FrancophonIA/ELRC3.0 huggingface dataset:
English: The risks and benefits of upadacitinib treatment should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing upadacitinib therapy in patients who develop a malignancy.
Croatian: Potrebno je razmotriti rizike i koristi liječenja upadacitinibom prije početka terapije u bolesnika s poznatom zloćudnom bolešću osim uspješno liječenog nemelanomskog raka kože ili kada se razmatra nastavak terapije upadacitinibom u bolesnika kod kojih se razvila zloćudna bolest.
English: • thrush in the mouth (white patches in the mouth)
Croatian: • gljivična infekcija kandidom u ustima (bijele mrlje u ustima)
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.
Croatian: Upadacitinib je bio teratogen u štakora i kunića, uz učinke na kosti ploda kod štakora i na srce ploda kod kunića kod izlaganja lijeku in utero.
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%).
Croatian: Učestalosti infekcija kao nuspojava zabilježenih uz upadacitinib u odnosu na placebo bile su sljedeće: infekcija gornjih dišnih putova (13,5% naspram 9,5%), pneumonija (0,5% naspram 0,3%), herpes zoster (0,7% naspram 0,2%), herpes simpleks (0,8% naspram 0,5%) i oralna kandidijaza (0,4%
English: • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
Croatian: • Jezgra tablete: mikrokristalična celuloza, manitol, tartaratna kiselina, hipromeloza, bezvodni koloidni silicijev dioksid, magnezijev stearat.
English: Time to onset of efficacy was rapid across measures with greater responses seen as early as week 1 for ACR20.
Croatian: Nastup djelotvornosti kod svih je mjerila bio brz, uz veće stope odgovora primijećene već od 1. tjedna za
English: Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
Croatian: Cmax upadacitiniba bio je sličan u ispitanika s normalnom i onih s oštećenom bubrežnom funkcijom.
English: (DAS28-CRP) at week 24
Croatian: (DAS28-CRP) u 24. tjednu
English: If hepatitis B virus DNA is detected while receiving upadacitinib, a liver specialist should be consulted.
Croatian: Ako se tijekom liječenja upadacitinibom utvrdi prisutnost DNK virusa hepatitisa B, treba se savjetovati sa specijalistom za jetrene bolesti.
English: If you stop taking RINVOQ
Croatian: Ako prestanete uzimati RINVOQ
English: RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Croatian: RINVOQ je dostupan u pakiranjima koja sadrže 28 ili 98 tableta s produljenim oslobađanjem te u višestrukim pakiranjima s 84 tablete, koja sadrže 3 kutije od 28 tableta s produljenim oslobađanjem.
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).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka RINVOQ u jednoj ili više podskupina pedijatrijske populacije za liječenje kroničnog idiopatskog artritisa (uključujući reumatoidni artritis, psorijatični artritis, spondiloartritis i juvenilni idiopatski artritis)
English: Upadacitinib partitions similarly between plasma and blood cellular components, as indicated by the blood to plasma ratio of 1.0.
Croatian: Upadacitinib se u sličnoj mjeri vezuje za plazmatske i krvne stanične komponente, što pokazuje omjer koncentracije lijeka u krvi i plazmi od
English: Upadacitinib has no or negligible influence on the ability to drive and use machines.
Croatian: Upadacitinib ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • A patient alert card
Croatian: • Karticu s upozorenjima za bolesnika
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).
Croatian: RINVOQ je dostupan u bočicama sa sredstvom za sušenje koje sadrže 30 tableta s produljenim oslobađanjem, a jedno pakiranje sadrži 1 bočicu (pakiranje od 30 tableta) ili 3 bočice (pakiranje od
English: RINVOQ is not recommended for use in children and adolescents under 18 years of age.
Croatian: Primjena lijeka RINVOQ ne preporučuje se u djece i adolescenata mlađih od 18 godina jer se nije ispitivao u toj dobnoj skupini.
English: Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles
Croatian: Obavijestite svog liječnika ako primijetite bolan kožni osip praćen mjehurićima, jer to može biti znak herpesa zostera.
English: Treatment should be interrupted if Hb is < 8 g/dL and may be restarted once Hb returns above this value
Croatian: Liječenje treba privremeno prekinuti ako je Hb < 8 g/dl, a može se ponovno započeti kad se
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
Croatian: Pretrage povišene vrijednosti CPKa u krvi povišene vrijednosti ALT-a povišene vrijednosti AST-a povećanje tjelesne težine * Infekcija gornjih dišnih putova uključuje: akutni sinusitis, laringitis, nazofaringitis, orofaringealna bol, faringitis, faringotonzilitis, rinitis, sinusitis, tonzilitis, virusnu infekciju gornjih dišnih putova.
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.
Croatian: Kalendarski blisteri od polivinilklorida/polietilena/poliklorotrifluoroetilena i aluminija u pakiranjima koja sadrže 28 ili 98 tableta s produljenim oslobađanjem ili u višestrukim pakiranjima koja sadrže
English: • Risk of foetal malformation o Language on teratogenicity of upadacitinib in animals o Details on how to reduce the risk of exposure during pregnancy for women of childbearing potential based on the following: upadacitinib is contraindicated during pregnancy, women of childbearing potential should be advised to use effective contraception both during treatment and for 4 weeks after the final dose of upadacitinib treatment, and to advise patients to inform their HCP immediately if they think they could be pregnant or if pregnancy is confirmed.
Croatian: • informacije o riziku od malformacija ploda o informacije o teratogenosti upadacitiniba u životinja o pojedinosti o tome kako u žena reproduktivne dobi smanjiti rizik od izlaganja lijeku tijekom trudnoće na temelju sljedećih činjenica: upadacitinib je kontraindiciran tijekom trudnoće, pa žene reproduktivne dobi treba uputiti da koriste učinkovitu kontracepciju tijekom liječenja i još 4 tjedna nakon posljednje doze upadacitiniba te da odmah obavijeste svog liječnika ako misle da bi mogle biti trudne ili ako potvrde trudnoću
English: Monitoring guidance
Croatian: Smjernice za praćenje
English: Week 24e/26f
Croatian: 24.e/26.f tjedan
English: If you forget to take RINVOQ
Croatian: Ako ste zaboravili uzeti RINVOQ
English: (DAS28-CRP) at week 12
Croatian: (DAS28-CRP) u 12. tjednu
English: CR DAS28-CRP <2.6 (% of patients)
Croatian: Klinička remisija: DAS28-CRP < 2,6 (% bolesnika)
English: • medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus)
Croatian: • lijekove koji djeluju na imunološki sustav (kao što su azatioprin, ciklosporin i takrolimus)
English: The recommended dose of upadacitinib is 15 mg once daily.
Croatian: Doziranje Preporučena doza upadacitiniba je 15 mg jedanput na dan.
English: Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as Week 1 which were maintained with continued treatment.
Croatian: Liječenje upadacitinibom bilo je povezano sa sniženjima srednjih vrijednosti hsCRP-a od početne razine već u 1. tjednu, koja su se održala i u nastavku liječenja.
English: How to take RINVOQ Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
Croatian: U kliničkim je ispitivanjima prijavljena reaktivacija virusa, uključujući slučajeve reaktivacije virusa herpesa (npr. herpes zoster) (vidjeti dio 4.8).
English: Baseline score, mean Week 12c/14d
Croatian: Početni rezultat, srednja vrijednost 12.c/14.d tjedan
English: Upadacitinib was teratogenic in both rats and rabbits.
Croatian: Upadacitinib se pokazao teratogenim i u štakora i u kunića.
English: • Clinical remission (DAS28-CRP)
Croatian: • Klinička remisija (DAS28-CRP)
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
Croatian: c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g p-vrijednost kontrolirana za multiplicitet ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX h nominalna p-vrijednost ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX i nominalna p-vrijednost ≤ 0,01 za upadacitinib u odnosu na adalimumab
English: Compared to adalimumab, significantly higher rates of low disease activity were achieved at week 12 in SELECT-COMPARE.
Croatian: U ispitivanju SELECT-COMPARE su u usporedbi s adalimumabom ostvarene značajno veće stope niske aktivnosti bolesti u 12. tjednu.
English: In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
Croatian: U kliničkim se ispitivanjima upadacitinib primjenjivao neovisno o obrocima (vidjeti dio 4.2).
English: Modified Total Sharps Score, mean change from baseline
Croatian: Rezultat prema modificiranoj Sharpovoj ljestvici, srednja vrijednost promjene od početne vrijednosti
English: • Instructions for how to access digital HCP information
Croatian: • upute za pristup informacijama za zdravstvene radnike u digitalnom formatu • informacije o tome gdje prijaviti nuspojave
English: • Low disease activity (DAS28-CRP) vs adalimumab
Croatian: • Niska aktivnost bolesti (DAS28-CRP) u odnosu na adalimumab
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).
Croatian: Apsolutni broj neutrofila (ABN) < 1 x 109 stanica/l, apsolutni broj limfocita (ABL) < 0,5 x 109 stanica/l i razina hemoglobina < 8 g/dl prijavljeni su u ≤ 1% bolesnika u kliničkim ispitivanjima (vidjeti dio 4.8).
English: In a clinical study, coadministration of upadacitinib after multiple doses of rifampicin (strong CYP3A inducer) resulted in approximately 50% and 60% decreases in upadacitinib Cmax and AUC, respectively.
Croatian: U kliničkom je ispitivanju istodobna primjena upadacitiniba nakon višestrukih doza rifampicina (snažnog induktora CYP3A) smanjila Cmax upadacitiniba za približno 50%, a njegov AUC za približno 60%.
English: Turn the cap over and place the cutting tool near the edge of the foil seal.
Croatian: Okrenite zatvarač i postavite rezač uz rub zaštitne folije.
English: • increased levels of liver enzymes, shown by blood tests (sign of liver problems)
Croatian: • povišene vrijednosti jetrenih enzima, vidljive u nalazima krvnih pretraga (znak jetrenih tegoba)
English: Common (may affect up to 1 in 10 people)
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) • kašalj
English: There are limited data in patients aged 75 years and older.
Croatian: Podaci o primjeni u bolesnika u dobi od 75 i više godina su ograničeni.
English: No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.
Croatian: Ne preporučuje se prilagođavati dozu supstrata CYP3A kao ni dozu rosuvastatina ili atorvastatina kada se ti lijekovi primjenjuju istodobno s upadacitinibom.
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Croatian: PRILOG I. 0BSAŽETAK OPISA SVOJSTAVA LIJEKA
English: Upadacitinib is metabolised mainly by CYP3A4.
Croatian: Upadacitinib se prvenstveno metabolizira putem enzima CYP3A4.
English: Week 24b/26c
Croatian: 24.b/26.c tjedan
English: Treatment with upadacitinib was associated with a small, transient increase in mean ALC from baseline up to Week 36 which gradually returned to at or near baseline levels with continued treatment.
Croatian: Liječenje upadacitinibom bilo je povezano s malim, prolaznim porastom srednje vrijednosti ABL-a od početka ispitivanja do 36. tjedna, koji se s nastavkom liječenja postupno vratio na početnu vrijednost ili blizu te vrijednosti.
English: Physical function response and health-related outcomes Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a significantly greater improvement in physical function compared to all comparators as measured by HAQ-DI (see Table 6).
Croatian: Liječenje upadacitinibom u dozi od 15 mg u monoterapiji ili u kombinaciji s ksDMARD-ovima dovelo je do značajno većeg poboljšanja tjelesne funkcije u odnosu na sve usporedne lijekove, što je utvrđeno upitnikom HAQ-DI (vidjeti Tablicu 6).
English: Remove the cap from the bottle by pushing down and while still pushing, turn the cap anti-clockwise.
Croatian: Skinite zatvarač s bočice tako da ga pritisnete i, držeći ga pritisnutim, okrećete zatvarač u smjeru suprotnom od kazaljke na satu.
English: How to take RINVOQ
Croatian: Kako uzimati RINVOQ
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).
Croatian: Liječenje se ne smije započeti ili se mora privremeno prekinuti u bolesnika u kojih se tijekom rutinskih postupaka u sklopu liječenja utvrdi ABN < 1 x 109 stanica/l, ABL < 0,5 x 109 stanica/l ili razina hemoglobina < 8 g/dl (vidjeti dio 4.2).
English: Treatment group MTX
Croatian: Liječena skupina MTX
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:
Croatian: • upozorenje bolesnicima i zdravstvenim radnicima o riziku povezanom s primjenom živih cjepiva tijekom terapije upadacitinibom o opis odabranih rizika radi povećanja svijesti bolesnika i zdravstvenih radnika koji sudjeluju u njegovu liječenju, uključujući:
English: Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
Croatian: Upadacitinib se ne smije primjenjivati u bolesnika s teškim (Child Pugh stadij C) oštećenjem jetrene funkcije (vidjeti dio 4.3).
English: Table 6: Mean change from baseline in HAQ-DIa,b Study
Croatian: Tablica 6: Srednja vrijednost promjene početnog HAQ-DI rezultataa,b
English: This is because some medicines may reduce how well RINVOQ works or may increase the risk of getting side effects.
Croatian: Naime, neki lijekovi mogu smanjiti djelovanje lijeka RINVOQ ili povećati rizik od nuspojava.
English: Coadministration with CYP3A4 inducers
Croatian: Istodobna primjena s induktorima CYP3A4
English: • Severe hepatic impairment (see section 4.2).
Croatian: • Teško oštećenje jetrene funkcije (vidjeti dio 4.2).
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
Croatian: 47h Kratice: ACR20 (ili 50 ili 70) = poboljšanje za ≥ 20% (ili ≥ 50% ili ≥ 70%) prema kriterijima Američkog reumatološkog društva; ADA = adalimumab; CDAI = klinički indeks aktivnosti bolesti; CRP = C-reaktivni protein, DAS28 = indeks aktivnosti bolesti na 28 zglobova; MTX = metotreksat; PBO = placebo; UPA = upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e p-vrijednost kontrolirana za multiplicitet ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX f p-vrijednost kontrolirana za multiplicitet ≤ 0,01 za upadacitinib u odnosu na placebo ili MTX g nominalna p-vrijednost ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX h nominalna p-vrijednost ≤ 0,001 za upadacitinib u odnosu na adalimumab i nominalna p-vrijednost ≤ 0,01 za upadacitinib u odnosu na adalimumab j nominalna p-vrijednost < 0,05 za upadacitinib u odnosu na adalimumab k nominalna p-vrijednost ≤ 0,01 za upadacitinib u odnosu na placebo ili MTX
English: Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnoj bočici, a bočicu držati čvrsto zatvorenom radi zaštite od vlage.
English: ACR20 (% of patients)
Croatian: ACR20 (% bolesnika)
English: Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
Croatian: Kratice: ACR20 (ili 50) = poboljšanje za ≥ 20% (ili ≥ 50%) prema kriterijima Američkog reumatološkog društva; bDMARD = biološki antireumatski lijek koji modificira tijek bolesti; CRP =
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK values were observed.
Croatian: U placebom kontroliranim ispitivanjima u kojima su bolesnici primali DMARD-ove kao osnovnu terapiju u trajanju do 12/14 tjedana opažena su povišenja vrijednosti CPK-a.
English: This is to check for a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high blood fat (cholesterol) or high levels of liver enzymes.
Croatian: Prije nego što započnete liječenje lijekom RINVOQ ili tijekom liječenja, morat ćete obavljati krvne pretrage kako bi se utvrdilo imate li nizak broj crvenih krvnih stanica (anemiju), nizak broj bijelih krvnih stanica (neutropeniju ili limfopeniju), visoku razinu masnoća (kolesterola) u krvi ili visoke razine jetrenih enzima.
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.
Croatian: Ukupna dugoročna stopa ozbiljnih infekcija u bolesnika liječenih upadacitinibom u dozi od 15 mg u svih pet kliničkih ispitivanja faze 3 iznosila je 3,8 događaja na 100 bolesnik-godina.
English: RINVOQ 15 mg prolonged-release tablets upadacitinib
Croatian: RINVOQ 15 mg tablete s produljenim oslobađanjem upadacitinib
English: ACR70 (% of patients)
Croatian: ACR70 (% bolesnika)
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
Croatian: e nominalna p-vrijednost ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX f p-vrijednost kontrolirana za multiplicitet ≤ 0,01 za upadacitinib u odnosu na placebo ili MTX g p-vrijednost kontrolirana za multiplicitet ≤ 0,001 za upadacitinib u odnosu na placebo ili MTX
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Unutarnja kutija s 49 tableta (za pakiranje od 98 tableta)
English: RINVOQ 15 mg prolonged-release tablets
Croatian: RINVOQ 15 mg tablete s produljenim oslobađanjem
English: Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.
Croatian: Upadacitinib se nije ispitivao u bolesnika s teškim (Child-Pugh stadij C) oštećenjem jetrene funkcije.
English: The decreases in neutrophil counts remained stable at a lower value than baseline over time including with extended therapy.
Croatian: Potom se broj neutrofila tijekom vremena stabilno zadržavao na razini nižoj od početne, čak i uz dugoročnu terapiju.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se upadacitinib izlučuje u mlijeko
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Bottle Label
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin).
Croatian: Cmax atorvastatina kao ni na plazmatsku izloženost orto-hidroksiatorvastatinu (glavnom aktivnom metabolitu atorvastatina).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Blister Carton (Individual carton)
Croatian: Kutija za blistere (pojedinačno pakiranje)
English: Patients 18 years of age and older were eligible to participate.
Croatian: U ispitivanjima su mogli sudjelovati bolesnici u dobi od 18 i više godina.
English: Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
Croatian: Za pomoć pri donošenju odluke o tome je li antituberkulozna terapija prikladna za određenog bolesnika preporučuje se konzultirati liječnika koji je stručnjak za liječenje TBC-a.
English: If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.
Croatian: ALT-a ili AST-a i posumnja na oštećenje jetre uzrokovano lijekom, terapiju upadacitinibom treba privremeno prekinuti dok se ta dijagnoza ne isključi.
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.
Croatian: • informacije o riziku od ozbiljnih i oportunističkih infekcija, uključujući TBC o informacije o riziku od infekcija tijekom liječenja upadacitinibom o pojedinosti o tome kako smanjiti rizik od infekcije provođenjem specifičnih kliničkih mjera (koje laboratorijske parametre treba odrediti prije uvođenja liječenja upadacitinibom, probir na TBC, cijepljenje bolesnika u skladu s lokalnim smjernicama i privremeni prekid liječenja upadacitinibom u slučaju razvoja infekcije)
English: Important to open
Croatian: Važno - odlijepiti