FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Croatian: Bolesnici su bili u dobi od 18 do 70 godina te su imali aktivni psorijatični artritis ( ≥ 3 otečena zgloba i ≥ 3 bolna zgloba) u najmanje jednom od sljedećih oblika: (1) zahvaćenost distalnih interfalangealnih prostora (DIP), (2) poliartikularni artritis (izostanak reumatoidnih čvorića te prisutnost psorijaze), (3) artritis mutilans, (4) asimetrični psorijatični artritis ili (5) spondilitisu slična ankiloza.
English: Gently pinch the skin at the injection site and insert the needle as shown.
Croatian: Lagano uštipnite kožu na mjestu primjene injekcije i ubodite iglu kako je prikazano.
English: Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Croatian: U usporedbi s placebom, liječenje etanerceptom rezultiralo je u statistički značajnim poboljšanjem u ASAS 40, ASAS 20 i ASAS 5/6.
English: Autoantibody formation Treatment with Erelzi may result in the formation of autoimmune antibodies (see section 4.8).
Croatian: Stvaranje autoprotutijela Liječenje Erelzijem može uzrokovati stvaranje autoimunih protutijela (vidjeti dio 4.8).
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group.
Croatian: Incidencija različitih vrsta ne-kožnih zloćudnih bolesti bila je značajno veća u bolesnika koji su liječeni etanerceptom u odnosu na kontrolnu skupinu.
English: Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: Erelzi je također indiciran u liječenju teškog, aktivnog i progresivnog reumatoidnog artritisa u odraslih koji prethodno nisu bili liječeni metotreksatom.
English: Worsening of symptoms of dermatomyositis
Croatian: Pogoršanje simptoma dermatomiozi tisa
English: If any serious allergic or anaphylactic reaction occurs, Erelzi therapy should be discontinued immediately and appropriate therapy initiated.
Croatian: U slučaju pojave bilo kakve ozbiljne alergijske ili anafilaktičke reakcije, mora se odmah obustaviti terapija Erelzijem i započeti odgovarajuća terapija.
English: In patients who develop HBV infection, Erelzi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika koji razviju HBV infekciju, terapiju Erelzijem treba prekinuti i započeti učinkovitu antivirusnu terapiju s odgovarajućim suportivnim liječenjem.
English: If an alternate dose is required, other etanercept products offering such an option should be used.
Croatian: Ako je nužna drugačija doza, potrebno je primijeniti druge lijekove koji sadrže etanercept i nude takvu mogućnost.
English: In adults (aged 18 and over), Erelzi can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Croatian: U odraslih (u dobi od 18 ili više godina) Erelzi se može primijeniti za liječenje umjerenog ili teškog reumatoidnog artritisa, psorijatičnog artritisa, teškog aksijalnog spondiloartritisa uključujući ankilozantni spondilitis i umjerene ili teške psorijaze - u svakom od tih slučajeva, obično kada ostali široko primjenjivani načini liječenja nisu djelovali dovoljno dobro ili su za Vas neprikladni.
English: ASAS 70 2 weeks
Croatian: ASAS 70 2 tjedna
English: • Request to show the Patient Alert Card to any treating doctor
Croatian: • zahtjev za pokazivanjem Kartice s upozorenjima za bolesnika svakom liječniku koji ordinira
English: Patients treated with Erelzi should be given the Patient Alert Card.
Croatian: Bolesnicima koji se liječe Erelzijem treba dati Karticu s upozorenjima za bolesnika.
English: If you are not sure, please talk to your doctor.
Croatian: Ako niste sigurni, molimo obratite se svojem liječniku.
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in a 2-year active-controlled study.
Croatian: Sto dvadeset devet (129) novih zloćudnih bolesti različitih tipova zabilježeno je u 4114 bolesnika s reumatoidnim artritisom liječenih etanerceptom u razdoblju do približno 6 godina u kliničkim ispitivanjima, uključujući 231 bolesnika liječenog etanerceptom u kombinaciji s metotreksatom u dvogodišnjem ispitivanju s aktivnom kontrolom.
English: In this situation, the benefit/risk balance of Erelzi therapy should be very carefully considered.
Croatian: U navedenoj situaciji nužno je vrlo pomno razmotriti omjer koristi i rizika terapije Erelzijem.
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses.
Croatian: Tijekom prvih 12 tjedana dvostruko slijepog perioda bolesnici su primali placebo ili jednu od tri navedene doze etanercepta.
English: If active tuberculosis is diagnosed, Erelzi therapy must not be initiated.
Croatian: Ako je postavljena dijagnoza aktivne tuberkuloze, nije dozvoljeno započeti terapiju Erelzijem.
English: Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to use.
Croatian: Nemojte koristiti ovaj lijek ako je folija na blisteru potrgana, budući da u tom slučaju štrcaljka možda nije sigurna za uporabu.
English: Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg.
Croatian: Etanercept nije uzrokovao smrtnost ni vidljive znakove toksičnosti u miševa i štakora nakon jednokratne supkutane doze od 2000 mg/kg, ni nakon jednokratne intravenske doze od 1000 mg/kg.
English: Treatment with Erelzi may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Croatian: Liječenje Erelzijem može reaktivirati hepatitis B u bolesnika koji su prethodno bili zaraženi virusom hepatitisa B.
English: In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with etanercept developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
Croatian: U kontroliranim ispitivanjima u bolesnika s plak psorijazom, otprilike 13,6% bolesnika liječenih etanerceptom razvilo je reakciju na mjestu primjene injekcije u usporedbi s 3,4% placebom liječenih bolesnika za vrijeme prvih 12 tjedana liječenja.
English: L-Lysine hydrochloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: L-lizinklorid natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH) voda za injekcije
English: In long-term (up to 34 months) open-label studies where etanercept was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Croatian: U dugotrajnim (do 34 mjeseca) otvorenim ispitivanjima gdje se etanercept primjenjivao bez prekida klinički odgovor bio je kontinuiran i sigurnost primjene je bila usporediva s ispitivanjima kraćeg trajanja.
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Erelzi.
Croatian: • Infekcije/operacija: ako Vi ili dijete razvijete novu infekciju ili u slučaju da morate na veliku operaciju, Vaš liječnik će možda htjeti nadgledati liječenje Erelzijem.
English: Patients should be tested for HBV infection before initiating treatment with Erelzi.
Croatian: Bolesnike treba testirati na HBV infekciju prije započinjanja terapije Erelzijem.
English: In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Croatian: Tijekom ispitivanja u trajanju od 48 tjedana u 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s plak psorijazom primijećeni štetni događaji bili su slični onima u prethodnim ispitivanjima u odraslih bolesnika s plak psorijazom.
English: Sandoz GmbH Schaftenau Biochemiestrasse 10
Croatian: Sandoz GmbH Schaftenau Biochemiestr. 10
English: *Some patients did not provide complete data for each endpoint **ASAS = Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0.001, b:< 0.01 and c:< 0.05, respectively between etanercept and placebo
Croatian: *Neki bolesnici nisu imali potpune podatke za svaku mjeru ishoda **ASAS= kriteriji Međunarodnog društva za procjenu spondiloartritisa ***Bathov indeks aktivnosti bolesti za ankilozantni spondilitis a: p< 0,001, b:< 0,01 odnosno c:< 0,05 između etanercepta i placeba
English: Your Erelzi pre-filled syringe with needle guard and add-on finger flange
Croatian: Vaša Erelzi napunjena štrcaljka sa štitnikom igle i dodanim hvatištem za prst
English: Remember to take the blister out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
Croatian: Ne zaboravite izvaditi blister iz hladnjaka i pustiti da dosegne sobnu temperaturu prije nego što je pripremite za injekciju (15-30 minuta).
English: This device will be provided to HCPs to support (self-) injection training and is intended to be used and trained in the HCP office or during a home care program
Croatian: Ta će naprava biti stavljena na raspolaganje zdravstvenim radnicima kao potpora obuci u (samo-) ubrizgavanju te ima služiti u obuci u sklopu ordinacije zdravstvenog radnika ili tijekom programa kućne njege
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10);
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti (broj bolesnika u kojih se očekuje pojava navedene reakcije), sukladno sljedećim kategorijama: vrlo često (≥ 1/10), često
English: In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Croatian: U kliničkim ispitivanjima nisu primijećene interakcije prilikom primjene etanercepta s glukokortikoidima, salicilatima (osim sulfasalazina), nesteroidnim protuupalnim lijekovima (NSAIL), analgeticima ni metotreksatom.
English: From the start of part 2, the median time to flare was ≥ 116 days for patients who received etanercept and 28 days for patients who received placebo.
Croatian: Od početka drugog dijela ispitivanja medijan vremena do javljanja pogoršanja bio je ≥ 116 dana za bolesnike koji su primili etanercept i 28 dana za bolesnike koji su primili placebo.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u.
English: At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving etanercept.
Croatian: U 12. tjednu primijećeno je statistički značajno poboljšanje u rezultatu SPARCC-a (Kanadskog istraživačkog konzorcija za spondiloartritis) za sakroilijakalni zglob mjereno putem MR-a za bolesnike koji primaju etanercept.
English: ASAS 50 2 weeks
Croatian: ASAS 50 2 tjedna
English: Re-introduction of treatment with etanercept after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received etanercept without interruption of therapy based on results of open-label studies.
Croatian: Ponovno uvođenje liječenja etanerceptom nakon prekida koji je trajao do 24 mjeseca dovelo je do istog učinka kao i u bolesnika koji su primali etanercept bez prekida liječenja, a na temelju otvorenih ispitivanja.
English: Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Liječenje odraslih s teškim aksijalnim spondiloartritisom bez radioloških dokaza s objektivnim znakovima upale na koje upućuju povišene vrijednosti C-reaktivnog proteina (CRP) i/ili rezultati snimanja magnetskom rezonancijom (MR), a koji nisu imali odgovarajući odgovor na nesteroidne protuupalne lijekove (NSAIL).
English: After the medicine has been injected, the needle guard will be activated to cover the needle.
Croatian: Nakon što je lijek ubrizgan aktivirat će se štitnik igle koji će prekriti iglu.
English: If any of the following happen, do not inject more Erelzi.
Croatian: Ako se pojavi bilo što od sljedećeg, prestanite s ubrizgavanjem Erelzija.
English: The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Croatian: Sigurnost primjene i djelotvornost etanercepta procjenjivana je u ispitivanju u dva dijela, a sudjelovalo je 69-ero djece s poliartikularnim juvenilnim idiopatskim artritisom koja su imala različite pojavne oblike juvenilnog idiopatskog artritisa (poliartritis, pauciartritis, sistemski nastup bolesti).
English: Patients with a significant exposure to varicella virus should temporarily discontinue Erelzi therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Croatian: Bolesnici koji su izloženi značajnom riziku infekcije virusom varicelle trebaju privremeno prekinuti liječenje Erelzijem te se mora razmotriti profilaktičko liječenje Varicella Zoster Imunoglobulinom.
English: There have been post-marketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi intersticijske plućne bolesti (uključujući pneumonitis i plućnu fibrozu), od kojih neki sa smrtnim ishodom.
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Croatian: Djelotvornost etanercepta procijenjena je u dvostruko slijepom, placebom kontroliranom, randomiziranom ispitivanju u 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s umjerenom do teškom plak psorijazom (prema definiciji sPGA bodovanja ≥ 3, uključujući ≥ 10% BSA i PASI ≥ 12).
English: Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on etanercept continued to improve from month 3 through month 7, while those who received placebo did not improve.
Croatian: Od svih bolesnika koji su pokazali klinički odgovor 90. dan i ušli u drugi dio ispitivanja neki, koji su ostali na etanerceptu, nastavili su s poboljšanjem od 3. do 7. mjeseca, dok oni koji su primali placebo nisu pokazali poboljšanje.
English: There have been reports of worsening of hepatitis C in patients receiving etanercept.
Croatian: Opisani su slučajevi pogoršanja hepatitisa C u bolesnika koji su primali etanercept.
English: Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Croatian: Etanercept je bio značajno bolji u usporedbi s placebom po svim mjerilima aktivnosti bolesti (p<0,001) te je odgovor na liječenje bio podjednak u slučaju sa ili bez istodobne primjene metotreksata.
English: You or the child should not use Erelzi with medicines that contain the active substance anakinra or abatacept.
Croatian: Ni Vi ni dijete ne biste smjeli primjenjivati Erelzi s lijekovima koji sadrže anakinru ili abatacept kao djelatnu tvar.
English: SC 50 mg / 1.0 ml
Croatian: s.c. 50 mg / 1,0 ml
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Erelzi therapy (see Vaccinations, above).
Croatian: Preporučuje se da, ako je moguće, pedijatrijski bolesnici obave cijepljenje prema trenutno važećem kalendaru cijepljenja prije nego se započne liječenje Erelzijem (vidjeti dio iznad: Cijepljenje).
English: What you additionally need for your injection:
Croatian: Što Vam treba za injekciju:
English: Some children and teenage patients who have received Erelzi or other medicines that work the same way as Erelzi have developed cancers, including unusual types, which sometimes resulted in death.
Croatian: U neke djece i adolescenata koji su liječeni Erelzijem ili nekim drugim lijekom s istim mehanizmom djelovanja zabilježeni su slučajevi određenih vrsta raka, uključujući neuobičajene vrste, od kojih su neki imali smrtni ishod.
English: • If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
Croatian: • Ako Vam njegovatelj ili zdravstveni radnik daju injekciju, mogu Vam je dati i u vanjski dio nadlaktice.
English: Consequently, Erelzi should not be used in patients for the treatment of alcoholic hepatitis.
Croatian: Dakle, Erelzi se ne smije koristiti u bolesnika za liječenje alkoholnog hepatitisa.
English: Thus, the combined use of Erelzi and anakinra is not recommended (see sections 4.5 and 4.8).
Croatian: Stoga se ne preporučuje kombinirana primjena Erelzija i anakinre (vidjeti dijelove 4.5 i
English: Pancytopenia* Aplastic anaemia*
Croatian: Pancitopenija* Aplastična anemija*
English: It is recommended that the conduct of these tests should be recorded in the Patient's Alert Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Liječnike koji propisuju lijek treba upozoriti na rizik lažno negativnih rezultata tuberkulinskog kožnog testa, osobito u bolesnika koji su teško bolesni ili imunokompromitirani.
English: Cartons contain 1, 2 or 4 pre-filled syringes or pre-filled pens of Erelzi.
Croatian: Pakiranja sadrže 1, 2 ili 4 napunjene štrcaljke ili napunjene brizgalice Erelzi.
English: The efficacy of etanercept versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing etanercept with other systemic therapies.
Croatian: Djelotvornost etanercepta u odnosu na sistemske lijekove u bolesnika s umjerenom do teškom psorijazom (koji su reagirali na druge sistemske lijekove) nije bila uspoređivana u ispitivanjima direktne usporedbe etanercepta s drugim sistemskim terapijama.
English: Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles.
Croatian: Ne upotrebljavajte ako je tekućina zamućena, promijenjene boje ili sadrži velike nakupine, pahuljice ili obojene čestice.
English: 2.3 †, ϕ
Croatian: 2,3†,φ
English: • Keep holding the pen firmly against your skin.
Croatian: • Nastavite držati brizgalicu čvrsto pritisnutu na kožu.
English: • Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Croatian: • Odložite upotrijebljenu brizgalicu u spremnik za odlaganje oštrih predmeta (tj. spremnik koji se može zatvoriti i otporan je na bušenje, ili nešto slično).
English: For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Croatian: Pri liječenju reumatoidnog artritisa Erelzi se obično primjenjuje u kombinaciji s metotreksatom, ali može se primjenjivati i kao jedini lijek, ako liječenje metotreksatom za Vas nije prikladno.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly or hard.
Croatian: • Nemojte ubrizgavati lijek u područja na kojima je koža osjetljiva, s modricama, crvena, ljuskasta ili tvrda.
English: In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Croatian: Uz to, primjena Fc fragmenta imunoglobulina kao spojnog elementa prilikom proizvodnje dimernih receptora produljuje poluvrijeme eliminacije iz seruma.
English: Immediate use is then recommended.
Croatian: Tada se preporučuje odmah primijeniti Erelzi.
English: On the basis of the scientific conclusions for etanercept (biosimilars) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing etanercept (biosimilars) is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za etanercept (i bioslične lijekove), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) etanercept (i bioslične lijekove) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Croatian: Etanercept također može utjecati na biološku aktivnost kontroliranu dodatnim molekulama koje se uključuju kasnije (npr. citokini, adhezijske molekule ili proteinaze), a koje inducira ili nadzire
English: The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
Croatian: Djelotvornost etanercepta uspoređena je s metotreksatom u randomiziranom, aktivno kontroliranom ispitivanju s radiološkom ocjenom na slijepo kao primarnom mjerom ishoda, u 632 odrasla bolesnika s aktivnim reumatoidnim artritisom (< 3 godine trajanja) koji nikada nisu bili liječeni metotreksatom.
English: This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines and individuals who assist self-injecting patients from accidental needle stick injuries.
Croatian: Svrha toga je da pomogne u zaštiti od ozljeda slučajnim ubodom igle u zdravstvenih radnika, bolesnika koji si sami ubrizgavaju lijek koji im je propisao liječnik te osoba koje pomažu bolesnicima koji sami ubrizgavaju lijek.
English: INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu
Croatian: 15. UPUTE ZA UPORABU „Treba navesti QR kod“ + www.erelzi.eu
English: Your doctor may decide if you or the child need less anti-diabetic medicine while using Erelzi.
Croatian: Liječnik može odlučiti trebate li Vi ili dijete za vrijeme liječenja Erelzijem uzimati manju količinu antidijabetičkog lijeka.
English: • A needle-free AI device for demonstration will be available for patient practice use.
Croatian: • bit će dostupna pokazna naprava bez igle namijenjena vježbi bolesnika.
English: • Do not freeze the pen.
Croatian: • Ne zamrzavajte brizgalicu.
English: The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg.
Croatian: Razlike TSS i JSN ocjena između metotreksata i etanercepta 25 mg nisu bile statistički značajne.