FrancophonIA/ELRC3.0 huggingface dataset:
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 Enbrel 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 Enbrelom (vidjeti dio iznad: Cijepljenje).
English: For rheumatoid arthritis, Enbrel 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 Enbrel 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 shake the pre-filled syringe of Enbrel.
Croatian: Nemojte tresti napunjenu štrcaljku Enbrela.
English: Some white foam may remain in the vial - this is normal.
Croatian: U bočici može preostati nešto bijele pjene - to je normalno.
English: Enbrel should be discarded if not used within four weeks after removal from the refrigerator.
Croatian: Enbrel treba baciti ako se ne upotrijebi u roku od četiri tjedna nakon što je izvađen iz hladnjaka.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with Enbrel due to the development of neutralising antibodies in rodents.
Croatian: Ispitivanja kancerogenosti, kao i uobičajena procjena utjecaja na plodnost i postnatalne toksičnosti, nisu provedena s Enbrelom zbog pojave neutralizirajućih protutijela u glodavaca.
English: From a microbiological point of view, the reconstituted medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek pripremljen za primjenu bi trebalo odmah primijeniti.
English: Consequently, Enbrel should not be used in patients for the treatment of alcoholic hepatitis.
Croatian: Dakle, Enbrel se ne smije koristiti u bolesnika za liječenje alkoholnog hepatitisa.
English: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Enbrel 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 Enbrelom i tri tjedna nakon prestanka liječenja.
English: If any of the following happen, do not inject more Enbrel.
Croatian: Ako se pojavi bilo što od sljedećeg, prestanite s ubrizgavanjem Enbrela.
English: Enbrel should be used with caution in patients with a history of hepatitis C.
Croatian: Enbrel se mora koristiti s oprezom u bolesnika s hepatitisom C u anamnezi.
English: Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Croatian: Povećane koncentracije etanercepta nisu bile opažene u bolesnika s akutnim zatajenjem jetre.
English: • Remove the plastic cap from the Enbrel vial.
Croatian: • Uklonite plastični poklopac s bočice Enbrela.
English: If you stop using Enbrel
Croatian: Ako prestanete primjenjivati Enbrel
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: Wyeth Pharmaceuticals New Lane
Croatian: Proizvođač: Wyeth Pharmaceuticals
English: Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs. 9%).
Croatian: U usporedbi s bolesnicima koji su primali placebo, u bolesnika s reumatskim bolestima koji su primali Enbrel uočena je značajno veća incidencija reakcija na mjestu primjene injekcije (36% naspram 9%).
English: There have been reports of worsening of hepatitis C in patients receiving Enbrel.
Croatian: Opisani su slučajevi pogoršanja hepatitisa C u bolesnika koji su primali Enbrel.
English: The combination Enbrel and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Croatian: Nije dokazano da kombinacija Enbrela i anakinre povećava kliničku korist te se stoga ne preporučuje.
English: Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Croatian: Pažljivo zbrinite preostalu otopinu Enbrela koja nije bila ubrizgana u roku od 6 sati.
English: If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje Enbrelom, moraju se slijediti gore navedene smjernice o trajanju terapije.
English: There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Croatian: Prijavljeni su također i slučajevi lupusa, stanja nalik lupusu i vaskulitisa.
English: Some children and teenage patients who have received Enbrel or other medicines that work the same way as Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Croatian: U neke djece i adolescenata koji su liječeni Enbrelom 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: In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Croatian: U ispitivanju koje je provedeno u 49 odraslih bolesnika s reumatoidnim artritisom liječenih Enbrelom nije bilo dokaza o smanjenju preosjetljivosti odgođenog tipa, smanjenju razine imunoglobulina ni promjeni ukupnog broja populacije izvršnih stanica.
English: In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika koji razviju HBV infekciju, terapiju Enbrelom treba prekinuti i započeti učinkovitu antivirusnu terapiju s odgovarajućim suportivnim liječenjem.
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
Croatian: Sto dvanaest (112) bolesnika bilo je randomizirano tako da su primili dozu od 25 mg Enbrela (n=57) ili placebo (n=55) dvaput tjedno tijekom 24 tjedna.
English: Please see section 5 for instructions on how to store Enbrel.
Croatian: Pročitajte dio 5 za upute o tome kako čuvati Enbrel.
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Croatian: Ako imate dodatnih pitanja, molimo obratite se liječniku, medicinskoj sestri ili ljekarniku koji su upoznati s Enbrelom.
English: Compared to placebo, treatment with Enbrel resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Croatian: U usporedbi s placebom, liječenje Enbrelom rezultiralo je u statistički značajnim poboljšanjem u ASAS 40, ASAS 20 i ASAS 5/6.
English: Infect ions and infestations
Croatian: Infekcije i infestacije
English: Summary of the safety profile
Croatian: Sažetak sigurnosnog profila.
English: Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.
Croatian: Obavijestite svog liječnika ako dijete razvije bilo kakve bolove ili grčeve u trbuhu, proljev, izgubi na težini ili uočite krv u stolici.
English: This section presents data from three studies in juvenile idiopathic arthritis, one study in paediatric patients with plaque psoriasis, four studies in adults with rheumatoid arthritis, and four studies in adults with plaque psoriasis.
Croatian: Ovaj dio prikazuje podatke iz tri ispitivanja juvenilnog idiopatskog artritisa, jednog ispitivanja u pedijatrijskih bolesnika s plak psorijazom, četiri ispitivanja u odraslih s reumatoidnim artritisom i četiri ispitivanja u odraslih s plak psorijazom.
English: In this situation, the benefit/risk balance of Enbrel therapy should be very carefully considered.
Croatian: U navedenoj situaciji nužno je vrlo pomno razmotriti omjer koristi i rizika terapije Enbrelom.
English: After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Croatian: Nakon 12 tjedana liječenja bolesnici u placebo skupini su počinjali slijepo liječenje Enbrelom (25 mg dvaput tjedno), a bolesnici u aktivnoj skupini nastavljali su liječenje do kraja 24. tjedna dozom na koju su od početka randomizirani.
English: At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Croatian: U 104. tjednu, 8 je ispitanika napredovalo do 2. stupnja bilateralno, mjereno rentgenom kralježnice prema modificiranim New York kriterijima za radiološku ocjenu, što ukazuje na aksijalnu spondiloartropatiju.
English: The efficacy of Enbrel 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 Enbrela 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: Hepat it is B reactivation, listeria
Croatian: Reaktivacija hepatitisa B, listeria
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: Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Croatian: Zabilježene alergijske reakcije uključivale su angioedem i urtikariju.Također su zabilježene i ozbiljne reakcije.
English: Enbrela
Croatian: Enbrel
English: Treatment with Enbrel 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Croatian: Liječenje dozom Enbrela od 25 mg rezultiralo je znatnim poboljšanjem nakon 12 mjeseci s oko 44% bolesnika koji su dostigli normalnu ocjenu na upitniku HAQ (manje od 0,5).
English: Withdrawing the Enbrel solution from the vial f.
Croatian: Izvlačenje otopine Enbrela iz bočice f.
English: Adding water for injections e.
Croatian: Dodavanje vode za injekciju e.
English: In long-term (up to 34 months) open-label studies where Enbrel 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 Enbrel primjenjivao bez prekida, klinički odgovor bio je kontinuiran i sigurnost primjene je bila usporediva s ispitivanjima kraćeg trajanja.
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 Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
Croatian: Sto dvadeset devet (129) novih zloćudnih bolesti različitih tipova zabilježeno je u 4114 bolesnika s reumatoidnim artritisom liječenih Enbrelom u razdoblju do približno 6 godina u kliničkim ispitivanjima, uključujući 231 bolesnika liječenog Enbrelom u kombinaciji s metotreksatom u dvogodišnjem ispitivanju s aktivnom kontrolom.
English: Do not touch this area again before injecting.
Croatian: NE DIRAJTE to područje ponovo prije davanja injekcije.
English: The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Croatian: Udio bolesnika liječenih Enbrelom u kojih su se razvila protutijela na kardiolipin bio je podjednako povećan kao u bolesnika koji su primali placebo.
English: • A needle-free demonstration device
Croatian: • pokazna naprava bez igle
English: • Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Croatian: • Upotrijebite novi jastučić natopljen alkoholom za brisanje sivog čepa na bočici Enbrela.
English: Preparing the Enbrel dose for injection d.
Croatian: Priprema doze Enbrela za injekciju d.
English: If active tuberculosis is diagnosed, Enbrel therapy must not be initiated.
Croatian: Ako je postavljena dijagnoza aktivne tuberkuloze, nije dozvoljeno započeti terapiju Enbrelom.
English: As you lift the pen, the purple needle safety shield will automatically extend to cover the needle.
Croatian: Kad podignete brizgalicu s kože, ljubičasti sigurnosni štitnik za iglu automatski će izaći i prekriti iglu.
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: There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
Croatian: U djece mlađe od 2 godine općenito nije primjerena primjena Enbrela u indikaciji juvenilnog idiopatskog artritisa.
English: Česká Republika
Croatian: Slovenská Republika
English: Efficacy Response in Placebo-Controlled nr-AxSpa Study: Percent of Patients Achieving Endpoints Double-Blind Clinical Responses at Week 12
Croatian: Odgovor djelotvornosti u placebom kontroliranom ispitivanju nr-AxSpa: Postotak bolesnika koji su postigli mjere ishoda Dvostruko slijepi klinički odgovori u 12. tjednu
English: Opportunistic infections have been reported in association with Enbrel, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Croatian: Oportunističke infekcije zabilježene su u vezi s Enbrelom, uključujući invazivne gljivične, parazitske (uključujući protozoalne), virusne (uključujući herpes zoster), bakterijske (uključujući bakterije Listeria i Legionella) i atipične mikobakterijske infekcije.
English: Do not use Enbrel
Croatian: Nemojte primjenjivati Enbrel
English: If any serious allergic or anaphylactic reaction occurs, Enbrel 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 Enbrelom i započeti odgovarajuća terapija.
English: Adjusted mean change from baseline was 3.8 for Enbrel treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Croatian: Prilagođena srednja promjena u odnosu na početak iznosila je 3,8 u bolesnika liječenih Enbrelom (n=95) naspram 0,8 u bolesnika liječenih placebom (n=105) (p <0,001).
English: After removal of the needle cap, you will see a purple needle safety shield extending slightly from the end of the pen.
Croatian: Nakon uklanjanja zatvarača igle, vidjet ćete ljubičasti sigurnosni štitnik igle kako se proteže malo izvan kraja brizgalice.
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Croatian: Infekcije koje su zabilježene u kliničkim ispitivanjima u bolesnika s juvenilnim idiopatskim artritisom u dobi od 2 do 18 godina općenito su po tipu bile blage do umjereno teške te odgovaraju onima koje se obično mogu vidjeti kod ambulantne pedijatrijske populacije.
English: Step 1: Preparing for an Enbrel injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of the used MYCLIC pen
Croatian: Korak 1: Priprema za injekciju Enbrela Korak 2: Odabir mjesta za injekciju Korak 3: Ubrizgavanje otopine Enbrela Korak 4: Odlaganje uporabljene brizgalice MYCLIC
English: Pfizer Luxembourg SARL filiāle Latvijā
Croatian: Pfizer Luxembourg SARL filiāle Latvijā Tel.
English: Inspect the solution in the pen by looking through the clear inspection window.
Croatian: Pregledajte otopinu u brizgalici tako što ćete pogledati kroz prozirni prozorčić za provjeru.
English: From the start of part 2, the median time to flare was ≥ 116 days for patients who received Enbrel 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 Enbrel i 28 dana za bolesnike koji su primili placebo.
English: Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Croatian: Liječenje s Enbrelom, u usporedbi s placebom, dovelo je do značajnog poboljšanja ASAS 20, ASAS 50 i ASAS 70 već nakon 2 tjedna nakon početka terapije.
English: Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2).
Croatian: Uklonite poklopac igle tako što ćete ga čvrsto povući ravno sa štrcaljke (vidjeti sliku 2).
English: In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Croatian: U dvogodišnjem aktivno kontroliranom ispitivanju u kojem su bolesnici liječeni samo Enbrelom, samo metotreksatom ili Enbrelom u kombinaciji s metotreksatom, stope ozbiljnih infekcija bile su slične za sve liječene skupine.
English: Enbrel is supplied with pre-filled syringes containing water for injection.
Croatian: Enbrel se pakira s napunjenim štrcaljkama koje sadrže vodu za injekcije.
English: This injection should not be mixed in the same syringe or vial with any other medicine.
Croatian: Ovu injekciju ne treba miješati u istoj štrcaljki ili bočici niti s jednim drugim lijekom.
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 nonsteroidal 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: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Croatian: Alternativno, dokazana je sigurnost primjene i djelotvornost 50 mg Enbrela primijenjenog jednom tjedno (vidjeti dio 5.1).
English: After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Croatian: Nakon što se izvukli Enbrel iz bočice, u štrcaljki može preostati nešto zraka.
English: Enbrel is administered by an injection under the skin (by subcutaneous injection).
Croatian: Enbrel se daje injekcijom pod kožu (supkutanom injekcijom).
English: There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
Croatian: U djece mlađe od 6 godina općenito nije primjerena primjena Enbrela u indikaciji plak psorijaze.
English: In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel 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 Enbrelom razvilo je reakciju na mjestu primjene injekcije u usporedbi s 3,4% placebom liječenih bolesnika za vrijeme prvih 12 tjedana liječenja.
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
Croatian: U skupnim podacima prikupljenim iz kliničkih ispitivanja ukupna incidencija oportunističkih infekcija bila je 0,09% na 15 402 ispitanika koji su dobivali Enbrel.
English: The difference between Enbrel alone and methotrexate alone was also significant (p<0.05).
Croatian: Također je značajna razlika između Enbrela u monoterapiji i metotreksata u monoterapiji (p<0,05).
English: It is very important that you tell your doctor if the child has ever had tuberculosis, or has been in close contact with someone who has had tuberculosis.
Croatian: Vrlo je važno da napomenete liječniku ako je dijete ikada imalo tuberkulozu ili je bilo u bliskom dodiru s osobom koja je imala tuberkulozu.
English: However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Croatian: Međutim, bilo koji od gore navedenih simptoma može upućivati na alergijsku reakciju na Enbrel, stoga je potrebno odmah zatražiti liječničku pomoć.
English: This injection should not be mixed with any other medicine.
Croatian: Ovu injekciju ne treba miješati niti s jednim drugim lijekom.
English: Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Croatian: Među bolesnicima s reumatoidnim artritisom u kojih su određivana antinuklearna protutijela (ANA) veći je postotak novopozitivnih na ANA (≥ 1:40) bio među onima liječenima Enbrelom (11%) nego među onima koji su primali placebo (5%).
English: Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis.
Croatian: Kombiniranjem rezultata kontroliranih kliničkih ispitivanja Enbrela primijećeno je više slučajeva NMSC-a u bolesnika koji su dobivali Enbrel u usporedbi s bolesnicima u kontrolnoj skupini, posebno u bolesnika sa psorijazom.
English: Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Croatian: Nemojte koristiti otopinu ako je obojena, zamućena ili sadrži čestice drugačije od opisanih.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Croatian: Reumatoidni artritis, psorijatični artritis i aksijalni spondiloartritis uključujući ankilozantni spondilitis
English: Patients received Enbrel 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Croatian: Bolesnici su primali Enbrel 0,8 mg/kg (do 50 mg) ili placebo jednom tjedno tijekom 12 tjedana.