FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the safety profile observed in patients with UC treated with tofacitinib was consistent with the safety profile of tofacitinib in the RA indication.
Maltese: B'mod globali, il-profil tas-sigurtà osservat f'pazjenti b'UC ikkurati b'tofacitinib kien konsistenti malprofil tas-sigurtà ta' tofacitinib fl-indikazzjoni ta' RA.
English: Concomitant stable doses of oral aminosalicylates and corticosteroids (prednisone or equivalent daily dose up to 25 mg) were permitted with taper of corticosteroids to discontinuation mandated within 15 weeks of entering the maintenance study.
Maltese: Dożi stabbli konkomitanti ta' amminosaliċilati u kortikosterojdi orali (prednisone jew doża ta' kuljum ekwivalenti sa 25 mg) ġew permessi, bi tnaqqis gradwali tal-kortikosterojdi għal twaqqif mandat fi żmien 15il ġimgħa mid-dħul fl-istudju ta' manteniment.
English: Tofacitinib 5 mg twice daily + MTX
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX
English: Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open).
Maltese: Il-pazjenti li ma kisbux rispons kliniku f'wieħed mill-istudji ta' induzzjoni (OCTAVE Induzzjoni 1 jew OCTAVE Induzzjoni 2) wara 8 ġimgħat ta' tofacitinib 10 mg darbtejn kuljum tħallew jidħlu fi studju ta' estensjoni open-label (OCTAVE Miftuħ).
English: 56 film-coated tablets 112 film-coated tablets 182 film-coated tablets
Maltese: 56 pillola miksija b'rita 112-il pillola miksija b'rita 182 pillola miksija b'rita
English: For patients (total 3,117) on background DMARDs, the rates were 41.0 and 50.3 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Maltese: Għall-pazjenti (total 3,117) fuq DMARDs fl-isfond, ir-rati kienu ta' 41.0 u 50.3 pazjent b'avvenimenti għal kull 100 sena talpazjent għal 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: In ORAL Start, tofacitinib monotherapy resulted in significantly greater inhibition of the progression of structural damage compared to MTX at months 6 and 12 as shown in Table 10, which was also maintained at month 24.
Maltese: F'ORAL Start, il-monoterapija b'tofacitinib irriżultat f'inibizzjoni statistikament akbar tal-progress ta' ħsara strutturali meta mqabbla ma' MTX f'xhur 6 u 12 kif murija f'Tabella 10, li nżammet ukoll f'xahar 24.
English: In post-marketing experience, cases of drug hypersensitivity associated with tofacitinib administration have been reported.
Maltese: Fl-esperjenza ta' wara t-tqegħid fis-suq, ġew irrapportati każijiet ta' sensittivita eċċessiva assoċjati mal-amministrazzjoni ta' tofacitinib.
English: EU/1/17/1178/010 30 prolonged-release tablets EU/1/17/1178/011 90 prolonged-release tablets
Maltese: EU/1/17/1178/010 30 pillola li terħi l-mediċina bil-mod EU/1/17/1178/011 90 pillola li terħi l-mediċina bil-mod
English: Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia.
Maltese: L-interruzzjoni tad-doża tista' tkun meħtieġa għall-immaniġġjar ta' anormalitajiet tal-laboratorju relatati mad-doża inkluż il-limfopenija, in-newtropenija, u l-anemija.
English: Remission
Maltese: LISTA
English: EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Maltese: EU/1/17/1178/001 60 pillola miksija b'rita EU/1/17/1178/002 180 pillola miksija b'rita
English: Proportion of patients meeting primary and key secondary efficacy endpoints at week 8 by TNF inhibitor therapy subgroups (OCTAVE induction study 1 and OCTAVE induction study 2, central endoscopy read) OCTAVE induction study 1
Maltese: Proporzjon ta' pazjenti li ssodisfaw il-punti tat-tmiem tal-effikaċja primarja u sekondarja ewlenin f'ġimgħa 8 minn sottogruppi ta' terapija b'inibitur ta' TNF (OCTAVE studju ta' induzzjoni 1 u OCTAVE studju ta' induzzjoni 2, qari talendoskopija ċentrali)
English: Placebo Tofacitinib 10 mg twice daily
Maltese: Plaċebo Tofacitinib 10 mg darbtejn kuljum
English: p<0.0001 for tofacitinib 5 mg twice daily versus placebo.
Maltese: p<0.0001 għal tofacitinib 5 mg darbtejn kuljum kontra l-plaċebo. p<0.
English: Gastrointestinal obstruction with a non-deformable prolonged-release formulation
Maltese: Ostruzzjoni gastrointestinali b'formulazzjoni li terħi l-mediċina bil-mod mhux deformabbli
English: The proportion of patients achieving a DAS28 clinical remission (DAS28-4(ESR) < 2.6) in ORAL Step, ORAL Sync, and ORAL Standard is shown in Table 9.
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: - Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Maltese: - Kull 11 mg pillola li terħi l-mediċina bil-mod fiha 11 mg ta' tofacitinib (bħala tofacitinib citrate).
English: Note: Reference group is administration of tofacitinib alone.
Maltese: Nota: Il-grupp ta' referenza huwa l-għoti ta' tofacitinib biss
English: In the long-term safety all exposure population, the overall rates of serious infections were 2.4 and 3.0 patients with events per 100 patient-years for 5 mg and 10 mg twice daily tofacitinib groups, respectively.
Maltese: Fil-popolazzjoni tas-sigurtà fit-tul b'esponiment sħiħ, ir-rati ġenerali ta' infezzjonijiet serji kienu ta' 2.4 u 3.0 pazjent b'avvenimenti għal kull 100 sena tal-pazjent għal grupp ta' tofacitinib ta' 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: The extent of decrease in MTX exposure does not warrant modifications to the individualised dosing of MTX.
Maltese: Il-limitu tat-tnaqqis fl-esponiment ta' MTX ma jurix li hemm bżonn ta' modifikazzjonijiet għad-doża individwalizzata ta' MTX.
English: There is a higher rate of shingles in Japanese and Korean patients.
Maltese: • Pazjenti Ġappuniżi jew Koreani.
English: Placebo Tofacitinib 5 mg twice daily
Maltese: Plaċebo Tofacitinib 5 mg darbtejn kuljum
English: This treatment difference from placebo was similar between tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily in the subgroup of patients without prior TNF inhibitor failure.
Maltese: Din iddifferenza fil-kura mill-plaċebo kienet simili bejn tofacitinib 5 mg darbtejn kuljum u tofacitinib 10 mg darbtejn kuljum fis-sottogrupp ta' pazjenti mingħajr falliment fil-passat ta' inibitur ta' TNF.
English: Patients screened positive for hepatitis B or C were excluded from clinical trials.
Maltese: Pazjenti li skrinjaw pożittiv għall-epatite B jew C ġew esklużi mill-provi kliniċi.
English: In the MTX group, 70% of patients experienced no radiographic progression at month 6 compared to 83% and 90% of patients treated with tofacitinib 5 mg or 10 mg twice daily respectively, both significant versus MTX.
Maltese: Fil-grupp ta' MTX, 70% tal-pazjenti ma esperjenzaw l-ebda progress radjugrafiku f'xahar 6 meta mqabbla ma' 83% u 90% tal-pazjenti kkurati b'tofacitinib ta' 5 mg jew ta' 10 mg darbtejn kuljum rispettivament, it-tnejn li huma sinfikanti kontra
English: Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer.
Maltese: Tumuri malinni oħrajn kienu osservati fi studji kliniċi u fl-isfond ta' wara t-tqegħid fis-suq, inkluż, iżda mhux limitati għal, kanċer tal-pulmun, kanċer tas-sider, melanoma, kanċer tal-prostata, u kanċer tal-frixa.
English: Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Maltese: Il-pazjenti li temmew 1 mill-istudji ta' induzzjoni (OCTAVE Induzzjoni 1 jew OCTAVE Induzzjoni 2) iżda li ma kisbux rispons kliniku jew il-pazjenti li temmew jew irtiraw kmieni minħabba falliment tal-kura fl-istudju ta' manteniment (OCTAVE Sostenn) kienu eleġibbli għal OCTAVE Miftuħ.
English: Signs of serious infections (common) include
Maltese: Sinjali ta' infezzjonijiet serji (komuni) jinkludu
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: 5% u 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, MDA nkisbet minn 22.9% u 14.5% tal-pazjenti kkurati b'tofacitinib 5 mg BID u plaċebo, rispettivament, madankollu tofacitinib 5 mg BID ma kisbux sinifikanza statistikament nominali (differenza fil-kura minn plaċebo 8.4% [95% CI: -1.0, 17.8] f'xahar 3).
English: XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
Maltese: XELJANZ 5 mg pilloli miksija b'rita XELJANZ 10 mg pilloli miksija b'rita
English: Exposure in monkeys at the no observed adverse effect level (NOAEL) for the lymphomas was approximately 1 or 0.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Maltese: L-esponiment fix-xadini fil-livell fejn ma jkunux osservati effetti avversi (NOAEL) għal-limfomi kien bejn wieħed u ieħor 1 jew 0.5 darbiet daqs il-livell talesponiment kliniku ta' 5 mg jew 10 mg darbtejn kuljum.
English: Impact of other medicinal products on PK of tofacitinib
Maltese: Impatt ta' prodotti mediċinali oħrajn fuq il-PK ta' tofacitinib
English: Study I (O RAL
Maltese: Studju I (ORAL Solo)
English: XELJANZ is for oral use.
Maltese: XELJANZ huwa għall-użu orali.
English: Inadequate response to at least one conventional synthetic DMARD (csDMARD) due to lack of efficacy and/or intolerability.
Maltese: Rispons inadegwat għal mill-inqas DMARD waħda konvenzjonali (csDMARD) minħabba nuqqas ta' effikaċja u/jew intollerabilità.
English: XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
Maltese: XELJANZ 10 mg pillola miksija b'rita - Is-sustanza attiva hija tofacitinib.
English: EU/1/17/1178/012 28 prolonged-release tablets EU/1/17/1178/013 91 prolonged-release tablets
Maltese: EU/1/17/1178/012 28 pillola li terħi l-mediċina bil-mod EU/1/17/1178/013 91 pillola li terħi l-mediċina bil-mod
English: Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
Maltese: Pazjenti b'indeboliment tal-kliewi sever għandhom jibqgħu fuq doża mnaqqsa anki wara emodijalisi (ara sezzjoni 5.2).
English: Changes in mean HAQ-DI and DAS28-4(ESR) were maintained in both tofacitinib treatment groups through to the end of the studies.
Maltese: Bidliet fl-HAQ-DI medju u fid-DAS28-4(ESR) inżammu fiż-żewġ gruppi ta' kura b'tofacitinib matul l-istudji u sat-tmiem.
English: Potential for tofacitinib to influence the PK of other medicinal products
Maltese: Potenzjal għal tofacitinib sabiex jinfluwenza l-PK ta' prodotti mediċinali oħrajn
English: Table 7: Phase 3 clinical trials of tofacitinib 5 mg and 10 mg twice daily doses in patients with RA
Maltese: Provi kliniċi tal-fażi 3 ta' dożi ta' tofacitinib 5 mg u 10 mg darbtejn kuljum f'pazjenti b'RA
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism.
Maltese: Tofacitinib 10 mg darbtejn kuljum huwa kontraindikat f'pazjenti li jinsabu f'riskju għoli għal emboliżmu pulmonari.
English: Overall, the safety profile observed in patients with active PsA treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib.
Maltese: B'mod globali, il-profil tas-sigurtà osservat f'pazjenti b'PsA attiva kkurati b'tofacitinib kien konsistenti mal-profil tas-sigurtà osservat f'pazjenti b'RA kkurati b'tofacitinib.
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa ġiet ivvalutata mill-Istħarriġ tas-Saħħa fil-Forma l-Qasira (SF36).
English: For recommended modifications based on haemoglobin level, see section 4.2.
Maltese: Għal modifikazzjonijiet rakkomandati abbażi talANC, ara sezzjoni 4.2.
English: Table 7 provides information regarding the pertinent study design and population characteristics.
Maltese: Tabella 7 tipprovdi informazzjoni rigward id-disinn tal-istudju pertinenti u l-karatteristiċi tal-popolazzjoni.
English: Induction efficacy data (OCTAVE Induction 1 and OCTAVE Induction 2) The primary endpoint of OCTAVE Induction 1 and OCTAVE Induction 2 was the proportion of patients in remission at week 8, and the key secondary endpoint was the proportion of patients with improvement of endoscopic appearance of the mucosa at week 8.
Maltese: Dejta dwar l-effikaċja tal-induzzjoni (OCTAVE Induzzjoni 1 u OCTAVE Induzzjoni 2) Il-punt tat-tmiem primarju ta' OCTAVE Induzzjoni 1 u OCTAVE Induzzjoni 2 kien il-proporzjon ta' pazjenti f'remissjoni f'ġimgħa 8, u l-punt tat-tmiem sekondarju ewlieni kien il-proporzjon ta' pazjenti b'titjib tad-dehra endoskopika tal-mukuża f'ġimgħa 8.
English: For recommended modifications based on lymphocyte counts (see section 4.2).
Maltese: Għal modifikazzjonijiet rakkomandati abbażi tal-għadd tallimfoċiti (ara sezzjoni 4.2).
English: Significant reductions in DAS28-4(ESR) from baseline (mean improvement) of 1.8-2.0 and 1.9-2.2 were observed in patients treated with 5 mg and 10 mg twice daily doses, respectively, compared to placebo-treated patients (0.7-1.1) at month 3.
Maltese: Tnaqqis sinifikanti fid-DAS28-4(ESR) mil-linja bażi (titjib medju) ta' 1.8-2.0 u 1.9-2.2 kien osservat f'pazjenti kkurati b'dożi ta' 5 mg u 10 mg darbtejn kuljum, rispettivament, meta mqabbel ma' pazjenti kkurati bil-plaċebo (0.7-1.1) f'xahar 3. Il-proporzjon ta' pazjenti li jilħqu remissjoni klinika DAS28 (DAS28-4(ESR) < 2.6) f'ORAL Step, ORAL Sync, u ORAL Standard huwa muri f'Tabella 9.
English: You may also be at higher risk of certain lung problems.
Maltese: Tista' wkoll tkun f'riskju ogħla ta' ċerti problemi tal-pulmun.
English: There is a higher rate of infections in patients aged 65 years and older.
Maltese: Hemm rata ogħla ta' infezzjonijiet f'pazjenti li għandhom 65 sena jew aktar.
English: Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development.
Maltese: Tofacitinib intwera li huwa teratoġeniku fil-firien u fil-fniek, u għandu effetti fil-firien fuq il-fertilità tan-nisa (tnaqqis fir-rata tat-tqala; tnaqqis fin-numri ta' corpora lutea, siti ta' impjantazzjoni, u feti vijabbli; u żieda fl-assorbimenti mill-ġdid kmieni), fuq il-ħlas, u l-iżvilupp ta' waqt u wara t-twelid.
English: The enzymatic activity of CYP enzymes is reduced in RA patients due to chronic inflammation.
Maltese: L-attività enzimatika tal-enzimi CYP titnaqqas fil-pazjenti b'RA minħabba l-infjammazzjoni kronika.
English: The efficacy and safety of tofacitinib were assessed in 6 randomised, double-blind, controlled multicentre studies in patients greater than 18 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria.
Maltese: L-effikaċja u s-sigurtà ta' tofacitinib kienu vvalutati f'6 studji li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati, multiċentriċi f'pazjenti akbar mill-età ta' 18-il sena b'RA attiva dijanjostikata skont il-kriterji tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR).
English: Tofacitinib 10 mg twice daily placebo
Maltese: Tofacitinib 10 mg darbtejn kuljum plaċebo
English: In studies of 6-, 12-, or 24-month duration, the rates of serious infections in the 5 mg twice daily and 10 mg twice daily tofacitinib plus DMARD groups were 3.6 and 3.4 patients with events per 100 patient-years, respectively, compared to 1.7 patients with events per 100 patient-years in the placebo plus DMARD group.
Maltese: Fi studji ta' tul ta' żmien ta' 6, 12, jew 24 xahar, ir-rati ta' infezzjonijiet serji fil-gruppi ta' tofacitinib kif ukoll DMARD ta' 5 mg darbtejn kuljum u 10 mg darbtejn kuljum kienu ta' 3.6 u 3.4 pazjent b'avvenimenti għal kull 100 sena tal-pazjent, rispettivament, meta mqabbla ma' 1.7 pazjent b'avvenimenti għal kull 100 sena tal-pazjent fil-grupp tal-plaċebo kif ukoll DMARD.
English: Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
Maltese: Il-kura għandha tiġi interrotta jekk pazjent jiżviluppa infezzjoni serja, infezzjoni opportunistika, jew sepsis.
English: Table 1: Low absolute lymphocyte count Low absolute lymphocyte count (ALC) (see section 4.4)
Maltese: Tabella 1: Għadd assolut tal-limfoċiti baxx Għadd assolut tal-limfoċiti baxx (ALC) (ara sezzjoni 4.4) Valur tal-laboratorju (ċelluli/mm
English: In this study, AST elevations greater than 3x ULN were observed in 3.3%, 1.6% and 1.5% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: F'dan l-istudju, lelevazzjonijiet fl-AST akbar minn 3x ULN kienu osservati fi 3.3%, 1.6% u 1.5% tal-pazjenti li jirċievu MTX, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: Patients from OCTAVE Induction 1 or OCTAVE Induction 2 who did not achieve clinical response after 8 weeks in OCTAVE Open were to be discontinued from OCTAVE Open.
Maltese: Il-pazjenti minn OCTAVE Induzzjoni 1 jew OCTAVE Induzzjoni 2 li ma kisbux rispons kliniku wara 8 ġimgħat f'OCTAVE Miftuħ kellhom jitwaqqfu minn OCTAVE Miftuħ.
English: Month 6 ORAL Standard: MTX inadequate responders Tofacitinib 5 mg twice daily + MTX
Maltese: Persuni li ma wiġbux b'mod adegwat għal MTX Tofacitinib 5 mg darbtejn kuljum + MTX
English: In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Maltese: Fil-pazjenti b'RA, l-eliminazzjoni orali ta' tofacitinib ma tvarjax maż-żmien, u dan jindika li l-kura b'tofacitinib ma tinnormalizzax l-attività tal-enzima CYP.
English: The efficacy and safety of tofacitinib for the treatment of adult patients with moderately to severely active UC (Mayo score 6 to 12 with endoscopy subscore ≥ 2 and rectal bleeding subscore ≥ 1) were assessed in 3 multicentre, double-blind, randomised, placebo-controlled studies: 2 identical induction studies (OCTAVE Induction 1 and OCTAVE Induction 2) followed by 1 maintenance study (OCTAVE Sustain).
Maltese: L-effikaċja u s-sigurtà ta' tofacitinib għall-kura ta' pazjenti adulti b'UC attiva moderata sa severa (punteġġ Mayo 6 sa 12 b'sottopunteġġ tal-endoskopija ≥ 2 u b'sottopunteġġ tal-fsada mir-rektum ≥ 1) ġew ivvalutati fi 3 studji multiċentriċi, double-blind, randomizzati, ikkontrollati bil-plaċebo:
English: In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
Maltese: Fi provi kliniċi, tofacitinib ma kienx evalwat f'pazjenti b'valuri tattneħħija tal-kreatinina tal-linja bażi (stmati permezz tal-ekwazzjoni Cockroft-Gault) anqas minn 40 mL/min (ara sezzjoni 4.2).
English: Month 3 ORAL Sync: DMARD inadequate responders Tofacitinib 5 mg twice daily
Maltese: Xahar 3 ORAL Sync: Persuni lLi mMa wWiġbux b'mMod aAdegwat għal DMARD Tofacitinib 5 mg darbtejn kuljum
English: XELJANZ 5 mg film-coated tablet - The active substance is tofacitinib.
Maltese: XELJANZ 5 mg pillola miksija b'rita - Is-sustanza attiva hija tofacitinib.
English: Tofacitinib 10 mg twice daily + MTX
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX
English: Severe (including patients undergoing haemodialysis)
Maltese: Sever (inkluż pazjenti li tkun qed issirilhom emodijaliżi)
English: The main objective of the programme is to increase awareness about the risks of the product, specifically in regards to serious infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities.
Maltese: L-objettiv ewlieni tal-programm hu li jżid l-għarfien dwar ir-riskji tal-prodott, speċifikament firrigward ta' infezzjonijiet serji, herpes zoster, tuberkulożi (TB) u infezzjonijiet opportunistiċi oħra, malinni, peforazzjonijiet gastrointestinali, mard tal-pulmun interstizjali, u anormalitajiet tallaboratorju.
English: The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8).
Maltese: Ir-riskju ta' infezzjonijiet opportunistiċi hu ogħla f'reġjuni ġeografiċi Asjatiċi (ara sezzjoni 4.8).
English: Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Maltese: Avvenimenti ta' perforazzjonijiet gastrointestinali ġew irrapportati fi provi kliniċi għalkemm ir-rwol tal-inibizzjoni ta' JAK f'dawn l-avvenimenti mhuwiex magħruf.
English: Aluminium foil/PVC backed aluminium foil blisters containing 7 prolonged-release tablets.
Maltese: Folji tal-fojl tal-aluminju/fojl tal-aluminju inforrati bil-PVC li fihom 7 pilloli li jerħu l-mediċina bilmod.
English: The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
Maltese: L-użu ta' tofacitinib flimkien ma' inibituri ta' phosphodiesterase 4 ma ġiex studjat fi studji kliniċi b'tofacitinib.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Maltese: Tofacitinib 10 mg darbtejn kuljum huwa kontraindikat f'pazjenti li jinsabu f'riskju għoli għal emboliżmu pulmonari (ara wkoll sezzjoni 4.3).
English: 50%d,***
Maltese: 05,***p<0.
English: In the RA long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical studies (see section 4.4).
Maltese: Fil-popolazzjoni tas-sigurtà fit-tul ta' RA, il-mudell u l-inċidenza ta' tnaqqis ikkonfermat fl-ANC baqa' konsistenti ma' dak li deher fl-istudji kliniċi kkontrollati (ara sezzjoni 4.4).
English: Normalisation of endoscopic appearance of the mucosa c
Maltese: Normalizzazzjoni tad-dehra endoskopika talmukuża
English: Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Xeljanz f'kull Stat Membru, il-MAH għandu jaqbel mal-Awtorità Kompetenti Nazzjonali dwar il-kontenut u l-format tal-programm edukattiv, inkluż midja tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm.
English: In these studies, AST elevations greater than 3x ULN were observed in 0.72%, 0.5% and 0.31% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: F'dawn listudji, l-elevazzjonijiet fl-AST akbar minn 3x ULN kienu osservati f'0.72%, 0.5% u 0.31% talpazjenti li jirċievu l-plaċebo, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.