FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with upadacitinib 15 mg resulted in significantly greater inhibition of the progression of structural joint damage compared to placebo in combination with MTX in SELECT-COMPARE and as monotherapy compared to MTX in SELECT-EARLY (Table 5).
Maltese: It-trattament b'upadacitinib 15 mg irriżulta f'inibizzjoni akbar b'mod sinifikanti tal-progressjoni tal ħsara strutturali fil-ġogi meta mqabbla mal-plaċebo flimkien ma' MTX f'SELECT-COMPARE u bħala monoterapija imqabbla ma' MTX f'SELECT-EARLY (Tabella 5).
English: Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolongedrelease tablets.
Maltese: Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - folji tal-aluminju bil-kalendarju f'pakketti li fihom 28 jew 98 pillola li jerħu l-mediċina bil-mod, jew pakketti multipli li fihom 84
English: Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.
Maltese: Upadacitinib ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C).
English: The overall long-term rate of serious infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 3.8 events per 100 patient-years.
Maltese: Ir-rata globali fit-tul ta' infezzjonijiet serji għall-grupp ta' upadacitinib 15 mg fil ħames studji kliniċi kollha ta' Fażi 3 kienet ta' 3.8 avveniment għal kull 100 sena ta' pazjent.
English: Upadacitinib was not carcinogenic in a 26-week carcinogenicity study in CByB6F1-Tg(HRAS)2Jic transgenic mice.
Maltese: Upadacitinib ma kienx karċinoġeniku fi studju dwar ir-riskju ta' kanċer ta' 26 ġimgħa fi ġrieden transġeniċi CByB6F1-Tg(HRAS)2Jic.
English: • you have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing urine more often than normal, severe headache with stiff neck), or if you have ever had an infection that keeps coming back - RINVOQ can reduce your body's ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection
Maltese: • għandek infezzjoni (deni, għaraq, jew tertir, qtugħ ta' nifs, ġilda sħuna, ħamra jew tuġgħa jew feriti fuq ġismek, tħossok għajjien, sogħla, sensazzjoni ta' ħruq meta tagħmel l-awrina jew tagħmel awrina aktar min-normal, uġigħ ta' ras qawwi b'għonq iebes), jew jekk qatt kellek infezzjoni li tirrepeti ruħha - RINVOQ jista' jnaqqas l-ħila ta' ġismek li jiġġieled kontra l infezzjonijiet u għalhekk jista' jiggrava l-infezzjoni li diġà għandek, jew jagħmilha aktar probabbli li jkollok infezzjoni ġdida
English: Age, sex, body weight, race, and ethnicity did not have a clinically meaningful effect on upadacitinib exposure.
Maltese: Fatturi intrinsiċi Età, sess, piż tal-ġisem, razza u etniċità ma kellhomx effett klinikament sinifikanti fuq l-espożizzjoni ta' upadacitinib.
English: • Primary endpoint: clinical remission (DAS28-CRP) at week 12
Maltese: • Il-punt aħħari primarju: remissjoni klinika (DAS28-CRP) f'ġimgħa 12
English: Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
Maltese: Upadacitinib m'għandux jintuża f'pazjenti b'indeboliment sever (Child-Pugh C) tal-fwied (ara sezzjoni 4.3).
English: In the studies SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-COMPARE, treatment with upadacitinib 15 mg resulted in a significantly greater improvement in the mean duration of morning joint stiffness compared to placebo or MTX.
Maltese: Fl-istudji SELECT-MONOTHERAPY, SELECT-NEXT, u SELECT-COMPARE, it-trattament b'upadacitinib 15 mg irriżulta f'titjib akbar b'mod sinifikanti fit-tul medju tal-ebusija fil-ġogi filgħodu meta mqabbel ma' plaċebo jew MTX.
English: • if you are pregnant (see section Pregnancy, breast-feeding and contraception)
Maltese: • jekk inti tqila (ara sezzjoni Tqala, treddigħ u kontraċezzjoni)
English: Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and week 48 in SELECT-EARLY and SELECT-COMPARE.
Maltese: Totali modifikat (mTSS - modified Total Sharp Score) u l-komponenti tiegħu, il-punteġġ ta' erożjoni u l-punteġġ tat-tidjiq tal-ispazju bejn il-ġogi, fil-ġimgħat 24/26 u l-ġimgħa 48 f'SELECT-EARLY u SELECT-COMPARE.
English: In the clinical studies, upadacitinib treated patients reported significant improvements in patientreported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score compared to placebo and MTX.
Maltese: Formola l-Qasira (36) (SF-36 - Short Form (36) Health Survey) meta mqabbla mal-plaċebo u MTX.
English: Moreover, upadacitinib treated patients reported significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) compared to placebo.
Maltese: Functional Assessment of Chronic Illness Therapy-Fatigue score) meta mqabbla mal-plaċebo.
English: On background csDMARDs
Maltese: Fuq csDMARDs flisfond
English: Immunosuppressive medicinal products
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Combination with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, and biologic DMARDs or other Janus kinase (JAK) inhibitors has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.
Maltese: tacrolimus, u DMARDs bijoloġiċi jew inibituri oħrajn ta' Janus kinase (JAK) ma ġietx evalwata fi studji kliniċi u mhijiex rakkomandata minħabba li r-riskju ta' immunosoppressjoni addizzjonali ma jistax jiġi eskluż.
English: In healthy volunteers, the administration of upadacitinib (immediate release formulation) resulted in a dose- and concentration-dependent inhibition of IL-6 (JAK1/JAK2) - induced STAT3 and IL-7 (JAK1/JAK3)-induced STAT5 phosphorylation in whole blood.
Maltese: F'voluntiera f'saħħithom, l-għoti ta' upadacitinib (formulazzjoni li terħi l-mediċina fil-pront) irriżulta f'inibizzjoni ta' fosforilizzazzjoni dipendenti mill-konċentrazzjoni u mid-doża ta' STAT3 indotta minn IL-6 (JAK1/JAK2) u ta' STAT5 indotta minn IL-7 (JAK1/JAK3) fid-demm sħiħ.
English: In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic infections over 12/14 weeks in the upadacitinib 15 mg group was 0.5% compared to 0.3% in the placebo group.
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo b'DMARDs fl-isfond, il-frekwenza ta' infezzjonijiet opportunistiċi fuq perjodu ta' 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg kienet ta' 0.5% mqabbla ma' 0.3% fil-grupp tal-plaċebo.
English: Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
Maltese: Pilloli tawwalin bikonvessi vjola ta'14 x 8 mm li jerħu l-mediċina bil-mod stampati fuq naħa waħda b'“a15”.
English: Intrinsic factors
Maltese: upadacitinib.
English: Upadacitinib is metabolised mainly by CYP3A4.
Maltese: L-għoti flimkien ma' indutturi ta' CYP3A4
English: • Risk of MACE o Language on the increased risk of MACE in RA patients and the need to consider typical CV risk factors (e.g., hypertension, hyperlipidaemia) when treating RA patients o Language on the risk of MACE during treatment with upadacitinib o Language on the risk of hyperlipidaemia during upadacitinib therapy o Details on monitoring of lipid levels and management of elevated lipid levels per clinical guidelines
Maltese: • Riskju ta' MACE o Lingwaġġ dwar ir-riskju akbar ta' MACE f'pazjenti b'RA u l-ħtieġa li jiġu kkunsidrati fatturi ta' riskju tipiċi ta' CV (eż., pressjoni għolja, iperlipidemija) meta jiġu ttrattati pazjenti b'RA o Lingwaġġ dwar ir-riskju ta' MACE matul it-trattament b'upadacitinib o Lingwaġġ dwar ir-riskju ta' iperlipidemija matul it-terapija b'upadacitinib o Dettalji dwar il-monitoraġġ tal-livelli tal-lipidi u l-immaniġġjar ta' żieda fil-livelli tal-lipidi skont linji gwida kliniċi
English: 47h Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%)
Maltese: ACR20 (jew 50 jew 70) = titjib ta' ≥20% (jew ta' ≥50% jew ta' ≥70%) skont il-Kulleġġ
English: 30 prolonged-release tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001 upadacitinib vs placebo or MTX comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison
Maltese: g upadacitinib ikkontrollat għall-multipliċità p≤0.001 vs paragun bi plaċebo jew b'MTX h upadacitinib nominali p≤0.001 vs paragun bi plaċebo jew b'MTX I upadacitinib nominali p≤0.01 vs paragun b'adalimumab
English: Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8).
Maltese: It-trattament m'għandux jinbeda f'pazjenti li jkollhom għadd assolut ta' limfoċiti (ALC - absolute lymphocyte count) li huwa < 500 ċellula/mm3, għadd assolut ta' newtrofili (ANC - absolute neutrophil count) li huwa < 1,000 ċellula/mm3 jew li għandhom livelli ta' emoglobina (Hb - haemoglobin) li huma < 8 g/dL (ara sezzjonijiet 4.4 u 4.8).
English: Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation.
Maltese: DVT/PE jinkludu età akbar, obeżità, storja medika ta' DVT/PE, pazjenti li tkun qed issirilhom operazzjoni maġġuri, u immobilizzazzjoni fit-tul.
English: RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
Maltese: RINVOQ huwa disponibbli fi flixken b'dessikant li fihom 30 pillola li jerħu l-mediċina bil-mod, kull pakkett fih flixkun wieħed (pakkett b'30 pillola) jew 3 flixken (pakkett b'90 pakkett).
English: Tel.: +48 22 372 78 00
Maltese: MSD Polska Sp. z o.o. Tel.: +48 22 372 78 00
English: Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in improvements in individual ACR components, including tender and swollen joint counts, patient and physician global assessments, HAQ-DI, pain assessment and hsCRP.
Maltese: It-trattament b'upadacitinib 15 mg, waħdu jew flimkien ma' csDMARDs, irriżulta f'titjib f'komponenti ACR individwali, inkluż l-għadd ta' ġogi sensittivi u minfuħin, evalwazzjoni globali tal pazjent u tat-tabib, HAQ-DI, evalwazzjoni tal-uġigħ u hsCRP.
English: There was a higher rate of serious infections in patients ≥ 75 years of age, although data are limited.
Maltese: Kien hemm rata ogħla ta' infezzjonijiet serji f'pazjenti ta' > 75 sena, għalkemm id-data hija limitata.
English: There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Maltese: Hemm data limitata dwar l-użu ta' upadacitinib f'individwi b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: The pharmacologic activity of upadacitinib is attributed to the parent molecule.
Maltese: L-attività farmakoloġika ta' upadacitinib hi attribwita lill-molekula oriġinali.
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 jiġi interott temporanjament f'pazjenti b'ANC < 1 x 109 ċelluli/L, ALC < 0.5 x 109 ċelluli/L jew emoglobina < 8 g/dL osservati waqt l immaniġġjar ta' rutina tal-pazjent (ara sezzjoni 4.2).
English: Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a All placebo data at week 48 derived using linear extrapolation b SELECT-EARLY c SELECT-COMPARE
Maltese: PBO = plaċebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE
English: Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Maltese: Għandha tiġi kkunsidrata terapija kontra t-TB qabel ma jinbeda upadacitinib f'pazjenti li ma kinux ittrattati fil passat għat-TB mhux attiva, jew f'pazjenti b'fatturi ta' riskju għal infezzjoni tat-TB.
English: In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX.
Maltese: Fi studji kkontrollati b'MTX, sa 12/14-il ġimgħa, ġew osservati żidiet f'ALT u AST ta' ≥ 3 x l-ULN f'mill-inqas kejl wieħed f'0.8% u 0.4% tal-pazjenti ttrattati b'upadacitinib 15 mg, imqabbla ma' 1.9% u 0.9% rispettivament, ta' pazjenti ttrattati b'MTX.
English: Upadacitinib should not be given to patients with active TB (see section 4.3).
Maltese: Upadacitinib m'għandux jingħata lil pazjenti li għandhom TB attiva (ara sezzjoni 4.3).
English: • you have heart problems, high blood pressure, or high cholesterol
Maltese: • għandek problemi tal-qalb, pressjoni għolja, jew kolesterol għoli
English: Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Maltese: Flixkun wieħed (30 pillola li jerħu l-mediċina bil-mod) jew 3 flixken (90 pillola li jerħu l-mediċina bil-mod).
English: Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.
Maltese: Methotrexate u prodotti mediċinali li jimmodifikaw il-pH (eż. antaċidi jew inibituri tal-pompa talprotoni) m'għandhom l-ebda effett fuq l-espożizzjoni ta' upadacitinib fil-plażma.
English: In placebo-controlled clinical studies with background DMARDs, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg group was 1.2% compared to 0.6% in the placebo group.
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo b'DMARDs fl-isfond, il-frekwenza ta' infezzjoni serja fuq perjodu ta' 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg kienet ta' 1.2% mqabbla ma' 0.6% filgrupp tal-plaċebo.
English: Ltd
Maltese: MTXa
English: • Risk of serious and opportunistic infections including TB o Language on the risk of infections during treatment with upadacitinib o Details on how to reduce the risk of infection with specific clinical measures (what laboratory parameters should be used to initiate upadacitinib, screening for TB, and getting patients immunised as per local guidelines, and interruption of upadacitinib if an infection develops) o Language on avoidance of live vaccines (i.e., Zostavax) prior to and during upadacitinib treatment o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Maltese: o Lingwaġġ dwar ir-riskju ta' infezzjonijiet matul it-trattament b'upadacitinib o Dettalji dwar kif wieħed inaqqas ir-riskju ta' infezzjoni permezz ta' miżuri kliniċi speċifiċi (liema parametri tal-laboratorju għandhom jintużaw biex jinbeda upadacitinib, ittestjar għat-TB, u li l-pazjenti għandhom jiġu mlaqqma skont il-linji gwida lokali, u l-interruzzjoni ta' upadacitinib jekk tiżviluppa infezzjoni) o Lingwaġġ dwar il-ħtieġa li jiġu evitati vaċċini ħajja (jiġifieri Zostavax) qabel u wara t-trattament b'upadacitinib o Dettalji biex jiġu avżati l-pazjenti dwar sinjali/sintomi ta' infezzjoni li wieħed għandu jkun konxju dwarhom, sabiex il-pazjenti jkunu jistgħu jfittxu attenzjoni medika malajr.
English: • shingles or painful skin rash with blisters (herpes zoster)
Maltese: • ħruq ta' Sant'Antin jew raxx tal-ġilda bl-infafet (herpes zoster)
English: Lipid elevations
Maltese: Żidiet tal-lipidi
English: Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed with a median Tmax of 2 to 4 hours.
Maltese: Wara l-għoti orali ta' formulazzjoni ta' upadacitinib li terħi l-mediċina bil-mod, upadacitinib jiġi assorbit b'Tmax medjan ta' 2 sa 4 sigħat.
English: • medicines to treat seizures or fits (such as phenytoin)
Maltese: • mediċini għat-trattament tal-epilessija jew aċċessjonijiet (bħal phenytoin)
English: The most commonly reported adverse drug reactions (ADRs) are upper respiratory tract infections (13.5%), nausea (3.5%), blood creatine phosphokinase (CPK) increased (2.5%) and cough (2.2%).
Maltese: creatine phosphokinase (CPK) fid-demm (2.5%) u sogħla (2.2%).
English: Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
Maltese: L-interruzzjoni tad-dożaġġ tista' tkun meħtieġa għall-immaniġġjar ta' anormalitajiet tal-laboratorju kif deskritt f'Tabella 1.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, one of which will usually be methotrexate.
Maltese: Jekk għandek artrite rewmatika attiva minn moderata sa severa, għallewwel tista' tingħata medicini oħra, li waħda minnhom ġeneralment tkun methotrexate.
English: The presence of at least 6 tender and 6 swollen joints and evidence of systemic inflammation based on elevation of hsCRP was required at baseline.
Maltese: Il-preżenza ta' mill-inqas 6 ġogi sensittivi u 6 ġogi minfuħin u evidenza ta' infjammazzjoni sistemika bbażata fuq l-elevazzjoni tal-hsCRP kienu meħtieġa fil-linja bażi.
English: Patients should be monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għall-iżvilupp ta' sinjali u sintomi ta' TB, inklużi pazjenti li kellhom test b'riżultat negattiv għal infezzjoni ta' TB mhux attiva qabel ma tinbeda t-terapija.
English: The most frequent serious infections reported with upadacitinib included pneumonia and cellulitis (see section 4.8).
Maltese: Liktar infezzjonijiet serji frekwenti li ġew irrappurtati b'upadacitinib kienu jinkludu pnewmonja u ċellulite (ara sezzjoni 4.8).
English: Durable response rates were observed (with or without MTX), with ACR20/50/70 responses maintained for at least 1 year.
Maltese: Rati ta' rispons li dam fit-tul ġew osservati (bi jew mingħajr MTX), b'risponsi ACR20/50/70 li nżammu għal mill-inqas sena.
English: In MTX-controlled studies, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 0.6% compared to 0.4% in the MTX group.
Maltese: 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg mogħti waħdu kienet ta' 0.6% mqabbla ma' 0.4% fil grupp ta' MTX.
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both studies.
Maltese: pazjenti mingħajr progressjoni radjugrafika (bidla f'mTSS ≤ 0) kien ogħla b'mod sinifikanti b'upadacitinib 15 mg fiż-żewġ studji.
English: In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
Maltese: F'assaġġi ċellulari umani, upadacitinib preferenzjalment jinibixxi s-sinjalar minn JAK1 jew JAK1/3 b'selettività funzjonali fuq ir-riċetturi ta'
English: • Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
Maltese: • Kolesterol totali ≥ 5.17 mmol/L (200 mg/dL): 62% vs.
English: • with underlying conditions that may predispose them to infection.
Maltese: • b'kundizzjonijiet sottostanti li jistgħu jippredisponuhom għal infezzjoni.
English: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders.
Maltese: Pazjenti b'artrite rewmatojde għandhom riskju akbar ta' disturbi kardjovaskulari.
English: • General introductory language that the HCP measure contains important information to assist the discussion with patients when prescribing upadacitinib.
Maltese: • Lingwaġġ introduttorju ġenerali li l-miżura tal-HCP fiha informazzjoni importanti biex tassisti d-diskussjoni mal-pazjenti meta jiġi preskritt upadacitinib.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun. PC
Maltese: Il-valuri medji tas-CPK żdiedu b'4 ġimgħat b'żieda medja ta' 60
English: Upadacitinib is contraindicated during pregnancy (see section 4.3).
Maltese: Upadacitinib huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: Compared to adalimumab, significantly higher rates of low disease activity were achieved at week 12 in SELECT-COMPARE.
Maltese: Imqabbla ma' adalimumab, inkisbu rati ogħla b'mod sinifikanti ta' attività baxxa tal-marda f'ġimgħa 12 f'SELECT-COMPARE.
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Maltese: ANNESS I 0BSOMMARJU TAL-KARATTERISTIĊI
English: Hepatic impairment
Maltese: Infezzjonijiet serji
English: Mean neutrophil counts decreased over 4 to 8 weeks.
Maltese: Għadd medju ta' newtrofili naqas fuq medda ta' 4 u 8 ġimgħat.
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha upadacitinib hemihydrate, ekwivalenti għal 15 mg ta'
English: The objective of the programme is to increase awareness of HCPs and patients on the risks of serious and opportunistic infections including TB, herpes zoster, foetal malformation (pregnancy risk), MACE, and VTEs and how to manage these risks.
Maltese: infezzjonijiet serji u opportunistiċi li jinkludu t-TB, herpes zoster, malformazzjoni tal-fetu (riskju għat-tqala), MACE, u VTEs u kif wieħed għandu jimmaniġġja dawn ir-riskji.
English: Upadacitinib had no effect on fertility in male or female rats at doses up to 50 mg/kg/day in males and 75 mg/kg/day in females in a fertility and early embryonic development study.
Maltese: Upadacitinib ma kellu l-ebda effett fuq il-fertilità f'firien nisa jew irġiel b'dożi sa 50 mg/kg/ġurnata fl irġiel u 75 mg/kg/ġurnata fin-nisa fi studju dwar il-fertilità u l-iżvilupp embrijoniku bikri.
English: In MTX-controlled studies, there were no cases of opportunistic infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group and 0.2% in the MTX group.
Maltese: Fi studji kkontrollati b'MTX, ma kien hemm l-ebda każ ta' infezzjoni opportunistika fuq perjodu ta' 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg mogħti waħdu, u 0.2% fil-grupp ta' MTX.
English: Each prolonged-release tablet contains 15 mg of upadacitinib (as upadacitinib hemihydrate).
Maltese: Kull pillola li terħi l-mediċina fuq tul ta' żmien fiha 15 mg ta' upadacitinib (bħala upadacitinib hemihydrate).
English: There are limited data in patients aged 75 years and older.
Maltese: Hemm data limitata dwar pazjenti li jkollhom 75 sena u aktar.
English: Prior to launch of RINVOQ in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' RINVOQ f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy, although evidence is limited.
Maltese: Żidiet f'LDL kolesterol naqsu għal livelli ta' qabel it-trattament b'rispons għat-terapija bl-istatins, għalkemm l evidenza hi limitata.