b'tofacitinib, ir-rata ta' inċidenza globali ta' infezzjonijiet kienet 60.3 avveniment għal kull 100 sena tal-pazjent (li involviet 49.4% tal-pazjenti; total ta' 572 pazjent).
English: TNF=tumour necrosis factor; N=number of patients in the analysis set.
Maltese: TNF=fattur tan-nekrożi tat-tumur; N=numru ta' pazjenti fis-sett tal-analiżi.
English: Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
Maltese: L-għoti flimkien ma' ketoconazole (inibitur qawwi ta' CYP3A4), fluconazole (inibitur moderat ta' CYP3A4 u qawwi ta' CYP2C19), tofacitinib (inibitur ħafif ta' CYP3A4) u ciclosporine (inibitur moderat ta' CYP3A4) żied l-AUC ta' tofacitinib, filwaqt li rifampicin (induttur ta' CYP) naqqas lAUC ta' tofacitinib.
English: This treatment difference was consistent between the 2 subgroups (Table 16).
Maltese: Din id-differenza fil-kura kienet konsistenti bejn iż-2 sottogruppi (Tabella 16).
English: XELJANZ 5 mg tablets tofacitinib
Maltese: XELJANZ 5 mg pilloli tofacitinib
English: All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
Maltese: Il-pazjenti kollha kienu meħtieġa jirċievu csDMARD konkomitanti 1; 71.6% tal-pazjenti rċivew MTX konkomitanti, 15.7 % tal-pazjenti rċivew sulfasalazine konkomitanti, u 8.6 % tal-pazjenti rċivew leflunomide konkomitanti.
English: Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE 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.
Maltese: Il-manteniment tar-rispons kliniku ġie definit bħala tnaqqis mill-punteġġ Mayo tal-linja bażi tal-istudju ta' induzzjoni (OCTAVE Induzzjoni 1, OCTAVE Induzzjoni 2) ta' ≥ 3 punti u ≥ 30%, bi tnaqqis ta' akkumpanjament fis-sottopunteġġ tal-fsada mir-rektum ta' ≥punt 1 jew sottopunteġġ ta' fsada mir-rektum ta' 0 jew 1.
English: BLISTER FOR 11 MG TABLETS
Maltese: FOLJA GĦAL 11 MG PILLOLI
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: 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: XELJANZ 10 mg tablets tofacitinib
Maltese: XELJANZ 10 mg pilloli tofacitinib
English: Tofacitinib is a potent, selective inhibitor of the JAK family.
Maltese: Tofacitinib huwa inibitur qawwi, selettiv tal-familja JAK.
English: 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Maltese: 7% u 49.2% tal-pazjenti kellhom entesite u daktilite, rispettivament.
English: Improvement of endoscopic appearance of the mucosab Normalisation of endoscopic appearance of the mucosac Clinical responsed
Maltese: Normalizzazzjoni tad-dehra endoskopika tal-mukuża Rispons kliniku
English: Common ≥1/100 to <1/10
Maltese: Komuni ≥1/100 sa
English: The HAQ-DI responder rate (response defined as having decrease from baseline of ≥ 0.35) at month 3 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: Ir-rata ta' dawk li wieġbu ta' HAQ-D1 (rispons definit bħala li jkun hemm tnaqqis mil-linja bażi ta' ≥ 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 BROADEN biss).
English: EU/1/17/1178/001 EU/1/17/1178/002 EU/1/17/1178/003 EU/1/17/1178/004 EU/1/17/1178/005 EU/1/17/1178/006 EU/1/17/1178/007 EU/1/17/1178/008 EU/1/17/1178/009 EU/1/17/1178/014
Maltese: EU/1/17/1178/006 EU/1/17/1178/007 EU/1/17/1178/008 EU/1/17/1178/009 EU/1/17/1178/014
English: Prolonged-release tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Maltese: L-elevazzjonijiet fil-parametri tal-lipidi (kolesterol totali, kolesterol tal-LDL, kolesterol tal-HDL, triglycerides) kienu vvalutati l-ewwel f'xahar 1 wara l-bidu ta' tofacitinib fil-provi kliniċi kkontrollati double-blind ta' RA.
English: * p<0.0001; † p<0.001; ‡ p<0.05.
Maltese: * p<0.0001; **p<0.
English: Tofacitinib 5 mg twice daily + MTX N=277 Mean (SD)a
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX N=277 Medja (SD)
English: Bronchitis Nasopharyngitis Pharyngitis
Maltese: .1 Proprjetajiet farmakodinamiċi
English: Table 3: Low haemoglobin value Low haemoglobin value (Section 4.4)
Maltese: Tabella 3:Valur tal-emoglobina baxx Valur tal-emoglobina baxx (Sezzjoni 4.4)
English: • Malignancy
Maltese: • Malinn
English: • Tofacitinib+MTX
Maltese: • Tofacitinib+
English: Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 59.44 mg ta' lactose.
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Maltese: L-għoti flimkien ta' tofacitinib ma kellux effett fuq il-PK ta' kontraċettivi orali, levonorgestrel u ethinyl estradiol, f'voluntiera nisa f'saħħithom.
English: MT X-IR
Maltese: MTX-IR
English: • Tofacitinib monotherapy
Maltese: • Monoterapij a b'tofacitinib
English: In patients with RA, treatment up to 6 months with tofacitinib was associated with dose-dependent reductions of circulating CD16/56+ natural killer (NK) cells, with estimated maximum reductions occurring at approximately 8-10 weeks after initiation of therapy.
Maltese: F'pazjenti b'RA, il-kura b'tofacitinib sa 6 xhur kienet assoċjata ma' tnaqqis dipendenti fuq id-doża ta' ċelluli natural killer (NK) CD16/56+ li jiċċirkolaw, bi tnaqqis massimu stmat li jseħħ f'bejn wieħed u ieħor 8-10 ġimgħat wara l-bidu tat-terapija.
English: Tofacitinib 5 mg twice daily N=344 Mean (SD)a
Maltese: Tofacitinib 5 mg darbtejn kuljum N=344 Medja (SD)
English: For pneumococcal polysaccharide vaccine the number of responders was as follows: 32% in patients receiving both tofacitinib and MTX; 62% for tofacitinib monotherapy; 62% for MTX monotherapy; and 77% for placebo.
Maltese: Għall-vaċċin polysaccharide pnewmokokkali n-numru ta' dawk li rrispondew kien kif ġej: 32% tal-pazjenti li kienu qed jirċievu kemm tofacitinib kif ukoll MTZ; 62% għall-monoterapija ta' tofacitinib; 62% għall-monoterapija ta' MTX; u 77% għall-plaċebo.
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 5 mg darbtejn kuljum.
English: Tofacitinib 10 mg twice daily + DMARD(s) N=315
Maltese: Tofacitinib 10 mg darbtejn kuljum + DMARD(s) N=315
English: • rheumatoid arthritis
Maltese: • artrite rewmatika
English: Tofacitinib 10 mg twice daily N=476
Maltese: Tofacitinib 10 mg darbtejn kuljum N=476
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, 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.
Maltese: Tofacitinib ma ġiex studjat u l-użu tiegħu għandu jiġi evitat f'kombinament ma' bijoloġiċi bħal TNF, antagonisti ta' interleukin (IL)-1R, antagonisti ta' IL-6R, antikorpi monoklonali kontra CD20, antagonisti ta' IL-17, antagonisti ta' IL-12/IL-23, antiintegrini, modulaturi selettivi ta' aktar minn stimulu wieħed u immunosuppressanti qawwija bħal azathioprine, 6-mercaptopurine, ciclosporine u tacrolimus minħabba l-possibbiltà ta' żieda fl-immunosuppressjoni u żieda fir-riskju tal-infezzjoni.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2),
Maltese: - Is-sustanzi l-oħra fil-pillola huma microcrystalline cellulose, lactose monohydrate (ara sezzjoni
English: In RA patients, coadministration of tofacitinib with MTX 15-25 mg once weekly decreased the AUC and Cmax of MTX by 10% and 13%, respectively.
Maltese: Fil-pazjenti b'RA, l-għoti flimkien ta' tofacitinib ma' MTX 15-25 mg darba fil-ġimgħa naqqas l-AUC u s-Cmax ta' MTX b'10% u 13%, rispettivament.
English: mTSS=modified Total Sharp Score, ACR20(70)=American College of Rheumatology ≥20% (≥70%) improvement, DAS28=Disease Activity Score 28 joints, ESR=Erythrocyte Sedimentation Rate, HAQ-DI=Health Assessment Questionnaire Disability Index, DMARD=disease-modifying antirheumatic drug, IR=inadequate responder, csDMARD=conventional synthetic DMARD, TNFi=tumour necrosis factor inhibitor, NA=not applicable, ADA=adalimumab, MTX=methotrexate.
Maltese: Punti tat-tmiem koprimarji kif ġejjin: bidla medja mil-linja bażi f'mTSS; perċentwali ta' individwi li laħqu risponsi ta' ACR20 jew ACR70; bidla medja mil-linja bażi f'HAQ-DI; perċentwali ta' individwi li laħqu DAS28-4(ESR) <2.6 (remissjoni). mTSS=bidla fil-punteġġ totali Sharp, ACR20(70)=titjib ta' ≥20% (≥70%) tal-Kulleġġ Amerikan tar-Rewmatoloġija, DAS28=Punteġġ tal-Attività tal-Marda 28 ġog, ESR=Rata ta' Sedimentazzjoni ta' Eritroċiti, HAQ-DI=Indiċi ta' Diżabilità ibbażat fuq Kwestjonarju ta' Valutazzjoni tas-Saħħa, DMARD=mediċina antirewmatika li timmodifika l-marda, IR=Pazjenti li Rrispondew b'mod Inadegwat, csDMARD=DMARD sintetika konvenzjonali, TNFi= inibitur tal-fattur tan-nekrożi tat-tumur, NA=mhux applikabbli, ADA=adalimumab, MTX=methotrexate.
English: mTSSc Baseline Month 6 Month 12
Maltese: mTSS Linja bażi Xahar 6
English: ΔLEIf Month 3 Month 6 Month 12
Maltese: ΔLEI Xahar 3 Xahar 6 Xahar 12
English: • Heart failure
Maltese: Qabel falliment ta'
English: Lymphoma was observed in 3 of 8 adult monkeys at 6 or 3 times the clinical tofacitinib exposure level (unbound AUC in humans at a dose of 5 mg or 10 mg twice daily), and 0 of 14 juvenile monkeys at 5 or 2.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Maltese: Il-limfoma kienet osservata fi 3 minn 8 xadini adulti f'6 jew 3 darbiet il-livell tal-esponiment kliniku ta' tofacitinib (AUC mhux marbut fil-bnedmin f'doża ta' 5 mg jew 10 mg darbtejn kuljum), u 0 minn 14-il xadina minorenni f'5 jew 2.5 darbiet il-livell tal-esponiment kliniku ta' 5 mg jew 10 mg darbtejn kuljum.
English: • who have underlying conditions that may predispose them to infection.
Maltese: • li għandhom kundizzjonijiet sottostanti li jistgħu jippredisponuhom għal infezzjoni.
English: Pharmacokinetics in patients
Maltese: Farmakokinetika f'pazjenti
English: Tofacitinib should not be initiated in patients with active infections, including localised infections.
Maltese: Tofacitinib ma għandux jinbeda f'pazjenti b'infezzjonijiet attivi, inkluż infezzjonijiet lokalizzati.
English: For recommended modifications based on ANC (see section 4.2).
Maltese: Għal modifikazzjonijiet irrakkomandati abbażi tal-ANC (ara sezzjoni 4.2).
English: Tofacitinib 10 mg twice daily N=368 Mean (SD)a
Maltese: Tofacitinib 10 mg darbtejn kuljum N=368 Medja (SD)
English: All patients were required to have 1 concomitant csDMARD; 83.9% of patients received concomitant MTX, 9.5% of patients received concomitant sulfasalazine, and 5.7% of patients received concomitant leflunomide.
Maltese: Il-pazjenti kollha kienu meħtieġa jirċievu csDMARD konkomitanti 1; 83.9% tal-pazjenti rċivew MTX konkomitanti, 9.5 % tal-pazjenti rċivew sulfasalazine konkoitanti, u 5.7 % tal-pazjenti rċivew leflunomide konkomitanti.
English: Tofacitinib 5 mg twice daily N=198
Maltese: Tofacitinib 5 mg darbtejn kuljum N=198
English: In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
Maltese: F'OPAL BROADEN, ma kinitx permessa kura preċedenti b'inibitur TNF.
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Maltese: Kull pakkett fih 56, 112, jew 182 pillola u kull flixkun fih 60 jew 180 pillola.
English: OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Maltese: 2 studji ta' induzzjoni identiċi (OCTAVE Induzzjoni 1 u OCTAVE Induzzjoni 2) segwiti minn studju ta' manteniment 1 (OCTAVE Sostenn).
English: Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Maltese: L-ALC ikkonfermat anqas minn 750 ċellula/mm 3 kien assoċjat ma' żieda fl-inċidenza ta' infezzjonijiet serji (ara sezzjoni 4.4).
English: (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Maltese: 2 (l-ewwel valutazzjoni wara l-linja bażi) matul xahar 3 meta mqabbel mal-plaċebo fi studji OPAL BROADEN u OPAL BEYOND (p≤ 0.05 nominali).
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: 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: XELJANZ 11 mg prolonged-release tablet contains sorbitol This medicine contains approximately 152 mg sorbitol in each prolonged-release tablet.
Maltese: XELJANZ 11 mg pillola li terħi l-mediċina bil-mod fih sorbitol Din il-mediċina fiha madwar 152 mg sorbitol f'kull pillola li terħi l-mediċina bil-mod.
English: Tofacitinib 10 mg twice daily N=429
Maltese: Tofacitinib 10 mg darbtejn kuljum N=429
English: Tofacitinib 11 mg prolonged-release tablets contains sorbitol.
Maltese: Tofacitinib 11 mg pilloli li jerħu l-mediċina bil-mod fih sorbitol.
English: Tofacitinib 10 mg twice daily + MTX N=290 Mean (SD)a
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX N=290 Medja (SD)
English: In the randomised 8-week Phase 2/3 induction studies, the proportions of patients with infections were 21.1% (198 patients) in the tofacitinib 10 mg twice daily group compared to 15.2% (43 patients) in the placebo group.
Maltese: Fi studji ta' induzzjoni randomizzati ta' 8 ġimgħat tal-Fażi 2/3, il-proporzjonijiet ta' pazjenti b'infezzjonijiet kienu 21.1% (198 pazjent) fil-grupp ta' tofacitinib 10 mg darbtejn kuljum meta mqabbel ma' 15.2% (43 pazjent) fil-grupp tal-plaċebo.
English: BLISTER FOR 10 MG TABLETS
Maltese: FOLJA GĦAL 10 MG PILLOLI
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 filplażma jintlaħqu fi żmien 0.5-siegħa), eliminazzjoni ta' malajr (half-life ta' ~3 sigħat) u żidiet proporzjonali mad-doża fl-esponiment sistemiku.
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: 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 mattnaqqis osservat wara d-doża għal żmien qasir, l-għadd taċ-ċelluli natural killer CD16/56+ urew żieda medja ta' 73% mil-linja bażi.
English: Local endoscopy read
Maltese: Qari tal-endoskopija lokali
English: The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Maltese: L-attività farmakoloġika ta' tofacitinib hija attribwita għall-molekula oriġinali.
English: Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post-marketing reports.
Maltese: Ġie osservat emboliżmu pulmonari (PE) f'pazjenti li ħadu tofacitinib fil-provi kliniċi u f'rapporti ta' wara t-tqegħid fis-suq.
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 f'ġimgħa 24 u f'ġimgħa 52.
English: Tofacitinib 10 mg twice daily N=197
Maltese: Tofacitinib 10 mg darbtejn kuljum N=197
English: Other medicines and XELJANZ
Maltese: Kif taħżen XELJANZ
English: BID=twice daily.
Maltese: BID=darbtejn kuljum.
English: • Patients undergoing major surgery
Maltese: • Pazjenti li ssirilhom kirurġija maġġuri
English: In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C.
Maltese: Fi provi kliniċi, tofacitinib ma kienx evalwat f'individwi b'indeboliment sever (Child Pugh C) tal-fwied (ara sezzjonijiet 4.2 u 4.4), jew f'pazjenti li skrinjaw pożittivi għall-epatite B jew C.
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 fiddoża f'OCTAVE Sostenn.
English: Changes from baseline in HAQ-DI in studies ORAL Standard, ORAL Step and ORAL Sync are shown in Table 11.
Maltese: Il-bidliet mil-linja bażi f'HAQ-DI fi studji ORAL Standard, ORAL Step u ORAL Sync qed jintwerew f'Tabella 11.
English: Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo at week 8 in the total and all 4 domain scores of the Inflammatory Bowel Disease Questionnaire (IBDQ) (bowel symptoms, systemic function, emotional function, and social function) in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Maltese: Tofacitinib 10 mg darbtejn kuljum wera titjib ikbar mil-linja bażi meta mqabbel mal-plaċebo f'ġimgħa 8 fil-punteġġi totali u fil-punteġġi tal-4 dominji kollha tal-Kwestjonarju tal-Mard Infjammatorju tal-Musrana (IBDQ, Inflammatory Bowel Disease Questionnaire) (sintomi tal-musrana, funzjoni sistemika, funzjoni emozzjonali, u funzjoni soċjali) fl-istudji ta' induzzjoni (OCTAVE Induzzjoni 1, OCTAVE Induzzjoni 2).
English: Haemoglobin should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Maltese: L-emoglobina għandha tkun immonitorjata fil-linja bażi u wara 4 sa 8 ġimgħat ta' kura u kull 3 xhur wara dan.
English: • with recurrent infections,
Maltese: • b'infezzjonijiet rikorrenti,
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 the total and all 4 domain scores of the IBDQ at week 24 and week 52.
Maltese: Fl-istudju ta' manteniment (OCTAVE Sostenn), tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum wera manteniment ikbar ta' titjib meta mqabbel mal-plaċebo fil-punteġġi totali u fil-punteġġi tal-4 dominji kollha tal-IBDQ f'ġimgħa 24 u f'ġimgħa 52.
English: • Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
Maltese: • Tromboemboliżmu venuż preċedenti, jew tromboemboliżmu venuż fond jew emboliżmu pulmonari
English: Of the 4,271 patients who enrolled in RA studies I-VI (see section 5.1), a total of 608 RA patients were 65 years of age and older, including 85 patients 75 years and older.
Maltese: I-VI dwar RA (ara sezzjoni 5.1), total ta' 608 pazjenti b'RA kienu ta' 65 sena u akbar, inkluż 85 pazjent ta' 75 sena u akbar.
English: Table 9: Number (%) of subjects achieving DAS28-4(ESR) < 2.6 remission at months 3 and 6
Maltese: Tabella 9: Numru (%) ta' individwi li kisbu remissjoni DAS28-4(ESR) ta' < 2.6 f'xhur 3 u 6 Punt ta' żmien ORAL Step:
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: Fi studji kliniċi kkontrollati tal-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: None b csDMARDs MTX MTX MTX None b
Maltese: MTX MTX MTX L-ebda
English: After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Maltese: Wara l-kura b'tofacitinib f'pazjenti b'RA, tnaqqis malajr tal-proteina C-reattiva (CRP) fis-serum kien osservat u nżamm matul id-doża.
English: The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Maltese: L-effikaċja u s-sigurtà ta' tofacitinib ġew ivvalutati f'2 studji li ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo ta' Fażi 3 f'pazjenti adulti b'PsA attiva (≥ 3 ġogi minfuħin u ≥ 3 ġogi sensittivi).
English: Tofacitinib 10 mg twice daily
Maltese: TOFACITINIB 10 mg BID
English: The frequency of serious infection among tofacitinib-treated patients 65 years of age and older was higher than those under the age of 65 (4.8 per 100 patient-years versus 2.4 per 100 patient-years, respectively).
Maltese: Il-frekwenza ta' infezzjoni serja fost pazjenti kkurati b'tofacitinib ta' 65 sena jew akbar kienet ogħla minn dawk taħt l-età ta' 65 (4.8 għal kull 100 sena tal-pazjent kontra 2.4 għal kull 100 sena tal-pazjent, rispettivament).
English: Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Maltese: Urosepsis TB mifruxa Faxxite nekrotika Batteremija Batteremija stafilokokkali Pulmonite pneumocystis jirovecii