FrancophonIA/ELRC3.0 huggingface dataset:
English: Enbrel is a medicine that is made from two human proteins.
Croatian: Enbrel je lijek napravljen od dva ljudska proteina.
English: Do not warm Enbrel in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Nemojte zagrijavati Enbrel ni na koji drugi način (na primjer, nemojte ga zagrijavati u mikrovalnoj pećnici ili toploj vodi).
English: b: Values for Disease Activity Score (DAS) are means.
Croatian: b: Vrijednosti za bodove za aktivnost bolesti (Disease Activity Score (DAS)) su srednje vrijednosti.
English: The powder is white.
Croatian: Prašak je bijele boje.
English: If you use more Enbrel than you should
Croatian: Ako primijenite više Enbrela nego što ste trebali
English: This appearance is normal for Enbrel.
Croatian: Ovakav izgled je normalan za Enbrel.
English: • The risk of opportunistic infections and tuberculosis (TB)
Croatian: • rizik od oportunističkih infekcija i tuberkuloze
English: • Leave the syringe in place.
Croatian: • Ostavite štrcaljku na mjestu.
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Croatian: Kontinuirana terapija dulja od 24 tjedna može biti prikladna u nekih odraslih bolesnika (vidjeti dio 5.1).
English: What Enbrel is and what it is used for
Croatian: Što je Enbrel i za što se koristi
English: These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Croatian: Ovo su rijetke ili manje česte nuspojave, ali su ozbiljna stanja (neka od njih ponekad mogu imati smrtni ishod).
English: The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Croatian: Liječnik će Vam dati detaljne upute za pripremu i određivanje odgovarajuće doze.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Croatian: Stopa prilagođena izloženosti bila je 0,06 događaja na 100 bolesnik-godina.
English: Start again with another dose tray.
Croatian: Počnite ponovno s drugom posudom za dozu.
English: Package Leaflet: Information for the User
Croatian: Uputa o lijeku: Informacije za korisnika
English: If you received Enbrel during pregnancy, your baby may have a higher risk of getting an infection.
Croatian: Ako primite Enbrel tijekom trudnoće, Vaše dijete može imati veći rizik za dobivanje infekcije.
English: Enbrel N=103 to 105*
Croatian: Enbrel N=103 do 105*
English: What Enbrel looks like and contents of the pack
Croatian: Kako Enbrel izgleda i sadržaj pakiranja
English: Serious infections affect fewer than 1 in 100 patients treated with Enbrel.
Croatian: Ozbiljne infekcije zahvaćaju manje od 1 na 100 bolesnika liječenih Enbrelom.
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Enbrel is generally not recommended.
Croatian: Primjena živih cjepiva dojenčadi 16 tjedana nakon majčine zadnje doze Enbrela obično se ne preporučuje.
English: Long-term experience with Enbrel was generally comparable to the original 48-week study and did not reveal any new safety findings.
Croatian: Dugoročno iskustvo s Enbrelom bilo je općenito usporedivo s originalnim ispitivanjem od 48 tjedana i nije otkrilo nijednu novu činjenicu o sigurnosti primjene.
English: What Enbrel contains
Croatian: Što Enbrel sadrži
English: Enbrel is also prescribed for the treatment of the following diseases in children and adolescents
Croatian: Enbrel se propisuje i za liječenje sljedećih bolesti u djece i adolescenata:
English: Patients were also required to have an inadequate response or intolerance to two or more NSAIDs.
Croatian: Od bolesnika se također zahtijevao neodgovarajući odgovor ili intolerancija na dva ili više nesteroidna protupalna lijeka.
English: When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Croatian: Kada uklonite poklopac igle, na vršku igle može se pojaviti kapljica tekućine; to je normalno.
English: Enbrel has not been studied in children aged less than 2 years.
Croatian: Enbrel nije ispitan u djece mlađe od 2 godine.
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 Enbrel.
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 Enbrelom.
English: Talk to your doctor before taking Enbrel.
Croatian: Razgovarajte sa svojim liječnikom prije uzimanja Enbrela.
English: If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je djelovanje Enbrela prejako ili preslabo, obratite se svom liječniku ili ljekarniku.
English: Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks.
Croatian: Liječenje Enbrelom se mora nastaviti dok se ne postigne remisija, najdulje do 24 tjedna.
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of Enbrel (10 mg, 25 mg or 50 mg).
Croatian: Liječnik će odrediti sadržaj doze za dijete i propisat će odgovarajuću jačinu Enbrela (10 mg, 25 mg ili 50 mg).
English: It blocks the activity of another protein in the body that causes inflammation.
Croatian: Koči aktivnost jednog proteina koji u tijelu uzrokuje upalu.
English: If the window is not completely purple, contact your nurse or pharmacist for assistance, since the pen may not have injected the Enbrel solution completely.
Croatian: Ako prozorčić nije potpuno ljubičast, obratite se medicinskoj sestri ili ljekarniku za pomoć, budući da se iz brizgalice možda nije u potpunosti ubrizgala otopina Enbrela.
English: (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nepoznata učestalost (ne može se procijeniti iz dostupnih podataka)
English: Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer.
Croatian: Djeca i odrasli liječeni Enbrelom mogu imati povećani rizik razvoja limfoma ili nekog drugog raka.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using Enbrel.
Croatian: Prije stavljanja u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti konačni edukacijski materijal s regulatornim tijelom u toj državi članici, koji obuhvaća informacije koje su pružene svim zdravstvenim radnicima od kojih se očekuje da propisuju lijek, a koje se odnose na ispravnu i sigurnu primjenu napunjenih brizgalica i Karticu s upozorenjima za bolesnika, koja se daje bolesnicima koji koriste Enbrel.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, and in accordance with local recommendations.
Croatian: Ako je postavljena dijagnoza inaktivne (‘latentne') tuberkuloze, mora se započeti liječenje latentne tuberkuloze antituberkuloticima prije početka primjene Enbrela, u skladu s lokalnim preporukama.
English: Green activation button
Croatian: Zelena tipka za aktivaciju
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja, kao i iskustvu nakon stavljanja lijeka u promet.
English: Date of last renewal: 03 February 2010
Croatian: Datum posljednje obnove odobrenja: 03. veljače 2010.
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Croatian: Utjecaj uznapredovale dobi ispitan je u populacijskoj analizi farmakokinetike serumskih koncentracija etanercepta.
English: If you have used more Enbrel 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 Enbrela nego što ste trebali (bilo da ste primijenili odjednom previše ili ste ga primjenjivali prečesto), odmah se savjetujte s liječnikom ili ljekarnikom.
English: Other medicines and Enbrel
Croatian: Drugi lijekovi i Enbrel
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of Enbrel 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 Enbrela nakon dugotrajne primjene u bolesnika s JIA.
English: • This medicine has been prescribed for you or a child in your care.
Croatian: • Ovaj je lijek propisan samo Vama ili djetetu za koje skrbite.
English: Enbrel contains no antibacterial preservative, and therefore, solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Croatian: Enbrel ne sadrži antibakterijski konzervans pa stoga otopinu pripravljenu s vodom za injekcije treba primijeniti što prije, u roku od 6 sati nakon priprave.
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 Enbrel 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 Enbrelom, vodeći računa o koristi dojenja za dijete i koristi terapije za ženu.
English: Enbrel works by reducing the inflammation associated with certain diseases.
Croatian: Enbrel smanjuje upalu povezanu s određenim bolestima.
English: If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper.
Croatian: Ako je igla ispravno postavljena, trebali biste osjetiti blagi otpor i zatim “pop” kad igla prođe kroz središte čepa.
English: If this occurs, you should stop using Enbrel.
Croatian: Ako se to dogodi, morate prestati uzimati Enbrel.
English: • Check your syringe contains 1 ml of water for injections.
Croatian: • Provjerite da štrcaljka sadrži 1 ml vode za injekcije.
English: The Patient's Alert Card should contain the following key elements for patients treated with Enbrel:
Croatian: Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne elemente za bolesnike koji se liječe lijekom Enbrel:
English: • Make sure your syringe does not contain any air bubbles.
Croatian: • Pazite da štrcaljka ne sadrži mjehuriće zraka.
English: However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.
Croatian: Međutim, ne može se isključiti mogućnost da je kombinacija Enbrela s metotreksatom povezana s porastom stope infekcija.
English: The other ingredients in Enbrel are:
Croatian: Pomoćne tvari u Enbrelu su:
English: T hrombocyt openia, anaemia, leukopenia, neutropenia
Croatian: Trombocitopenija, anemija, leukopenija, neutropenija
English: The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.
Croatian: Ostali slučajevi bile su različite vrste zloćudnih bolesti, uključujući rijetke zloćudne bolesti tipično povezane sa imunosupresijom.
English: • Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
Croatian: • Uklonite zaštitni poklopac s vrška štrcaljke tako što ćete slomiti bijeli poklopac duž perforacijske crte.
English: Enbrel is not recommended for the treatment of Wegener's granulomatosis.
Croatian: Enbrel se ne preporučuje za liječenje Wegenerove granulomatoze.
English: Do not use this medicine if you notice the solution is not clear or contains particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra ili da sadrži čestice.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
Croatian: Ovi simptomi mogu upućivati na moguće životno opasne poremećaje krvi koji zahtijevaju prekid liječenja Enbrelom.
English: The use of Enbrel is not expected to affect the ability to drive or use machines.
Croatian: Ne očekuje se da će primjena Enbrela utjecati na sposobnost upravljanja vozilima ili strojevima.
English: The effect of Enbrel on radiographic progression was maintained in patients who continued on treatment during the second year.
Croatian: Učinak Enbrela na radiološku progresiju održan je u bolesnika koji su nastavili s liječenjem tijekom druge godine.
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Croatian: Bez promjena ili gotovo bez promjena na koži definirano kao 0 ili 1 na skali od 0 do 5.
English: Introduction b.
Croatian: Uvod b.
English: Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije početka terapije Enbrelom svi bolesnici moraju proći pregled s obzirom na aktivnu i inaktivnu (‘latentnu') tuberkulozu.
English: Do not attempt to administer an injection until you are sure that you understand how to use the MYCLIC pen properly.
Croatian: Nemojte pokušavati primijeniti injekciju dok niste sigurni da razumijete kako se upotrebljava MYCLIC brizgalica.
English: Women using Enbrel should not breast-feed, since Enbrel passes into human breast milk.
Croatian: Žene koje primaju Enbrel ne bi smjele dojiti, budući da Enbrel prelazi u majčino mlijeko.
English: • Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Croatian: • Wegenerova granulomatoza: Enbrel se ne preporučuje za liječenje Wegenerove granulomatoze, rijetke upalne bolesti.
English: Step 4: Disposing of the used MYCLIC pen
Croatian: Korak 4: Uklanjanje uporabljene brizgalice MYCLIC
English: If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Croatian: Ako Enbrel nema učinka na Vašu bolest ni nakon 12 tjedana, liječnik Vam može reći da prestanete uzimati ovaj lijek.
English: A total of 401 patients were enrolled, from which 203 were treated with Enbrel.
Croatian: Uključen je ukupno 401 bolesnik, od čega su 203 liječena Enbrelom.
English: What you need to know before you use Enbrel
Croatian: Što morate znati prije nego počnete primjenjivati Enbrel
English: The dosage of Enbrel is based on body weight for paediatric patients.
Croatian: Doza Enbrela temelji se na tjelesnoj težini pedijatrijskih bolesnika.
English: Patients should be evaluated for infections before, during, and after treatment with Enbrel, 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 Enbrelom, vodeći računa o tome da prosječno poluvrijeme eliminacije etanercepta iznosi otprilike 70 sati (raspon od 7 do 300 sati).
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: Ispitivanje je procijenilo 215 odraslih bolesnika (modificirana populacija s namjerom liječenja) s aktivnim nr-AxSpa (u dobi od 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: No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Croatian: Nisu dostupni podaci o sekundarnom prijenosu infekcija putem živih cjepiva u bolesnika koji primaju Enbrel.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Enbrel 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 Enbrela tijekom trudnoće (za više informacija vidjeti dio 2, ''Cijepljenje'').
English: The needle cover contains dry natural rubber (latex) (see section 4.4).
Croatian: Poklopac za iglu sadrži suhu prirodnu gumu (lateks) (vidjeti dio 4.4).
English: Be careful not to push down on the plunger.
Croatian: Pazite da ne potisnete klip u štrcaljku.
English: Some patients receiving Enbrel have developed skin cancers.
Croatian: Neki od bolesnika koji su primali Enbrel razvili su rak kože.
English: Autoantibody formation Treatment with Enbrel may result in the formation of autoimmune antibodies (see section 4.8).
Croatian: Stvaranje autoprotutijela Liječenje Enbrelom može uzrokovati stvaranje autoimunih protutijela (vidjeti dio 4.8).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (except for 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 (uz iznimku biosličnih lijekova), znanstveni zaključci CHMP-a su sljedeći:
English: The 10 mg Enbrel dose had consistently less effect on structural damage than the 25 mg dose.
Croatian: Doza od 10 mg Enbrela imala je značajno manji učinak na strukturalno oštećenje u usporedbi s dozom od 25 mg.
English: If you are not sure, please talk to your doctor.
Croatian: Ako niste sigurni, molimo obratite se svom liječniku.
English: • You will also need the following items: A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs
Croatian: • Bit će Vam potreban i sljedeći pribor: - Sterilna štrcaljka i igla (igle) od 25G x16 mm ili slična - Jedna bočica ili ampula vode za injekcije - 2 jastučića natopljena alkoholom
English: When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Croatian: Kad to učinite, ako slučajno istisnete i dio otopine natrag u bočicu, polako povucite klip kako biste je uvukli natrag u štrcaljku.
English: It is recommended that you record the date that Enbrel is removed from the refrigerator and the date after which Enbrel should be discarded (no more than 4 weeks following the removal from the refrigerator).
Croatian: Preporučuje se zabilježiti datum kada je Enbrel izvađen iz hladnjaka i datum nakon kojega Enbrel treba baciti (do 4 tjedna od vađenja iz hladnjaka).
English: The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Croatian: Primjena Enbrela u kombinaciji s drugom sustavnom terapijom ili fototerapijom za liječenje psorijaze nije ispitana.
English: In addition, one study found more birth defects when the mother had received Enbrel in pregnancy, compared with mothers who had not received Enbrel or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Croatian: Nadalje, jedno ispitivanje je zabilježilo više urođenih mana u slučaju kada je majka tijekom trudnoće primila Enbrel u usporedbi s majkama koje nisu primile Enbrel ili druge slične lijekove (antagoniste TNF-a), iako nije zabilježeno o kojem se tipu prijavljenih urođenih mana radi.
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Croatian: Ozbiljne infekcije javile su se u 6,3% bolesnika s reumatoidnim artritisom liječenih Enbrelom tijekom najdulje 48 mjeseci.
English: After discontinuation of Enbrel, symptoms of arthritis generally returned within a month.
Croatian: Općenito, nakon prekida liječenja Enbrelom simptomi artritisa su se ponovno javili u roku od mjesec dana.
English: • Push the plunger in VERY SLOWLY until all the water for injections is in the vial.
Croatian: • IZRAZITO POLAKO potiskujte klip sve dok sva voda za injekciju ne bude u bočici.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Croatian: Postoji povećani osnovni rizik za pojavu limfoma i leukemija u bolesnika s dugotrajnom, visoko aktivnom upalnom bolesti, što otežava procjenu rizika.
English: Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Enbrel se može davati kao monoterapija u slučaju nepodnošljivosti metotreksata ili kada je nastavak liječenja metotreksatom neodgovarajući.
English: Enbrel treatment may increase mortality in patients with established sepsis.
Croatian: Liječenje Enbrelom može povećati smrtnost bolesnika s dokazanom sepsom.
English: • Swelling of the face, throat, hands, or feet
Croatian: • Oticanje lica, grla, šaka ili stopala.
English: Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Croatian: Bolesnike u kojih se razviju nove infekcije za vrijeme liječenja Enbrelom mora se pažljivo nadgledati.
English: • Alcohol abuse: Enbrel should not be used for the treatment of hepatitis related to alcohol abuse.
Croatian: • Alkoholizam: Enbrel se ne smije primjenjivati za liječenje hepatitisa povezanog s pretjeranom konzumacijom alkohola.
English: Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Croatian: Dokazana je kemijska i fizikalna stabilnost u trajanju od 6 sati na temperaturi do 25°C nakon pripreme za primjenu.
English: If you notice any of the following, you or the child may need urgent medical attention.
Croatian: Ako primijetite bilo koji od slijedećih znakova, možda će te Vi ili dijete trebati hitnu medicinsku pomoć.
English: The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Croatian: Većina izvješća sa smrtnim ishodom zabilježena je u bolesnika s pneumocističnom pneumonijom, nespecifičnim sistemskim gljivičnim infekcijama i aspergilozom (vidjeti dio 4.4).
English: If Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Croatian: Ako Enbrel ne utječe na stanje djeteta nakon 12 tjedana terapije, Vaš će Vam liječnik možda reći da prestanete primjenjivati ovaj lijek.
English: On pressing the centre of the button, you will hear a click.
Croatian: Kad pritisnete sredinu tipke, začut ćete “klik”.
English: If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi smjeli biti dulji od 6 sati na temperaturi do 25°C, osim ako je lijek pripremljen za primjenu u kontroliranim i validiranim aseptičkim uvjetima.
English: Enbrel should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
Croatian: Enbrel se obično ne bi smio primjenjivati u djece s poliartikularnim artritisom ili produljenim oligoartritisom mlađe od 2 godine, kao ni u djece s artritisom povezanim s entezitisom ili psorijatičnim artritisom mlađe od 12 godina, niti u djece s psorijazom mlađe od 6 godina.