FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose related increases in foetal resorptions associated with post-implantation losses at 25 and 75 mg/kg/day in this study in rats were attributed to the developmental/teratogenic effects of upadacitinib.
Croatian: U ovom su ispitivanju na štakorima pri dozama od 25 i 75 mg/kg na dan opažena o dozi ovisna povećanja stope resorpcije ploda povezane s gubitkom ploda nakon implantacije, koja su pripisana razvojnoj toksičnosti/teratogenim učincima upadacitiniba.
English: Coadministration with CYP3A4 inhibitors
Croatian: Istodobna primjena s inhibitorima CYP3A4
English: Renal impairment has no clinically relevant effect on upadacitinib exposure.
Croatian: Oštećenje funkcije bubrega Oštećenje bubrežne funkcije nema klinički značajnog učinka na izloženost upadacitinibu.
English: • Low disease activity (DAS28-CRP)
Croatian: • Niska aktivnost bolesti (DAS28-CRP)
English: • Risk of herpes zoster o Language on the risk of herpes zoster during treatment with upadacitinib o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Croatian: • informacije o riziku od herpesa zostera o informacije o riziku od herpesa zostera tijekom liječenja upadacitinibom o napomenu da bolesnike treba upoznati sa znakovima/simptomima infekcije kojih moraju biti svjesni kako bi mogli brzo potražiti liječničku pomoć
English: • The patient alert card shall contain the following key messages: o Contact details of the upadacitinib prescriber o Language that the PAC should be carried by the patient at any time and to share it with HCPs involved in their care (i.e., non-upadacitinib prescribers, emergency room HCPs, etc.) o Description of signs/symptoms of infections the patient needs to be aware of, so that they can seek attention from their HCP:
Croatian: • Kartica s upozorenjima za bolesnika mora sadržavati sljedeće ključne poruke: o kontaktne podatke liječnika koji je propisao upadacitinib o napomenu da bolesnik mora uvijek sa sobom nositi Karticu s upozorenjima za bolesnika i pokazati je zdravstvenim radnicima koji sudjeluju u njegovu liječenju (tj. liječnicima koji mu nisu propisali upadacitinib, zdravstvenim radnicima u hitnoj službi itd.) o opis znakova/simptoma infekcija s kojima bolesnik mora biti upoznat kako bi mogao potražiti liječničku pomoć:
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.
Croatian: Osim toga, u usporedbi s bolesnicima koji su primali placebo, oni liječeni upadacitinibom prijavili su i značajno poboljšanje umora, koje se određivalo rezultatom za umor u Upitniku za funkcionalnu ocjenu terapije za kroničnu bolest (FACIT-F).
English: Prior to initiating upadacitinib, it is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement with current immunisation guidelines.
Croatian: Preporučuje se da prije početka liječenja upadacitinibom bolesnici prime sva potrebna cjepiva u skladu s važećim smjernicama za cijepljenje, uključujući profilaktičko cijepljenje protiv herpesa zostera.
English: • increased levels of cholesterol (a type of fat in the blood) as shown in tests
Croatian: • povišene vrijednosti kolesterola (jedne vrste masnoća u krvi), vidljive u nalazima krvnih pretraga
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.
Croatian: b Indeks onesposobljenosti prema upitniku za ocjenu zdravstvenog stanja: 0 = najbolje, 3 = najgore; 20 pitanja, 8 kategorija: odijevanje i njega, ustajanje, hranjenje, hod, higijena, dohvaćanje stvari, stisak šake i aktivnosti.
English: HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Croatian: Bočice izrađene od polietilena visoke gustoće (HDPE), sa sredstvom za sušenje i polipropilenskim zatvaračem, koje dolaze u kutijama i sadrže 30 tableta s produljenim oslobađanjem.
English: Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Croatian: U bolesnika koji su primali upadacitinib prijavljeni su slučajevi bakterijskog meningitisa.
English: Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
Croatian: Ljubičaste, ovalne, bikonveksne tablete s produljenim oslobađanjem dimenzija 14 x 8 mm, koje na jednoj strani imaju utisnutu oznaku „a15”.
English: LDA DAS28-CRP ≤3.2 (% of patients)
Croatian: Niska aktivnost bolesti: DAS28-CRP ≤ 3,2 (% bolesnika)
English: Treatment should be interrupted if ALC is < 500 cells/mm3 and may be restarted once ALC returns above this value
Croatian: Liječenje treba privremeno prekinuti ako je ABL < 500 stanica/mm3, a može se ponovno započeti kad se ABL
English: On background csDMARDs
Croatian: Osnovna terapija ksDMARD-ovima
English: Treatment should be interrupted if ANC is < 1,000 cells/mm3 and may be restarted once ANC returns above this value
Croatian: Liječenje treba privremeno prekinuti ako je ABN < 1000 stanica/mm3, a može se ponovno započeti kad se ABN
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.
Croatian: U placebom kontroliranim ispitivanjima u kojima su bolesnici primali DMARD-ove kao osnovnu terapiju u trajanju do 12/14 tjedana povišenja vrijednosti alanin transaminaze (ALT) i aspartat transaminaze (AST) ≥ 3 x iznad gornje granice normale (GGN) pri najmanje jednom mjerenju opažena su u 2,1% odnosno 1,5% bolesnika liječenih upadacitinibom u dozi od 15 mg, u usporedbi s 1,5% odnosno 0,7% bolesnika koji su primali placebo.
English: INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: 16. PODACI NA BRAILLEOVOM PISMU 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
Croatian: U usporedbi s ispitanicima s normalnom jetrenom funkcijom, Cmax upadacitiniba bio je nepromijenjen u onih s blagim oštećenjem jetrene funkcije te 43% veći u onih s umjerenim oštećenjem jetrene funkcije.
English: ACR50 (% of patients)
Croatian: ACR50 (% bolesnika)
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.
Croatian: U ispitivanju plodnosti i ranog embrionalnog razvoja upadacitinib nije utjecao na plodnost mužjaka ni ženki štakora pri dozama do 50 mg/kg na dan u mužjaka i 75 mg/kg na dan u ženki.
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.
Croatian: Ukupna dugoročna stopa oportunističkih infekcija u bolesnika liječenih upadacitinibom u dozi od 15 mg u svih pet kliničkih ispitivanja faze 3 iznosila je 0,6 događaja na 100 bolesnik-godina.
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.
Croatian: 15 mg u svih pet kliničkih ispitivanja faze 3 (2630 bolesnika) iznosila je 93,7 događaja na 100 bolesnik-godina.
English: Upadacitinib was administered in clinical studies up to doses equivalent in daily AUC to 60 mg prolonged-release once daily.
Croatian: U kliničkim se ispitivanjima upadacitinib primjenjivao do doza koje s obzirom na dnevni AUC odgovaraju tabletama s produljenim oslobađanjem od 60 mg primijenjenima jedanput na dan.
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.
Croatian: dovela je do o dozi i koncentraciji ovisne inhibicije fosforilacije STAT3 inducirane djelovanjem IL-6 (JAK1/JAK2) i fosforilacije STAT5 inducirane djelovanjem IL-7 (JAK1/JAK3).
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.
Croatian: U MTX-om kontroliranim ispitivanjima u trajanju do 12/14 tjedana, povišenja vrijednosti ALT-a i AST-a ≥ 3 x GGN pri najmanje jednom mjerenju opažena su u 0,8% odnosno 0,4% bolesnika liječenih upadacitinibom u dozi od 15 mg, u usporedbi s 1,9% odnosno 0,9% bolesnika koji su primali MTX.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija s 98 tableta
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.
Croatian: U svim je ispitivanjima faze 3 djelotvornost opažena kod primjene upadacitiniba u dozi od 15 mg jedanput na dan u načelu bila slična onoj opaženoj kod primjene upadacitiniba u dozi od 30 mg jedanput na dan.
English: Note: Week 48-data derived from analysis on Full Analysis set (FAS) by randomised group using NonResponder Imputation
Croatian: l nominalna p-vrijednost < 0,05 za upadacitinib u odnosu na MTX Napomena: Podaci za 48. tjedan proizlaze iz analize potpunog skupa podataka za analizu prema randomiziranoj skupini, u kojoj se koristila zamjena nedostajućih podataka (imputacija) za bolesnike bez odgovora.
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.
Croatian: umjerenim (procijenjena brzina glomerularne filtracije: 30 - 59 ml/min/1,73 m2) odnosno teškim (procijenjena brzina glomerularne filtracije: 15 - 29 ml/min/1,73 m2) oštećenjem bubrežne funkcije.
English: Store in the original blister or bottle in order to protect from moisture.
Croatian: Čuvati u originalnom blisteru ili bočici radi zaštite od vlage.
English: • increased levels of triglycerides (a type of fat in the blood) as shown in tests
Croatian: • povišene vrijednosti triglicerida (jedne vrste masnoća u krvi), vidljive u nalazima krvnih pretraga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija unutar višestrukog pakiranja od 84 tablete (bez plavog okvira)
English: In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
Croatian: U kliničkom je ispitivanju istodobna primjena upadacitiniba i ketokonazola povećala Cmax upadacitiniba za 70%, a njegov AUC
English: The use of upadacitinib has not been studied in subjects with end stage renal disease.
Croatian: Primjena upadacitiniba nije se ispitivala u osoba u završnom stadiju bubrežne bolesti.
English: 98 prolonged-release tablets.
Croatian: 98 tableta s produljenim oslobađanjem.
English: Each prolonged-release tablet contains 15 mg of upadacitinib (as upadacitinib hemihydrate).
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 15 mg upadacitiniba (u obliku upadacitinib hemihidrata).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati RINVOQ Lijek čuvajte izvan pogleda i dohvata djece.
English: The pattern and incidence of elevation in ALT/AST remained stable over time including in long term extension studies.
Croatian: Obrazac i incidencija povišenja vrijednosti ALT-a/AST-a ostali su stabilni tijekom vremena,
English: There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Croatian: Podaci o primjeni upadacitiniba u osoba s teškim oštećenjem bubrežne funkcije su ograničeni (vidjeti dio 5.2).
English: Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.
Croatian: Žene reproduktivne dobi treba uputiti da koriste učinkovitu kontracepciju tijekom liječenja i još
English: Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.
Croatian: U bolesnika koji su primali upadacitinib prijavljene su ozbiljne infekcije koje su ponekad imale smrtni ishod.
English: Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:
Croatian: Prije početka liječenja upadacitinibom potrebno je razmotriti rizike i koristi liječenja u bolesnika:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija višestrukog pakiranja od 84 tablete (s plavim okvirom)
English: There was a higher rate of serious infections in patients ≥ 75 years of age, although data are limited.
Croatian: Premda su podaci ograničeni, stopa ozbiljnih infekcija bila je viša u bolesnika u dobi od ≥ 75 godina.
English: • Do not swallow the desiccant.
Croatian: • Nemojte progutati sredstvo za sušenje.
English: Upadacitinib AUC was 28% and 24% higher in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal liver function.
Croatian: U usporedbi s ispitanicima s normalnom jetrenom funkcijom, AUC upadacitiniba bio je 28% odnosno 24% veći u onih s blagim odnosno umjerenim oštećenjem jetrene funkcije.
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).
Croatian: Liječenje upadacitinibom u dozi od 15 mg dovelo je do značajno veće inhibicije progresije strukturnog oštećenja zglobova u usporedbi s placebom u kombinaciji s MTX-om u ispitivanju
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
Croatian: Kutija za bočicu (pakiranje od 30 i 90 tableta)
English: Upper respiratory tract infections (URTI)*
Croatian: Infekcije i infestacije infekcije gornjih dišnih putova*
English: Evaluate at baseline and thereafter according to routine patient management
Croatian: Ocijeniti na početku liječenja, a zatim u skladu s rutinskim postupcima u sklopu liječenja bolesnika
English: Store in original blister or bottle with the lid tightly closed to protect from moisture.
Croatian: Čuvati u originalnom blisteru ili čvrsto zatvorenoj bočici radi zaštite od vlage.
English: • Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
Croatian: • Trigliceridi ≥ 2,26 mmol/l (200 mg/dl): 25% u skupini koja je primala upadacitinib u dozi od 15 mg naspram 15% u skupini koja je primala placebo
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy, although evidence is limited.
Croatian: Premda su dokazi ograničeni, terapija statinima snizila je povišene vrijednosti LDL-kolesterola na razine zabilježene prije početka liječenja.
English: 30 prolonged-release tablets
Croatian: 30 tableta s produljenim oslobađanjem
English: Upadacitinib should be used with caution in patients with severe renal impairment.
Croatian: Upadacitinib treba primjenjivati uz oprez u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Therefore, upadacitinib plasma exposures can be affected by medicinal products that strongly inhibit or induce CYP3A4.
Croatian: Stoga lijekovi koji snažno inhibiraju ili induciraju CYP3A4 mogu utjecati na plazmatsku izloženost upadacitinibu.
English: • HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
Croatian: • HDL-kolesterol ≥ 1,03 mmol/l (40 mg/dl): 89% u skupini koja je primala upadacitinib u dozi od 15 mg naspram 61% u skupini koja je primala placebo
English: Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Croatian: Ako se u bolesnika razvije ozbiljna infekcija, liječenje treba privremeno prekinuti dok se ona ne stavi pod kontrolu.
English: 49 prolonged-release tablets.
Croatian: 49 tableta s produljenim oslobađanjem.
English: Overall, both low disease activity and clinical remission rates were consistent across patient populations, with or without MTX.
Croatian: Sveukupno su i stope niske aktivnosti bolesti i stope kliničke remisije bile dosljedne u svim populacijama bolesnika,
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.
Croatian: U 2-godišnjem ispitivanju kancerogenosti na Sprague-Dawley štakorima upadacitinib nije imao kancerogeni učinak pri izloženosti koja je u mužjaka bila približno 4, a u ženki približno 10 puta veća od one koja se postiže kliničkom dozom od 15 mg (na temelju AUC-a).
English: If you are a woman of child-bearing potential, you must use effective contraception to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose of RINVOQ.
Croatian: Ako ste žena koja može zatrudnjeti, morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom
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.
Croatian: U placebom kontroliranim kliničkim ispitivanjima u kojima su bolesnici primali DMARD-ove kao osnovnu terapiju učestalost infekcija tijekom 12/14 tjedana iznosila je 27,4% u skupini liječenoj upadacitinibom u dozi od 15 mg te 20,9% u skupini koja je primala placebo.
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Croatian: U bolesnika koji su primali JAK inhibitore, uključujući upadacitinib, prijavljeni su slučajevi duboke venske tromboze (DVT) i plućne embolije (PE).
English: Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Croatian: Od oportunističkih su infekcija kod primjene upadacitiniba prijavljene tuberkuloza, herpes zoster koji zahvaća više dermatoma, kandidijaza usne šupljine/jednjaka te kriptokokoza.
English: Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy.
Croatian: Prije početka liječenja upadacitinibom u bolesnika treba provesti probir na tuberkulozu (TBC).
English: AbbVie Kft. Tel.:+36 1 455 8600
Croatian: Tel.:+36 1 455 8600
English: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim (Child Pugh stadij A) ili umjerenim (Child
English: 28 prolonged-release tablets
Croatian: 28 tableta s produljenim oslobađanjem
English: 28 prolonged-release tablets.
Croatian: 28 tableta s produljenim oslobađanjem.
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).
Croatian: apsolutnim brojem neutrofila (ABN) < 1000 stanica/mm3 ili vrijednošću hemoglobina (Hb) < 8 g/dl (vidjeti dijelove 4.4 i 4.8).
English: • LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
Croatian: • LDL-kolesterol ≥ 3,36 mmol/l (130 mg/dl): 42% u skupini koja je primala upadacitinib u dozi od 15 mg naspram 19% u skupini koja je primala placebo
English: • Primary endpoint: clinical remission (DAS28-CRP) at week 12
Croatian: • Primarna mjera ishoda: niska aktivnost bolesti (DAS28-CRP) u 12. tjednu
English: Hypercholesterolaemia Hypertriglyceridaemia
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemija hipertrigliceridemija
English: • Language for HCPs to inform patients of the importance of the PAC
Croatian: • napomenu zdravstvenim radnicima da bolesnicima objasne važnost Kartice s upozorenjima za bolesnika
English: • Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
Croatian: • ukupan kolesterol ≥ 5,17 mmol/l (200 mg/dl): 62% u skupini koja je primala upadacitinib u dozi od 15 mg naspram 31% u skupini koja je primala placebo
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.
Croatian: U bolesnika s prethodno neliječenim latentnim TBC-om ili faktorima rizika za infekciju TBC-om potrebno je razmotriti antituberkuloznu terapiju prije početka liječenja upadacitinibom.
English: In methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group.
Croatian: U ispitivanjima kontroliranima metotreksatom (MTX) učestalost infekcija tijekom 12/14 tjedana iznosila je 19,5% u skupini koja je primala monoterapiju upadacitinibom u dozi od 15 mg te 24,0% u skupini koja je primala MTX.
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.
Croatian: U placebom kontroliranim ispitivanjima u kojima su bolesnici primali DMARD-ove kao osnovnu terapiju u trajanju do 12/14 tjedana, pad broja neutrofila ispod 1000 stanica/mm3 pri najmanje jednom mjerenju zabilježen je u 1,1% bolesnika liječenih upadacitinibom u dozi od 15 mg te < 0,1% onih koji su primali placebo.
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
Croatian: o informacije o riziku od MACE događaja tijekom liječenja upadacitinibom o informacije o riziku od hiperlipidemije tijekom terapije upadacitinibom o pojedinosti o praćenju razina lipida i zbrinjavanju povišenih razina lipida u skladu s kliničkim smjernicama
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.
Croatian: U kliničkim su ispitivanjima bolesnici liječeni upadacitinibom, u usporedbi s onima koji su primali placebo ili MTX, prijavili značajno poboljšanje kvalitete života prema ocjeni bolesnika, koje se određivalo rezultatom za tjelesnu komponentu u Kratkom upitniku o zdravstvenom stanju od