FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Erelzi is generally not recommended.
Croatian: Primjena živih cjepiva dojenčadi 16 tjedana nakon majčine zadnje doze Erelzija obično se ne preporučuje.
English: Erelzi works by reducing the inflammation associated with certain diseases.
Croatian: Erelzi smanjuje upalu povezanu s određenim bolestima.
English: Several seconds later a 2nd click will indicate that the injection is almost finished.
Croatian: Nekoliko sekundi kasnije drugi klik označit će da je injekcija skoro gotova.
English: If this occurs, you should stop using Erelzi.
Croatian: Ako se to dogodi, morate prestati uzimati Erelzi.
English: This indicates the injection is almost complete.
Croatian: On označava da je injekcija skoro gotova.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Croatian: Važno je da si ne pokušavate sami dati injekciju dok Vas liječnik, medicinska sestra ili ljekarnik nisu tome poučili.
English: • Do not touch the cleaned area again before injecting.
Croatian: • Ne dirajte ponovno očišćeno područje prije primjene injekcije.
English: The use of Erelzi is not expected to affect the ability to drive or use machines.
Croatian: Ne očekuje se da će primjena Erelzija utjecati na sposobnost upravljanja vozilima ili strojevima.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Erelzi.
Croatian: • Vaš liječnik će Vam također uručiti Karticu s upozorenjima za bolesnika koja sadrži važne informacije o sigurnosti o kojima morate voditi računa prije i za vrijeme liječenja Erelzijem.
English: • The pen can now be removed.
Croatian: • Brizgalica se sada može maknuti.
English: Erelzi is a biosimilar medicinal product.
Croatian: Erelzi je biosličan lijek.
English: By touching them, the needle guard may be activated too early.
Croatian: Ako ih dodirnete, štitnik igle mogao bi se prerano aktivirati.
English: Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Erelzi.
Croatian: Vaš liječnik može odlučiti da Vas ili dijete nastavi pratiti s obzirom na prisutnost infekcije nakon što ste Vi ili dijete prestali uzimati Erelzi.
English: If you feel that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je djelovanje Erelzija prejako ili preslabo, obratite se svom liječniku ili ljekarniku.
English: The primary measure of efficacy (ASAS 20) was a ≥ 20% improvement in at least 3 of the 4
Croatian: Primarna mjera djelotvornosti (ASAS 20) bila je ≥ 20%-tno poboljšanje kod najmanje 3 od 4
English: What you need to know before you use Erelzi
Croatian: Što morate znati prije nego počnete primjenjivati Erelzi
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Croatian: Specifična aktivnost etanercepta iznosi 1,7x106 jedinica/mg.
English: Do not mix the Erelzi solution with any other medicine.
Croatian: Nemojte miješati otopinu Erelza niti s jednim drugim lijekom.
English: In post-marketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Croatian: Prema iskustvima nakon stavljanja lijeka u promet približno polovica od svih izvješća o slučajevima oportunističkih infekcija diljem svijeta bile su invazivne gljivične infekcije.
English: • Press the pen firmly against the skin to start the injection.
Croatian: • Pritisnite brizgalicu čvrsto na kožu da biste započeli injekciju.
English: • Check the green indicator fills the window and has stopped moving.
Croatian: • Provjerite je li zeleni indikator ispunio prozorčić i prestao se micati.
English: • Request to ask the doctor to record test, date and results of last TB screening on the alert card
Croatian: • zahtjev liječniku za evidentiranjem ispitivanja, datuma i rezultata posljednjeg probira na tuberkulozu na kartici s upozorenjima
English: If you have used more Erelzi than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Croatian: Ako ste primijenili više Erelzija nego što ste trebali (bilo da ste primijenili odjednom previše ili ste ga primjenjivali prečesto), odmah se savjetujte s liječnikom ili ljekarnikom.
English: Children and adults taking Erelzi may have an increased risk of developing lymphoma or another cancer.
Croatian: Djeca i odrasli liječeni Erelzijem mogu imati povećani rizik razvoja limfoma ili nekog drugog raka.
English: Erelzi is administered by subcutaneous injection (see section 6.6).
Croatian: Erelzi se primjenjuje supkutanom injekcijom (vidjeti dio 6.6).
English: In order to minimize the risk for the most critical side effects “infection” and “worsening of congestive heart failure” of Erelzi, a Patient Alert Card has been developed.
Croatian: Kako bi se minimizirao rizik najkritičnijih nuspojava lijeka Erelzi „infekcija” i „pogoršanje kongestivnog srčanog zatajenja”, razvijena je Kartica s upozorenjima za bolesnika.
English: You can press a cotton ball or gauze over the injection site and hold it for 10 seconds.
Croatian: Možete pritisnuti pamučnu vatu ili gazu na mjesto primjene injekcije i držati je 10 sekundi.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Erelzi, and in accordance with local recommendations.
Croatian: Ako je postavljena dijagnoza inaktivne (‘latentne') tuberkuloze, mora se započeti liječenje latentne tuberkuloze antituberkuloticima prije početka primjene Erelzija, u skladu s lokalnim preporukama.
English: Slowly press the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
Croatian: Polako gurajte klip dokle je moguće tako da glava klipa bude u potpunosti između krilca štitnika igle.
English: Treatment with etanercept should continue until remission is achieved, for up to 24 weeks.
Croatian: Liječenje etanerceptom se mora nastaviti dok se ne postigne remisija, najdulje do 24 tjedna.
English: Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Croatian: Držite klip pritisnut do kraja dok držite štrcaljku na istom mjestu 5 sekundi.
English: Paediatric plaque psoriasis (age 6 years and above)
Croatian: Pedijatrijska plak psorijaza (u dobi od 6 godina ili više)
English: • Use the pen within 5 minutes of removing the cap.
Croatian: • Upotrijebite brizgalicu u roku od 5 minuta nakon što skinete poklopac.
English: • Any core educational materials for HCPs are subject to country-specific adaptation according to local regulatory requirements
Croatian: • sav temeljni edukacijski materijal za zdravstvene radnike podložan je prilagodbi zahtjevima propisa u svakoj pojedinoj državi
English: • Request to keep the Patient Alert Card during and after treatment
Croatian: • zahtjev za čuvanjem Kartice s upozorenjima za bolesnika tijekom i nakon liječenja
English: This card provides important safety information for patients, including information relating to infections and to worsening of congestive heart failure related to Erelzi.
Croatian: Ta kartica sadrži važne sigurnosne informacije za bolesnike, uključujući informacije o infekcijama i pogoršanju kongestivnog srčanog zatajenja te njihovoj povezanosti s lijekom Erelzi.
English: Not included in the carton:
Croatian: Nije uključeno u kutiju:
English: Holding your pen: • Hold the pen at 90 degrees to the cleaned injection site.
Croatian: Držanje brizgalice: • Držite brizgalicu pod kutem od 90 stupnjeva u odnosu na očišćeno mjesto primjene.
English: • Request to ask the doctor to list other medications that may increase the risk of infection on the alert card
Croatian: • zahtjev liječniku za navođenjem drugih lijekova koji mogu povisiti rizik infekcije na kartici s upozorenjima
English: Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Erelzi therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Budući da se imunoglobulini, zajedno s mnogim lijekovima, mogu izlučivati u majčino mlijeko u ljudi, mora se donijeti odluka da li prekinuti dojenje ili prekinuti liječenje Erelzijem, vodeći računa o koristi dojenja za dijete i koristi terapije za ženu.
English: Single use.
Croatian: Jednokratna primjena.
English: The injection site is the place on the body where you are going to use the pre-filled syringe.
Croatian: Mjesto primjene injekcije je mjesto na tijelu na kojem ćete upotrijebiti napunjenu štrcaljku.
English: • Sandoz staff will be trained on the correct use of Erelzi in order to support HCPs in case of questions
Croatian: • osoblje tvrtke Sandoz obučit će se u pravilnoj primjeni lijeka Erelzi kako bi u slučaju pitanja moglo pomoći zdravstvenim radnicima.
English: Before starting treatment with Erelzi, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije početka terapije Erelzijem svi bolesnici moraju proći pregled s obzirom na aktivnu i inaktivnu (‘latentnu') tuberkulozu.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Erelzi.
Croatian: Ovi simptomi mogu upućivati na moguće životno opasne poremećaje krvi koji zahtijevaju prekid liječenja Erelzijem.
English: The same information is also available on www.erelzi.eu and through the code below.
Croatian: Iste informacije također su dostupne na www.erelzi.eu i putem QR koda u nastavku.
English: Treatment with Erelzi should not be initiated in patients with active infections, including chronic or localised infections.
Croatian: Liječenje Erelzijem se ne smije započeti u bolesnika s aktivnim infekcijama, uključivši kronične i lokalizirane infekcije.
English: Simulation of dosing suggests that while older children (1017 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Croatian: Simulacija doziranja upućuje na zaključak da će starija djeca (u dobi od 10 do 17 godina) imati serumske razine slične onima u odraslih, dok će mlađa djeca imati znatno niže razine.
English: Leave it to dry before injecting.
Croatian: Pustite da se osuši prije primjene injekcije.
English: Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
Croatian: Polako otpustite klip i pustite da štitnik igle automatski prekrije izloženu iglu.
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.
Croatian: Ako imate bilo kakvih pitanja, obratite se liječniku, medicinskoj sestri ili ljekarniku koji je upoznat s Erelzijem.
English: Erelzi is not recommended for the treatment of Wegener's granulomatosis.
Croatian: Erelzi se ne preporučuje za liječenje Wegenerove granulomatoze.
English: The following list of adverse reactions is based on experience from clinical trials in adults and on post-marketing experience.
Croatian: Tablični popis nuspojava Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja u odraslih osoba, kao i iskustvu nakon stavljanja lijeka u promet.
English: • A visually engaging instruction guide demonstrating step-by-step procedure for the use of the AI will be developed and distributed to nurses and HCPs to facilitate training of patients and staff in the prescriber´s office or during a homecare program
Croatian: • vizualno atraktivan vodič koji korak po korak prikazuje postupak uporabe automatske brizgalice razvit će se i podijeliti medicinskim sestrama i zdravstvenim radnicima radi obuke bolesnika i osoblja u ordinacijama u kojima se lijek propisuje ili tijekom programa kućne njege
English: • Alcohol wipe
Croatian: • Alkoholni tupfer
English: Women using Erelzi should not breast-feed, since Erelzi passes into human breast milk.
Croatian: Žene koje primaju Erelzi ne bi smjele dojiti, budući da Erelzi prelazi u majčino mlijeko.
English: Do not open the outer box until you are ready to use this medicine.
Croatian: Ne otvarajte kutiju dok niste spremni upotrijebiti ovaj lijek.
English: If Erelzi has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.
Croatian: Ako Erelzi nema učinka na Vašu bolest ni nakon 12 tjedana, liječnik Vam može reći da prestanete uzimati ovaj lijek.
English: What Erelzi contains
Croatian: Što Erelzi sadrži
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of etanercept following its long-term use in patients with JIA.
Croatian: Nadalje, nisu provedena ni ispitivanja kojima bi se procijenili učinci prekida primjene ili smanjenja preporučene doze etanercepta nakon dugotrajne primjene u bolesnika s JIA.
English: • The recommended site is the front of the thighs.
Croatian: • Preporučeno mjesto je prednja strana bedara.
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Croatian: Gurnite iglu do kraja kako biste osigurali da se lijek može u cijelosti primijeniti.
English: DO NOT FREEZE.
Croatian: NE ZAMRZAVATI.
English: • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Erelzi (listed in section 6).
Croatian: • ako ste Vi ili dijete za koje skrbite alergični na etanercept ili neki drugi sastojak Erelzija (naveden u dijelu 6.).
English: It is recommended that you record the date that Erelzi is removed from the refrigerator and the date after which Erelzi should be discarded (no more than 4 weeks following the removal from the refrigerator).
Croatian: Preporučuje se zabilježiti datum kada je Erelzi izvađen iz hladnjaka i datum nakon kojega Erelzi treba baciti (do 4 tjedna od vađenja iz hladnjaka).
English: • Wegener's granulomatosis: Erelzi is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Croatian: • Wegenerova granulomatoza: Erelzi se ne preporučuje za liječenje Wegenerove granulomatoze, rijetke upalne bolesti.
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Croatian: Bolesnici s teškim reumatoidnim artritisom, koji boluju dulje vrijeme, mogu imati veći rizik razvoja limfoma od prosjeka.
English: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Erelzi therapy and for three weeks after discontinuation of therapy.
Croatian: Žene u reproduktivnoj dobi trebaju razmotriti korištenje odgovarajuće kontracepcije kako bi spriječile trudnoću tijekom liječenja Erelzijem, kao i tri tjedna nakon prestanka liječenja.
English: The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year.
Croatian: Učinak etanercepta na radiološku progresiju održan je u bolesnika koji su nastavili s liječenjem tijekom druge godine.
English: An educational program is developed in order to assist in training and educating HCPs for proper use of Erelzi:
Croatian: Razvijen je edukacijski program s ciljem potpore obuci i edukaciji zdravstvenih radnika u pravilnoj primjeni lijeka Erelzi:
English: A-6336 Langkampfen Austria
Croatian: A-6336 Langkampfen
English: YOU MUST READ THIS BEFORE INJECTING.
Croatian: MORATE OVO PROČITATI PRIJE PRIMJENE INJEKCIJE.
English: Some patients receiving Erelzi have developed skin cancers.
Croatian: Neki od bolesnika koji su primali Erelzi razvili su rak kože.
English: The educational material is intended to prevent or reduce potential medication errors related to improper use of Erelzi prefilled-pen (autoinjector (AI):
Croatian: Edukacijski materijal namijenjen je prevenciji ili smanjenju potencijalnih pogrešaka u primjeni lijeka povezanih s uporabom napunjene brizgalice Erelzi (automatska brizgalica):
English: Etanercept N = 103 to 105*
Croatian: Etanercept N = 103 do 105*
English: Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Croatian: Ispitivanje 3 procijenilo je 583 bolesnika i imalo je iste kriterije uključivanja kao i ispitivanje 2.
English: If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
Croatian: Ako se pojave ovi znakovi, hitno se javite liječniku ili otiđite na odjel hitne pomoći u najbližoj bolnici.
English: • Advice that patients should not be treated with Erelzi in case of infection
Croatian: • savjet da bolesnici u slučaju infekcije ne bi trebali primati Erelzi
English: Patients should be evaluated for infections before, during, and after treatment with Erelzi, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Croatian: Bolesnike treba ocijeniti s obzirom na moguće infekcije prije, za vrijeme i nakon liječenja Erelzijem, vodeći računa o tome da prosječno poluvrijeme eliminacije etanercepta iznosi otprilike 70 sati (raspon od 7 do 300 sati).
English: • Tuberculosis: As cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will check for signs and symptoms of tuberculosis before starting Erelzi.
Croatian: • Tuberkuloza: budući da su u bolesnika koju su liječeni Erelzijem opisani slučajevi tuberkuloze, liječnik će provjeriti postoje li znakovi ili simptomi tuberkuloze prije nego što počnete terapiju Erelzijem.
English: Do not use Erelzi
Croatian: Nemojte primjenjivati Erelzi
English: TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defences against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je etanercept, utječu na imunološki sustav i njihova primjena može imati učinak na obranu organizma protiv infekcija i raka.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (biosimilars), the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za etanercept (i bioslične lijekove), znanstveni zaključci CHMP-a su sljedeći:
English: Take the syringe out of the blister.
Croatian: Izvadite štrcaljku iz blistera.
English: The pre-filled syringe has a needle guard that will be activated to cover the needle after the injection is finished.
Croatian: Napunjena štrcaljka ima štitnik igle koji će se aktivirati radi pokrivanja igle nakon što je ubrizgavanje završeno.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mg / 1.0 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 50 mg / 1,0 ml
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept.
Croatian: Liječnik će odrediti potrebnu dozu za dijete i propisati odgovarajuću jačinu etanercepta.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Erelzi during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Croatian: Važno je da prije cijepljenja djeteta obavijestite pedijatra i druge zdravstvene radnike o uporabi Erelzija tijekom trudnoće prije cijepljenja djeteta. (za više informacija vidjeti dio 2, ''Cijepljenje'').
English: Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Erelzi se može davati kao monoterapija u slučaju nepodnošljivosti metotreksata ili kada je nastavak liječenja metotreksatom neodgovarajući.
English: Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Croatian: Radiološka progresija nakon 12 mjeseci bila je značajno manja u skupini s etanerceptom, nego u skupini s metotreksatom, dok je kombinacija bila značajno bolja od obje monoterapije u smislu usporavanja radiološke progresije (vidjeti sljedeću sliku).
English: Thus, it is not possible to administer Erelzi to paediatric patients that require less than a full 25 mg or 50 mg dose.
Croatian: Stoga Erelzi nije moguće primijeniti pedijatrijskim bolesnicima kojima treba manja doza od pune doze od 25 mg ili 50 mg.
English: • Brief introduction to the aim of the Patient Alert Card
Croatian: • kratak uvod s opisom cilja Kartice s upozorenjima za bolesnika
English: Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Croatian: Pogoršanje bolesti definirano je kao ≥ 30% pogoršanje u tri od šest temeljnih JRA kriterija i ≥ 30% poboljšanje u ne više od jednom od šest temeljnih JRA kriterija i minimalno dva zahvaćena zgloba.
English: Do not use if the syringe is broken or the needle guard is activated.
Croatian: Ne upotrebljavajte ako je štrcaljka razbijena ili štitnik igle aktiviran.
English: The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus and Histoplasma.
Croatian: Najčešće prijavljene invazivne gljivične infekcije uključivale su Candidu, Pneumocystis, Aspergillus i Histoplasmu.
English: In this configuration the needle guard is NOT ACTIVATED and the pre-filled syringe is ready for use
Croatian: U ovom položaju štitnik igle NIJE AKTIVIRAN i napunjena štrcaljka je spremna za uporabu
English: Patients who develop a new infection while undergoing treatment with Erelzi should be monitored closely.
Croatian: Bolesnike u kojih se razviju nove infekcije za vrijeme liječenja Erelzijem mora se pažljivo nadgledati.
English: The box contains Erelzi pre-filled syringe(s) individually sealed in a plastic blister.
Croatian: Kutija sadrži Erelzi napunjenu(e) štrcaljku(e) pojedinačno zapakiranu(e) u plastičnom blisteru.
English: Etanercept treatment may increase mortality in patients with established sepsis.
Croatian: Liječenje etanerceptom može povećati smrtnost bolesnika s dokazanom sepsom.
English: If Erelzi has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Croatian: Ako Erelzi ne utječe na stanje djeteta nakon 12 tjedana terapije, Vaš će Vam liječnik možda reći da prestanete primjenjivati ovaj lijek.
English: These instructions are to help you to inject correctly using the Erelzi SensoReady pen.
Croatian: Svrha ovih uputa je da Vam pomognu pravilno ubrizgati lijek korištenjem Erelzi SensoReady brizgalice.
English: Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Erelzi.
Croatian: Pedijatrijski bolesnici kojima treba drugačija doza od pune doze od 25 mg ili 50 mg ne smiju primiti Erelzi.
English: The 10 mg etanercept dose had consistently less effect on structural damage than the 25 mg dose.
Croatian: Doza od 10 mg etanercepta imala je značajno manji učinak na strukturalno oštećenje u usporedbi s dozom od 25 mg.
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Croatian: Također su rijetko (< 0,1%) prijavljeni slučajevi novog nastupa kongestivnog zatajenja srca, uključujući kongestivno zatajenje srca u bolesnika sa poznatom postojećom kardiovaskularnom bolešću.
English: Placebo N = 106 to 109*
Croatian: Placebo N = 106 do 109*
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with etanercept for up to 48 months.
Croatian: Ozbiljne infekcije javile su se u 6,3% bolesnika s reumatoidnim artritisom liječenih etanerceptom tijekom najdulje 48 mjeseci.
English: • Alcohol abuse: Erelzi should not be used for the treatment of hepatitis related to alcohol abuse.
Croatian: • Alkoholizam: Erelzi se ne smije primjenjivati za liječenje hepatitisa povezanog s pretjeranom konzumacijom alkohola.