FrancophonIA/ELRC3.0 huggingface dataset:
English: 14 film-coated tablets 28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 35 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita 28 x 1 pillola miksija b'rita 84 x 1 pillola miksija b'rita
English: Immune disorders
Maltese: Disturbi fissistema immuni
English: Taking into account information provided by MAH, at least part of non-specific events were indeed systemic however due the limited information it is not possible to categorise them properly.
Maltese: Meta tikkunsidra l-informazzjoni pprovduta mill-MAH, mill-inqas parti mill-avvenimenti mhux speċifiċi kienu fil-verità sistemiċi iżda minħabba li l-informazzjoni hija limitata mhuwiex possibbli li jiġu kklassifikati b'mod korrett.
English: Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other.
Maltese: Pilloli roża medju, tondi ta' 8.5 mm, imnaqqxa b'“Lilly” fuq naħa waħda u “4” fuq in-naħa l-oħra.
English: EU/1/16/1170/009 EU/1/16/1170/010 EU/1/16/1170/011 EU/1/16/1170/012 EU/1/16/1170/013 EU/1/16/1170/014 EU/1/16/1170/015 EU/1/16/1170/016
Maltese: EU/1/16/1170/011 EU/1/16/1170/012 EU/1/16/1170/013 EU/1/16/1170/014
English: • At week 48: 57/73 (78 %) continuing 4 mg vs. 51/86 (59 %) reduced to 2 mg (p ≤ 0.05)
Maltese: • Fil-ġimgħa 48: 57/73 (78%) ikomplu b'4 mg vs. 51/86 (59%) imnaqqsa għal 2 mg (p ≤ 0.05)
English: The most common concomitant DMARDs in these subjects were MTX (79% of patients), hydroxychloroquine (19%), leflunomide
Maltese: L-aktar DMARDs konkomitanti komuni f'dawn l-individwi kienu MTX (79% tal-pazjenti), hydroxychloroquine (19%), leflunomide (11%), u sulphasalazine (9%).
English: Olumiant 4 mg vs. 2 mg
Maltese: Olumiant 4 mg vs.
English: An imbalance in reports of VTE with 0% (EAIR of 0,0) for placebo vs. 0,53% (EAIR of 1,3) for baricitinib 4-mg was noted in placebo-controlled trials.
Maltese: Ġie nnotat żbilanċ fir-rapporti ta' VTE b'0% (EAIR ta' 0,0) għal plaċebo vs. 0,53% (EAIR ta' 1,3) għal baricitinib 4-mg f'provi kkontrollati bil-plaċebo.
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see section 4.8).
Maltese: Ir-riattivazzjoni virali, inkluż każijiet ta' riattivazzjoni tal-virus tal-erpete (eż., erpete zoster, erpete simplex) ġiet irrappurtata fi provi kliniċi (ara sezzjoni 4.8).
English: Mean apparent clearance (CL/F) and half-life in patients with rheumatoid arthritis was 9.42 L/hr (CV = 34.3 %) and 12.5 hrs (CV = 27.4 %), respectively.
Maltese: 42 L/siegħa (CV = 34.3%) u 12.5 sigħat (CV = 27.4%), rispettivament.
English: Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity.
Maltese: Dożi waħdiet sa 40 mg u ħafna dożi sa 20 mg kuljum għal 10 ijiem ingħataw fi provi kliniċi mingħajr tossiċità li tillimita d-doża.
English: The mean ratios of Cmax in patients with mild and moderate renal impairment to patients with normal renal function are 1.16 (90 %CI: 0.92-1.45) and 1.46 (90 %CI: 1.17-1.83), respectively.
Maltese: Il-proporzjonijiet medji tas-Cmax f'pazjenti b'indeboliment ħafif u moderat tal-kliewi għal pazjenti b'funzjoni normali tal-kliewi huma 1.16 (90%CI: 0.92-1.45) u 1.46 (90%CI: 1.17-1.83), rispettivament.
English: b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
Maltese: b Terminu kkombinat (ekżema erpetikum, erpete simplex, erpete simplex fl-għajn, erpete fil-ħalq).
English: • That Olumiant increases the potential risk of infections.
Maltese: • Li Olumiant iżid ir-riskju possibbli ta' infezzjonijiet.
English: • Increased LDL cholesterol ≥ 3.36 mmol/L: 33.6 % vs. 10.3 %, respectively
Maltese: • Żieda ≥ 3.36 mmol/L fil-kolesterol LDL: 33.6% vs. 10.
English: Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).
Maltese: Età ta' ≥ 65 sena jew ta' ≥ 75 sena ma kellha l-ebda effett fuq l-epsoniment għal baricitinib (Cmax u AUC).
English: Baricitinib is approximately 50 % bound to plasma proteins.
Maltese: Madwar 50% ta' baricitinib huwa marbut mal-proteini tal plażma.
English: Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.
Maltese: L-għoti ta' baricitinib flimkien ma' fluconazole (inibitur moderat ta' CYP3A/CYP2C19/CYP2C9) jew rifampicin (induttur qawwi ta' CYP3A) ma' wassal għall-ebda bidliet ta' sinifikat kliniku fl-esponiment għal baricitinib.
English: QR code to be included + www.olumiant.eu
Maltese: Għandu jiġi nkluż il-kodiċi QR+ www.olumiant.eu
English: • At week 12: 234/251 (93 %) continuing 4 mg vs. 207/251 (82 %) reduced to 2 mg (p ≤ 0.001)
Maltese: • Fil-ġimgħa 12: 234/251 (93%) ikomplu b'4 mg vs. 207/251 (82%) imnaqqsa għal 2 mg (p
English: The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Olumiant fi tfal u adolexxenti minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: What Olumiant contains - The active substance is baricitinib.
Maltese: X'fih Olumiant - Is-sustanza attiva hi baricitinib.
English: EU/1/16/1170/001 (14 film-coated tablets) EU/1/16/1170/002 (28 film-coated tablets) EU/1/16/1170/003 (28 x 1 film-coated tablets) EU/1/16/1170/004 (35 film-coated tablets) EU/1/16/1170/005 (56 film-coated tablets) EU/1/16/1170/006 (84 film-coated tablets) EU/1/16/1170/007 (84 x 1 film-coated tablets) EU/1/16/1170/008 (98 film-coated tablets)
Maltese: EU/1/16/1170/001 (14-il pillola miksija b'rita) EU/1/16/1170/002 (28 pillola miksija b'rita) EU/1/16/1170/003 (28 x 1 pillola miksija b'rita) EU/1/16/1170/004 (35 pillola miksija b'rita) EU/1/16/1170/005 (56 pillola miksija b'rita) EU/1/16/1170/006 (84 pillola miksija b'rita) EU/1/16/1170/007 (84 x 1 pillola miksija b'rita) EU/1/16/1170/008 (98 pillola miksija b'rita)
English: • At week 24: 163/191 (85 %) continuing 4 mg vs. 144/189 (76 %) reduced to 2 mg (p ≤ 0.05)
Maltese: • Fil-ġimgħa 24: 163/191 (85%) ikomplu b'4 mg vs. 144/189 (76%) imnaqqsa għal 2 mg (p
English: Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.
Maltese: L-għoti ta' baricitinib flimkien ma' ciclosporin (inibitur ta' Pgp/BCRP) jew methotrexate (sustrat ta' diversi trasportaturi inkluż OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, u MRP4) ma wassal għall-ebda effetti ta' sinifikat kliniku fuq l-esponiment għal baricitinib.
English: In a clinical pharmacology study, baricitinib was excreted predominately as the unchanged active substance in urine (69 %) and faeces (15 %) and only 4 minor oxidative metabolites were identified (3 in urine; 1 in faeces) constituting approximately 5 % and 1 % of the dose, respectively.
Maltese: Fi studju farmakoloġiku kliniku, baricitinib tneħħa b'mod predominanti bħala s-sustanza attiva mhux mibdula fl-awrina (69%) u fl-ippurgar (15%) u ġew identifikati biss 4 metaboliti ossidattivi minuri (3 fl-awrina; 1 fl-ippurgar) li jagħmlu 5% u 1 % tad-doża, rispettivament.
English: Absolute Neutrophil Count (ANC)
Maltese: Għadd Assolut tanNewtrofili (ANC)
English: The mean ratios of AUC in patients with mild and moderate renal impairment to patients with normal renal function are 1.41 (90 % CI: 1.15-1.74) and 2.22 (90 % CI: 1.81-2.73), respectively.
Maltese: Ilproporzjonijiet medji tal-AUC f'pazjenti b'indeboliment ħafif u moderat tal-kliewi għal pazjenti b'funzjoni normali tal-kliewi huma 1.41 (90% CI: 1.15-1.74) u 2.22 (90% CI: 1.81-2.73), rispettivament.
English: Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials.
Maltese: Ġew irrappurtati żidiet fl-alanine transaminase (ALT) u fl-aspartate transaminase (AST) għal ≥ 5 u ≥ 10 x aktar mill-ogħla limitu tan-normal (ULN, upper limit of normal) f'anqas minn 1% tal-pazjenti fi provi kliniċi.
English: Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90 % of the administered dose is expected to be eliminated within 24 hours.
Maltese: Dejta farmakokinetika minn doża waħda ta' 40 mg f'voluntiera f'saħħithom tindika li aktar minn 90% tad-doża mogħtija hija mistennija li titneħħa fi żmien 24 siegħa.
English: EU/1/16/1170/009 (14 film-coated tablets) EU/1/16/1170/010 (28 film-coated tablets) EU/1/16/1170/011 (28 x 1 film-coated tablets) EU/1/16/1170/012 (35 film-coated tablets) EU/1/16/1170/013 (56 film-coated tablets) EU/1/16/1170/014 (84 film-coated tablets) EU/1/16/1170/015 (84 x 1 film-coated tablets) EU/1/16/1170/016 (98 film-coated tablets)
Maltese: EU/1/16/1170/009 (14-il pillola miksija b'rita) EU/1/16/1170/010 (28 pillola miksija b'rita) EU/1/16/1170/011 (28 x 1 pillola miksija b'rita) EU/1/16/1170/012 (35 pillola miksija b'rita) EU/1/16/1170/013 (56 pillola miksija b'rita) EU/1/16/1170/014 (84 pillola miksija b'rita) EU/1/16/1170/015 (84 x 1 pillola miksija b'rita) EU/1/16/1170/016 (98 pillola miksija b'rita)
English: Absolute Lymphocyte Count (ALC)
Maltese: Għadd Assolut talLimfoċiti (ALC)
English: • Low disease activity and Remission (SDAI)
Maltese: • Attività baxxa tal-marda u Remissjoni (SDAI)
English: • Adalimumab 40 mg SC Q2W
Maltese: • Olumiant 4 mg QD • Adalimumab 40 mg SC Q2W
English: Polyvinylchloride/aluminium/oriented polyamide - aluminium perforated unit dose blisters in cartons of 28 x 1 or 84 x 1 film-coated tablets.
Maltese: Folji tal-aluminju u tal-polyvinylchloride/aluminju/poliamide orientat b'sarbut toqob biex tinqata' doża waħda f'kartun ta' 28 x 1 jew 84 x 1 pillola miksija b'rita.
English: In controlled studies, for up to 16 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in 1.4 % and 0.8 % of patients treated with Olumiant, compared to 1.0 % and 0.8 % respectively of patients treated with placebo.
Maltese: Fi studji kkontrollati, sa 16-il ġimgħa, żidiet fl-alanine transaminase (ALT) u fl-aspartate transaminase (AST) ≥ 3 x ogħla mil-limitu tan-normal (ULN, upper limit of normal) kienu oservati f'1.4% u 0.8% tal-pazjenti trattati b'Olumiant, meta mqabbla ma' 1.0% u 0.8% rispettivament ta' pazjenti ttrattati bi plaċebo.
English: Food intake led to a decreased exposure by up to 14 %, a decrease in Cmax by up to 18 % and delayed tmax by 0.5 hours.
Maltese: It-teħid tal-ikel wassal għal tnaqqis fl-esponiment sa 14%, tnaqqis fis-Cmax sa 18% u tmax imdewwem b'0.5 sigħat.
English: Weight increased Creatine phosphokinase increased >5 x ULNc a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection).
Maltese: Żieda ta' >5 x ULN filcreatine phosphokinasec a Terminu kkombinat (sinożite akuta, epiglottite, larinġite, nażofarinġite, uġigħ fil-ħalq u fil-larinġi,
English: Statistically significant pain reduction was seen as early as Week 1 and in studies RA-BEGIN and RA-BEAM this was maintained for up to 52 weeks.
Maltese: Tnaqqis sinifikanti b'mod statistiku fl-uġigħ deher minn kmieni anke sa minn Ġimgħa 1 u fl-istudji RA-BEGIN u RA-BEAM dan inżamm sat-52 ġimgħa.
English: In a combined male/female rat fertility study, baricitinib decreased overall mating performance (decreased fertility and conception indices).
Maltese: Fi studju kombinat ta' fertilità fil-far raġel/mara, baricitinib naqqas it-twettiq totali ta' tagħmmir (tnaqqis fl-indiċi tal-fertilità u l-konċepiment).
English: In studies which included both doses, a dose-relationship was observed with increased total cholesterol ≥ 5.17 mmol/L reported in 48.8 %, 34.7 % and 17.8 % 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, ġiet osservata relazzjoni mad-doża b'żieda ≥ 5.17 mmol/L fil kolesterol totali rrappurtata fi 48.8%, 34.7% u 17.8% tal-pazjenti sa 16-il ġimgħa fil-gruppi ta' 4 mg, 2 mg u tal-plaċebo, rispettivament.
English: The rate of serious infections with Olumiant (1.1 %) was similar to placebo (1.2 %).
Maltese: Ir-rata ta' infezzjonijiet serji b'Olumiant (1.1%) kienet tixbah dik bil-plaċebo (1.2%).
English: In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.
Maltese: Fi studji farmakoloġiċi kliniċi, l-għoti ta' baricitinib ma' sustrati ta' CYP3A simvastatin, ethinyl oestradiol, jew levonorgestrel ma' wassal għall-ebda bidliet ta' sinifikat kliniku fil PK ta' dawn ilprodotti mediċinali.
English: As of 01 July 2019, 114 VTEs have been reported in 102 cases from post-marketing reports.
Maltese: Mill-01 ta' Lulju 2019, ġew irrapportati 114-il VTE f'102 każijiet minn rapporti wara li l-prodott tqiegħed fis-suq.
English: In vitro, baricitinib is a substrate for CYP3A4, OAT3, Pgp, BCRP and MATE2-K, and may be a clinically relevant inhibitor of the transporter OCT1 (see section 4.5).
Maltese: In vitro, baricitinib huwa sustrat għal CYP3A4, OAT3, Pgp, BCRP u MATE2-K, u jista' jkun inibitur klinikament rilevanti tattrasportaturi OCT1 (ara sezzjoni 4.5). Baricitinib mhuwiex inibitur tat-trasportaturi
English: HAQ-DI Minimum Clinically Important Difference (decrease in HAQ-DI score of ≥ 0.30): Week 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Week 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Week 52 53 % 65 %* 67 %**
Maltese: HAQ-DI Differenza Minima Importanti b'mod Kliniku (tnaqqis ta' ≥ 0.30 fil-punteġġ ta' HAQ-DI): Ġimgħa 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Ġimgħa 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Ġimgħa 52 53 % 65 %* 67 %**
English: The mean effects of intrinsic factors on PK parameters (AUC and Cmax) were generally within the inter-subject PK variability of baricitinib.
Maltese: L-effetti medji tal-fatturi intrinsiċi fuq il-parametri PK (AUC u Cmax) kienu ġeneralment fil-varjabilità PK ta' bejn individwu u ieħor ta' baricitinib.
English: The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min.
Maltese: Id-doża rrakkomandata hija ta' 2 mg darba kuljum f'pazjenti bi tneħħija tal-kreatinina bejn 30 u 60 mL/min.
English: In all 4 studies, a significantly higher proportion of patients treated with Olumiant 4 mg compared to placebo or MTX achieved low disease activity or remission (DAS28-ESR or DAS28-hsCRP ≤ 3.2 and DAS28-ESR or DAS28-hsCRP < 2.6) at Weeks 12 and 24.
Maltese: Fl-4 studji, proporzjon akbar b'mod sinifikanti ta' pazjenti trattati b'Olumiant 4 mg mqabbel ma' plaċebo jew MTX kisbu attività baxxa tal-marda jew remissjoni (DAS28-ESR jew DAS28-hsCRP ≤ 3.2 u DAS28-ESR jew DAS28-hsCRP < 2.6) fil-Ġimgħat 12 u 24.
English: • Primary endpoint:ACR20 at week 12
Maltese: • Skop finali primarju:ACR20 f'ġimgħa 12
English: In vitro, baricitinib is not an inhibitor of OAT1, OAT2, OAT3, organic cationic transporter (OCT) 2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.
Maltese: In vitro, baricitinib mhuwiex inibitur ta' OAT1, OAT2,OAT3, t-trasportatur ta' katjoni organiċi (OCT, organic cationic transporter) 2, OATP1B3, BCRP, MATE1 u MATE2-K f'konċentrazzjonijiet li huma klinikament rilevanti..
English: Thrombocytosis >600 x 109 cells/Lc
Maltese: >600 x 109 ċelluli/Lc
English: A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
Maltese: Ġiet osservata relazzjoni mad-doża b'żidiet ≥ 5 x ULN min-normal fis-CPK irrappurtati f'1.5%, 0.8% u 0.6% tal-pazjenti fis-16-il ġimgħa fil-gruppi ta' 4 mg, 2 mg u tal-plaċebo, rispettivament.
English: Mean volume of distribution following intravenous infusion administration was 76 L, indicating distribution of baricitinib into tissues.
Maltese: Il-medja tal-volum ta' distribuzzjoni wara għoti ta' infużjoni fil-vini kienet 76 L, li tindika distribuzzjoni ta' baricitinib ġot-tessuti.
English: Light pink, 9.0 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other.
Maltese: x 7.5 mm, imnaqqxa b'“Lilly” fuq naħa waħda u “2” fuq in-naħa l-oħra.
English: Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Maltese: Fis-sensiela ta' reazzjonijiet intraċellulari li jagħtu sinjali, JAKs jiffosforilizzaw u jattivaw konvertituri ta' sinjali u attivaturi ta' transkrizzjoni (STATs, signal transducers and activators of transcription), li jattivaw l-espressjoni tal-ġeni fiċ-ċellula.
English: Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo a Placebo data at week 52 derived using linear extrapolation b No progression defined as mTSS change ≤ 0.
Maltese: OLU = Olumiant; PBO = Plaċebo a Dejta tal-plaċebo f'ġimgħa 52 miksuba bl-użu ta' estrapolazzjoni lineari b L-ebda progressjoni ddefinita bħala bidla ta' ≤ 0 f'mTSS.
English: Week 52 0.81 0.55 0.34**
Maltese: Ġimgħa 24 0.47 0.33 0.26* Ġimgħa 52 0.81 0.55 0.34**
English: Modified Total Sharp Score, mean change from baseline:
Maltese: Punteġġ Totali Modifikat ta' Sharp, bidla medja mil-linja bażi:
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, L-Olanda.
English: Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Maltese: Pazjenti bi xhieda ta' infezzjoni attiva tal-epatite B jew Ċ ġew esklużi mill-provi kliniċi.
English: Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as undergoing biotransformation.
Maltese: Il-metaboliżmu ta' baricitinib huwa medjat minn CYP3A4, b'anqas minn 10% tad-doża identifikata li tgħaddi minn bijotrasformazzjoni.
English: Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Maltese: Olumiant jaħdem billi jnaqqas l-attività ta' enzima fil-ġisem msejħa ‘Janus kinase', li hija involuta flinfjammazzjoni.
English: The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric population (see section 4.2).
Maltese: Is-sigurtà, l-effikaċja u l-farmakokinetika ta' baricitinib għadhom ma ġewx determinati filpopolazzjoni pedjatrika (ara sezzjoni 4.2).
English: Week 52 1.02 0.80 0.40**
Maltese: Ġimgħa 24 0.61 0.39 0.29* Ġimgħa 52 1.02 0.80 0.40**
English: In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).
Maltese: sinifikat kliniku fuq l-esponiment meta baricitinib ingħata flimkien ma' digoxin (sustrat ta' Pgp) jew methotrexate (sustrat ta' diversi trasportaturi).
English: • Signs or symptoms of infections including general symptoms, and specifically tuberculosis and herpes zoster signs and symptoms; and a warning for the patients to seek immediate medical attention if signs or symptoms suggesting infection appear
Maltese: • Sinjali u sintomi ta' infezzjonijiet inkluż sintomi ġenerali, u b'mod speċifiku sinjali u sintomi ta' erpete zoster u tuberkulożi; u twissijja għall-pazjenti biex ifittxu għajnuna medika immedjata jekk jidhru sinjali u sintomi li jissuġġerixxu infezzjoni
English: Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
Maltese: Olumiant huwa indikat għat-trattament ta' artrite rewmatojd attiva minn moderata sa severa f'pazjenti adulti li rrispondew b'mod inadegwat, jew li huma intolleranti għal mediċina jew mediċini antirewmatiċi li jimmodifikaw il-marda.
English: Use of baricitinib with potent immunosuppressive medicinal products such as azathioprine, tacrolimus, or ciclosporin was limited in clinical studies of baricitinib, and a risk of additive immunosuppression cannot be excluded (see section 4.4).
Maltese: L-użu ta' baricitinib ma' prodotti mediċinali immunosoppressivi potenti bħal azathioprine, tacrolimus, jew ciclosporin kien limitat fi studji kliniċi ta' baricitinib, u ma jistax jiġi eskluż ir-riskju ta'
English: Each tablet contains 2 or 4 milligrams of baricitinib.
Maltese: Kull pillola fiha 2 jew 4 milligrammi ta' baricitinib.
English: A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure.
Maltese: Total ta' 3,464 pazjent ġew ittrattati b'Olumiant fi studji kliniċi ta' artrite rewmatojd li jirrapreżentaw
English: Pregnancy (see section 4.6).
Maltese: Prodott, sezzjoni 4.2).
English: 1 Patients who had received less than 3 doses of Methotrexate (MTX); naïve to other conventional or biologic DMARDs
Maltese: 1 Pazjenti li kienu rċivew anqas minn 3 dożi ta' Methotrexate (MTX); li qatt ma ħadu DMARDs konvenzjonali jew bijoloġiċi
English: How to store Olumiant
Maltese: Tiħux Olumiant:
English: Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Week 52 13 % 25 %** 30 %***
Maltese: Ġimgħa 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Ġimgħa 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Ġimgħa 52 13 % 25 %** 30 %***
English: c Includes changes detected during laboratory monitoring (see text below).
Maltese: c Jinkludu bidliet li nstabu waqt il-monitoraġġ tal-laboratorju (ara l-kitba taħt).
English: Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Maltese: It-trattament m'għandux jinbeda, jew għandu jitwaqqaf b'mod temporanju, f'pazjenti b'ANC < 1 x 109 ċellula/L, ALC < 0.5 x 109 ċelluli/L jew emoglobina < 8 g/dL li jiġu osservati waqt immaniġgjar ta' rutina tal-pazjenti (ara sezzjoni 4.2).
English: Of these, 2166 rheumatoid arthritis patients were exposed to Olumiant for at least one year.
Maltese: Minn dawn, 2,166 pazjent b'artrite rewmatojd ġew esposti għal Olumiant għal mill-inqas sena.
English: Potential for other medicinal products to affect the pharmacokinetics of baricitinib
Maltese: Il-possibbiltà li prodotti mediċinali oħra jaffettwaw il-farmakokinetika ta' baricitinib
English: A statistically significantly greater proportion of patients treated with Olumiant 4 mg compared to placebo or MTX achieved remission, as defined by SDAI ≤ 3.3 and CDAI ≤ 2.8, at weeks 12 and 24 (Table 4).
Maltese: Proporzjon sinifikament akbar b'mod statistiku ta' pazjenti ttrattati b'Olumiant 4 mg mqabbel ma' plaċebo jew MTX kisbu remissjoni, kif iddefinit permezz ta' SDAI ≤ 3.3 u CDAI ≤ 2.8, filġimgħat 12 u 24 (Tabella 4).
English: Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in less than 1 % of patients in clinical trials.
Maltese: (ALC) < 0.5 x 109 ċelluli/L u emoglobina < 8 g/dL ġew irrappurtati f'anqas minn 1% tal-pazjenti fil provi kliniċi.