FrancophonIA/ELRC3.0 huggingface dataset:
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving etanercept during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Croatian: 17 godina, 43 od 69 (62%) djece imalo je infekciju tijekom primanja etanercepta u toku tromjesečnog ispitivanja (prvi dio, otvoreno ispitivanje), a učestalost i težina infekcija bile su slične u 58 bolesnika koji su završili produljeno liječenje tijekom 12 mjeseci otvorenog ispitivanja.
English: n =
Croatian: n = tj.
English: Instructions for use of the Erelzi SensoReady pen
Croatian: Upute za uporabu Erelzi SensoReady brizgalice
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Croatian: bolesnika; 1,0 događaja po bolesnik-godini), bolove u abdomenu (19% bolesnika; 0,74 događaja po bolesnik-godini) i povraćanje (13%; 0,74 događaja po bolesnik-godini).
English: Erelzi is supplied as a solution for injection in a pre-filled pen (SensoReady).
Croatian: Erelzi je dostupan kao otopina za injekciju u napunjenoj brizgalici (SensoReady).
English: Removing the cap:
Croatian: Skidanje poklopca:
English: Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Croatian: Liječenje dozom etanercepta od 25 mg rezultiralo je znatnim poboljšanjem nakon 12 mjeseci s oko 44% bolesnika koji su dostigli normalnu ocjenu na upitniku
English: Erelzi is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Croatian: Djeca i adolescenti Erelzi nije indiciran za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg.
English: 63.2% †, ϕ
Croatian: 43,0% 63,2% †,φ
English: Etanercept was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Croatian: Etanercept je primijenjen u dozama od 25 mg jednom tjedno, 25 mg dvaput tjedno ili 50 mg dvaput tjedno tijekom 6 uzastopnih mjeseci.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including etanercept, in the post-marketing setting.
Croatian: U razdoblju nakon stavljanja lijeka u promet među djecom, adolescentima i mlađim odraslima (do 22 godine) liječenih antagonistima TNF-a, uključujući etanercept (početak liječenja ≤ 18 godina starosti), prijavljeni su slučajevi zloćudnih bolesti, od kojih su neki imali smrtni ishod.
English: The needle cap should not be removed while allowing the pre-filled syringe to reach room temperature.
Croatian: Poklopac igle se ne smije ukloniti dok napunjena brizgalica ne dosegne sobnu temperaturu.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n = 153) and 1.40 the spine (n = 154).
Croatian: MR-a za sve etanerceptom liječene ispitanike bila je 4,64 za sakroilijalni zglob (n = 153) i 1,40 za kralježnicu (n = 154).
English: Other etanercept products with appropriate dosage forms for children are available.
Croatian: Dostupni su drugi lijekovi koji sadrže etanercept s jačinom prikladnom za primjenu u djece.
English: Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis
Croatian: (uključujući angioedem, bronhospazam) , sarkoidoza
English: Multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes or pre-filled pens or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes of Erelzi.
Croatian: Višestruka pakiranja sadrže 12 (3 pakiranja po 4) napunjenih štrcaljki ili napunjenih brizgalica od 25 mg ili 50 mg ili 8 (2 pakiranja po 4) ili 24 (6 pakiranja po 4) napunjenih štrcaljki Erelzi od 25 mg
English: How to store Erelzi
Croatian: Kako čuvati Erelzi
English: 37% †, ϕ
Croatian: 18% 37%†,φ
English: Clear type I glass syringe with a stainless steel 27 gauge ½ inch needle with a needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.5 ml or 1.0 ml of solution.
Croatian: Prozirna (staklo tipa I) štrcaljka s iglom od nehrđajućeg čelika, veličine igle 27 gauge i 1,27 cm, sa štitnikom igle s hvatištem za prst, gumenim poklopcem igle i plastičnim klipom, a sadrži 0,5 ml ili
English: Clinical efficacy results at 12 months: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration
Croatian: Pokazatelji kliničke djelotvornosti kroz 12 mjeseci: usporedba etanercepta prema metotreksatu i prema etanerceptu u kombinaciji s metotreksatom u bolesnika s RA koji traje od 6 mjeseci do 20 godina
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike whitegrey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Croatian: Ozbiljne alergijske reakcije (uključujući izraženo lokalizirano oticanje kože i piskanje pri disanju); limfomi (vrsta raka krvi); leukemija (rak koji zahvaća krv i koštanu srž); melanom (vrsta raka kože); istodobno smanjenje broja krvnih pločica, crvenih i bijeli krvnih stanica; poremećaji živčanog sustava (s jakom mišićnom slabošću i znakovima i simptomima sličnim onima u multiploj sklerozi ili upala vidnog živca ili leđne moždine); tuberkuloza; novi nastupi kongestivnog zatajenja srca; napadaji; lupus ili sindrom nalik lupusu (simptomi mogu uključivati osip produljenog trajanja, vrućicu, bol u zglobovima i umor); osip kože koji može dovesti do teške pojave mjehura i guljenja kože; lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici); upala jetre izazvana reakcijom vlastitog imunološkog sustava (autoimuni hepatitis; u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost je manje česta); poremećaji imunološkog sustava koji mogu zahvatiti pluća, kožu i limfne čvorove (sarkoidoza); upala ili ožiljkasto zacjeljivanje pluća (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost upale ili ožiljkastog zacjeljivanja pluća je manje česta).
English: Whether used alone or in combination with methotrexate, Erelzi can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Croatian: Bilo da se Erelzi primjenjuje sam ili u kombinaciji s metotreksatom, Erelzi može usporiti razvoj oštećenja na Vašim zglobovima uzrokovanih reumatoidnim artritisom i poboljšati
English: For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly.
Croatian: Za psorijazu u bolesnika u dobi od navršenih 6 godina i tjelesne težine 62,5 kg ili više, uobičajena doza je 50 mg i treba je primijeniti jednom tjedno.
English: • Instruction to immediately seek for medical attention after developing or worsening of symptoms for congestive heart failure
Croatian: • upute da u slučaju razvoja ili pogoršanja simptoma kongestivnog srčanog zatajenja odmah treba zatražiti pomoć liječnika
English: • Do not use the pen if it has been dropped with the cap removed.
Croatian: • Ne koristite brizgalicu ako Vam je pala nakon što je poklopac uklonjen.
English: For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Croatian: 25 mg dvaput tjedno kroz cijelo ispitivanje PASI 75 odgovor nastavio se poboljšavati između 12. i
English: Do not remove the needle cap until just before you give the injection.
Croatian: Ne uklanjajte poklopac igle prije nego što je vrijeme da primijenite injekciju.
English: Each pack contains 1, 2 or 4 pre-filled syringes with a needle guard, multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes with a needle guard or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes with a needle guard.
Croatian: Jedno pakiranje sadrži 1, 2 ili 4 napunjene štrcaljke sa štitnikom igle, višestruka pakiranja sadrže 12 (3 pakiranja po 4) napunjenih štrcaljki od 25 mg ili 50 mg sa štitnikom igle ili 8 (2 pakiranja po 4) ili 24 (6 pakiranja po 4) napunjenih štrcaljki od 25 mg sa štitnikom igle.
English: Patients who “failed to respond to” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Croatian: PGA manji od dobar) ili pogoršanjem bolesti za vrijeme liječenja, a koji su liječeni adekvatnom dozom tijekom dovoljno dugog razdoblja da postignu odgovor sa svakim od 3 glavna raspoloživa sistemska lijeka.
English: Erelzi is supplied as a pre-filled syringe containing a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection).
Croatian: Erelzi je dostupan kao napunjena štrcaljka koja sadrži bistru ili blago opalescentnu, bezbojnu do blijedožutu otopinu za injekciju (injekciju).
English: Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Croatian: Poremećaji kože i potkožnog tkiva), nastanak autoprotutijela
English: The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Croatian: Djelotvornost etanercepta u bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza (nrAxSpa, engl. non-radiographic axial spondyloarthritis) procijenjena je u randomiziranom, 12tjednom, dvostruko slijepom, placebom kontroliranom ispitivanju.
English: In study 1, the etanercept-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001).
Croatian: U ispitivanju 1 skupina liječena etanerceptom imala je nakon 12 tjedana značajno veći udio bolesnika s odgovorom PASI 75 (30%) u usporedbi sa skupinom na placebu (2%) (p< 0,0001).
English: • Reminder to record brand name and batch number of the medication
Croatian: • podsjetnik kako treba evidentirati zaštićeni naziv i broj serije lijeka
English: A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Croatian: koji je obuhvaćao ocjenu nesposobnosti, vitalnosti, mentalnog zdravlja, općeg zdravstvenog stanja kao i potpitanja za ocjenu zdravstvenog stanja u bolesnika s artritisom.
English: The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Croatian: Primarna mjera ishoda djelotvornosti u sva četiri ispitivanja bila je udio bolesnika u svakoj ispitivanoj skupini koji su postigli PASI 75 (tj. najmanje 75% poboljšanja u
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi.
Croatian: • Upalna bolest crijeva: prijavljeni su slučajevi upalne bolesti crijeva u bolesnika s juvenilnim idiopatskim artritisom liječenih Erelzijem.
English: The other ingredients are: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: Drugi sastojci su: bezvodna citratna kiselina, natrijev citrat dihidrat, natrijev klorid, saharoza, L-lizinklorid, natrijev hidroksid, kloridna kiselina i voda za injekcije.
English: There have been post-marketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi pancitopenije i aplastične anemije, od kojih neki sa smrtnim ishodom (vidjeti dio 4.4).
English: Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Croatian: Liječenje etanerceptom dovelo je do poboljšanja fizičke funkcije tijekom dvostruko slijepog razdoblja,
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Croatian: Alergijske reakcije, vrućica, osip, svrbež, nastanak protutijela na vlastito tkivo (autoprotutijela).
English: • Do not shake the pen.
Croatian: • Ne tresite brizgalicu.
English: Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen.
Croatian: Pedijatrijskim bolesnicima tjelesne težine 62,5 kg ili više može se davati doza od 25 mg dva puta tjedno ili 50 mg jednom tjedno pomoću napunjene štrcaljke s fiksnom dozom ili napunjene brizgalice s fiksnom dozom.
English: The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Croatian: Prosječne najniže koncentracije u serumu u stanju dinamičke ravnoteže kretale su se od 1,6 do 2,1 μg/ml u 12., 24. i 48. tjednu.
English: If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).
Croatian: smijete izravno ubrizgati u povišena, zadebljala, crvena ili ljuskama prekrivena područja kože ili lezije („psorijatične kožne lezije“).
English: Radiographic progression: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration (12 month results)
Croatian: Radiološka progresija: usporedba etanercepta prema metotreksatu i prema etanerceptu u kombinaciji s metotreksatom u bolesnika s RA u trajanju od 6 mjeseci do 20 godina (rezultati nakon 12 mjeseci)
English: Responses of patients with psoriatic arthritis in a placebo-controlled trial Percent of Patients
Croatian: Odgovori bolesnika s psorijatičnim artritisom u placebom kontroliranom ispitivanju Postotak bolesnika
English: The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Croatian: 18 do 49 godina), koji su definirani kao oni bolesnici koji ispunjavaju kriterije ASAS klasifikacije aksijalnog spondiloartritisa, ali nisu ispunili modificirane New York kriterije za AS.
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Croatian: Smatra se da etanercept djeluje mehanizmom kompetitivne inhibicije vezanja TNF-a za TNFR-e na površini stanice čime inaktivira biološko djelovanje TNF-a i tako sprječava stanični odgovor posredovan TNF-om.
English: Uncommon ≥ 1/1,000 to
Croatian: ≥ 1/1000 i
English: • Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Erelzi.
Croatian: • Vodene kozice: obavijestite svog liječnika ako ste Vi ili dijete bili izloženi vodenim kozicama za vrijeme primjene Erelzija.
English: Your Erelzi SensoReady pen:
Croatian: Vaša Erelzi SensoReady brizgalica:
English: There were no differences in rates of infection among patients treated with etanercept and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Croatian: Kod liječenja plak psorijaze nisu zabilježene razlike u stopi infekcija između bolesnika liječenih etanerceptom i onih koji su primali placebo u placebom kontroliranim ispitivanjima u trajanju do
English: Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Croatian: Štrcaljka se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili naljepnici na štrcaljki iza oznake „EXP“.
English: EU/1/17/1195/008 12 pre-filled syringes
Croatian: EU/1/17/1195/008 12 napunjenih štrcaljki
English: Read ALL the way through these instructions before injecting.
Croatian: Pročitajte ove upute DO KRAJA prije primjene injekcije.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima nisu provedena.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA)
Croatian: Upalne bolesti crijeva i uveitis u bolesnika s juvenilnim idiopatskim artritisom (JIA)
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Croatian: U jednom drugom otvorenom ispitivanju na jednoj skupini 60 bolesnika s oligoartritisom produljenog trajanja (15 bolesnika u dobi od 2 do 4 godine, 23 bolesnika u dobi od 5 do 11 godina i 22 bolesnika u dobi od 12 do 17 godina), 38 bolesnika s artritisom povezanim s entezitisom (u dobi od 12 do
English: Solution for injection (injection)
Croatian: OBLIK Otopina za injekciju (injekcija).
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Croatian: (uključujući hipersenzitivni vaskulitis), erythema multiforme, lihenoidne reakcije
English: • Signs of blood disorders, such as bleeding, bruising, or paleness;
Croatian: • Znakovi poremećaja krvi, kao što su krvarenje, modrice ili bljedilo.
English: Check the green indicator fills the window:
Croatian: Provjerite je li zeleni indikator ispunio prozorčić: • To znači da je lijek ubrizgan.
English: The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
Croatian: Preporučena doza je 0,8 mg/kg (do maksimalno 50 mg po dozi) jednom tjedno u trajanju do 24 tjedna.
English: Multipack: 12 (3 packs of 4) pre-filled SensoReady pens.
Croatian: Višestruko pakiranje: 12 (3 pakiranja po 4) SensoReady napunjenih brizgalica.
English: At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
Croatian: 56% bolesnika u skupini liječenoj etanerceptom postiglo je PASI 75 u usporedbi s 5% u skupini na placebu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 25mg or 50 mg, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 25 mg ili 50 mg, odnosno zanemarive količine natrija.
English: The other ingredients are citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: Drugi sastojci su bezvodna citratna kiselina, natrijev citrat dihidrat, natrijev klorid, saharoza, Llizinklorid, natrijev hidroksid, kloridna kiselina i voda za injekcije.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the post-marketing period (see section 4.4).
Croatian: Razne zloćudne bolesti (uključujući karcinom dojke i pluća te limfom) zabilježene su, također, i u razdoblju nakon stavljanja etanercepta u promet (vidjeti dio 4.4).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 25 mg etanercepta (etanerceptum).
English: Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Croatian: Supkutano su davane doze od 25 mg etanercepta (na temelju ispitivanja o određivanju doze u bolesnika s reumatoidnim artritisom) odnosno placebo dva puta tjedno tijekom 6 mjeseci u 138 bolesnika.
English: Discard the needle cap. You may see a drop of liquid at the end of the needle.
Croatian: Možda ćete vidjeti kapljicu tekućine na vrhu igle.
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Croatian: (uključujuć i krvarenje, modrice, eritem, svrbež, bol, oticanje)*
English: Contents of the pack and other information Instructions for Use of the Erelzi SensoReady pen
Croatian: Sadržaj pakiranja i druge informacije Upute za primjenu Erelzi SensoReady napunjene brizgalice
English: The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Croatian: Profili djelotvornosti i sigurnosti dva režima liječenja etanerceptom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA.
English: Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Croatian: Istodobno liječenje anakinrom Istodobno davanje etanercepta i anakinre povezano je s povećanim rizikom od ozbiljnih infekcija i neutropenije u usporedbi s monoterapijom etanerceptom.