FrancophonIA/ELRC3.0 huggingface dataset:
English: You will also need 1 ml of water for injections and a syringe to administer Enbrel 16.
Croatian: Trebat će Vam i 1 ml vode za injekcije i štrcaljka za primjenu Enbrela.
English: • While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.
Croatian: • Držeći iglu i spremnik u jednoj ruci, uzmite štrcaljku i uvedite vršak štrcaljke u otvor igle.
English: Treatment with Enbrel may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Croatian: Liječenje Enbrelom može reaktivirati hepatitis B u bolesnika koji su prethodno bili zaraženi virusom hepatitisa B.
English: Enbrel should only be used during pregnancy if clearly needed.
Croatian: Enbrel se tijekom trudnoće smije primjenjivati samo ako je to posve neophodno.
English: After preparing the Enbrel solution, immediate use is recommended (up to a maximum of 6 hours).
Croatian: Nakon pripreme otopine Enbrela, preporučuje se odmah je primijeniti (u roku od najviše 6 sati).
English: Serious allergic/anaphylactic react ions (including angioedema, bronchospasm), sarcoidosis
Croatian: Ozbiljne alergijske/anafila ktične reakcije (uključujući angioedem, bronhospazam), sarkoidoza
English: If this is the case, start again with another vial.
Croatian: Ako se to dogodi, ponoviti postupak s novom bočicom.
English: In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including Enbrel, has been reported.
Croatian: Zabilježena je reaktivacija hepatitisa B u bolesnika koji su prethodno bili zaraženi virusom hepatitisa B (HBV) i primali antagoniste TNF-a, uključujući Enbrel.
English: Enbrel did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg.
Croatian: Enbrel 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: As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Croatian: Kako razina otopine u bočici pada, možda ćete morati djelomično izvući iglu kako bi vrh igle ostao u otopini.
English: The safety and efficacy profiles of the two Enbrel 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 Enbrelom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA Podaci u 16. tjednu nisu bili usporedivi (ne-inferiornost) za dva režima.
English: Information in this leaflet is organised under the following 7 sections:
Croatian: Informacije u ovoj uputi organizirane su u sljedećih 7 odjeljaka:
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Enbrel treatment.
Croatian: Iako ne uvjerljivo, podaci iz jednog od ovih ispitivanja upućivali su na moguću tendenciju pogoršanja kongestivnog zatajenja srca u bolesnika liječenih Enbrelom.
English: • Tuberculosis: As cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check for signs and symptoms of tuberculosis before starting Enbrel.
Croatian: • Tuberkuloza: budući da su u bolesnika koju su liječeni Enbrelom opisani slučajevi tuberkuloze, liječnik će provjeriti postoje li znakovi ili simptomi tuberkuloze prije nego što počnete terapiju Enbrelom.
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 Enbrel.
Croatian: Vaš liječnik može odlučiti da Vas ili dijete nastavi pratiti s obzirom na prisutnost infekcije nakon što ste Vi ili dijete prestali uzimati Enbrel.
English: TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body's defenses against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je Enbrel, utječu na imunološki sustav i njihova primjena može imati učinak na obranu organizma protiv infekcija i raka.
English: Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
Croatian: Počnite ponovno s novom bočicom Enbrela, vodom za injekcije, štrcaljkom, iglom i jastučićima natopljenima alkoholom.
English: Do not insert the needle at an angle, this may cause the needle to bend and/or prevent proper addition of the solvent into the vial (see Diagram 4).
Croatian: Nemojte uvoditi iglu pod kutom, jer to može prouzročiti savijanje igle i/ili onemogućiti ispravno dodavanje otapala u bočicu (vidjeti sliku 4).
English: Enbrel + Methotrexate (n = 231)
Croatian: Enbrel + Metotreksat (n = 231)
English: Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: Enbrel je također indiciran u liječenju teškog, aktivnog i progresivnog reumatoidnog artritisa u odraslih koji prethodno nisu bili liječeni metotreksatom.
English: In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Croatian: U kliničkim ispitivanjima nisu primijećene interakcije prilikom primjene Enbrela s glukokortikoidima, salicilatima (osim sulfasalazina), nesteroidnim protuupalnim lijekovima (NSAIL), analgeticima ni metotreksatom.
English: • Pull the needle completely out of the vial.
Croatian: • Potpuno izvucite iglu iz bočice.
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.
Croatian: Incidencija različitih vrsta ne-kožnih zloćudnih bolesti bila je značajno veća u bolesnika koji su liječeni Enbrelom u odnosu na kontrolnu skupinu.
English: You can press a cotton ball or gauze over the injection site for 10 seconds.
Croatian: Možete pritisnuti komadić vate ili gazu na mjesto davanja injekcije tijekom slijedećih 10 sekundi.
English: Psoriatic Arthritis Response n = 104
Croatian: Odgovori bolesnika s psorijatičnim artritisom n = 104
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received Enbrel without interruption.
Croatian: Opaženi su kontinuirano trajni učinci i do 10 godina u otvorenim ispitivanjima s produžetkom kada su bolesnici primali Enbrel bez prekida.
English: • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision
Croatian: • Znakovi autoimune reakcije (kada se stvaraju protutijela koja mogu oštetiti normalno tkivo u tijelu) kao što su bol, svrbež, slabost i poremećeno disanje, razmišljanje, osjet ili vid
English: In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.
Croatian: U kliničkim ispitivanjima istodobna primjena abatacepta i Enbrela rezultirala je povećanom incidencijom ozbiljnih štetnih događaja.
English: The impact of long-term treatment with Enbrel on the development of autoimmune diseases is unknown.
Croatian: Nije poznat utjecaj dugotrajnog liječenja Enbrelom na razvoj autoimunih bolesti.
English: There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment.
Croatian: Zabilježeni su dokazi koji podupiru korist ponovne primjene Enbrela u bolesnika koji su inicijalno odgovorili na liječenje.
English: Enbrel powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Croatian: Prije primjene Enbrel prašak za otopinu mora se rekonstituirati u 1 ml otapala (vidjeti dio 6.6).
English: Although no clinical trials have been performed evaluating Enbrel therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Croatian: Premda nisu provedena klinička ispitivanja Enbrela u terapiji bolesnika s multiplom sklerozom, klinička ispitivanja drugih antagonista TNF-a u bolesnika s multiplom sklerozom pokazala su porast aktivnosti bolesti.
English: On the basis of the scientific conclusions for etanercept (except for biosimilars) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing etanercept (except for biosimilars) is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za etanercept (uz iznimku biosličnih lijekova), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) etanercept (uz iznimku biosličnih lijekova) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Responses of Patients with Psoriasis in Studies 2, 3 And 4
Croatian: Odgovor bolesnika sa psorijazom u ispitivanjima 2, 3 i 4
English: Based on the review of the literature and spontaneous reporting presented in this PSUSA, covering the period from 03 February 2018 to 02 February 2019, as well as cumulative data since the European birth date, the PRAC considered that a causal relationship between inflammatory bowel disease and etanercept cannot be excluded and therefore recommends that the product information of medicinal products containing the active substance etanercept should be updated as follows: update of section 4.8 of the SmPC to add inflammatory bowel disease with a frequency uncommon.
Croatian: Na temelju pregleda literature i spontanog prijavljivanja predstavljenih u ovoj zajedničkoj ocjeni PSUR-ova koja obuhvaća razdoblje od 3. veljače 2018. do 2. veljače 2019., kao i kumulativnih podataka od datuma prvog odobrenja koje je nositelju dano u nekoj zemlji članici EU, PRAC smatra da se uzročni odnos između upalne bolesti crijeva i etanercepta ne može isključiti te stoga preporučuje da se informacije o lijeku za lijekove koji sadrže djelatnu tvar etanercept ažuriraju kako slijedi: potrebno je ažurirati dio 4.8 sažetka opisa svojstava lijeka kako bi se uvrstila upalna bolest crijeva s učestalosti „manje često“.
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three Enbrel doses.
Croatian: Tijekom prvih 12 tjedana dvostruko slijepog perioda bolesnici su primali placebo ili jednu od tri navedene doze Enbrela.
English: Another study found no increased risk of birth defects when the mother had received Enbrel in pregnancy.
Croatian: Drugo ispitivanje nije zabilježilo povećani rizik od urođenih mana kada je majka primala Enbrel tijekom trudnoće.
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Croatian: U dvostruko slijepim otvorenim ispitivanjima psorijatičkog artritisa u jednog je bolesnika opisana ozbiljna infekcija (pneumonija).
English: Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections.
Croatian: Liječenje Enbrelom se ne smije započeti u bolesnika s aktivnim infekcijama, uključivši kronične i lokalizirane infekcije.
English: If any of the following happen to the child, do not give the child more Enbrel.
Croatian: Ako se kod djeteta pojavi bilo što od sljedećeg, prestanite djetetu davati Enbrel.
English: Disposing of supplies a.
Croatian: Odlaganje uporabljenog pribora a.
English: Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with Enbrel during pregnancy.
Croatian: Etanercept prolazi kroz placentu i može se otkriti u serumu dojenčadi žena koje su bile liječene Enbrelom tijekom trudnoće.
English: Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the grey button again.
Croatian: Napomena - ako ne možete pokrenuti ubrizgavanje kako je opisano, čvršće pritisnite brizgalicu na kožu, zatim ponovo pritisnite sivi gumb.
English: The solvent is a clear, colourless liquid.
Croatian: Otopina je bistra, bezbojna tekućina.
English: Enbrel 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: Enbrel 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: Enbrel 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 Enbrelom dovelo je do poboljšanja fizičke funkcije tijekom dvostruko slijepog razdoblja, pri čemu je ovo poboljšanje održano i tijekom dugotrajnog izlaganja do 2 godine.
English: The differences in TSS and JSN were not statistically significant between methotrexate and Enbrel 25 mg.
Croatian: Razlike TSS i JSN ocjena između metotreksata i Enbrela 25 mg nisu bile statistički značajne.
English: • Remove the plastic cap from the Enbrel vial (see Diagram 1).
Croatian: • Uklonite plastični poklopac s bočice Enbrela (vidjeti sliku 1).
English: Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Croatian: Među bolesnicima koji su završili puna 24 mjeseca terapije u ispitivanju stopa ne-progresije je bila 78%,70% odnosno 61%.
English: Live vaccines should not be given concurrently with Enbrel.
Croatian: Živa cjepiva ne smiju se davati istodobno s Enbrelom.
English: If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “pop”.
Croatian: Ako igla nije ispravno postavljena, stalno će se osjećati otpor dok igla prolazi kroz čep i neće se čuti “pop”.
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 sa teškim reumatoidnim artritisom, koji boluju dulje vrijeme, mogu imati veći rizik razvoja limfoma od prosjeka.
English: • Do not use the syringe if this perforation is already broken.
Croatian: • Nemojte uporabiti štrcaljku ako je već slomljena duž perforacijske crte.
English: If you notice any of the following, the child may need urgent medical attention.
Croatian: Ako primijetite bilo koji od slijedećih znakova, možda će dijete trebati hitnu medicinsku pomoć.
English: Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Croatian: Ponovno uvođenje liječenja Enbrelom nakon prekida koji je trajao do 24 mjeseca dovelo je do istog učinka kao i u bolesnika koji su primali Enbrel bez prekida liječenja, a na temelju otvorenih ispitivanja.
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) Tηλ: +357 22 817690
Croatian: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
English: See section 5 for instructions on how to store Enbrel.
Croatian: Vidjeti dio 5 za upute o tome kako čuvati Enbrel.
English: A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener's granulomatosis.
Croatian: Placebom kontrolirano ispitivanje u kojem je 89 odraslih bolesnika liječeno Enbrelom koji je dodan standardnoj terapiji (koja je uključivala ciklofosfamid ili metotreksat te glukokortikoide) s medijanom trajanja od 25 mjeseci nije pokazalo da je Enbrel učinkovit u liječenju Wegenerove granulomatoze.
English: Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy.
Croatian: U bolesnika s juvenilnim idiopatskim artritisom nisu provedena ispitivanja učinaka kontinuirane terapije Enbrelom u onih koji nisu odgovorili u roku od 3 mjeseca nakon početka terapije Enbrelom.
English: There have been postmarketing 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: Be careful not to bend or twist the cover during removal to avoid damage to the needle.
Croatian: Pazite da ne savijate i ne zakrećete poklopac tijekom uklanjanja kako ne biste oštetili iglu.
English: For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities.
Croatian: U bolesnika s psorijatičnim artritisom koji zahvaća više zglobova Enbrel može poboljšati sposobnost obavljanja uobičajenih dnevnih aktivnosti.
English: Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel 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 Enbrelom te se mora razmotriti profilaktičko liječenje Varicella Zoster Imunoglobulinom.
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.
Croatian: U ispitivanjima faze III u reumatoidnom artritisu, psorijatičnom artritisu i ankilozantnom spondilitisu nije primijećena ukupna razlika u pojavi štetnih događaja, ozbiljnih štetnih događaja i ozbiljnih infekcija između bolesnika u dobi od 65 godina ili starijih koji su primali Enbrel, u usporedbi s mlađim bolesnicima.
English: Patients treated with Enbrel should be given the Patient Alert Card.
Croatian: Bolesnicima koji se liječe Enbrelom treba dati Karticu s upozorenjima za bolesnika.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.
Croatian: Melanom i nemelanomski rak kože (engl. non-melanoma skin cancer, NMSC) primijećeni su u bolesnika liječenih antagonistima TNF-a, uključujući Enbrel.
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Croatian: Ispitivanje 2 je procijenilo 652 bolesnika s kroničnom plak psorijazom koristeći iste kriterije uključivanja kao u ispitivanju 1, uz dodatak minimalnog PASI indeksa 10 na probiranju.
English: Radiographic progression at 12 months was significantly less in the Enbrel 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 Enbrelom nego u skupini s metotreksatom, dok je kombinacija bila značajno bolja od obje monoterapije u smislu usporavanja radiološke progresije (vidjeti sljedeću sliku).
English: Enbrel showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Croatian: Enbrel je pokazao statistički značajno veće poboljšanje u odnosu na početak do 12. tjedna u usporedbi s placebom u većini procjena kvalitete života vezane uz zdravlje i fizičke funkcije, uključujući BASFI (Bathov funkcionalni indeks za ankilozantni spondiloartritis), rezultat ukupnog zdravstvenog stanja EuroQol 5D i rezultat fizičke komponente SF-36.
English: The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
Croatian: Djelotvornost Enbrela 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 Enbrela s drugim sistemskim terapijama.
English: • Take the ENBREL vial out of the refrigerator and place it on a flat surface.
Croatian: • Izvadite bočicu Enbrela iz hladnjaka i postavite je na ravnu površinu.
English: Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Croatian: Neke su se pojavile nekoliko tjedana nakon početka liječenja Enbrelom u bolesnika s postojećim stanjima (npr. šećerna bolest, kongestivno zatajenje srca, aktivne ili kronične infekcije u anamnezi) uz reumatoidni artritis (vidjeti dio 4.4).
English: Two large clinical trials evaluating the use of Enbrel in the treatment of CHF were terminated early due to lack of efficacy.
Croatian: Dva velika klinička ispitivanja primjene Enbrela u liječenju kongestivnog zatajenja srca prekinuta su ranije uslijed nedostatne djelotvornosti.
English: Within the organ system 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); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
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 (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Each vial of Enbrel 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Croatian: Svaku bočicu Enbrela od 10 mg treba uporabiti jednokratno u samo jednog bolesnika, a ostatak sadržaja bočice treba baciti.
English: Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using Enbrel.
Croatian: Vaš liječnik može odlučiti nastaviti pratiti dijete s obzirom na prisutnost infekcije nakon što dijete prestane primati Enbrel.
English: In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score.
Croatian: U ovom ispitivanju strukturalno oštećenje zglobova procijenjeno je radiološki te prikazano kao promjena ocjene na Sharpovoj ljestvici (Total Sharp Score - TSS) i njenim dijelovima, ocjene erozije i ocjene suženja zglobnog prostora (Joint Space Narrowing score - JSN).