FrancophonIA/ELRC3.0 huggingface dataset:
English: 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: Signs of allergic reactions (rare) include
Maltese: Sinjali ta' reazzjonijiet allerġiċi (rari) jinkludu
English: Tofacitinib 10 mg Twice Daily Monotherapy N=243
Maltese: Tofacitinib 10 mg Monoterapija Darbtejn Kuljum N=243
English: Impairment
Maltese: Dispnea
English: 4.1 Therapeutic indication
Maltese: 4.1 Indikazzjoni terapewtika Artrite rewmatika
English: XELJANZ 10 mg film-coated tablets
Maltese: XELJANZ 10 mg pilloli tofacitinib
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Maltese: • Tuberkulożi (TB) attiva, infezzjonijiet serji bħas-sepsis, jew infezzjonijiet opportunistiċi
English: Pulmonary embolism
Maltese: Artralġja
English: Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Potenzjal għal prodotti mediċinali oħrajn sabiex jinfluwenzaw il-farmakokinetika (PK) ta' tofacitinib
English: Month 3 Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Maltese: Xahar 3 Xahar 6 (individwi li jieħdu lplaċebo b'titjib ta' <20% flgħadd ta' ġogi minfuħin u teneri avvanzaw għal tofacitinib f'xahar 3)
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.
English: 4 weeks prior to the visit at both week 24 and week 52. f. N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Maltese: N=59 għall-plaċebo, N=65 għal tofacitinib 5 mg darbtejn kuljum, N=55 għal tofacitinib 10 mg darbtejn kuljum.
English: Placebo + MTX N=139 Mean (SD)a
Maltese: N=139 Medja (SD)a
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 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 jew ta' 10 mg darbtejn kuljum rispettivament, kemm sinfikanti kontra
English: - Each 10 mg film-coated tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Maltese: Kull pillola fiha 10 mg ta' tofacitinib (bħala tofacitinib citrate).
English: Tofacitinib 5 mg Twice Daily + MTX N=133
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + MTX N=133
English: Tofacitinib 5 mg Twice Daily + MTX N=316
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + MTX N=316
English: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Maltese: L-analiżi PK tal-popolazzjoni f'pazjenti b'RA tindika li l-esponiment sistemiku (AUC) ta' tofacitinib fl-estremi tal-piż tal-ġisem (40 kg, 140 kg) kienu simili (f'medda ta' 5%) għal dak ta' pazjent ta'
English: Tofacitinib 10 mg Twice Daily + MTX N=134
Maltese: Tofacitinib 10 mg Darbtejn Kuljum + MTX N=134
English: At baseline, 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: Remission among patients in remission at baselinea,f
Maltese: Remissjoni fost pazjenti f'remissjoni fil linja bażia,f
English: Secondary effects from immunosuppression, such as bacterial and viral infections and lymphoma were observed at clinically relevant doses.
Maltese: Effetti sekondarji mill immunosuppressjoni, bħall-infezzjonijiet batterjali u virali u limfoma kienu osservati f'dożi klinikament rilevanti.
English: In the controlled portion of the RA Phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: Fil-parti kkontrollata tal-istudju ta' RA ta' monoterapija tal-Fażi 3 (0-3 xhur) (studju I, ara sezzjoni 5.1), l-elevazzjonijiet fl-ALT akbar minn 3x ULN kienu osservati f'1.65%, 0.41%, u 0% talpazjenti li jirċievu l-plaċebo, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: Table 10: Radiographic Changes at Months 6 and 12 ORAL Scan: MTX Inadequate Responders
Maltese: Bidliet Radjugrafiċi fix-Xhur 6 u 12 ORAL Scan: Persuni Li Ma Wiġbux b'Mod Adegwat għal MTX
English: Clinical responsed
Maltese: KLINIKU
English: Study VI (ORAL Start)
Maltese: Studju VI (ORAL Step)
English: Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
Maltese: Studji Kliniċi tal-Fażi 3 ta' Dożi ta' Tofacitinib 5 u 10 mg Darbtejn Kuljum f'Pazjenti b'UC
English: Placebo Tofacitinib 10 mg Twice Daily
Maltese: Plaċebo Tofacitinib 10 mg Darbtejn Kuljum
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
Maltese: EU/1/17/1178/007 56 pillola miksija b'rita EU/1/17/1178/008 112-il pillola miksija b'rita EU/1/17/1178/009 182 pillola miksija b'rita
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Maltese: d Inkiseb sinifikat statistiku globalment f'p≤ 0.05 skont il-proċedura ta' ttestjar pass 'l isfel speċifikata minn qabel.
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: 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'
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 id differenza 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
Maltese: KARTUNA TAL-PAKKETT TAL-FOLJA TA' 10 MG
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
Maltese: EU/1/17/1178/003 56 pillola miksija b'rita EU/1/17/1178/004 182 pillola miksija b'rita EU/1/17/1178/014 112-il pillola miksija b'rita
English: 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
English: How to Take XELJANZ
Maltese: X'fih XELJANZ
English: Table 15: Proportion of Patients Meeting Efficacy Endpoints at Week 8 (OCTAVE Induction Study 1 and OCTAVE Induction Study 2) OCTAVE Induction Study 1 Central Endoscopy Read
Maltese: Tabella 15 Proporzjon ta' Pazjenti Li Ssodisfaw il-Punti tat-tmiem tal-Effikaċja f'Ġimgħa 8 (OCTAVE Studju ta' Induzzjoni 1 u OCTAVE Studju ta' Induzzjoni 2) OCTAVE Studju ta' Induzzjoni 1 Qari tal-Endoskopija Ċentrali Qari tal-Endoskopija Lokali
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Maltese: Potenzjal għal tofacitinib sabiex jinfluwenza l-PK ta' prodotti mediċinali oħrajn L-għoti flimkien ta' tofacitinib ma kellux effett fuq il-PK ta' kontraċettivi orali, levonorgestrel u ethinyl estradiol, f'voluntiera nisa f'saħħithom.
English: Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Maltese: XELJANZ 5 mg pilloli miksija b'rita XELJANZ 10 mg pilloli miksija b'rita tofacitinib
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Maltese: Ir-remissjoni ġiet definita bħala remissjoni klinika (punteġġ Mayo totali ≤ 2 bl-ebda sottopunteġġ individwali > 1) u sottopunteġġ tal-fsada mir rektum ta' 0.
English: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Maltese: prodotti mediċinali li jinibixxu jew jinduċu CYP3A4.
English: Placebo Tofacitinib 5 mg Twice Daily
Maltese: Plaċebo Tofacitinib 5 mg Darbtejn Kuljum
English: Table 6: Adverse Drug Reactions
Maltese: Tabella 6: Reazzjonijiet Avversi tal-Mediċina Sistema tal-Klassifika tal-Organi
English: XELJANZ 5 mg film-coated tablet contains approximately 59 mg lactose in each tablet and XELJANZ 10 mg film-coated tablet contains approximately 119 mg lactose in each tablet.
Maltese: XELJANZ 5 mg pillola miksija b'rita fiha bejn wieħed u ieħor 59 mg ta' lactose f'kull pillola u XELJANZ 10 mg pillola miksija b'rita fiha bejn wieħed u ieħor 119 mg ta' lactose f'kull pillola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Maltese: EU/1/17/1178/005 60 pillola miksija b'rita EU/1/17/1178/006 180 pillola miksija b'rita
English: Time to Treatment Failure in Maintenance Study OCTAVE Sustain (Kaplan-Meier Curves)
Maltese: Żmien għall-Falliment tal-Kura fi Studju ta' Manteniment OCTAVE Sostenn
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted until ALC is greater than 750.
Maltese: Għal tnaqqis persistenti (2 valuri sekwenzali f'din il-medda wara ttestjar ta' rutina) f'din il-medda, id-dożaġġ għandu jitnaqqas jew jiġi interrott sakemm l-ALC ikun aktar minn 750.
English: Baseline Month 6
Maltese: Sentejn 6 xhur
English: The most common serious infections included pneumonia, herpes zoster, urinary tract infection, cellulitis, gastroenteritis and diverticulitis.
Maltese: Fost l-aktar infezzjonijiet serji komuni kien hemm il pulmonite, il-herpes zoster, l-infezzjoni fl-apparat tal-awrina, iċ-ċellulite, il-gastroenterite u d divertikulite.
English: Table 1: Low Absolute Lymphocyte Count Low Absolute Lymphocyte Count (ALC) (see section 4.4)
Maltese: Għadd Assolut tal-Limfoċiti Baxx (ALC) (ara sezzjoni 4.4) Valur tal-Laboratorju
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 tal esponiment kliniku ta' 5 mg jew 10 mg darbtejn kuljum.
English: In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: aktar minn 3 darbiet tal-ULN ġew osservati f'1.8% u 1.6% tal-pazjenti li kienu qed jirċievu tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: Prior TNFi failure Prior corticosteroid failure
Maltese: Qabel falliment ta' TNFi
English: d. Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or 1.
Maltese: Ir-rispons kliniku ġie definit bħala tnaqqis mil-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30%, bi tnaqqis ta' akkumpanjament fis-sottopunteġġ għal fsada mir-rektum ta' ≥punt 1 jew sottopunteġġ assolut għal fsada mir-rektum ta' 0 jew 1.
English: NAME OF THE MEDICINAL PRODUCT 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: Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo
Maltese: Tofacitinib 5 mg Darbtejn Kuljum Tofacitinib 10 mg Darbtejn Kuljum
English: Table 12: Proportion (%) of PsA Patients Who Achieved Clinical Response and Mean Change from Baseline in OPAL BROADEN and OPAL BEYOND Studies Conventional Synthetic DMARD Inadequate Responders a
Maltese: Bażi fl-Istudji OPAL BROADEN u OPAL BEYOND DMARD Sintetika Konvenzjonali
English: It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Maltese: Mhuwex irrakkomandat li tibda l-kura b'tofacitinib f'pazjenti b'ANC anqas minn 1,000 ċellula/mm3.
English: In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Maltese: Fil-popolazzjoni tas-sigurtà fit-tul ta' RA, tnaqqis ikkonfermat fl-għadd tal-limfoċiti taħt 500 ċellula/mm3 seħħ f'1.3% tal-pazjenti għad-dożi ta' 5 mg darbtejn kuljum u 10 mg darbtejn kuljum ikkombinati.
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,
English: Tofacitinib 5 mg Twice Daily + MTX
Maltese: Tofacitinib 5 mg darbtejn kuljum + MTX
English: Table 4: Dose Adjustment for Hepatic Impairment Hepatic
Maltese: Tabella 4: Aġġustament tad-Doża għal Indeboliment tal-Fwied
English: Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
Maltese: uġigħ fil-muskoli u fil-ġogi, tendonite, nefħa fil-ġogi, sensazzjonijiet mhux normali, irqad ħażin, konġestjoni tas-sinus, qtugħ ta' nifs jew diffikultà sabiex tieħu nifs, ħmura tal-ġilda, ħakk, fwied xaħmi, infjammazzjoni bl-uġigħ ta' spazji żgħar fir-rita (divertikulite), infezzjonijiet virali, infezzjonijiet virali li jaffetwaw l-imsaren, xi tipi ta' kanċers tal-ġilda (tat-tipi mhux tal-melanoma).
English: TNFi Inadequate Responders b
Maltese: Informazzjoni għall-pazjent
English: (TNFi-Naïve)
Maltese: (Mingħajr esperjenza ta' TNFi)
English: b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Maltese: b Rispons inadegwat għal mill-inqas TNFi 1 minħabba nuqqas ta' effikaċja u/jew intollerabilità.
English: Maintenance of clinical responsed
Maltese: Manteniment tarrispons klinikud
English: a. Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Maltese: Ir-remissjoni ġiet definita bħala remissjoni klinika (punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ individwali > 1) u sottopunteġġ tal-fsada mir-rektum ta' 0.
English: For recommended modifications based on haemoglobin level, see section 4.2.
Maltese: Għal modifikazzjonijiet irrakkomandati abbażi tal-għadd tallimfoċiti, ara sezzjoni 4.2.
English: Table 17: Proportion of Patients Meeting Efficacy Endpoints at Week 52 (OCTAVE Sustain) Central Endoscopy Read
Maltese: Tabella 17: Proporzjon ta' Pazjenti Li Ssodisfaw il-Punti tat-tmiem tal-Effikaċja f'Ġimgħa 52 (OCTAVE Sostenn)
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: 5 mg darbtejn kuljum urew titjib aktar mil-linja bażi meta mqabbel mal-plaċebo fid-dominju tal funzjonament fiżiku SF-36v2, il-punteġġ tas-sommarju tal-komponent fiżiku SF-36v2 u l-punteġġi
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Maltese: Infezzjonijiet serji u xi kultant fatali minħabba patoġeni batterjali, mikobatterjali, invażivi fungali, virali, jew patoġeni opportunistiċi oħrajn ġew irrapporti f'pazjenti li jirċievu tofacitinib.
English: Table 2: Low Absolute Neutrophil Count Low Absolute Neutrophil Count (ANC) (see section 4.4)
Maltese: għandha tintuża l-kawtela meta tikkura lill-anzjani (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) 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: Patients who completed 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) but did not achieve clinical response or patients who completed or withdrew early due to treatment failure in the maintenance study (OCTAVE Sustain) were eligible for OCTAVE Open.
Maltese: 2 studji ta' induzzjoni identiċi (OCTAVE Induzzjoni 1 u OCTAVE Induzzjoni 2) segwiti minn studju ta' manteniment 1 (OCTAVE Sostenn).
English: X-Ray
Maltese: MTX-IR
English: Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
Maltese: Normalizzazzjoni tad-dehra endoskopika tal-mukużac Rispons klinikud
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Maltese: Il-bidliet fl-għadd tal-limfoċiti-T u s-subsettijiet tal-limfoċiti-T (CD3+, CD4+ u
English: Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Maltese: Rispons inadegwat għal mill-inqas inibitur TNF 1 (TNFi) minħabba nuqqas ta' effikaċja u/jew intollerabilità.
English: Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Maltese: 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: • The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Maltese: o Dettalji tal-popolazzjoni li tinsab f'riskju ogħla għat-tħassib dwar is-sikurezza indirizzat mill-aRMM (jiġifieri, kontraindikazzjonijiet, fatturi ta' riskju, riskju miżjud minn interazzjonijiet ma' ċerta mediċina) o Dettalji dwar kif jiġi mminimizzat it-tħassib dwar is-sikurezza indirizzat mill-aRMM permezz ta' monitoraġġ xieraq u ġestjoni xierqa (jiġifieri, x'għandu jsir, x'm'għandux isir, u min għandu l-iktar probabbiltà li jintlaqat skont xenarji differenti, bħal meta l-għoti talmediċina b'riċetta/inġestjoni għandhom jiġu llimitati jew jitwaqqfu, kif għandha tingħata l-mediċina, meta għandu jiżdied/jitnaqqas id-dożaġġ skont miżuri tal-laboratorju, sinjali u sintomi)
English: The virus may become active while you are taking XELJANZ.
Maltese: Il-virus jista' jsir attiv waqt li qed tieħu XELJANZ.
English: Note: Reference group is administration of tofacitinib alone.
Maltese: Nota: Il-grupp ta' referenza huwa l-għoti ta' tofacitinib biss a
English: Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a
Maltese: Tofacitinib 10 mg Darbtejn Kuljum + MTX N=290
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: Tofacitinib 10 mg Twice Daily + DMARD(s) ORAL Sync: DMARD Inadequate Responders
Maltese: Bidla Medja fil-least squares Mil-Linja bażi f'HAQ-DI DMARD Sintetika Konvenzjonali