FrancophonIA/ELRC3.0 huggingface dataset:
English: There are limited data in patients aged 75 years and older.
Maltese: Hemm dejta limitata f'pazjenti li għandhom 75 sena u aktar.
English: Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval)
Maltese: Differenza bejn il-least squares means ta' tofacitinib minus plaċebo (95% CI=95% intervall ta' kunfidenza)
English: Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Maltese: Tne., Tli., Erb., Ħam., Ġim., Sib., Ħad.
English: Study VII (O RAL Strategy)
Maltese: Studju VII (ORAL Strategy)
English: Study III (O RAL Standard)
Maltese: Studju III (ORAL Standard)
English: OPAL BEYOND had a duration of 6 months.
Maltese: OPAL BEYOND kellu tul ta' 6 xhur.
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 (Kurvi ta' Kaplan-Meier)
English: MTX N=168 Mean (SD)
Maltese: MTX N=168 Medja (SD)
English: Placebo N=198
Maltese: Plaċebo N=198
English: The median PsA disease duration was 7.5 years.
Maltese: Id-durata tal-marda medja ta' PsA kienet 7.5 snin.
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Maltese: Għal pazjenti b'BSA ≥ 3% u PASI > 0 fil-Linja bażi.
English: Tel: 1800 633 363 (toll free)
Maltese: Tel: 1800 633 363 (bla ħlas)
English: The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Maltese: L-aktar infezzjonijiet irrapportati b'mod komuni kienu infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju u nasofariniġite (3.7% u 3.2%, rispettivament).
English: Remission a
Maltese: Remissjoni a
English: Study II (O RAL Sync)
Maltese: Studju II (ORAL Sync)
English: Study IV (O RAL Scan)
Maltese: Studju IV (ORAL Scan)
English: Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Maltese: Tofacitinib huwa assorbit tajjeb, b'bijodisponibbiltà ta' 74%.
English: 3 Parallel arms:
Maltese: 3 Fergħat paralleli:
English: Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
Maltese: Tofacitinib mhuwiex inibitur jew induttur ta' CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, u CYP3A4) u mhuwiex inibitur ta' UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, u UGT2B7).
English: Cases of opportunistic infections have been reported (see section 4.4).
Maltese: Ġew irrapportati każijiet ta' infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: Study V (O RAL Step)
Maltese: Studju V (ORAL Step)
English: N=number of patients in the analysis set.
Maltese: N=numru ta' pazjenti fis-sett tal-analiżi.
English: Printing ink shellac (E904) ammomium hydroxide (E527) propylene glycol (E1520) black iron oxide (E172)
Maltese: Linka tal-istampar shellac (E904) ammomium hydroxide (E527) propylene glycol (E1520) black iron oxide (E172)
English: Lab Value (g/dL)
Maltese: Valur tal-Laboratorju (g/dL)
English: Women were estimated to have 7% lower AUC compared to men.
Maltese: In-nisa kienu stmati li għandhom 7% AUC aktar baxx meta mqabbla mal-irġiel.
English: Open-label extension study (OCTAVE Open)
Maltese: Studju ta' estensjoni open-label (OCTAVE Miftuħ)
English: Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Maltese: Differenza bejn il-least squares means ta' tofacitinib minus MTX (95% CI=95% intervall ta' kunfidenza)
English: Drug hypersensitivity* Angioedema* Urticaria*
Maltese: Sensittività eċċessiva għal mediċina* Anġjoedema* Urtikarja*
English: At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Maltese: F'xahar 12 f'OCTAVE Miftuħ, 52% (25/48) u 45% (37/83) ta' dawn ilpazjenti kisbu remissjoni, rispettivament.
English: • Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Maltese: • pazjenti b'ALC inqas minn 1,000 ċellola/mm3 (ara sezzjoni 4.2).
English: The median PsA disease duration was 3.8 years.
Maltese: Id-durata tal-marda medja ta' PsA kienet ta' 3.8 snin.
English: T uberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Maltese: Tuberkulożi Divertikulite Pijelonefrite Ċellulite Herpes simplex Gastroenterite virali
English: • Use of combined hormonal contraceptives or hormone replacement therapy
Maltese: • Użu ta' kontraċettivi ormonali kombinati jew terapija ta' sostituzzjoni tal-ormoni
English: Allergic reactions included angioedema and urticaria; serious reactions have occurred.
Maltese: Reazzjonijiet allerġiċi inkludew anġjoedema u urtikarja; seħħew reazzjonijiet serji.
English: Placebo N=112
Maltese: Plaċebo N=112
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 (ara sezzjoni 4.4).
English: Month 6: ACR50
Maltese: Xahar 6: ACR50
English: Month 3 NA
Maltese: Xahar 3 NA NA
English: 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 N=122
Maltese: Plaċebo N=122
English: Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD.
Maltese: Studju PsA-II (OPAL BEYOND) evalwa 394 pazjent li waqqfu inibitur TNF minħabba nuqqas ta' effikaċja jew intolleranza; 36.0% kellhom rispons inadegwat preċedenti għal DMARD bijoloġika > 1.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Maltese: - Is-sustanzi l-oħra fil-pillola huma microcrystalline cellulose, lactose monohydrate (ara sezzjoni 2), croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), u FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
English: Month 6: mT SS ACR70
Maltese: Xahar 6: mTSS ACR70
English: Month 6:
Maltese: Xahar 6:
English: • ulcerative colitis
Maltese: • kolite ulċerattiva
English: Musculoskeletal pain
Maltese: Uġigħ muskoluskeletal
English: Table 13: Change from baseline in HAQ-DI in PsA studies OPAL BROADEN and OPAL BEYOND
Maltese: Tabella 13:Bidla mil-linja bażi f'HAQ-DI fi studji dwar PsA OPAL BROADEN u OPAL BEYOND
English: Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Maltese: Inkiseb sinifikat statistiku fil-familja tal-ACR (ACR50 u ACR70) f'p≤ 0.05 skont il-proċedura ta' ttestjar pass 'l isfel speċifikata minn qabel.
English: Film coat hypromellose 6cP (E464) titanium dioxide (E171) lactose monohydrate macrogol 3350 triacetin (E1518)
Maltese: Kisja b'rita hypromellose 6cP (E464) titanium dioxide (E171) lactose monohydrate macrogol 3350 triacetin (E1518)
English: • persistent headaches
Maltese: • uġigħ ta' ras persistenti
English: DAS284(ESR)<2.6 Month 3:
Maltese: DAS284(ESR) <2.6
English: DAS28-4(ESR) response
Maltese: DAS284(ESR)
English: Table 8: Proportion (%) of patients with an ACR response ORAL Solo: DMARD inadequate responders
Maltese: Tabella 8: Proporzjon (%) ta' pazjenti b'rispons tal-ACR ORAL Solo: Pazjenti li rrispondew b'mod inadegwat għal DMARD
English: Meningitis cryptococcal Mycobacteriu m avium complex infection
Maltese: Infezzjoni kumplessa mycobacteriu m avium
English: Pfizer Europe MA EEIG (as MA holder logo)
Maltese: Pfizer Europe MA EEIG (bħala lowgo tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq)
English: - The other ingredients are sorbitol (E420) (see section 2), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).
Maltese: - Is-sustanzi mhux attivi l-oħra huma sorbitol (E420) (ara sezzjoni 2), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) u black iron oxide (E172).
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Maltese: In vitro, tofacitinib huwa sottostrat għal MDR1, iżda mhux għall-proteina ta' reżistenza għall-kanċer tas-sider (BCRP, breast cancer resistance protein), OATP1B1/1B3, jew OCT1/2.
English: N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Maltese: N=101 għall-plaċebo, N=101 għal tofacitinib 5 mg darbtejn kuljum, N=87 għal tofacitinib 10 mg darbtejn kuljum.
English: ANC less than 500
Maltese: ANC anqas minn 500
English: OCTAVE induction study 2
Maltese: OCTAVE studju ta' induzzjoni 2
English: EU/1/17/1178/010 EU/1/17/1178/011 EU/1/17/1178/012 EU/1/17/1178/013
Maltese: EU/1/17/1178/011 EU/1/17/1178/012 EU/1/17/1178/013
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 CD8+) kienu żgħar u inkonsistenti.
English: Normalisation 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: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Maltese: Il-pazjenti rreġistrati ma kinitx irnexxitilhom tal-inqas terapija konvenzjonali 1, inkluż kortikosterojdi, immunomodulatori, u/jew inibitur ta' TNF.
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 65% AUC ogħla, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Maltese: Fost l-infezzjonijiet opportunistiċi, TB u infezzjonijiet mikobatterjali oħrajn, kriptokokkus, istoplażmożi, kandidijasi esofagali, herpes zoster multidermatomali, ċitomegalovirus, infezzjonijiet bil-virus BK u listerożi, ġew irrappurtati b'tofacitinib.
English: Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
Maltese: Id-dejta farmakokinetika sa u inkluż doża waħda ta' 100 mg f'voluntiera f'saħħithom tindika li aktar minn 95% tad-doża mogħtija hija mistennija li tkun eliminata f'24 siegħa.
English: At baseline, 79.9% and 56.2% of patients had enthesitis and dactylitis, respectively.
Maltese: Fil-linja bażi, 79.9% u 56.2% tal-pazjenti kellhom entesite u daktilite, rispettivament.
English: Placebo + MTX N=156
Maltese: Plaċebo + MTX N=156
English: Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other.
Maltese: Pillola blu, tonda b'dijametru ta' 9.5 mm, bi “Pfizer” ibbuzzata fuq naħa waħda u “JKI 10” fuq l-oħra.
English: Film coat cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
Maltese: Kisja b'rita cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
English: Viral reactivation and cases of herpes virus reactivation (e.g., herpes zoster) were observed in clinical studies with tofacitinib.
Maltese: Ir-riattivazzjoni virali u każijiet ta' riattivazzjoni tal-virus tal-herpes (eż., herpes zoster) kienu osservati fi studji kliniċi b'tofacitinib.
English: The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8.
Maltese: Rispons tal-ACR Il-perċentwali ta' pazjenti kkurati b'tofacitinib li laħqu risponsi tal-ACR20, tal-ACR50 u tal-ACR70 fi studji ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start u ORAL Strategy huma murija f'Tabella 8.
English: ORAL Step: TNF inhibitor inadequate responders N=118
Maltese: ORAL Step: persuni li ma rrispondewx b'mod adegwat għal inibitur ta' TNF N=118
English: After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission.
Maltese: Wara 8 ġimgħat addizzjonali ta' tofacitinib 10 mg darbtejn kuljum f'OCTAVE Miftuħ, 53% (154/293) tal-pazjenti kisbu rispons kliniku u 14% (42/293) tal-pazjenti kisbu remissjoni.
English: • Severe hepatic impairment (see section 4.2).
Maltese: • Indeboliment sever tal-fwied (ara sezzjoni 4.2).
English: Placebo
Maltese: PLAĊEBO
English: Placebo Placebo MTX MTX, ADA
Maltese: Plaċebo Plaċebo Plaċebo Plaċebo Plaċebo MTX MTX, ADA
English: The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Maltese: Il-metaboliżmu ta' tofacitinib huwa primarjament medjat minn CYP3A4 b'kontribuzzjoni żgħira minn CYP2C19.
English: mTSS
Maltese: MTX
English: QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70% improvement, NA=not applicable, MTX=methotrexate.
Maltese: QOW=kull ġimagħtejn, N=numru ta' individwi analizzati, ACR20/50/70=titjib ta' ≥20%, 50%, 70% talKulleġġ Amerikan tar-Rewmatoloġija, NA=mhux applikabbli;
English: Improvements were also observed in the EuroQoL 5-Dimension (EQ-5D) and various domains of the Work Productivity and Activity Impairment (WPAI-UC) questionnaire in both induction and maintenance studies compared to placebo.
Maltese: It-titjib ġie osservat ukoll fil-EuroQoL 5-Dimension (EQ-5D) u f'diversi dominji tal-kwestjonarju Produttività tax-Xogħol u Indeboliment tal-Attività (WPAI-UC, Work Productivity and Activity Impairment) fiż-żewġ studji ta' induzzjoni u ta' manteniment meta mqabbel mal-plaċebo.
English: Patients in the phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Maltese: Il-pazjenti fl-istudji tal-fażi 3 kellhom Punteġġ tal-Attività tal-Marda (DAS28-4[ESR]) ta' 6.1-6.7 fillinja bażi.
English: Tofacitinib is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Maltese: Tofacitinib mhuwiex inibitur ta' MDR1, OATP1B1/1B3, OCT2, OAT1/3, jew MRP b'konċentrazzjonijiet klinikament sinifikanti.
English: Placebo + MTX N=132
Maltese: Plaċebo + MTX N=132
English: • psoriatic arthritis
Maltese: • artrite psorjatika
English: Oral use.
Maltese: ORAL Start:
English: OCTAVE induction study 2 Central endoscopy read
Maltese: OCTAVE studju ta' induzzjoni 2 Qari tal-endoskopija ċentrali
English: Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 118.88 mg lactose.
English: Pink, oval tablet of approximate average dimension of 10.8 mm × 5.5 mm × 4.4 mm (length by width by thickness) with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
Maltese: 8 mm × 5.5 mm × 4.4 mm (tul b'wisa' bilħxuna) b'toqba mħaffra f'tarf wieħed tal-faxxa tal-pillola u “JKI 11” stampata fuq naħa waħda talpillola.
English: Improvements from baseline in SF-36v2 and FACIT-F were maintained through month 6 (OPAL BROADEN and OPAL BEYOND) and month 12 (OPAL BROADEN).
Maltese: It-titjib millinja bażi f'SF-36v2 u FACIT-F inżamm matul Xahar 6 (OPAL BROADEN u OPAL BEYOND) u xahar 12 (OPAL BROADEN).
English: *p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Maltese: ǂp<0.05 - tofacitinib 5 mg + MTX kontra tofacitinib 5 mg għal ORAL Strategy (valuri p normali mingħajr aġġustament ta' tqabbil multiplu)
English: • fluconazole, ketoconazole, used to treat fungal infections
Maltese: • fluconazole, ketoconazole, użati sabiex jikkuraw infezzjonijiet fungali
English: Benign testicular interstitial (Leydig) cell tumours were observed in rats: benign Leydig cell tumours in rats are not associated with a risk of Leydig cell tumours in humans.
Maltese: Tumuri beninni ta' ċelluli testikulari interstizjali (Leydig) kienu osservati fil-firien: tumuri beninni ta' ċelluli Leydig fil-firien m'humiex assoċjati ma' riskju ta' tumuri ta' ċelluli Leydig fil-bnedmin.
English: XELJANZ is a medicine that contains the active substance tofacitinib.
Maltese: XELJANZ hu mediċina li fiha s-sustanza attiva tofacitinib.
English: • Risk management plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: • with a history of a serious or an opportunistic infection,
Maltese: • bi storja ta' infezzjoni serja jew opportunistika,
English: • who have resided or travelled in areas of endemic TB.
Maltese: • li kienu residenti jew li vvjaġġaw f'żoni fejn kien hemm TB endemika.
English: Uncommon ≥1/1,000 to
Maltese: Mhux komuni ≥1/1,000 sa
English: NA ORAL Sync: DMARD inadequate responders
Maltese: NA ORAL Sync: Pazjenti li rrispondew b'mod inadegwat għal DMARD
English: 30 prolonged-release tablets 90 prolonged-release tablets 2 silica gel desiccants
Maltese: 30 pillola li terħi l-mediċina bil-mod 90 pillola li terħi l-mediċina bil-mod 2 ġells dessikanti tas-silika
English: The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Maltese: L-ADRs elenkati f'din it-tabella hawn taħt huma minn studji kliniċi b'RA, PsA, u UC u huma ppreżentati permezz tas-Sistema tal-Klassifika tal-Organi (SOC) u l-kategoriji ta' frekwenza, iddefiniti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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 talkreatinina 30-49 mL/min), u sever (tneħħija tal-kreatinina < 30 mL/min) tal-kliewi kellhom 37%, 43% u 123% AUC ogħla, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi (ara sezzjoni 4.2).
English: White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other.
Maltese: Pillola bajda, tonda b'dijametru ta' 7.9 mm, bi “Pfizer” ibbuzzat fuq naħa waħda u “JKI 5” fuq l-oħra.
English: Each prolonged-release tablet contains 152.23 mg of sorbitol.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 152.23 mg ta' sorbitol.
English: Month 3:
Maltese: Xahar 3:
English: Tofacitinib binds predominantly to albumin and does not appear to bind to 1-acid glycoprotein.
Maltese: Tofacitinib jintrabat b'mod predominanti mal-albumina u ma jidhirx li jintrabat ma' 1-acid glikoproteina.
English: Prior immunosuppressant failure
Maltese: Immunosuppressanti, Immunosuppressanti Selettivi;
English: Mean LDL cholesterol/HDL cholesterol ratios and Apolipoprotein B (ApoB)/ApoA1 ratios were essentially unchanged in tofacitinib-treated patients.
Maltese: Il-proporzjonijiet medji tal-kolesterol tal-LDL/kolesterol tal-HDL u proporzjonijiet ta' Apolipoproteina B (ApoB)/ApoA1 kienu essenzjalment mhux mibdula f'pazjenti kkurati b'tofacitinib.
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: Tabella 12: Proporzjon (%) ta' pazjenti b'PsA li kisbu rispons kliniku u bidla medja mil-linja bażi fl-istudji OPAL BROADEN u OPAL BEYOND DMARD sintetika konvenzjonali dawk li ma wiġbux b'mod adegwat a (Mingħajr esperjenza ta' TNFi)
English: Tuberculosis of central nervous system
Maltese: Tuberkulożi tas-sistema nervuża ċentrali Meninġite kriptokokkali
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Maltese: Fi prova klinika kkontrollata ta' pazjenti b'RA li jibdew tofacitinib 10 mg darbtejn kuljum jew ilplaċebo, in-numru ta' dawk li rrispondew għall-vaċċin tal-influwenza kien simili fiż-żewġ gruppi: tofacitinib (57%) u plaċebo (62%).
English: Abbreviations: BSA=body surface area; ΔLEI=change from baseline in Leeds Enthesitis Index; ΔDSS=change from baseline in Dactylitis Severity Score; ACR20/50/70=American College of Rheumatology ≥ 20%, 50%, 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 Severity index; PASI75=≥ 75% improvement in PASI.
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: • Patients with an ALC less than 1,000 cells/mm
Maltese: • Pazjenti b'ALC inqas minn 1,000 ċellola/mm
English: Lymphocytes In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm occurred in
Maltese: Fl-istudji kliniċi kkontrollati dwar RA, tnaqqis ikkonfermat fl-ALC taħt 500 ċellula/mm
English: Following a single dose of 10 mg, mean AUC in subjects with ESRD based on concentrations measured on a non-dialysis day was approximately 40% (90% confidence intervals: 1.5-95%) higher compared to subjects with normal renal function.
Maltese: Wara doża waħda ta' 10 mg, l-AUC medju f'individwi b'ESRD abbażi ta' konċentrazzjonijiet imkejla fuq jum mhux tad-dijalisi kien bejn wieħed u ieħor 40% (90% intervalli ta' kunfidenza: 1.5-95%) ogħla meta mqabbel ma' individwi b'funzjoni normali tal-kliewi.