FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections: Olumiant may make an existing infection worse or increase the chance of you getting a new infection or increase the chance of viral reactivation.
Croatian: Olumiant može pogoršati postojeću infekciju ili povećati vjerojatnost razvoja nove infekcije ili povećati vjerojatnost reaktivacije virusa.
English: Significant increases (> 5 x ULN) occurred in 0.8 % of patients treated with Olumiant and 0.3 % of patients treated with placebo.
Croatian: Značajan porast vrijednosti (> 5 x GGN) zabilježen je u 0,8% bolesnika liječenih lijekom Olumiant i 0,3% bolesnika koji su primali placebo.
English: You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
Croatian: Ako zatrudnite, morate o tome obavijestiti svog liječnika jer se Olumiant ne smije uzimati tijekom trudnoće.
English: Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials.
Croatian: Povišenja vrijednosti alanin transaminaze (ALT) i aspartat transaminaze (AST) na ≥ 5 odnosno ≥ 10 x iznad gornje granice normale (GGN) prijavljena su u manje od 1% bolesnika u kliničkim ispitivanjima.
English: Co-administration with OAT3 inhibitors
Croatian: Istodobna primjena s inhibitorima OAT3
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see section 4.8).
Croatian: U kliničkim je ispitivanjima prijavljena ponovna aktivacija virusa, uključujući slučajeve ponovne aktivacije virusa herpesa (npr. herpes zoster, herpes simpleks) (vidjeti dio 4.8).
English: It is unknown whether baricitinib/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se baricitinib/njegovi metaboliti u majčino mlijeko.
English: If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, Olumiant should be temporarily interrupted until this diagnosis is excluded.
Croatian: Ako se tijekom rutinskih mjera skrbi u bolesnika primijete povišenja vrijednosti ALT-a ili AST-a i posumnja na lijekom izazvano oštećenje jetre, primjenu lijeka Olumiant treba privremeno prekinuti dok se ta dijagnoza ne isključi.
English: Olumiant is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Croatian: Primjena lijeka Olumiant ne preporučuje se u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Data concerning use of baricitinib with potent immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and caution should be exercised when using such combinations (see section 4.5).
Croatian: Podaci o primjeni baricitiniba zajedno sa snažnim imunosupresivima (npr. azatioprinom, takrolimusom, ciklosporinom) su ograničeni pa je kod primjene tih kombinacija potreban oprez (vidjeti dio 4.5).
English: BEACON (24 weeks)
Croatian: RA-BEACON (24 tjedna)
English: Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
Croatian: Olumiant je indiciran za liječenje umjerenog do teškog oblika aktivnog reumatoidnog artritisa u odraslih bolesnika koji nisu dovoljno dobro odgovorili na jedan ili više antireumatskih lijekova koji modificiraju tijek bolesti ili koji ne podnose takve lijekove.
English: A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure.
Croatian: U kliničkim ispitivanjima primjene kod reumatoidnog artritisa, lijekom Olumiant bila su liječena ukupno 3464 bolesnika, što predstavlja 4214 bolesnik-godina izloženosti.
English: RA-BEAM (52 weeks)
Croatian: RA-BEAM (52 tjedna)
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Renal elimination is the principal mechanism for baricitinib's clearance through glomerular filtration and active secretion via OAT3, Pgp, BCRP and MATE2-K.
Croatian: Eliminacija kroz bubrege glavni je mehanizam klirensa baricitiniba, koji se odvija glomerularnom filtracijom i aktivnim izlučivanjem putem prijenosnika OAT3, P-gp, BCRP i MATE2-K.
English: Prior to launch of Olumiant in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Olumiant u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskih materijala,
English: Baricitinib induced a mean increase in serum creatinine levels of 3.8 µmol/L after two weeks of treatment, as compared to placebo, which remained stable thereafter during up to 104 weeks of treatment.
Croatian: U usporedbi s placebom, baricitinib je inducirao srednji porast razine kreatinina za 3,8 µmol/l nakon dva tjedna liječenja, koja je nakon toga ostala stabilna do 104. tjedna liječenja.
English: ALT increased ≥3 x ULNc AST increased ≥3 x ULNc
Croatian: Poremećaji jetre i žuči povišene vrijednosti ALT-a ≥ 3 x GGNc povišene vrijednosti AST-a ≥ 3 x GGNc
English: • Additional Patient Alert Cards
Croatian: • Dodatne kartice s upozorenjima za bolesnika
English: Renal function was found to significantly affect baricitinib exposure.
Croatian: Utvrđeno je da bubrežna funkcija značajno utječe na izloženost baricitinibu.
English: If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once a day.
Croatian: Ako imate smanjenu bubrežnu funkciju, preporučena doza lijeka Olumiant je 2 mg jedanput na dan.
English: Tell your doctor if you get symptoms such as fever, wounds, feeling more tired than usual or dental problems as these can be signs of infection.
Croatian: Recite svom liječniku ako se pojave simptomi poput vrućice, rana, pojačanog umora ili problema sa zubima, jer to mogu biti znakovi infekcije.
English: 5 Most common concomitant cDMARDs included MTX, hydroxychloroquine, leflunomide and sulfasalazine
Croatian: Najčešći kDMARD-ovi u istodobnoj primjeni uključivali su metotreksat, hidroksiklorokin, leflunomid i sulfasalazin
English: Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tuberculosis - have had a herpes infection (shingles), because Olumiant may allow it to come back.
Croatian: Obavijestite svog liječnika ako tijekom liječenja lijekom Olumiant primijetite dugotrajan kašalj, vrućicu, noćno znojenje i gubitak tjelesne težine, jer to mogu biti znakovi tuberkuloze. - ako ste nekada imali herpesnu infekciju (herpes zoster), jer Olumiant može uzrokovati njegov povratak.
English: Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score
Croatian: Kratice: ACR (American College of Rheumatology) = Američko reumatološko društvo; SDAI (Simplified Disease Activity Index) = pojednostavljen indeks aktivnosti bolesti; HAQ-DI (Health Assessment Questionnaire-Disability Index) = indeks onesposobljenosti prema upitniku za ocjenu zdravstvenog stanja; kDMARD = konvencionalni DMARD; mTSS (modified Total Sharp Score) = ukupan rezultat prema modificiranoj Sharpovoj ljestvici; MTX = metotreksat; s.c. = supkutano
English: Each tablet contains 2 or 4 milligrams of baricitinib.
Croatian: Jedna tableta sadrži 2 ili 4 miligrama baricitiniba.
English: If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted until the episode resolves.
Croatian: Ako se u bolesnika razvije herpes zoster, liječenje lijekom Olumiant mora se privremeno prekinuti dok se epizoda ne povuče.
English: In RA-BEAM and RA-BUILD, treatment with Olumiant 4 mg resulted in a significant improvement in the mean duration and severity of morning joint stiffness compared to placebo or adalimumab as assessed using daily electronic patient diaries for 12 weeks.
Croatian: U ispitivanjima RA-BEAM i RA-BUILD, liječenje lijekom Olumiant u dozi od 4 mg dovelo je do značajnog poboljšanja srednje vrijednosti trajanja i težine jutarnje ukočenosti zglobova u odnosu na placebo i adalimumab, što se ocjenjivalo na temelju unosa iz elektroničkih dnevnika bolesnika tijekom
English: Opportunistic infections related to demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure.
Croatian: U pasa su pri razinama izloženosti približno 7 puta većima od onih u ljudi primijećene oportunističke infekcije povezane s demodikozom (šugom).
English: • That treatment with Olumiant may increase the risk of infections, and viral reactivation.
Croatian: • Upozorenje da liječenje lijekom Olumiant može povećati rizik od infekcija i ponovne aktivacije virusa.
English: Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.
Croatian: CYP3A/CYP2C19/CYP2C9) ili rifampicina (snažnog induktora CYP3A) nije dovela do klinički značajnih promjena u izloženosti baricitinibu.
English: Patients should not be immunised using live attenuated vaccines shortly before or during treatment with Olumiant.
Croatian: Bolesnici se ne smiju cijepiti živim atenuiranim cjepivima neposredno prije ni tijekom liječenja lijekom Olumiant.
English: EU/1/16/1170/001 (14 film-coated tablets) EU/1/16/1170/002 (28 film-coated tablets) EU/1/16/1170/003 (28 x 1 film-coated tablets) EU/1/16/1170/004 (35 film-coated tablets) EU/1/16/1170/005 (56 film-coated tablets) EU/1/16/1170/006 (84 film-coated tablets) EU/1/16/1170/007 (84 x 1 film-coated tablets) EU/1/16/1170/008 (98 film-coated tablets)
Croatian: EU/1/16/1170/001 (14 filmom obloženih tableta) EU/1/16/1170/002 (28 filmom obloženih tableta) EU/1/16/1170/003 (28 x 1 filmom obložena tableta) EU/1/16/1170/004 (35 filmom obloženih tableta) EU/1/16/1170/005 (56 filmom obloženih tableta) EU/1/16/1170/006 (84 filmom obložene tablete) EU/1/16/1170/007 (84 x 1 filmom obložena tableta) EU/1/16/1170/008 (98 filmom obloženih tableta)
English: In controlled studies, for up to 16 weeks, increases in CPK values were common.
Croatian: U kontroliranim se ispitivanjima tijekom razdoblja do 16 tjedana često bilježio porast vrijednosti kreatin fosfokinaze (engl. creatine phosphokinase, CPK).
English: Summary of key outcome measures
Croatian: Sažetak ključnih mjera ishoda
English: Mean absolute lymphocyte count increased by 1 week after starting treatment with Olumiant, returned to baseline by week 24, and then remained stable through at least 104 weeks.
Croatian: Srednja vrijednost apsolutnog broja limfocita povećala se već prvog tjedna nakon početka liječenja lijekom Olumiant, vratila se na početnu vrijednost do 24. tjedna, a zatim je bila stabilna barem do 104. tjedna.
English: Therefore, the PRAC requests the MAH to update section 4.4 of the SmPC to modify the wording on “Venous Thromboembolism” to indicate that if clinical features of DVT/PE occur, baricitinib treatment should be discontinued and to update section 4.8 of the SmPC to add the adverse reaction pulmonary embolism and deep vein thrombosis with a frequency not known.
Croatian: Stoga PRAC traži od nositelja odobrenja da ažurira dio 4.4 sažetka opisa svojstava lijeka izmjenom teksta u odlomku „Venska tromboembolija“ kako bi se uvrstilo upozorenje da u slučaju pojave kliničkih značajki DVT-a/PE-a liječenje baricitinibom treba obustaviti te da ažurira dio 4.8 sažetka opisa svojstava lijeka radi uključivanja plućne embolije i duboke venske tromboze kao nuspojava nepoznate učestalosti.
English: Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.
Croatian: Ne preporučuje se primjena živih, atenuiranih cjepiva tijekom ili neposredno prije liječenja lijekom Olumiant.
English: EU/1/16/1170/009 (14 film-coated tablets) EU/1/16/1170/010 (28 film-coated tablets) EU/1/16/1170/011 (28 x 1 film-coated tablets) EU/1/16/1170/012 (35 film-coated tablets) EU/1/16/1170/013 (56 film-coated tablets) EU/1/16/1170/014 (84 film-coated tablets) EU/1/16/1170/015 (84 x 1 film-coated tablets) EU/1/16/1170/016 (98 film-coated tablets)
Croatian: EU/1/16/1170/009 (14 filmom obloženih tableta) EU/1/16/1170/010 (28 filmom obloženih tableta) EU/1/16/1170/011 (28 x 1 filmom obložena tableta) EU/1/16/1170/012 (35 filmom obloženih tableta) EU/1/16/1170/013 (56 filmom obloženih tableta) EU/1/16/1170/014 (84 filmom obložene tablete) EU/1/16/1170/015 (84 x 1 filmom obložena tableta) EU/1/16/1170/016 (98 filmom obloženih tableta)
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 mjera skrbi 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: Olumiant contains the active substance baricitinib.
Croatian: Olumiant sadrži djelatnu tvar baricitinib.
English: In vitro, baricitinib is a substrate for CYP3A4, OAT3, Pgp, BCRP and MATE2-K, and may be a clinically relevant inhibitor of the transporter OCT1 (see section 4.5).
Croatian: In vitro je baricitinib supstrat CYP3A4, OAT3, P-gp-a, BCRP-a i MATE2-K te bi mogao biti klinički značajan inhibitor prijenosnika OCT1 (vidjeti dio 4.5).
English: In a pre- and postnatal development study, decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, respectively, the human exposure.
Croatian: U ispitivanju učinaka na prenatalni i postnatalni razvoj primijećena je smanjena tjelesna težina mladunčadi i smanjeno postnatalno preživljenje pri razinama izloženosti koje su bile 4 odnosno 21 puta veće od onih u ljudi.
English: Patients should be managed according to international clinical guidelines for hyperlipidaemia
Croatian: Mjere skrbi u bolesnika trebaju biti u skladu s međunarodnim kliničkim smjernicama za hiperlipidemiju
English: In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F).
Croatian: U svim su ispitivanjima bolesnici liječeni lijekom Olumiant prijavili poboljšanje kvalitete života prema vlastitoj ocjeni, koje se određivalo rezultatom za tjelesnu komponentu u Kratkom upitniku o zdravstvenom stanju od 36 pitanja (engl.
English: In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.
Croatian: U prethodno neliječenih bolesnika, kombinacija s metotreksatom povećala je učestalost infekcija u usporedbi s monoterapijom baricitinibom.
English: Mean apparent clearance (CL/F) and half-life in patients with rheumatoid arthritis was 9.42 L/hr (CV = 34.3 %) and 12.5 hrs (CV = 27.4 %), respectively.
Croatian: Srednja vrijednost prividnog klirensa (CL/F) i poluvijeka u bolesnika s reumatoidnim artritisom iznosila je 9,42 l/hr (CV = 34,3%) odnosno 12,5 sati
English: Viral reactivation
Croatian: Ponovna aktivacija virusa
English: Neutropaenia
Croatian: Neutropenija
English: Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.
Croatian: P-gp-a/BCRP-a) ili metotreksatom (supstratom nekoliko prijenosnika, uključujući OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3 i MRP4) nije imala klinički značajnih učinaka na izloženost baricitinibu.
English: In controlled studies, for up to 16 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in 1.4 % and 0.8 % of patients treated with Olumiant, compared to 1.0 % and 0.8 % respectively of patients treated with placebo.
Croatian: U kontroliranim je ispitivanjima tijekom razdoblja do 16 tjedana porast vrijednosti alanin transaminaze (ALT) i aspartat transaminaze (AST) ≥ 3 x iznad gornje granice normale (GGN) primijećen u 1,4% odnosno 0,8% bolesnika liječenih lijekom Olumiant, u usporedbi s 1,0% odnosno 0,8% bolesnika koji su primali placebo.
English: For most patients, changes in lymphocyte count occurred within the normal reference range.
Croatian: U većine su se bolesnika promjene broja limfocita zadržale unutar normalnog referentnog raspona.
English: For up to 52 weeks, the frequency of ALT and AST elevations ≥ 3 x ULN were greater for the combination treatment of methotrexate and Olumiant (7.5 % and 3.8 %) compared to methotrexate alone (2.9 % and 0.5 %) or Olumiant alone (1.9 % and 1.3 %).
Croatian: Tijekom razdoblja do 52 tjedna, učestalost porasta vrijednosti ALT-a i AST-a ≥ 3 x GGN bila je veća uz kombinirano liječenje metotreksatom i lijekom Olumiant (7,5% odnosno 3,8%) nego uz metotreksat primijenjen samostalno (2,9% odnosno 0,5%) ili Olumiant primijenjen samostalno (1,9% naspram 1,3%).
English: Gastric pH modifying agents Elevating gastric pH with omeprazole had no clinically significant effect on baricitinib exposure.
Croatian: Lijekovi koji mijenjaju želučani pH Povišenje želučanog pH uslijed djelovanja omeprazola nije klinički značajno utjecalo na izloženost baricitinibu.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see section 5.3).
Croatian: Dostupni farmakokinetički/toksikološki podaci u životinja pokazali su da se baricitinib izlučuje u mlijeko
English: Laboratory monitoring
Croatian: Laboratorijsko mjerilo
English: • At week 12: 234/251 (93 %) continuing 4 mg vs. 207/251 (82 %) reduced to 2 mg (p ≤ 0.001)
Croatian: • U 12. tjednu: 234/251 (93%) bolesnika koji su nastavili liječenje dozom od 4 mg naspram207/251 (82%) bolesnika kojima je doza smanjena na 2 mg (p ≤ 0,001)
English: Polyvinylchloride/aluminium/oriented polyamide - aluminium perforated unit dose blisters in cartons of 28 x 1 or 84 x 1 film-coated tablets.
Croatian: Perforirani blisteri s jediničnim dozama, od polivinilklorida/aluminija/orijentiranog poliamida i aluminija, u kutijama koje sadrže 28 x 1 ili 84 x 1 filmom obloženu tabletu.
English: • Prescribers should screen the patients for viral hepatitis before commencing Olumiant treatment.
Croatian: • Napomenu da liječnici koji propisuju lijek moraju provesti probir bolesnika na virusni hepatitis prije nego što započnu liječenje lijekom Olumiant.
English: Monitoring Guidance
Croatian: Smjernice za praćenje
English: For most patients, changes in immunoglobulins occurred within the normal reference range.
Croatian: U većine su bolesnika promjene u vrijednostima imunoglobulina bile unutar normalnog referentnog raspona.
English: The mean ratios of Cmax in patients with mild and moderate renal impairment to patients with normal renal function are 1.16 (90 %CI: 0.92-1.45) and 1.46 (90 %CI: 1.17-1.83), respectively.
Croatian: Srednja vrijednost omjera Cmax u bolesnika s blagim odnosno umjerenim oštećenjem bubrežne funkcije i bolesnika s normalnom bubrežnom funkcijom iznosi 1,16 (90% CI: 0,92 - 1,45) odnosno 1,46 (90% CI: 1,17 - 1,83).
English: Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted.
Croatian: međutim trenutno nema poznatih selektivnih supstrata prijenosnika OCT1 za koje bi se mogle predvidjeti klinički značajne interakcije.
English: On background cDMARDs5 if on stable cDMARD at study entry
Croatian: Bolesnici su primali kDMARD-ove5 kao osnovnu terapiju ako su pri uključivanju u ispitivanje primali stabilnu dozu kDMARD-a
English: You should use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after the last Olumiant treatment.
Croatian: Morate koristiti učinkovitu metodu kontracepcije tijekom liječenja lijekom Olumiant i još najmanje tjedan dana po njegovu završetku kako biste izbjegli trudnoću.
English: to < 1/100).
Croatian: 5% odnosno 1% doze.
English: In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi preosjetljivosti na lijek povezani s primjenom baricitiniba.
English: Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of shingles (herpes zoster): - painful skin rash with blisters and fever
Croatian: Obavijestite svog liječnika ili odmah potražite liječničku pomoć ako se pojave sljedeći simptomi, koji mogu biti znakovi herpesa zoster:
English: INFORMATION IN BRAILLE Olumiant 4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olumiant 4 mg
English: Statistically significant pain reduction was seen as early as Week 1 and in studies RA-BEGIN and RA-BEAM this was maintained for up to 52 weeks.
Croatian: Statistički značajno smanjenje boli primijećeno je već u 1. tjednu, a u ispitivanjima RA-BEGIN i
English: You may need tests to check for tuberculosis before you are given Olumiant.
Croatian: Možda ćete prije liječenja lijekom Olumiant morati napraviti pretrage kako bi se utvrdilo imate li tuberkulozu.
English: The use of baricitinib has not been studied in patients with severe hepatic impairment.
Croatian: Primjena baricitiniba nije se ispitivala u bolesnika s teškim oštećenjem jetrene funkcije.
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 less than 1 % of patients in clinical trials.
Croatian: Apsolutan broj neutrofila (ABN) < 1 x 109 stanica/l, apsolutan broj limfocita (ABL) < 0,5 x 109 stanica/l i razina hemoglobina < 8 g/dl prijavljeni su u manje od 1% bolesnika u kliničkim ispitivanjima.
English: Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Croatian: Preporučuje se da prije početka liječenja lijekom Olumiant svi bolesnici obave sva potrebna cijepljenja u skladu s važećim smjernicama za cijepljenje.
English: INFORMATION IN BRAILLE Olumiant 2 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olumiant 2 mg
English: Decreases in lymphocytes, eosinophils and basophils as well as lymphoid depletion in organs/tissues of the immune system were observed in mice, rats and dogs.
Croatian: U miševa, štakora i pasa primijećen je pad broja limfocita, eozinofila i bazofila, kao i limfoidna deplecija u organima/tkivima imunosnog sustava.
English: In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.
Croatian: Istodobna primjena baricitiniba i supstrata CYP3A simvastatina, etinilestradiola ili levonorgestrela u kliničkim farmakološkim ispitivanjima nije uzrokovala klinički značajne promjene u farmakokinetici tih lijekova.
English: Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i još najmanje tjedan dana po njegovu završetku.