FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated with Olumiant monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and nausea (2.8 %).
Maltese: L-aktar reazzjonijiet avversi għall-mediċina (ADRs, adverse drug reactions) rrappurtati b'mod komuni li seħħew fi ≥ 2% tal-pazjenti li kienu ttrattati b'Olumiant waħdu jew flimkien ma' DMARDs sintetiċi konvenzjonali kienu żieda fil-kolesterol LDL (33.6%), infezzjonijiet fin-naħa ta' fuq tal apparat tan-nifs (14.7%) u dardir (2.8%).
English: The overall incidence rate of serious infections in the clinical trial programme was 3.2 per 100 patient-years.
Maltese: Ir-rata ta' inċidenza totali ta' infezzjonijiet serji fil-programm ta' provi kliniċi kienet 3.2 għal kull 100 sena li ġew esposti l-pazjenti.
English: Following oral administration, baricitinib is rapidly absorbed with a median tmax of approximately 1 hour (range 0.5 - 3.0 h) and an absolute bioavailability of approximately 79 % (CV = 3.94 %).
Maltese: 0.5 - 3.0 siegħa) u bijodisponibbiltà assoluta ta' madwar 79% (CV = 3.94%).
English: In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the dose is metabolised via oxidation.
Maltese: In vitro, baricitinib huwa sustrat tal-enzima taċ-ċitokrom P450 (CYP, cytochrome P450) 3A4
English: Significant increases (> 5 x ULN) occurred in 0.8 % of patients treated with Olumiant and 0.3 % of patients treated with placebo.
Maltese: Żidiet sinifikanti (> 5 x ULN) seħħew f'0.8% tal-pazjenti ttrattati b'Olumiant u 0.3% tal-pazjenti ttrattati bil-plaċebo.
English: In studies which included both doses, infections were reported in 31.9%, 28.8% and 24.1% of patients up to 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
Maltese: Fi studji li kienu jinkludu ż-żewġ dożi, kienu rrappurtati infezzjonijiet f'31.9%, 28.8% u 24.1% tal-pazjenti sa 16-il ġimgħa fil-gruppi ta' 4 mg, 2 mg u tal-plaċebo, rispettivament.
English: From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Maltese: Mit-316-il avveniment inklużi fl-evalwazzjoni mir-rapportati wara li l-prodott tqiegħed fis-suq, raxx (n=95) kien l-avveniment li ġie rrapportat b'mod l-aktar frekwenti.
English: 2 Patients who had an inadequate response to MTX (+/- other cDMARDs); biologic-naïve 3 Patients who had an inadequate response or were intolerant to ≥ 1 cDMARDs; biologic- naïve 4 Patients who had an inadequate response or were intolerant to ≥ 1 bDMARDs; including at least one TNF inhibitor
Maltese: 2 Patients li ma kellhomx rispons xieraq għal MTX (+/- cDMARDs oħra); qatt ma ħadu bijoloġiku 3 Patients li ma kellhomx rispons xieraq jew li kienu intolleranti għal ≥ 1 cDMARDs; qatt ma ħadu bijoloġiku
English: 5 Most common concomitant cDMARDs included MTX, hydroxychloroquine, leflunomide and sulfasalazine
Maltese: L-aktar cDMARDs komuni mogħtija flimkien miegħu kienu jinkludu MTX, hydroxychloroquine,
English: In treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy (see section 4.8).
Maltese: F'pazjenti li qatt ma kienu ħadu trattament qabel, l-għoti flimkien ma' methotrexate wassal għal żieda fil-frekwenza ta' żidiet fit-transaminase epatiku meta mqabbel ma' monoterapija b'baricitinib (ara sezzjoni 4.8).
English: Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Week 52 56 % 73 %*** 73 %***
Maltese: Ġimgħa 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Ġimgħa 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Ġimgħa 52 56 % 73 %*** 73 %***
English: Olumiant is not recommended for use in patients with creatinine clearance < 30 mL/min (see section 5.2).
Maltese: < 30 mL/min (ara sezzjoni 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first Authorisation: 13 February 2017
Maltese: Data tal-ewwel Awtorizzazzjoni: 13 Frar 2017
English: Neutropaenia
Maltese: Tilqim
English: • That treatment with Olumiant may increase the risk of infections, and viral reactivation.
Maltese: • Li t-tattament b'Olumiant jista' jżid ir-riskju ta' infezzjonijiet, u attivazzjoni mill-ġidid ta' virusis.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal baricitinib, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Cmax and AUC at steady state are 1.4- and 2.0-fold higher, respectively, in subjects with rheumatoid arthritis compared to healthy subjects.
Maltese: Is-Cmax u l-AUC fl-istat fiss huma 1.4 u 2.0 drabi ogħla, rispettivament, f'individwi b'artrite rewmatojd meta mqabbla ma' individwi f'saħħithom.
English: This could be a sign of a herpes zoster infection.
Maltese: Dan jista' jkun sinjal ta' infezzjoni b'erpete zoster.
English: Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted.
Maltese: Baricitinib jista' jkun inibitur klinikament rilevanti ta' OCT1, madankollu bħalissa ma huma magħrufa l-ebda sustrati selettivi ta' OCT1 li jisgħu jitbassru interazzjonijiet sinifikanti b'mod kliniku għalihom.
English: No metabolites were quantifiable in plasma.
Maltese: Ma kien hemm l-ebda metaboliti kwantifikabbli fil-plażma.
English: In treatment-naïve patients, for up to 52 weeks, the frequency of upper respiratory tract infections was greater for the combination treatment of methotrexate and Olumiant (26.0 %) compared to methotrexate alone (22.9 %) or Olumiant alone (22.0 %).
Maltese: F'pazjenti li qatt ma ħadu trattament qabel, sat-52 ġimgħa, il-frekwenza ta' infezzjonijiet fin-naħa ta' fuq tal-apparat tan-nifs kienet akbar għat-trattament b'methotrexate flimkien ma' Olumiant (26.0%) meta mqabbel ma' methotrexate waħdu (22.9%) jew Olumiant waħdu (22.0%).
English: Doctor's name (who prescribed Olumiant):
Maltese: Isem it-tabib (li ordnalek Olumiant):
English: Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.
Maltese: L-użu flimkien mal-inibituri ta' OAT3 ibuprofen u diclofenac jista' jwassal għal żieda flesponiment għal baricitinib, madankollu l-possibbiltà tal-inibizzjoni ta' OAT3 tagħhom hija inqas meta mqabbla ma' dik ta' probenecid u b'hekk mhijiex mistennija interazzjoni rilevanti b'mod kliniku.
English: From the 316 events retrieved as of 13 May 2019, 78 were categorised as systemic/oedema and 38 were categorised as non-specific.
Maltese: 316-il avveniment li ġew miksuba sad-data tat-13 ta' Mejju 2019, 78 ġew ikklassifikati bħala sistemiċi/edima u 38 ġew ikklassifikati bħala mhux speċifiċi.
English: Therefore, the PRAC requests the MAH to update section 4.4 of the SmPC to modify the wording on “Venous Thromboembolism” to indicate that if clinical features of DVT/PE occur, baricitinib treatment should be discontinued and to update section 4.8 of the SmPC to add the adverse reaction pulmonary embolism and deep vein thrombosis with a frequency not known.
Maltese: Għalhekk, il-PRAC titlob lill-MAH taġġorna s-sezzjoni 4.4 tal-SmPC sabiex timmodifika l-kliem dwar “Tromboemboliżmu fil-Vini” biex jindika li jekk iseħħu karatteristiċi kliniċi ta' DVT/PE, it-trattament b'baricitinib għandu jitwaqqaf u biex taġġorna s-sezzjoni 4.8 tal-SmPC biex jiżdiedu r-reazzjonijiet avversi emboliżmu pulmonarju u trombożi fil-vini fil-fond b'frekwenza mhux magħrufa.
English: Olumiant is contraindicated during pregnancy (see section 4.3).
Maltese: Olumiant m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: Baricitinib is not an inhibitor of the transporters OAT1, OAT2, OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.
Maltese: OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 u MATE2-K f'konċentrazzjonijiet li huma klinikament rilevanti.
English: Body weight, sex, race, and ethnicity did not have a clinically relevant effect on the PK of baricitinib.
Maltese: Fatturi intrinsiċi oħra Il-piż tal-ġisem, is-sess tal-persuna, ir-razza, u l-etniċità ma kellhomx effett rilevanti b'mod kliniku fuq il-PK ta' baricitinib.
English: Differences in efficacy between the 4 mg and the 2 mg doses were most notable in the bDMARD-IR population (RA-BEACON), in which statistically significant improvements in the ACR components of swollen joint count, tender joint count and ESR were shown for Olumiant 4 mg compared to placebo at Week 24 but not for Olumiant 2 mg compared to placebo.
Maltese: ACR ta' għadd ta' ġogi minfuħa, għadd ta' ġoġi sensittivi u ESR intwerew għal Olumiant 4 mg meta mqabbel ma' plaċebo f'Ġimgħa 24 iżda mhux għal Olumiant 2 mg mqabbel mal-plaċebo.
English: No association was observed between increased platelet counts and adverse events of a thrombotic nature.
Maltese: Ma kienet osservata l-ebda assoċjazzjoni bejn żieda fl-għadd tal-plejtlits u avvenimenti avversi ta' natura trombotika.
English: Renal elimination is the principal mechanism for baricitinib's clearance through glomerular filtration and active secretion via OAT3, Pgp, BCRP and MATE2-K.
Maltese: Eliminazzjoni mill-kliewi hija l-mekkaniżmu prinċipali għat-tneħħija ta' baricitinib permezz ta' filtrazzjoni mill-glomeruli u sekrezzjoni attiva permezz ta' OAT3, Pgp, BCRP u MATE2-K.
English: In controlled studies, for up to 16 weeks, the following rates were observed for Olumiant vs. placebo:
Maltese: Fi studji kkontrollati, sa 16 il ġimgħa, ir-rati li ġejjin kienu osservati għal Olumiant vs. plaċebo:
English: Olumiant 2 mg film-coated tablets
Maltese: Olumiant 2 mg pilloli baricitinib
English: In a long-term extension study, patients from Studies RA-BEAM, RA-BUILD and RA-BEACON who achieved sustained low disease activity or remission (CDAI ≤ 10) after at least 15 months of treatment with Olumiant 4 mg once daily were re-randomized 1:1 in a double-blind manner to continue 4 mg once daily or reduce dose to 2 mg once daily.
Maltese: Fi studju ta' estensjoni fit-tul, il-pazjenti mill-Istudji RA-BEAM, RA-BUILD u RA-BEACON li kisbu attività baxxa sostnuta tal-marda jew remissjoni (CDAI ≤ 10) wara mill-inqas 15-il xahar ta' trattament b'Olumiant 4 mg darba kuljum ntagħżlu b'mod arbitrarju 1:1 mill-ġdid b'manjiera fejn la l investigaturi u lanqas il-pazjenti ma kienu jafu liema doża qed tintuża biex ikomplu 4 mg darba kuljum jew inaqqsu għal 2 mg darba kuljum.
English: The efficacy and safety of Olumiant once daily was assessed in 4 Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis diagnosed according to the ACR/EULAR 2010 criteria (see Table 3).
Maltese: III fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża f'pazjenti b'artrite rewmatojd attiva minn moderata sa severa b'dijanjosi skont il-kriterji ACR/EULAR 2010
English: Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
Maltese: Janus kinases (JAKs) huma enzimi li jikkonvertu sinjali intraċellulari minn riċetturi fuq il-wiċċ taċċellula għal numru ta' ċitokini u fatturi ta' tkabbir involuti fl-ematopoeżi, fl-infjammazzjoni u filfunzjoni immuni.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' baricitinib fil-ħalib tas-sider (ara sezzjoni 5.3).
English: RA-BEGIN (52 weeks)
Maltese: RA-BEGIN
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.
Maltese: Tromboemboliżmu fil-Vini Ġew irrapportati avvenimenti ta' trombożi fil-vini tal-fond (DVT-deep vein thrombosis) u emboliżmu pulmonari (PE-pulmonary embolism) f'pazjenti li kienu qed jirċievu baricitinib.
English: Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Week 52 38 % 57 %*** 62 %***
Maltese: Ġimgħa 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Ġimgħa 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Ġimgħa 52 38 % 57 %*** 62 %***
English: Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
Maltese: L-għoti flimkien ma' DMARDs bijoloġiċi jew inibituri oħra ta' Janus kinase (JAK) mhuwiex irrakkomandat, minħabba li ma jistax jiġi eskluż ir-riskju ta' immunosoppressjoni addittiva.
English: Other medicines and Olumiant
Maltese: Mediċini oħra u Olumiant
English: EXP
Maltese: ASTc
English: RA-BUILD (24 weeks)
Maltese: (24 ġimgħa)
English: In treatment-naïve patients, through 52 weeks, the frequency of nausea was greater for the combination treatment of methotrexate and Olumiant (9.3 %) compared to methotrexate alone (6.2 %) or Olumiant alone (4.4 %).
Maltese: F'pazjenti li qatt ma kienu ħadu trattament qabel, sat-52 ġimgħa, il-frekwenza ta' nawsja kienet akbar għat-trattament b'methotrexate flimkien ma' Olumiant (9.3%) meta mqabbel ma' methotrexate waħdu (6.2%) jew Olumiant waħdu (4.4%).
English: RA-BEAM (52 weeks)
Maltese: (52 ġimgħa)
English: Consequently, the recommended dose in patients taking OAT3 inhibitors with a strong inhibition potential, such as probenecid, is 2 mg once daily (see section 4.2).
Maltese: Konsegwenza ta' dan, id-doża rrakkomandata f'pazjenti li jkunu qed jieħdu inibituri ta' OAT3 b'potenzjal ta' inibizzjoni qawwija, bħal ma huwa probenecid, hija 2 mg darba kuljum (ara sezzjoni 4.2).
English: Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Week 52 27 % 36 % 45 %***
Maltese: Ġimgħa 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Ġimgħa 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Ġimgħa 52 27 % 36 % 45 %***
English: Uncommon side effects (may affect up to 1 in 100 people): - low number of white bloods cells (neutrophils), shown by blood test - increase in an enzyme called creatine kinase, shown by blood test - high levels of blood fat (triglycerides), shown by blood test - acne - weight gain - swelling of the face - urticaria - blood clots in the blood vessels of the lungs - blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (DVT)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): - numru baxx ta' ċelluli bojod tad-demm (newtrofili), muri b'test tad-demm - żieda f'enzima msejħa creatine kinase, murija b'test tad-demm - livelli għoljin ta' xaħam fid-demm (trigliċeridi), murija b'test tad-demm - akne
English: Olumiant should not be given to patients with active TB.
Maltese: Għandu jiġi aċċertat ukoll li ma hemmx tuberkulożi attiva.
English: On background cDMARDs5 if on stable cDMARD at study entry
Maltese: Fuq cDMARDs5 fl-isfond jekk kienu fuq cDMARD stabbli meta ġew irreġistrati fl-istudju
English: NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg tablets baricitinib
Maltese: Olumiant 4 mg pilloli baricitinib
English: Data from clinical studies shows that the incidence rate of urticaria and face oedema is higher in the baricitinib 4 mg arm [urticarial: 0.60; face oedema: 0.89] compared to placebo arm [urticarial: 0.29; face oedema:0.29].
Maltese: Tagħrif minn studji kliniċi juri li r-rata ta' inċidenza ta' urtikarja u edima tal-wiċċ hija ogħla fil-fergħa ta' baricitinib 4 mg [urtikarjali: 0.60; edima tal-wiċċ: 0.89] meta mqabbla mal-fergħa ta' plaċebo [urtikarjali: 0.29; edima tal-wiċċ:0.29].
English: Lymphocytes
Maltese: Tromboċitożi
English: Olumiant 4 mg film-coated tablets are medium pink, round tablets, with “Lilly” on one side and “4” on the other.
Maltese: Il-pilloli Olumiant 4 mg huma pilloli roża medju, tondi, b'“Lilly” fuq naħa waħda u “4” fuq in-naħa l oħra.
English: Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
Maltese: mingħajr antiġen tas-superfiċje tal-epatite B, ukoll tħallew jipparteċipaw; pazjenti bħal dawn għandhom jiġu mmonitorjati għall-espressjoni tad-DNA tal-virus tal-epatite B (HBV, hepatitis B
English: Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Week 52 16 % 25 %* 28 %**
Maltese: Ġimgħa 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Ġimgħa 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Ġimgħa 52 16 % 25 %* 28 %**
English: In RA-BEAM, treatment with Olumiant resulted in significant improvement in patient and physician global assessments, HAQ-DI, pain assessment and CRP at Weeks 12, 24 and 52 compared to adalimumab.
Maltese: F'RA-BEAM, trattament b'Olumiant wassal għal titjib sinifikanti fl-istimi globali tal-pazjenti u t-tobba, HAQ-DI, l-istima tal-uġigħ u CRP fil-Ġimgħat 12, 24 u 52 meta mqabbel ma' adalimumab.
English: Physical function response and health-related outcomes Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in physical function compared to all comparators (placebo, MTX, adalimumab), as measured by HAQ-DI, at 12, 24 and 52 weeks.
Maltese: Rispons ta' funzjoni fiżika u riżultati marbuta mas-saħħa Trattament b'Olumiant 4 mg, waħdu jew flimkien ma' cDMARDs, wassal għal titjib sinifikanti filfunzjoni fiżika meta mqabbel mal-kumparaturi l-oħra kollha (plaċebo, MTX, adalimumab), imkejjel permezz HAQ-DI, fil-ġimgħat 12, 24 u 52.
English: Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets
Maltese: Olumiant 2 mg pilloli miksija b'rita Olumiant 4 mg pilloli miksija b'rita
English: The proportion of patients achieving a clinically significant improvement (HAQ-DI ≥ 0.30) was also higher with Olumiant compared to placebo or MTX at week 12 (Table 4).
Maltese: Il-proporzjon ta' pazjenti li kisbu titjib sinifikanti b'mod kliniku (HAQ-DI ≥ 0.30) kien ukoll ogħla b'Olumiant meta mqabbel ma' plaċebo jew MTX filġimgħa 12 (Tabella 4).
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy.
Maltese: Żidiet fil-kolesterol LDL naqsu għal-livelli ta' qabel it-trattament b'rispons għal terapija bi statin.
English: In a pre- and postnatal development study, decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, respectively, the human exposure.
Maltese: Fi studju ta' qabel u wara l-iżvilupp, ġew osservati tnaqqis fil-piżijiet tal-frieħ u tnaqqis fis-sopravivenza wara t-twelid f'esponimenti 4 darbiet u 21 darba aktar, rispettivament, mill-esponiment uman.
English: Data concerning use of baricitinib with potent immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and caution should be exercised when using such combinations (see section 4.5).
Maltese: Dejta dwar l-użu ta' baricitinib ma' prodotti mediċinali immunosoppressivi potenti (eż., azathioprine, tacrolimus, ciclosporin) hija limitata u għandu jkun hemm kawtela meta jintużaw kombinazzjonijiet bħal dawn (ara sezzjoni 4.5).
English: Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.
Maltese: Kienu osservati rati ta' rispons li damu u servew, b'risponsi ACR20/50/70 li nżammu għal mill-anqas sentejn inkluż fl-istudju ta' estensjoni fit-tul.
English: In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.
Maltese: Fi studju ta' farmakoloġija klinika, madwar 75% tad-doża mogħtija ġiet eliminata fl-awrina, filwaqt li madwar
English: Most cases were transient and did not require treatment discontinuation.
Maltese: Il-biċċa l kbira tal-każijiet kienu temporanji u ma kinux jeħtieġu t-twaqqif tat-trattament.
English: Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Week 52 38 % 57 %*** 63 %***
Maltese: Ġimgħa 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Ġimgħa 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Ġimgħa 52 38 % 57 %*** 63 %***
English: Mean serum IgG, IgM, and IgA values decreased by 12 weeks after starting treatment with Olumiant, and remained stable at a lower value than baseline through at least 104 weeks.
Maltese: Il-valuri medji tal-IgG, IgM, u IgA fis-serum naqsu sat-12-il ġimgħa wara li nbeda t-trattament b'Olumiant, u baqgħu stabbli b'valur inqas minn tal-linja bażi sa mill-anqas 104 ġimgħat.
English: Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.
Maltese: Erpete zoster kienet irrappurtata b'mod aktar komuni f'pazjenti ≥ 65 sena li qabel kienu ġew ittrattati kemm b'DMARDs bijoloġiċi kif ukoll b'mod konvenzjonali.
English: Decreases in lymphocytes, eosinophils and basophils as well as lymphoid depletion in organs/tissues of the immune system were observed in mice, rats and dogs.
Maltese: Tnaqqis fil-limfoċiti, fl-eosinofili u fil-basofili kif ukoll tnaqqis fil-kwantità ta' limfojd fl-organi/fit tessuti tas-sistema immuni ġew osservati fil-ġrieden, fil-firien u fil-klieb.
English: See section 4.2 for dose recommendations.
Maltese: Ara sezzjoni 4.2 għal rakkomandazzjonijiet tad-doża.
English: For up to 52 weeks, the frequency of ALT and AST elevations ≥ 3 x ULN were greater for the combination treatment of methotrexate and Olumiant (7.5 % and 3.8 %) compared to methotrexate alone (2.9 % and 0.5 %) or Olumiant alone (1.9 % and 1.3 %).
Maltese: Sat-52 ġimgħa, il-frekwenza taż-żidiet fl-ALT u fl-AST ≥ 3 x ULN kienet akbar għat trattament b'methotrexate flimkien ma' Olumiant (7.5% u 3.8%) meta mqabbla ma' methotrexate waħdu (2.9% u 0.5%) jew Olumiant waħdu (1.9% u 1.3%).
English: Hypertriglyceridaemiac
Maltese: Ipertrigliċeridemijac
English: The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib.
Maltese: Id-dejta klinika mhijiex biżżejjed biex tiġi stmata l-inċidenza possibbli ta' tumuri malinni wara esponiment għal baricitinib.
English: If you are taking probenecid, the recommended dose of Olumiant is 2 mg once a day - injectable anti-rheumatic medicine - medicines which are used to control the body's immune response, such as azathioprine,
Maltese: - mediċina antirewmatika li tiġi injettata - mediċini li jintużaw biex jikkontrollaw ir-rispons immuni tal-ġisem, bħal azathioprine,
English: In controlled studies, for up to 16 weeks, increases in CPK values were common.
Maltese: Fi studji kkontrollati, sa 16-il ġimgħa, żidiet fil-valuri ta' CPK kienu komuni.