FrancophonIA/ELRC3.0 huggingface dataset:
English: Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
Slovenian: Upadacitiniba se pri bolnikih s hudo (Child-Pugh C) okvaro jeter ne sme uporabljati (glejte poglavje 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Blister Carton (Individual carton)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti (posamezna škatla)
English: In all studies, more patients treated with upadacitinib 15 mg achieved ACR20, ACR50, and ACR70 responses at 12 weeks compared to placebo, MTX, or adalimumab (Table 4).
Slovenian: V vseh študijah je odzive ACR20, ACR50 in ACR70 po 12 tednih doseglo več bolnikov, ki so prejemali 15 mg upadacitiniba, kot bolnikov, ki so prejemali placebo, MTX ali adalimumab
English: Upper respiratory tract infections (URTI)*
Slovenian: Okužbe zgornjih dihal*
English: • Low disease activity (DAS28-CRP)
Slovenian: • Nizka aktivnost bolezni (DAS28-CRP)
English: ACR20 (% of patients)
Slovenian: ACR20 (% bolnikov)
English: Hypercholesterolaemia Hypertriglyceridaemia
Slovenian: Hiperholesterolemija Hipertrigliceridemija
English: Treatment group MTX
Slovenian: Terapevts ka skupina MTX
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
English: Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy.
Slovenian: Bolnikom je treba pred začetkom zdravljenja z upadacitinibom opraviti presejanje glede tuberkuloze
English: ACR70 (% of patients)
Slovenian: ACR70 (% bolnikov)
English: Upadacitinib was teratogenic in rats and rabbits with effects in bones in rat foetuses and in the heart in rabbit foetuses when exposed in utero.
Slovenian: Upadacitinib je bil pri podganah in kuncih teratogen ter je v primeru izpostavljenosti in utero vplival na kosti podganjih plodov in srce kunčjih plodov.
English: Package leaflet: Information for the patient RINVOQ 15 mg prolonged-release tablets upadacitinib This medicine is subject to additional monitoring.
Slovenian: RINVOQ 15 mg tablete s podaljšanim sproščanjem upadacitinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Silica, colloidal anhydrous Magnesium stearate
Slovenian: Silicijev dioksid, koloidni, brezvodni Magnezijev stearat
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.
Slovenian: Celotni dolgoročni delež resnih okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze 3,8 dogodka na 100 bolnik-let.
English: Patients who develop adverse reactions should receive appropriate treatment.
Slovenian: morajo biti deležni ustreznega zdravljenja.
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.
Slovenian: V klinični študiji se je po večkratnih dnevnih odmerkih 30 mg upadacitiniba enkrat na dan pri zdravih osebah AUC rosuvastatina zmanjšala za 33 % in AUC atorvastatina za 23 %, Cmax rosuvastatina pa se je zmanjšala za 23 %.
English: RINVOQ 15 mg prolonged-release tablets upadacitinib
Slovenian: RINVOQ 15 mg tablete s podaljšanim sproščanjem upadacitinib
English: Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.
Slovenian: Pri bolnikih, ki so prejemali upadacitinib, so poročali o resnih okužbah, v nekaterih primerih s smrtnim izidom.
English: The use of upadacitinib has not been studied in subjects with end stage renal disease.
Slovenian: Uporaba upadacitiniba ni bila preučena pri preiskovancih s končno odpovedjo ledvic.
English: RINVOQ is not recommended for use in children and adolescents under 18 years of age.
Slovenian: Uporaba zdravila RINVOQ pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva, ker zdravilo v tej starostni skupini ni raziskano.
English: Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6.
Slovenian: Presnova upadacitiniba poteka s posredovanjem CYP3A4 in z možnim majhnim prispevkom
English: 98 prolonged-release tablets.
Slovenian: 98 tablet s podaljšanim sproščanjem.
English: • Upadacitinib 30 mg
Slovenian: • 30 mg upadacitiniba
English: 47h Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%)
Slovenian: Okrajšave: ACR20 (ali 50 ali 70) = izboljšanje za ≥ 20 % (ali ≥ 50 % ali ≥ 70 %) po American College of Rheumatology, ADA = adalimumab, CDAI = indeks klinične aktivnosti bolezni (Clinical Disease Activity
English: The overall longterm rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 0.6 events per 100 patient-years.
Slovenian: Celotni dolgoročni delež oportunističnih okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze 0,6 dogodka na 100 bolnik-let.
English: • increased levels of triglycerides (a type of fat in the blood) as shown in tests
Slovenian: • zvišana koncentracija trigliceridov (vrsta maščob v krvi); pokaže se na preiskavah krvi
English: Treatment should be interrupted if ANC is < 1,000 cells/mm3 and may be restarted once ANC returns above this value
Slovenian: Zdravljenje je treba prekiniti, če se AŠN zmanjša na < 1.000 celic/mm3, in ga je mogoče znova začeti, ko se AŠN
English: Upadacitinib was not mutagenic or genotoxic based on the results of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Slovenian: Upadacitinib glede na rezultate testov za genske mutacije in kromosomske aberacije in vitro in in vivo ni bil mutagen ali genotoksičen.
English: Treatment should be interrupted if ALC is < 500 cells/mm3 and may be restarted once ALC returns above this value
Slovenian: < 500 celic/mm3, in ga je mogoče znova začeti, ko se AŠL vrne nad to vrednost.
English: How to take RINVOQ
Slovenian: Kako jemati zdravilo RINVOQ
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
Slovenian: a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE
English: Absolute Lymphocyte Count (ALC)
Slovenian: Absolutno število limfocitov (AŠL)
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%).
Slovenian: (3,5 %), zvišanje kreatin-fosfokinaze (CPK) v krvi (2,5 %) in kašelj (2,2 %).
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje upadacitinibijev hemihidrat, kar ustreza 15 mg upadacitiniba.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Notranja škatla za skupno pakiranje s 84 tabletami (brez modrega okenca)
English: Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended.
Slovenian: Tik pred zdravljenjem z upadacitinibom in med zdravljenjem z njim ni priporočljivo uporabljati živih, oslabljenih cepiv.
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.
Slovenian: Pri bolnikih z latentno TB, ki predhodno ni bila zdravljena, ali pri bolnikih z dejavniki tveganja za TB je treba razmisliti o protituberkuloznem zdravljenju pred začetkom zdravljenja z upadacitinibom.
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.
Slovenian: Dveletna študija kancerogenosti pri Sprague-Dawleyjevih podganah je pokazala, da upadacitinib pri izpostavljenosti (osnovani na AUC), ki je bila približno 4-krat (pri samcih Sprague-Dawleyjevih podgan) in 10-krat (pri samicah Sprague-Dawleyjevih podgan) tolikšna, kot je med uporabo kliničnega odmerka, ni bil kancerogen.
English: ACR50 (% of patients)
Slovenian: ACR50 (% bolnikov)
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.
Slovenian: V študijah upadacitiniba, ki so bile kontrolirane z MTX, so v obdobju do 12/14 tednov opažali zvišanje ALT in AST na ≥ 3-krat nad ZNM na vsaj enem merjenju pri 0,8 % (ALT) oz. 0,4 % (AST) bolnikov, ki so prejemali 15 mg upadacitiniba, in pri 1,9 % (ALT) oz. 0,9 % (AST) bolnikov, ki so prejemali MTX.
English: • Primary endpoint: clinical remission (DAS28-CRP) at week 12
Slovenian: • Primarni opazovani dogodek: klinična remisija (DAS28-CRP) po 12 tednih
English: A patient who develops a new infection during treatment with upadacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to antimicrobial therapy.
Slovenian: uvesti je treba ustrezno protimikrobno zdravljenje, bolnika skrbno spremljati, zdravljenje z upadacitinibom pa prekiniti, če se bolnik ne odzove na protimikrobno zdravljenje.
English: Name and address of the manufacturers responsible for batch release
Slovenian: SPROŠČANJE SERIJ Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: Lipid elevations
Slovenian: Zvišanje AST
English: RINVOQ contains the active substance upadacitinib.
Slovenian: Zdravilo RINVOQ vsebuje učinkovino upadacitinib.
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
Slovenian: Okrajšave: ADA = adalimumab, IR = neustrezno odziven (inadequate responder), MTX = metotreksat, PBO = placebo, UPA= upadacitinib.
English: On background MTX
Slovenian: Ob osnovnem MTX
English: If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking RINVOQ.
Slovenian: Če kaj od naštetega velja za vas (ali ste negotovi), se posvetujte s svojim zdravnikom ali farmacevtom,
English: QR code to be included
Slovenian: Vstavite QR-kodo
English: No dose adjustment is required in patients aged 65 years and older.
Slovenian: Bolnikom, starim 65 let in več, odmerka ni treba prilagoditi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla za skupno pakiranje s 84 tabletami (z modrim okencem)
English: Patients 18 years of age and older were eligible to participate.
Slovenian: Za sodelovanje so bili primerni bolniki, stari 18 let in več.
English: Hepatic transaminases
Slovenian: Jetrne transaminaze
English: • HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
Slovenian: • holesterol HDL ≥ 1,03 mmol/l (40 mg/dl): 89 % v skupini s 15 mg upadacitiniba in 61 % v skupini s placebom,
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).
Slovenian: absolutnim številom nevtrofilcev (AŠN) < 1.000 celic/mm3 ali hemoglobinom (Hb) < 8 g/dl (glejte poglavji 4.4 in 4.8).
English: • you are at high risk of developing skin cancer, your doctor may recommend preventive measures such as regular skin examinations while taking RINVOQ.
Slovenian: • če imate visoko tveganje za razvoj raka kože; zdravnik vam lahko med jemanjem zdravila
English: • infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus
Slovenian: • pasovec ali boleč kožni izpuščaj z mehurji (herpes zoster) • okužba pljuč (pljučnica), ki lahko povzroči težko dihanje, zvišano telesno temperaturo in kašelj s sluzjo
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).
Slovenian: x 109 celic/l in o hemoglobinu < 8 g/dl so v kliničnih preskušanjih poročali pri ≤ 1 % bolnikov (glejte poglavje 4.8).
English: 49 prolonged-release tablets.
Slovenian: 49 tablet s podaljšanim sproščanjem.
English: • Language for HCPs to inform patients of the importance of the PAC
Slovenian: • Informacije za zdravstvene delavce o seznanjanju bolnikov s pomenom opozorilne kartice za bolnika.
English: Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
Slovenian: tableta s podaljšanim sproščanjem Vijoličaste, podolgovate, bikonveksne tablete s podaljšanim sproščanjem, velike 14 x 8 mm, ki imajo na eni strani vtisnjeno oznako "a15".
English: • Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
Slovenian: • trigliceridi ≥ 2,26 mmol/l (200 mg/dl): 25 % v skupini s 15 mg upadacitiniba in 15 % v skupini s placebom.
English: • increased levels of cholesterol (a type of fat in the blood) as shown in tests
Slovenian: • zvišana koncentracija holesterola (vrsta maščob v krvi); pokaže se na preiskavah krvi
English: Store in original blister or bottle with the lid tightly closed to protect from moisture.
Slovenian: Shranjujte v originalnem pretisnem omotu ali plastenki; pokrovček plastenke naj bo tesno zaprt za zagotovitev zaščite pred vlago.
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.
Slovenian: V študijah upadacitiniba, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali zvišanje alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST) na ≥ 3-krat nad zgornjo normalno mejo (ZNM) na vsaj enem merjenju pri 2,1 % (ALT) oz. 1,5 % (AST) bolnikov, ki so prejemali 15 mg upadacitiniba, in pri 1,5 %
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla z 98 tabletami
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.
Slovenian: V kliničnih študijah z osnovnimi imunomodulirajočimi antirevmatiki (DMARD), nadzorovanih s placebom, je bila pogostnost okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 27,4 % in v skupini s placebom 20,9 %.
English: Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Slovenian: Shranjujte v originalni plastenki, ki mora biti tesno zaprta za zagotovitev zaščite pred vlago.
English: 30 prolonged-release tablets
Slovenian: 30 tablet s podaljšanim sproščanjem
English: • Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
Slovenian: • celokupni holesterol ≥ 5,17 mmol/l (200 mg/dl): 62 % v skupini s 15 mg upadacitiniba in 31 % v skupini s placebom,
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.
Slovenian: Okrajšave: ADA = adalimumab, HAQ-DI = indeks Health Assessment Questionnaire Disability Index, IR = neustrezno odziven (inadequate responder), MTX = metotreksat, PBO = placebo, UPA = upadacitinib.
English: Store in the original blister or bottle in order to protect from moisture.
Slovenian: Shranjujte v originalnem pretisnem omotu ali plastenki za zagotovitev zaščite pred vlago.
English: Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.
Slovenian: Med dolgoročno uporabo razmislite o alternativah zdravilom, ki so močni zaviralci CYP3A4.
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, decreases in neutrophil counts below 1,000 cells/mm3 in at least one measurement occurred in 1.1% and <0.1% of patients in the upadacitinib 15 mg and placebo groups, respectively.
Slovenian: V študijah, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali znižanje števila nevtrofilcev pod 1.000 celic/mm3 na vsaj enem merjenju pri 1,1 % bolnikov, ki so prejemali 15 mg upadacitiniba, in pri < 0,1 % bolnikov, ki so prejemali placebo.
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
Slovenian: d Bolniki, ki se niso ustrezno odzvali na MTX; bolniki, predhodno izpostavljeni največ enemu bDMARD (razen adalimumaba), so bili primerni (do 20 % celotnega števila bolnikov v študiji), če so bili ali izpostavljeni krajši čas (< 3 mesece) ali so morali bDMARD prenehati uporabljati zaradi neprenašanja.
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).
Slovenian: Remisija in nizka aktivnost bolezni V študijah je nizko aktivnost bolezni (DAS28-CRP ≤ 3,2) in klinično remisijo (DAS28-CRP < 2,6)
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Slovenian: Pri bolnikih, ki so prejemali zaviralce JAK, vključno z upadacitinibom, so poročali o globoki venski trombozi (GVT) in pljučni emboliji (PE).
English: Time to onset of efficacy was rapid across measures with greater responses seen as early as week 1 for ACR20.
Slovenian: Čas do pojava učinkovitosti je bil pri vseh merah hiter in večji odzivi so bili za
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.
Slovenian: V kliničnih študijah z osnovnimi DMARD, nadzorovanih s placebom, je bila pogostnost resnih okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 1,2 % in v skupini s placebom 0,6 %.
English: • LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
Slovenian: • holesterol LDL ≥ 3,36 mmol/l (130 mg/dl): 42 % v skupini s 15 mg upadacitiniba in 19 % v skupini s placebom,
English: 28 prolonged-release tablets.
Slovenian: 28 tablet s podaljšanim sproščanjem.
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.
Slovenian: V kliničnih študijah z osnovnimi DMARD, nadzorovanih s placebom, je bila pogostnost oportunističnih okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 0,5 % in v skupini s placebom
English: 28 prolonged-release tablets
Slovenian: 28 tablet s podaljšanim sproščanjem
English: No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.
Slovenian: Med sočasno uporabo z upadacitinibom prilagoditev odmerka substratov CYP3A ali rosuvastatina ali atorvastatina ni potrebna.
English: • Do not swallow the desiccant.
Slovenian: • Sušilnega sredstva ne smete zaužiti.
English: • medicines to treat seizures or fits (such as phenytoin)
Slovenian: • zdravila za zdravljenje napadov krčev (npr. fenitoin)
English: Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Slovenian: Pri bolnikih z velikim tveganjem za GVT/PE je treba upadacitinib uporabljati previdno.
English: Upadacitinib AUC was 28% and 24% higher in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal liver function.
Slovenian: večja in pri preiskovancih z zmerno okvaro jeter 24 % večja kot pri tistih z normalnim delovanjem jeter.
English: improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g nominal p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001upadacitinib vs adalimumab comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison j nominal p<0.05 upadacitinib vs adalimumab comparison k nominal p≤0.01 upadacitinib vs placebo or MTX comparison l nominal p<0.05 upadacitinib vs MTX comparison
Slovenian: CRP = C-reaktivni protein, DAS28 = ocena aktivnosti bolezni v 28 sklepih (Disease Activity Score 28 joints), mTSS = modificirana celotna Sharpova ocena, csDMARD = konvencionalni sintezni imunomodulirajoči antirevmatik (conventional synthetic disease-modifying anti-rheumatic drug), HAQ-DI = indeks Health Assessment Questionnaire Disability Index, SF-36 PCS = ocena telesne komponente vprašalnika SF-36 (Short Form (36) Health Survey (SF-36) Physical Component Score), CDAI = indeks klinične aktivnosti bolezni (Clinical Disease Activity Index), FACIT-F = ocena utrujenosti (Functional Assessment of Chronic Illness Therapy-Fatigue score), IR = neustrezno odziven (inadequate responder), MTX = metotreksat, n = število randomiziranih.