FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequencies of infection ADRs for upadacitinib compared to placebo were: URTI (13.5% vs 9.5%), pneumonia (0.5% vs 0.3%), herpes zoster (0.7% vs 0.2%), herpes simplex (0.8% v 0.5%), and oral candidiasis (0.4% vs. <0.1%).
Maltese: 9.5%), pnewmonja (0.5% vs 0.3%), herpes zoster (0.7% vs 0.2%), herpes simplex (0.8% vs 0.5%), u kandidajasi tal-ħalq (0.4% vs.
English: • Clinical remission (DAS28-CRP)
Maltese: • Remissjoni klinika (DAS28-CRP)
English: • Patient Alert Card (PAC)
Maltese: • Kartuna ta' Allert għall-Pazjent (PAC - Patient Alert Card)
English: • medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
Maltese: • mediċini għat-trattament ta' infezzjonijiet fungali (bħal itraconazole, posaconazole jew voriconazole)
English: Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6.
Maltese: Il-metaboliżmu ta' upadacitinib hu medjat minn CYP3A4 b'kontribuzzjoni żgħira potenzjali minn CYP2D6.
English: • Low disease activity (DAS28-CRP) vs adalimumab
Maltese: • Attività baxxa tal-marda (DAS28CRP) vs adalimumab
English: • medicines to treat tuberculosis (such as rifampicin)
Maltese: • mediċini għat-trattament tat-tuberkulożi (bħal rifampicin)
English: Upadacitinib 15 mg treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Maltese: It-trattament b'upadacitinib 15 mg ġie assoċjat ma' żidiet fil-parametri tal-lipidi dipendenti fuq iddoża, inklużi kolesterol totali, trigliċeridi, kolesterol LDL u kolesterol HDL.
English: In the studies, a significantly higher proportion of patients treated with upadacitinib 15 mg achieved low disease activity (DAS28-CRP ≤3.2) and clinical remission (DAS28-CRP <2.6) compared to placebo, MTX or adalimumab (Table 4).
Maltese: Fl-istudji, proporzjon ogħla b'mod sinifikanti ta' pazjenti ttrattati b'upadacitinib 15 mg kisbu attività baxxa tal-marda (DAS28-CRP ≤3.2) u remissjoni klinika (DAS28-CRP <2.6) imqabbla mal-plaċebo, MTX jew adalimumab (Tabella 4).
English: Treatment group MTX
Maltese: Grupp ta' trattament MTX
English: Clinical Response:
Maltese: Rispons Kliniku:
English: ACR20 (% of patients)
Maltese: ACR20 (% ta' pazjenti)
English: ACR70 (% of patients)
Maltese: ACR70 (% ta' pazjenti)
English: Week 24b/26c
Maltese: Ġimgħa 24b/26c
English: Patients 18 years of age and older were eligible to participate.
Maltese: Pazjenti ta' 18-il sena u aktar kienu eliġibbli biex jipparteċipaw.
English: Modified Total Sharps Score, mean change from baseline
Maltese: Punteġġ Sharp Totali Modifikat, bidla medja mil-linja bażi
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: Ibla' l-pillola sħiħa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
Maltese: Kartuna tal-Flixkun (pakkett ta' 30 u 90)
English: S.R.
Maltese: L.U.
English: ACR50 (% of patients)
Maltese: ACR50 (% ta' pazjenti)
English: In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
Maltese: upadacitinib flimkien ma' ketoconazole rriżulta f'żidiet ta' 70% u 75% fis-Cmax u l-AUC ta' upadacitinib, rispettivament.
English: Hepatic transaminases
Maltese: Transaminases tal-fwied
English: • medicines to treat bacterial infections (such as clarithromycin)
Maltese: • mediċini għat-trattament ta' infezzjonijiet batterjali (bħal clarithromycin)
English: Treatment Group
Maltese: Grupp ta' Trattament
English: RINVOQ works by reducing the activity of an enzyme in the body called ‘Janus kinase'.
Maltese: RINVOQ jaħdem billi jnaqqas l-attività ta' enzima fil-ġisem imsejħa ‘Janus kinase'.
English: Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
Maltese: Fl-istudji ta' Fażi 3 kollha, l-effikaċja li ġiet osservata b'upadacitinib 15 mg QD ġeneralment kienet simili għal dik osservata b'upadacitinib 30 mg QD.
English: Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation
Maltese: L-inibizzjoni ta' fosforilizzazzjoni ta' STAT3 indotta minn IL-6 u ta' STAT5 indotta minn IL-7
English: QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Maltese: Għal aktar informazzjoni u appoġġ fuq it-teħid ta' RINVOQ żur www.rinvoq.eu
English: In a clinical study, rosuvastatin and atorvastatin AUC were decreased by 33% and 23%, respectively, and rosuvastatin Cmax was decreased by 23% following the administration of multiple 30 mg once daily doses of upadacitinib to healthy subjects.
Maltese: Fi studju kliniku, l-AUC ta' rosuvastatin u atorvastatin naqqsu b'33% u 23% rispettivament, u s-Cmax naqas b'23% wara l-għoti ta' dożi multipli ta' 30 mg darba kuljum ta' upadacitinib lil individwi f'saħħithom.
English: Upper respiratory tract infections (URTI)*
Maltese: Infezzjoni fin-naħa ta' fuq tal-apparat respiratorju (URTIupper respiratory tract infection)*
English: Upadacitinib should not be initiated in patients with an active, serious infection, including localised infections.
Maltese: Upadacitinib m'għandux jinbeda f'pazjenti b'infezzjoni serja attiva, inklużi infezzjonijiet lokalizzati.
English: No active metabolites have been identified for upadacitinib.
Maltese: L-ebda metaboliti attivi ma ġew identifikati għal upadacitinib.
English: Administration of multiple 30 mg once daily doses of upadacitinib (a dose that is twice the recommended upadacitinib dose) to healthy subjects had a limited effect on midazolam (sensitive drug substrate for CYP3A) plasma exposures (26% decrease in midazolam AUC and Cmax), indicating that upadacitinib 30 mg once daily may have a weak induction effect on CYP3A.
Maltese: L-amministrazzjoni ta' dożi multipli ta' 30 mg darba kuljum ta' upadacitinib (doża li hi d-doppju taddoża rakkomandata ta' upadacitinib) f'individwi f'saħħithom kellha effett limitat fuq l-espożizzjoni ta' midazolam (sottostrat sensittiv ta' mediċina għal CYP3A) fil-plażma (tnaqqis ta' 26% l-AUC u s-Cmax ta' midazolam), li jindika li upadacitinib 30 mg darba kuljum jista' jkollu effett dgħajjef ta' induzzjoni fuq CYP3A.
English: Upadacitinib is 52% bound to plasma proteins.
Maltese: Upadacitinib hu marbut mal-proteini tal-plażma b'52%.
English: • Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
Maltese: • Trigliċeridi ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, fil-gruppi ta' upadacitinib 15 mg u tal plaċebo, rispettivament
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenza tar-reazzjonijiet avversi elenkata hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100);
English: Approximately 34% of upadacitinib dose was excreted as metabolites.
Maltese: Madwar 34% tad-doża ta' upadacitinib tneħħiet bħala metaboliti.
English: Multipack: 84 (3 packs of 28) prolonged-release tablets
Maltese: U KONTENUT Pakkett multiplu: 84 (3 pakketti ta' 28) pillola li jerħu l-mediċina bil-mod
English: • HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
Maltese: • Kolesterol HDL ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, fil-gruppi ta' upadacitinib 15 mg u tal-plaċebo, rispettivament
English: EU/1/19/1404/001 EU/1/19/1404/002 EU/1/19/1404/003 EU/1/19/1404/004 EU/1/19/1404/005
Maltese: EU/1/19/1404/001 EU/1/19/1404/002 EU/1/19/1404/003
English: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment ħafif (Child Pugh A) jew moderat (Child Pugh B) tal-fwied (ara sezzjoni 5.2).
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared to 1.5% and 0.7%, respectively, of patients treated with placebo.
Maltese: Żidiet ta' transaminases epatiċi Fi studji kliniċi kkontrollati bil-plaċebo b'DMARDs fl-isfond, sa 12/14-il ġimgħa ġew osservati żidiet f'alanine transaminase (ALT) u aspartate transaminase (AST) ta' ≥ 3 x il-limitu a' fuq tan-normal (ULN - upper limit of normal) f'mill-inqas kejl wieħed fi 2.1% u 1.5% tal-pazjenti ttrattati b'upadacitinib 15 mg, imqabbla ma' 1.5% u 0.7% rispettivament, ta' pazjenti ttrattati bi plaċebo.
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 ≤1 % of patients in clinical trials (see section 4.8).
Maltese: Għadd Assolut tan-Newtrofili (ANC) < 1 x 109 celluli/L, Għadd Assolut tal-Limfoċiti (ALC) < 0.5 x 109 ċelluli/L u emoglobina < 8 g/dL ġew irrappurtati f'≤1 % mill-pazjenti fil-provi kliniċi (ara sezzjoni 4.8).
English: Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment has no clinically relevant effect on upadacitinib exposure.
Maltese: Indeboliment tal-fwied ħafif (Child-Pugh A) u moderat (Child-Pugh B) m'għandu l-ebda effett klinikament relevani fuq l-espożizzjoni ta' upadacitinib.
English: • Instructions on where to report AEs
Maltese: • Istruzzjonijiet dwar fejn jiġu rrappurtati l-AEs
English: Following single dose administration of [14C]-upadacitinib immediate-release solution, upadacitinib was eliminated predominantly as the unchanged parent substance in urine (24%) and faeces (38%).
Maltese: upadacitinib ġie eliminat prinċipalment bħala s-sustanza oriġinali mhux mibdula fl-awrina (24%) u fl ippurgar (38%).
English: How to take RINVOQ
Maltese: Tiħux RINVOQ
English: The pharmacokinetics of upadacitinib have not yet been evaluated in a paediatric population (see section 4.2).
Maltese: Il-farmakokinetika ta' upadacitinib għadha ma ġietx evalwata fil-popolazzjoni pedjatrika (ara sezzjoni 4.2).
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
Maltese: Attivazzjoni virali mill-ġdid, inklużi każijiet ta' attivazzjoni mill-ġdid tal-virus tal-herpes (eż., herpes zoster), ġiet irrappurtata fl-istudji kliniċi (ara sezzjoni 4.8).
English: In clinical studies, treatment was interrupted in response to ANC < 1,000 cells/mm3 (see section 4.2).
Maltese: Fi studji kliniċi, it-trattament twaqqaf b'risposta għal ANC < 1,000 ċellula/mm3 (ara sezzjoni 4.2).
English: Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies).
Maltese: Madwar 90% ta' upadactinib fiċ-ċirkolazzjoni sistemika hu eliminat fi żmien 24 siegħa mid-dożaġġ (fil-medda ta' dożi evalwati fl-istudji kliniċi).
English: e nominal p≤0.001 upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison
Maltese: e upadacitinib nominali p≤0.001 vs paragun bi plaċebo jew b'MTX f upadacitinib ikkontrollat għall-multipliċità p≤0.01 vs paragun bi plaċebo jew b'MTX g upadacitinib ikkontrollat għall-multipliċità p≤0.001 vs paragun bi plaċebo jew b'MTX
English: bDMARD = biologic disease-modifying anti-rheumatic drug, CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints, mTSS = modified Total Sharp Score, csDMARD = conventional synthetic diseasemodifying anti-rheumatic drug, HAQ-DI = Health Assessment Questionnaire Disability Index, SF-36 PCS = Short Form (36) Health Survey (SF-36) Physical Component Score, CDAI = Clinical Disease Activity Index, FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue score, IR = inadequate responder, MTX = methotrexate, n = number randomised a. Patients were naïve to MTX or received no more than 3 weekly MTX doses b Patients had inadequate response to MTX c Patients who had an inadequate response to csDMARDs; patients with prior exposure to at most one bDMARD were eligible (up to 20% of total number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability d Patients who had an inadequate response to MTX; patients with prior exposure to at most one bDMARD (except adalimumab) were eligible (up to 20% of total study number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability e Patients who had an inadequate response or intolerance to at least one bDMARD
Maltese: Pazjenti li qatt ma kienu rċivew MTX jew li rċivew mhux aktar minn 3 dożi ta' MTX fil-ġimgħa b Pazjenti kellhom rispons mhux adegwat għal MTX c Pazjenti li kellhom rispons mhux adegwat għal csDMARDs; pazjenti b'espożizzjoni minn qabel għal mhux aktar minn bDMARD waħda, kienu eliġibbli (sa 20% tan-numri totali ta' pazjenti) jekk kellhom espożizzjoni limitata (<3 xhur) jew kellhom iwaqfu l-bDMARD minħabba l-intollerabilità d Pazjenti li kellhom rispons mhux adegwat għal MTX; pazjenti b'espożizzjoni minn qabel għal mhux aktar minn bDMARD waħda (minbarra adalimumab), kienu eliġibbli (sa 20% tan-numru totali ta' pazjenti tal istudju) jekk kellhom espożizzjoni limitata (<3 xhur) jew kellhom iwaqqfu l-bDMARD minħabba l intollerabilità e Pazjenti li kellhom rispons mhux adegwat jew intolleranza għal mill-inqas bDMARD waħda
English: Do not use this medicine after the expiry date which is stated on the blister label and carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-folja u l-kartuna wara ‘EXP'.
English: How to store RINVOQ 6.
Maltese: Kif taħżen RINVOQ 6.
English: SELECT-EARLY MTX-naivea
Maltese: SELECT-EARLY Qatt ma rċivew
English: RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side with ‘a15'.
Maltese: RINVOQ 15 mg pilloli li jerħu l-mediċina bil-mod huma vjola, tawwalin, bikonvessi, stampati fuq naħa waħda b'“a15”.
English: Approximately 97% of drug-related material in milk was parent drug.
Maltese: Madwar 97% tal-materjal relatat mal-mediċina fil ħalib kien mediċina oriġinali.
English: Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.
Maltese: CYP1A2, CYP2B6, CYP2C9, CYP2C19, jew CYP2D6.
English: RINVOQ is used to treat adults with rheumatoid arthritis.
Maltese: RINVOQ jintuża għat-trattament tal-artrite rewmatojde fl-adulti.
English: RINVOQ 15 mg prolonged-release tablets upadacitinib
Maltese: RINVOQ 15 mg pilloli li jerħu l-mediċina bil-mod upadacitinib
English: Coadministration with CYP3A4 inducers
Maltese: CYP3A4.
English: Janus Kinases (JAKs) are intracellular enzymes that transmit cytokine or growth factor signals involved in a broad range of cellular processes including inflammatory responses, hematopoiesis and immune surveillance.
Maltese: Janus Kinase (JAK) huma enzimi intraċellulari li jittrasmettu cytokine jew sinjali tal-fatturi tat-tkabbir involuti f'firxa wiesgħa ta' proċessi ċellulari, inklużi risponsi infjammatorji, ematopojesi u sorveljanza immuni.
English: In a human radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma while the main metabolite (product of monooxidation followed by glucuronidation) accounted for 13% of the total plasma radioactivity.
Maltese: Fi studju radjutikkettat fuq il-bniedem, upadacitinib mhux mibdul ammonta għal 79% tar-radjuattività totali fil plażma filwaqt li l-metabolit ewlieni (il-prodott ta' mono-ossidazzjoni segwita minn glukuronidazzjoni) ammonta għal 13% tar-radjuattività totali fil-plażma.
English: The same information is also available on the following URL: www.rinvoq.eu
Maltese: L-istess informazzjoni hi disponibbli wkoll fuq dan il-URL: www.rinvoq.eu kodiċi QR biex tiġi inkluża
English: • LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
Maltese: • Kolesterol LDL ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, fil-gruppi ta' upadacitinib 15 mg u tal-plaċebo, rispettivament
English: Upadacitinib, at exposures (based on AUC) approximately 4 and 10 times the clinical dose of 15 mg in male and female Sprague-Dawley rats, respectively, was not carcinogenic in a 2-year carcinogenicity study in Sprague-Dawley rats.
Maltese: Upadacitinib, f'espożizzjonijiet (ibbażat fuq l-AUC) ta' madwar 4 u 10 darbiet id-doża klinika ta' 15 mg f'firien Sprague-Dawley irġiel u nisa, rispettivament, ma kienx karċinoġeniku fi studji dwar irriskju ta' kanċer ta' sentejn f'firien Sprague-Dawley.
English: Hypercholesterolaemia Hypertriglyceridaemia
Maltese: Iperkolesterolemija Ipertrigliċeridemija
English: • medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus)
Maltese: • mediċini li jaffettwaw is-sistema immuni tiegħek (bħal azathioprine, ciclosporin u tacrolimus)
English: Tel + 385 (0)1 5625 501
Maltese: AbbVie d.o.o. Tel + 385 (0)1 5625 501
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
Maltese: Kartuna intermedja ta' pakkett multiplu ta' 84 pillola (mingħajr il-Kaxxa l-Blu)
English: Potential for other medicinal products to affect the pharmacokinetics of upadacitinib
Maltese: Potenzjal għal upadacitinib li jinfluwenza l-farmakokinetika ta' prodotti mediċinali oħrajn
English: In placebo-controlled clinical studies with background DMARDs, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg group was 27.4% compared to 20.9% in the placebo group.
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo b'DMARDs fl-isfond, il-frekwenza ta' infezzjoni fuq perjodu ta' 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg kienet ta' 27.4% mqabbla ma' 20.9% fil-grupp tal-plaċebo.
English: Overall, both low disease activity and clinical remission rates were consistent across patient populations, with or without MTX.
Maltese: Globalment, kemm rati ta' attività baxxa tal-marda u remissjoni klinika kienu konsistenti fuq medda ta' popolazzjonijiet ta' pazjenti, bi u mingħajr MTX.
English: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, posaconazole, voriconazole, and clarithromycin).
Maltese: (bħal ketoconazole, itraconazole, posaconazole voriconazole, u clarithromycin).
English: Table 3: Clinical trials summary Study name Population (n) Treatment arms
Maltese: Tabella 3: Sommarju tal-provi kliniċi Isem tal-istudju
English: Absolute Lymphocyte Count (ALC)
Maltese: Għadd Assolut ta' Limfoċiti (ALC)
English: • with a history of a serious or an opportunistic infection
Maltese: • Riskji ta' infezzjonijiet serji u opportunistiċi, inkluż it-TB
English: Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin).
Maltese: rosuvastatin jew fuq l-espożizzjoni ta' ortho-hydroxyatorvastatin (metabolit attiv maġġuri ta' atorvastatin) fil-plażma.
English: NMSCs have been reported in patients treated with upadacitinib.
Maltese: NMSCs ġew irrappurtati f'pazjenti ttrattati b'upadacitinib.
English: Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
Maltese: Is-Cmax ta' upadacitinib kien simili f'individwi b'indeboliment fil-funzjoni tal-kliewi u b'funzjoni normali tal-kliewi.
English: The most common serious adverse reactions were serious infections (see section 4.4).
Maltese: Ir-reazzjonijiet avversi serji l-aktar komuni kienu infezzjonijiet serji (ara sezzjoni 4.4).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with RINVOQ in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'RINVOQ f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika f'artrite idjopatika kronika (inkluża artrite rewmatojde, artrite psorjatika, spondyloarthritis u artrite idjopatika fil-minorenni) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The overall long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies (2,630 patients) was 93.7 events per 100 patient-years.
Maltese: Ir-rata globali fit-tul ta' infezzjonijiet għall-grupp ta' upadacitinib 15 mg fil-ħames studji kliniċi kollha ta' Fażi 3 (2,630 pazjent) kienet ta' 93.7 avveniment għal kull 100 sena ta'
English: Table 6: Mean change from baseline in HAQ-DIa,b Study
Maltese: Tabella 6: Bidla medja mil-linja bażi f'HAQ-DIa,b
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Maltese: Avvenimenti ta' trombożi fil-vini tal-fond (DVT - deep venous thrombosis) u emboliżmu pulmonari (PE - pulmonary embolism) ġew irrappurtati f'pazjenti li kienu qed jirċievu inibituri tal-JAK inkluż upadacitinib.
English: Treatment with upadacitinib was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol (see section 4.8).
Maltese: kolesterol ta' 'lipoproteina ta' densità baxxa (LDL - low-density lipoprotein), u kolesterol ta'
English: • Language to advise patients and their HCPs about the risk of live vaccinations when given during upadacitinib therapy o Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
Maltese: • Lingwaġġ li jagħti parir lill-pazjenti u l-HCPs tagħhom dwar ir-riskji ta' ċertu tilqim ħaj meta jingħataw waqt terapija b'upadicitinib o Deskrizzjoni tar-riskji mmirati għall-għarfien tal-pazjenti u l-HCPs involuti fil-kura tagħhom, li jinkludu:
English: Coadministration of upadacitinib with a high-fat meal had no clinically relevant effect on upadacitinib exposures (increased AUC by 29% and Cmax by 39%).
Maltese: xaħam, ma kellu l-ebda effett klinikament rilevanti fuq l-espożizzjonijiet ta' upadacitinib (żidiet flAUC ta' 29% u fis-Cmax ta' 39%).
English: Neutropaenia
Maltese: Kontraċezzjoni
English: Blood CPK increased ALT increased AST increased Weight increased * URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection ** Herpes simplex includes oral herpes
Maltese: faringotonsillite, rinite, sinożite, tonsillite, infezzjoni virali fil-parti ta' fuq tal-passaġġ respiratorju ** Herpes simplex tinkludi herpes orali
English: How to store RINVOQ
Maltese: X'fih RINVOQ
English: Abbreviations: ADA = adalimumab; HAQ-DI = Health Assessment Questionnaire Disability Index; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA = upadacitinib a Data shown are mean b Health Assessment Questionnaire-Disability Index: 0=best, 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Maltese: upadacitinib a Id-data murija hi l-medja b.Indiċi tad-Diżabilità tal-Kwestjonarju tal-Evalwazzjoni tas-Saħħa: 0=l-aqwa, 3=l-agħar; 20 mistoqsija;
English: • Low disease activity (DAS28-CRP)
Maltese: • Attività baxxa tal-marda (DAS28-CRP)
English: Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika disponibbli fl-annimali uriet li kien hemm eliminazzjoni ta' upadacitinib fil-ħalib tas-sider (gћad-dettalji ara sezzjoni 5.3).