FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Maltese: Il-profil ta' sigurtà għal pazjenti b'artrite psorijatika trattati b'Cimzia kienet konsistenti mal-profil ta' sigurtà f'artrite rewmatika u esperjenza preċedenti b'Cimzia.
English: Ear and labyrinth disorders
Maltese: Tumuri u mard limfoproliferattiv
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 6.8%.
Maltese: Il-perċentaġġ globali tal-pazjenti li kienu pożittivi għall-antikorpi b'reduzjoni persistenti għal konċentrazzjoni tal-mediċina fil-plażma kien stmat li hu ta' 6.8%.
English: • The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
Maltese: • Id-doża tal-bidu għall-adulti b'spondiloartrite hija ta' 400 mg li tingħata fil-ġimgħat 0, 2 u 4.
English: The most frequent serious infections included pneumonia, tuberculosis infections.
Maltese: L-iżjed Infezzjonijiet serji frekwenti jinkludu infezzjonijiet ta' pnewmonja u tuberkulożi.
English: No effect of age was observed in a population pharmacokinetic analysis in adult patients with plaque psoriasis.
Maltese: Ma ġie osservat l-ebda effett tal-età fl-analiżi fuq il-farmakokinetika fil-popolazzjoni f'pazjenti adulti bilpsorjasi tal-plakka.
English: Injection site pain was observed in 1.5% of patients treated with Cimzia with no cases leading to withdrawal.
Maltese: Uġigh fil-post ta' l-injezzjoni kien osservat f'1.5% tal-pazjenti trattati b'Cimzia, b'ebda każ jwassal għal waqfien tat-trattament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/544/008
English: The pre-filled syringe contains 200 mg of certolizumab pegol.
Maltese: U MNEJN GĦANDU JINGĦATA CIMZIA 200 mg injezzjoni certolizumab pegol
English: Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region) (see section 5.3).
Maltese: Studji mhux kliniċi jissuġġerixxu livell baxx jew negliġibli ta' trasferiment mill-plaċenta ta'framment omologu Fab ta' certolizumab pegol (ebda reġun Fc) (ara sezzjoni 5.3).
English: PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.
Maltese: PEGylation, iż-żieda kovalenti ta' PEG polimers mal-peptidi, iddewwem l-eliminazzjoni ta' dawn issustanzi miċ-ċirkulazzjoni b' diversi mekkaniżmi, inkużi tneħħija renali mnaqqsa, proteoliżi mnaqqas, u immunoġeniċita` mnaqqsa.
English: Radiographic set with linear extrapolation.
Maltese: Set radjografiku b' estrapolazzjoni linejari.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Maltese: Din it-tip rari ta' limfoma taċ-ċelloli-T hija aggressiva u ħafna drabi fatali.
English: Key efficacy outcomes from the AS001 clinical trial are shown in Table -8.
Maltese: Ir-riżultati importanti rigward l-effikaċja mill-prova klinika AS001 huma murija f'Tabella 8.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni f'siringa mimlija għal lest 2 siringi mimlija għal-lest għal użu ta' darba 2 biċċiet bl-alkoħol
English: • anxiety and mood disorders such as depression, appetite disorders, weight change
Maltese: • ansjeta` u disturbi fil-burdata bħal depressjoni, disturbi fl-aptit, tibdil fil-piż
English: Patient on Cimzia 400 mg every 2 weeks were re-randomized to Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo.
Maltese: Pazjenti fuq Cimzia 400 mg kull ġimagħtejn intgħażlu mill-ġdid b'mod każwali għal Cimzia 400 mg kull ġimagħtejn, Cimzia 200 mg kull ġimagħtejn, jew plaċebo.
English: • The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4.
Maltese: • Id-doża tal-bidu għall-adulti b'artrite rewmatika hija ta' 400 mg li tingħata fil-ġimgħat 0, 2 u 4.
English: The time left is shown on screen.
Maltese: Dawn id-dejta jaqblu raġunevolarment mad-dejta osservata.
English: Cimzia can be taken together with: methotrexate, corticosteroids, or pain medicines including nonsteroidal anti-inflammatory medicines (also called NSAIDs).
Maltese: Cimzia tista' tittieħed flimkien ma': - methotrexate, - kortikosterojdi,jew - mediċina kontra l-uġigħ li jinkludu mediċinali anti-infjammatorji mhux sterojdi (li jissejħu wkoll NSAIDs).
English: One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Maltese: Siringa mimlija għal-lest ta' ml wieħed (ħġieġ tat-tip I) b'tapp planger (gomma tal-bromobutyl)li fiha 200 mg ta' certolizumab.
English: The observed ACR 20 response rate at this timepoint was 91%.The reduction (RA-I) from Baseline in DAS28 (ESR) also was significantly greater (p<0.001) at Week 52 (RA-I) and Week 24 (RA-II) compared to placebo and maintained through 2 years in the open-label extension trial to RA-I.
Maltese: 001) f'Ġimgħa 52 (RA-I) u Ġimgħa 24 (RA-II) meta mqabbel mal-plaċebo u kienu mantenuti matul issentejn fil-prova t' estenzjoni open-label għal RAI.
English: Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Maltese: Cimzia jista' jingħata bħala monoterapija f'każi ta' intolleranza għal methotrexate jew meta m'hemmx bżonn li tkompli trattament b'methotrexate.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cimzia 200 mg injection certolizumab pegol
Maltese: Fi studju kliniku, 16-il mara ġew ikkurati b'certolizumab pegol (200 mg kull ġimagħtejn jew 400 mg kull 4 ġimgħat) matul it-tqala.
English: Clinically meaningful and statistically significant differences in Cimzia-treated patients compared with placebo-treated patients were demonstrated at each post-baseline visit.
Maltese: Differenzi statistikament sinifikanti u klinikament importanti f'pazjenti ttrattati b' Cimzia meta mqabbla ma' pazjenti ttrattati b'plaċeba kienu murija f'kull viżta ta' wara l-punt ta' bażi.
English: PC: SN: NN:
Maltese: X'fih Cimzia:
English: Renal and urinary disorders
Maltese: Disturbi fil-kliewi u s-sistema urinarja
English: a Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4
Maltese: a Cimzia mogħti kull ġimagħtejn preċedut minn doża tal-bidu ta' 400 mg f'Ġimgħat 0, 2 u 4
English: Therefore the use of certolizumab pegol in combination with anakinra or abatacept is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' certolizumab pegol u anakinra jew abatacept mhux rikkmandata (ara sezzjoni 4.4).
English: How to store Cimzia
Maltese: Jekk tinsa tuża Cimzia
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 6 (3 x 2) single-use dose-dispenser cartridges and 6 (3 x 2) alcohol wipes
Maltese: 6 (3 x 2) siringi mimlija għal-lest għal użu ta' darba u 6(3 x 2) biċċiet bl-alkoħol)
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus (i.e., surface antigen positive).
Maltese: L-attivazzjoni mill-ġdid ta' epatite B seħħet f'pazjenti li kienu qed jirċievu antagonist tat-TNF inkluż certolizumab pegol, li jġorru b'mod kroniku dan il-vajrus (i.e., huma pożittivi għall-antiġen tassuperfiċi).
English: Non-radiographic AxSpA
Maltese: Ilma għall-injezzjoni
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jew jkunu fis-suq.
English: In the C-EARLY trial patients were ≥ 18 years of age and had ≥ 4 swollen and tender joints each and must have been diagnosed with moderate to severe active and progressive RA within 1 year (as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria).
Maltese: Fil-prova C-EARLY, ilpazjenti kienu ≥ 18-il sena u kellhom ≥ 4 ġogi minfuħa u sensittivi kull wieħed u kellhom ikollhom dijanjożi ta' RA progressiva u attiva moderata għal severa fi żmien sena (kif definita bil- kriterji ta' klassifikazzjoni tal- ACR/Lega Ewropea kontra r-Rewmatiżmu 2010
English: Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Rari ħafna (< 1/10,000), mhux magħruf (ma jistax jiġi stmat mid-dejta diponibli.
English: • sepsis (serious infection which can result in organ failure, shock or death)
Maltese: • sepsis (infezzjoni serja li tista' tirrizulta f'falliment ta' l-organi jew mewt)
English: Efficacy and safety of Cimzia in patients with PsA whose predominant symptoms were sacroiliitis or axial spondyloarthritis have not been separately analysed.
Maltese: L-effikaċja u s-sigurta` ta' Cimzia f'pazjenti b' PsA li kellhom s-simtomi predominanti ta' sakrojilijite jew spondiloartrite axjali ma kienux analizzati separatament.
English: Cimzia).
Maltese: SC).
English: Axial spondyloarthritis • The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
Maltese: Cimzia ngħata kull 4 ġimgħat preċedut minn doża kbira tal-bidu ta'400 mg f'Ġimgħa 0, 2 u 4
English: Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.
Maltese: Minkejja trattament profilattiku minn qabel jew fl-istess waqt għat-tuberkulożi, każijiet ta' tuberkulożi attiva seħħew f'pazjenti trattati b'antagonisti tat-TNF li jinkludu Cimzia.
English: Similar results were achieved in both the ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations.
Maltese: Kien hemm riżultati simili kemm fis-sub-popolazzjonjiet ta' spondilite ankilosing u spondiloartrite axjali mhux radjografika.
English: Cimzia treated patients also had significant improvements in ACR 50 and 70 response rates.
Maltese: Pazjenti ttrattati b'Cimzia kellhom ukoll ameljorament sinifikanti f'rati ta' rispons ACR 50 u 70.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks, or 400 mg every 2 weeks as instructed by your physician.
Maltese: • Din tkun segwita minn doża ta' manteniment ta' 200 mg kull ġimagħtejn jew 400 mg kull ġimagħtejn kif indikat mit-tabib tiegħek.
English: Of the 783 patients initially randomised to active treatment in RA-I, 508 completed 52 weeks of placebo-controlled treatment and entered the open-label extension study.
Maltese: Mill 783 pazjent randomised fil-bidu biex jieħdu trattament attiv f' RA-I, 508 temmew 52 ġimgħa ta' trattament ikkontrollat mill-plaċebo u daħlu fl-istudju ta' estenzjoni open-label.
English: Key efficacy outcomes from the PsA001 clinical trial are shown in Table10.
Maltese: Ir-rizultati importanti dwar l-effikaċja mill-prova klinika PsA001 huma murija f'Tabella 10.
English: Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.
Maltese: Ma sarux provi kliniċi speċifiċi biex jiġi eżaminat l-effett ta' indeboliment renali fuq ilfarmakokinetika ta' certolizumab pegol jew il-parti PEG.
English: • after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis, or
Maltese: • wara 12-il ġimgħa jekk għandek artrite rewmatika, spondiloartrite axjali, jew artrite tal-psorjasi,
English: Haematological reactions
Maltese: Artite rewmatika
English: • breast disorders
Maltese: • fejqan impedit
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Maltese: F'studju kliniku esploratorju li jevalwa l-użu ta' antagonista ieħor ta' kontra TNF, infliximab, f'pazjenti b'mard pulmonarju ostruttiv, kroniku u sever (COPD), iżjed tumuri, l-iżjed fil-pulmun jew ras jew għonq, kienu rappurtati f'pazjenti trattati b'infliximab meta mqabbla ma' pazjenti ta' kontroll.
English: Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the foetal compartment.
Maltese: Dejta minn mudell ex vivo ta' human closed-circuit placental transfer jissuġġerixxi trasferiment baxx jew negliġibli għall-kompartament tal-fetu.
English: Medication: dose-dispenser cartridge
Maltese: • uġigħ fil-post tal-injezzjoni • dardir
English: The safety profile of Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks were generally similar.
Maltese: Il-profili tas-sigurtà ta' Cimzia 400 mg kull ġimagħtejn u ta' Cimzia 200 mg kull ġimagħtejn kienu ġeneralment simili.
English: Cimzia 200 mg solution for injection in pre-filled syringe certolizumab pegol
Maltese: IL-PRODOTT MEDIĊINALI CIMZIA 200 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: • This is followed by a maintenance dose of 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8) as instructed by your physician.
Maltese: • Din hijasegwita minn doża ta' manteniment ta' 200 mg kull ġimgħatejn (minn ġimgħa 6)
English: Cimzia is used to treat moderate to severe plaque psoriasis.
Maltese: Cimzia jintuża biex jittratta psorjasi tal-plakka minn moderata sa severa.
English: • white blood cell morphology abnormal
Maltese: • morfloġija abnormali taċ-ċelloli bojod tad-demm
English: Cimzia 200 mg solution for injection in dose-dispenser cartridge certolizumab pegol
Maltese: Cimzia 200 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest certolizumab pegol
English: There have been rare reports of other immunemediated conditions; the causal relationship to Cimzia is not known.
Maltese: Kien hemm rapporti rari ta' kondizzjonijiet marbuta mal-immunita`; mhux magħruf jekk Cimzia għandhiex'taqsam mal-kawża.
English: Treatment success of “clear” (0) or “almost clear”(1) consisted of no signs of psoriasis or normal to pink coloration of lesions, no thickening of the plaque, and none to minimal focal scaling.
Maltese: Trattament b'suċċess ta' “xejn” (0) jew “kważi xejn”(1) ma kellu l-ebda sinjal ta' psorjasi jew ta' bidla fil-kulur tal-leżjonijiet minn normali sa roża, ebda tħaxxin tal-plakka, u ebda għal minimu ta' qxur fil-ġilda fokali.
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Maltese: Fis-sitwazzjoni ta' wara it-tqegħid fis-suq, kienu rrapportati każijiet ta' lukimja f'pazjenti trattati b' antagonista ta' TNF.
English: **Cimzia+MTX vs placebo+MTX: p<0.001 p value was estimated from a logistic regression model with factors for treatment, region, and time since RA diagnosis at Baseline (≤4 months vs >4 months)
Maltese: * Punti ta'stima tal-bidla Hodges-Lehmann u 95% asymptotic (Moses) confidence interval. **Cimzia+MTX vs plaċebo+MTX p<0.001. valur p kien stmat minn mudell ANCOVA fuq l-istess livell tat-trattament, reġjun, ħin mid-dijanjożi ta' RA fil-Linja bażi (≤4 xhur vs >4 xhur) bħala fatturi u l-livell tal-Linja bażi bħala covariate.
English: • impaired healing
Maltese: • disfunzjoni sesswali
English: In a clinical study in 17 lactating women treated with Cimzia, minimal transfer of certolizumab pegol from the plasma to breast milk was observed.
Maltese: Fi studju kliniku fi 17-il mara li qed tredda' ttrattati b'Cimzia, ma kien osservat ftit li xejn trasferiment ta' certolizumab pegol mill-plażma għal ġol-ħalib tas-sider.
English: There is limited experience with Cimzia in pregnant women.
Maltese: Hemm esperjenza limitata b'Cimzia f'nisa tqal.
English: The additional following adverse reactions have been observed uncommonly with Cimzia in other indications: gastrointestinal stenosis and obstructions, general physical health deterioration, abortion spontaneous and azoospermia.
Maltese: Ma kienux komuni iżda kienu osservati dawn ir-reazzjonijeit avversi addiżżjonali li ġejjin b' Cimzia f'indikazzjonijiet oħra: stenożi gastro-intestinali u ostruzzjoni, deterjorazzjoni fis-saħħa fiżika ġenerali, abort spontanju, azoospermja
English: • headaches (including migraines)
Maltese: • problemi tal-kliewi (inkluż nefrite)
English: The potential role of TNF-antagonist therapy in the development of malignancies is not known.
Maltese: Mhux magħruf ir-rwol potenzjali ta' terapija b'mediċini ta' kontra TNF fl-iżvillup ta' tumuri.
English: Cimzia-treated patients also had improvements compared to placebo in multiple components of axial spondyloarthritis disease activity, including CRP.
Maltese: Il-pazjenti kkurati b'Cimzia kellhom ukoll titjib meta mqabbel ma' plaċebo f'bosta komponenti tal-attività tal-marda spondiloartrite axjali, inkluż CRP.
English: Uncommo skin injuries, impaired healing
Maltese: Mhux komuni ġilda mweġġa', impediment fil-fejqan
English: The dose-dispenser cartridges may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Maltese: Is-siringi mimlija għal-lest jistgħu jinżammu f'temperatura tal-kamra (sa 25°C) għal perjodu wieħed sa massimu ta' 10 ijiem bi protezzjoni mid-dawl.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Maltese: • deterjorament ta' kondizzjoni msejħa dermatomijosite (osservata bħala raxx fil-ġilda li jseħħ flimkien ma' dgħufija fil-muskoli)
English: • viral infections (including cold sores, shingles, and influenza)
Maltese: • infezzjonijiet virali (jinkludu herpes simplex, ħruq ta' sant'antnin, u influwenza)
English: • Do not use the medication if it has been dropped after taking it out of the pack.
Maltese: • Tużax il-medikazzjoni jekk twaqqgħet wara li nħarrġet mil-pakkett.
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1.59 per patient-year for placebo-treated patients.
Maltese: Ir-rata ta' inċidenza ta' każijiet ġodda ta' infezzjonijiet fi provi kliniċi kkontrollati bil-plaċebo filpsorjasi kienet ta' 1.37 għal kull sena ta' pazjent għall-pazjenti kollha ttrattati b'Cimzia u 1.59 għal kull sena ta' pazjent għall-pazjenti ttrattati bil-plaċebo.
English: Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.
Maltese: Is-siringa mimlija lesta fiha 200 mg ta' certolizumab pegol.
English: In both studies patients were randomized to receive placebo or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4) or Cimzia 400 mg every 2 weeks.
Maltese: Fiż-żewġ studji lpazjenti ntgħażlu b'mod każwali biex jirċievu plaċebo jew Cimzia 200 mg kull ġimgħatejn (wara doża inizjali qawwija ta' Cimzia 400 mg f'Ġimgħat 0, 2 u 4) jew Cimzia 400 mg kull ġimgħatejn.
English: Opportunistic infections (excluding tuberculosis)
Maltese: Infezzjonijiet opportunistiċi (eskluża t-tuberkulożi)
English: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
Maltese: Titanium dioxide (E171) Iron oxide iswed (E172)
English: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italy
Maltese: S.R. 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) l-Italja
English: UPA 15mg N 314 317 216 217 221 221 651 651 327 169 164 Week
Maltese: UPA 15mg N 314 317 216 217 221 221 651 651 327 169 164
English: Table 4: Response and remission
Maltese: Tabella 4: Rispons u remissjoni
English: -0.5 -0.8h -0.3 -0.7g -0.3 -0.6g -0.3 -0.6g,i
Maltese: -0.5 -0.8h -0.3 -0.7g -0.3 -0.6g -0.3 -0.
English: • The active substance is upadacitinib.
Maltese: • Is-sustanza attiva hi upadacitinib.
English: Zwolle, 8017 JV, Netherlands
Maltese: Zwolle, 8017 JV, L-Olanda
English: CDAI ≤10 (% of patients)
Maltese: CDAI ≤10 (% ta' pazjenti)
English: • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
Maltese: • Il-qalba tal-pillola: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
English: • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide red (E172), iron oxide black (E172).
Maltese: • Kisja b'rita: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide aħmar (E172), iron oxide iswed (E172).
English: • cold sores (herpes simplex)
Maltese: • feriti tad-deni (herpes simplex)
English: CR DAS28-CRP <2.6 (% of patients)
Maltese: CR DAS28-CRP <2.6 (% ta' pazjenti)
English: LDA DAS28-CRP ≤3.2 (% of patients)
Maltese: LDA DAS28-CRP ≤3.2 (% ta' pazjenti)
English: Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma.
Maltese: Prodotti mediċinali immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni, inkluż il-limfoma.
English: Week 24e/26f
Maltese: 4e/26f
English: -0.3 -0.7h,i
Maltese: -0.3 -0.7h,i Taqsiriet:
English: • if you have active tuberculosis (TB)
Maltese: • Jekk għandek tuberkulożi (TB) attiva
English: Upadacitinib AUC was 18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function.
Maltese: L-AUC ta' upadacitinib kienet 18%, 33%, u 44% ogħla f'individwi b'indeboliment talkliewi ħafif (rata stmata ta' filtrazzjoni glomerulari ta' 60 sa 89 mL/min/1.73 m2), moderat (rata stmata ta' filtrazzjoni glomerulari ta' 30 sa 59 mL/min/1.73 m2), u sever (rata stmata ta' filtrazzjoni glomerulari ta' 15 sa 29 mL/min/1.73 m2) rispettivament, mqabbla ma' individwi b'funzjoni tal-kliewi normali.
English: Pneumonia Herpes zoster Herpes simplex** Oral candidiasis
Maltese: Pnewmonja Herpes zoster Herpes simplex** Kandidajasi tal-ħalq
English: In vitro, upadacitinib is a substrate for the efflux transporters P-gp and BCRP.
Maltese: In vitro, upadacitinib hu substrat għat-trasportaturi tal-effluss P-gp u BCRP.
English: Upadacitinib mean terminal elimination half-life ranged from 9 to 14 hours.
Maltese: Il-medja tal-half-life terminali tal-eliminazzjoni ta' upadacitinib varjat minn 9 sa 14-il siegħa.
English: The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of transcription (STATs).
Maltese: Il-familja ta' enzimi JAK fiha erba' membri, JAK1, JAK2, JAK3 u TYK2 li jaħdmu bħala pari biex jiffosforilizzaw u jattivaw transducers tas-sinjali u attivaturi tat-traskrizzjoni (STATs - signal transducers and activators of transcription).
English: Each calendar blister contains 7 tablets.
Maltese: Kull folja b'kalendarju fiha 7 pilloli.
English: SELECT BEYOND bDMARD-IR
Maltese: SELECT BEYOND DMARD-IR
English: Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Maltese: Fost l-infezzjonijiet opportunistiċi, it-tuberkulożi, l-herpes zoster multidermatomali, il-kandidijasi orali/esofagali, u l-cryptococcus ġew irrappurtati b'upadacitinib.
English: • medicines to treat Cushing's syndrome (such as ketoconazole)
Maltese: • mediċini għat-trattament tas-sindrome ta' Cushing (bħal ketoconazole)
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: not yet assigned
Maltese: Immunosoppressanti, immunosoppressanti selettivi, Kodiċi ATC:
English: Adverse reactions System Organ Class
Maltese: Sistema talKlassifika tal-Organi
English: • Active tuberculosis (TB) or active serious infections (see section 4.4).
Maltese: • Tuberkulożi (TB - tuberculosis) attiva jew infezzjonijiet serji attivi (ara sezzjoni 4.4).