FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Benepali 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 Benepalija tijekom trudnoće (za više informacija pogledajte dio 2 "Cijepljenja").
English: Immediate use is then recommended.
Croatian: Tada se preporučuje odmah primijeniti lijek.
English: • Wegener's granulomatosis: Benepali is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Croatian: • Wegenerova granulomatoza: Benepali se ne preporučuje za liječenje Wegenerove granulomatoze, rijetke upalne bolesti.
English: • Always keep the container out of the sight and reach of children.
Croatian: • Uvijek čuvajte spremnik izvan pogleda i dohvata djece.
English: ● Keep this card with you for 2 months after the last Benepali dose, since side effects may occur after your last dose of Benepali.
Croatian: Ovu karticu nosite sa sobom još 2 mjeseca nakon što ste primili posljednju dozu Benepalija, jer se nuspojave mogu javiti nakon posljednje doze.
English: If you forget to inject Benepali
Croatian: Ako ste zaboravili ubrizgati Benepali
English: Benepali is not recommended for the treatment of Wegener's granulomatosis.
Croatian: Benepali se ne preporučuje za liječenje Wegenerove granulomatoze.
English: Etanercept 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 etanerceptom dovelo je do poboljšanja fizičke funkcije tijekom dvostruko slijepog razdoblja pri čemu je ovo poboljšanje održano i tijekom dugotrajnog izlaganja do 2 godine.
English: Non-melanoma skin cancers* (see section 4.4)
Croatian: Ne-melanomski rak kože* (vidjeti dio 4.4)
English: Placebo n = 106 to 109*
Croatian: Placebo n = 106 do 109*
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: Radiografska 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 radiografske progresije (vidjeti sljedeću sliku).
English: • Do not use heat sources, such as a microwave or hot water, to warm Benepali.
Croatian: • Za grijanje Benepalija nemojte koristiti izvore topline poput mikrovalne pećnice ili tople vode.
English: Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: Benepali je također indiciran u liječenju teškog, aktivnog i progresivnog reumatoidnog artritisa u odraslih koji prethodno nisu bili liječeni metotreksatom.
English: Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Croatian: Temeljem farmakokinetičkih podataka (vidjeti dio 5.2) u liječenju bolesnika s oštećenjem funkcije bubrega ili jetre nije potrebna prilagodba doza; podaci o kliničkim iskustvima s takvim bolesnicima su ograničeni.
English: It is recommended that you record the date that Benepali is removed from the refrigerator and the date after which Benepali should be discarded (no more than 4 weeks following the removal from the refrigerator).
Croatian: Preporučuje se zabilježiti datum kada je Benepali izvađen iz hladnjaka i datum nakon kojega Benepali treba baciti (do 4 tjedna od vađenja iz hladnjaka).
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 uključenja kao i ispitivanje 2.
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group.
Croatian: Incidencija različitih vrsta ne-kožnih zloćudnih bolesti bila je značajno veća kod bolesnika koji su liječeni etanerceptom nego u kontrolnoj skupini.
English: If Benepali has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.
Croatian: Ako Benepali nema učinka na Vašu bolest ni nakon 12 tjedana, liječnik Vam može reći da prestanete primjenjivati ovaj lijek.
English: What Benepali looks like and contents of the pack
Croatian: Kako Benepali izgleda i sadržaj pakiranja
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 zadovoljavaju kriterije klasifikacije ASAS aksijalnog spondiloartritisa, ali nisu zadovoljili modificirane njujorške kriterije za AS.
English: Continue to hold the pre-filled pen firmly pressed into the site.
Croatian: Nastavite držati napunjenu brizgalicu čvrsto pritisnutu u mjestu.
English: Some patients receiving Benepali have developed skin cancers.
Croatian: Neki od bolesnika koji su primali Benepali razvili su rak kože.
English: Serious allergic/anaphyla ctic reactions (including angioedema, bronchospasm), sarcoidosis
Croatian: Ozbiljne alergijske/anafila ktične reakcije (uključujući angioedem, bronhospazam), sarkoidoza
English: • Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Croatian: • Poremećaji živčanog sustava i oka: Obavijestite svog liječnika ako Vi ili dijete bolujete od multiple skleroze, optičkog neuritisa (upala vidnog živca) ili transverznog mijelitisa (oblik upale kralježničke moždine).
English: • Do not release pressure against the injection site before the injection is complete.
Croatian: • Nemojte popustiti pritisak na mjestu injekcije prije nego je injekcija gotova.
English: This card contains important safety information that you need to be aware of before you are given Benepali and during treatment with Benepali.
Croatian: Ova kartica sadrži važne sigurnosne podatke s kojima trebate biti upoznati prije nego primite Benepali, kao i tijekom liječenja Benepalijem.
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 znatno manji učinak na strukturalno oštećenje u usporedbi s dozom od 25 mg.
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0.001, b: < 0.01 and c: < 0.05, respectively between etanercept and placebo
Croatian: *Neki bolesnici nisu imali potpune podatke za svaku mjeru ishoda **ASAS = kriteriji Međunarodnog društva za procjenu spondiloartritisa ***Bathov indeks aktivnosti bolesti za ankilozantni spondilitis a: p < 0,001, b: < 0,01 i c: < 0,05, između etanercepta i placeba
English: Hold the pre-filled syringe at 45 degrees to the skin.
Croatian: Napunjenu štrcaljku držite pod kutem od 45 stupnjeva u odnosu na kožu.
English: ASAS partial remission
Croatian: ASAS djelomična remisija
English: Date:
Croatian: Datum:
English: TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defenses 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: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali.
Croatian: Ovi simptomi mogu upućivati na moguće po život opasne poremećaje krvi koji zahtijevaju prekid liječenja Benepalijem.
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 dugotrajnim, visoko aktivnim reumatoidnim artritisom, što otežava procjenu rizika.
English: Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Benepali se može davati kao monoterapija u slučaju nepodnošljivosti metotreksata ili kada je nastavak liječenja metotreksatom neodgovarajući.
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: 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 etanercept therapy (see Vaccinations, above).
Croatian: Preporučuje se da, ako je moguće, pedijatrijski bolesnici obave sva cijepljenja prema trenutno važećem kalendaru cijepljenja prije nego se započne liječenje etanerceptom (vidjeti dio iznad: Cijepljenje).
English: Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali.
Croatian: Pedijatrijski bolesnici koji trebaju dozu drugačiju od pune doze od 25 mg ili 50 mg, ne smiju primati Benepali.
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 kod 6,3% bolesnika s reumatoidnim artritisom liječenih etanerceptom tijekom najduže 48 mjeseci.
English: The use of etanercept in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Croatian: Primjena etanercepta u kombinaciji s drugom sustavnom terapijom ili fototerapijom za liječenje psorijaze nije ispitana.
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: • Stretching the skin creates a firm surface.
Croatian: • Zatezanjem kože nastaje čvrsta podloga.
English: After discontinuation of etanercept, symptoms of arthritis generally returned within a month.
Croatian: Općenito, nakon prekida liječenja etanerceptom simptomi artritisa su se ponovno javili u roku od mjesec dana.
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment.
Croatian: Iako ne uvjerljivo, podaci iz jednog od ovih ispitivanja upućivali su na moguću tendenciju pogoršanja kongestivnog zatajenja srca u bolesnika liječenih etanerceptom.
English: The central volume of distribution of etanercept is 7.6 L, while the volume of distribution at steady-state is 10.4 L.
Croatian: Središnji volumen raspodjele etanercepta iznosi 7,6 l, dok je volumen raspodjele u stanju dinamičke ravnoteže 10,4 l.
English: Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose.
Croatian: Stoga Benepali nije moguće primjenjivati u pedijatrijskih bolesnika kojima treba manje od pune doze od 25 mg ili 50 mg.
English: • Do not touch this area again before giving the injection.
Croatian: • Nemojte ponovno dirati odabrano mjesto prije davanja injekcije.
English: In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Croatian: Nadalje, jedno ispitivanje je zabilježilo više urođenih u slučaju kada je majka tijekom trudnoće primila etanercept u usporedbi s majkama koje nisu primile etanercept ili druge slične lijekove (antagoniste TNF-a), iako nije zabilježeno o kojem se tipu prijavljenih urođenih mana radi.
English: The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Croatian: Nije dokazano da kombinacija etanercepta i anakinre povećava kliničku korist te se stoga ne preporučuje.
English: Components inside the pre-filled pen may be broken.
Croatian: Dijelovi unutar napunjene brizgalice mogu biti slomljeni.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Patients who develop a new infection while undergoing treatment with Benepali should be monitored closely.
Croatian: Bolesnike u kojih se razviju nove infekcije za vrijeme liječenja Benepalijem mora se pažljivo nadgledati.
English: If Benepali has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Croatian: Ako Benepali ne utječe na stanje djeteta nakon 12 tjedana terapije, Vaš će Vam liječnik možda reći da prestanete primjenjivati ovaj lijek.
English: Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Croatian: U usporedbi s placebom, liječenje lijekom etanercept rezultiralo je u statistički značajnom poboljšanju u ASAS 40, ASAS 20 i ASAS 5/6.
English: In long-term (up to 34 months) open-label studies where etanercept was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Croatian: U dugotrajnim (do 34 mjeseca) otvorenim ispitivanjima gdje se etanercept primjenjivao bez prekida, klinički odgovor bio je kontinuiran i sigurnost primjene bila je usporediva s ispitivanjima kraćeg trajanja.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept.
Croatian: Nisu dostupni podaci o sekundarnom prijenosu infekcija putem živih cjepiva u bolesnika koji primaju etanercept.
English: Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg.
Croatian: Etanercept nije uzrokovao smrtnost ni vidljive znakove toksičnosti u miševa i štakora nakon jednokratne supkutane doze od 2000 mg/kg ni nakon jednokratne intravenske doze od 1000 mg/kg.
English: Other etanercept products with appropriate dosage forms for children are available.
Croatian: Dostupni su i drugi pripravci etanercepta s odgovarajućim farmaceutskim oblicima za primjenu u djece.
English: Benepali treatment may increase mortality in patients with established sepsis.
Croatian: Liječenje Benepalijem može povećati smrtnost bolesnika s dokazanom sepsom.
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: Treatment with etanercept 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 etanercepta 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: 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 su neki imali smrtni ishod.
English: Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Croatian: Ispitivanje 1 bilo je ispitivanje faze II u koje su uključeni bolesnici s aktivnom, ali klinički stabilnom plak psorijazom koja zahvaća ≥ 10% površine tijela u dobi od ≥ 18 godina.
English: There was some evidence to support a benefit of re-treatment with etanercept in patients initially responding to treatment.
Croatian: Bilo je nekih dokaza u prilog koristi od ponovne primjene etanercepta u bolesnika koji su inicijalno odgovorili na liječenje.
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Croatian: Zabilježena je reaktivacija hepatitisa B kod bolesnika koji su prethodno bili zaraženi virusom hepatitisa B (HBV) i primali antagoniste TNF-a, uključujući etanercept.
English: Treatment with Benepali may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Croatian: Liječenje Benepalijem može reaktivirati hepatitis B u bolesnika koji su prethodno bili zaraženi virusom hepatitisa B.
English: Please tell your doctor if you or the child in your care have a history of alcohol abuse.
Croatian: Recite svom liječniku ako Vi ili dijete o kojem skrbite u anamnezi imate alkoholizam.
English: Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Croatian: U ispitivanju 2 također je postojalo razdoblje bez primjene lijeka za vrijeme kojeg je, u bolesnika s postignutim PASI poboljšanjem od najmanje 50% u 24. tjednu, primjena lijeka obustavljena.
English: From the start of part 2, the median time to flare was 116 days for patients who received etanercept and 28 days for patients who received placebo.
Croatian: Od početka drugog dijela ispitivanja medijan vremena do javljanja pogoršanja bio je 116 dana za bolesnike koji su primili etanercept i 28 dana za bolesnike koji su primili placebo.
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Benepali.
Croatian: • Infekcije/operacija: Ako Vi ili dijete razvijete novu infekciju ili u slučaju da morate na veliku operaciju, Vaš liječnik će možda htjeti nadgledati liječenje Benepalijem.
English: Response
Croatian: Odgovor
English: Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Croatian: Klinički odgovori su prikazani kao postotak bolesnika koji su postigli odgovore ACR 20, 50 i 70 te kao postotak bolesnika s poboljšanjem u PsARC (Psoriatic Arthritis Response Criteria).
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Croatian: Nuspojave u djece i adolescenata Nuspojave opažene u djece i adolescenata i njihova učestalost slične su ovima opisanima gore.
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 prijava slučajeva sa smrtnim ishodom zabilježena je u bolesnika s pneumocističnom pneumonijom, nespecifičnim sistemskim gljivičnim infekcijama i aspergilozom (vidjeti dio 4.4).
English: Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Croatian: Etanercept također može utjecati na biološku aktivnost kontroliranu dodatnim molekulama koje se uključuju kasnije (npr. citokini, adhezijske molekule ili proteinaze), a koje inducira ili nadzire TNF.
English: Thus, the combined use of Benepali and anakinra is not recommended (see sections 4.5 and 4.8).
Croatian: Stoga se ne preporučuje kombinirana primjena Benepalija i anakinre (vidjeti dio 4.5 i
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses.
Croatian: Tijekom prvih 12 tjedana dvostruko slijepog razdoblja bolesnici su primali placebo ili jednu od tri navedene doze etanercepta.
English: Check with your healthcare provider for instructions on how to properly dispose a filled sharps container.
Croatian: Pitajte svog zdravstvenog djelatnika za upute kako na odgovarajući način zbrinuti puni spremnik za odlaganje oštrih predmeta.
English: Within the System Organ Class, 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: Unutar klasifikacije organskih sustava nuspojave su navedene prema 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: Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites.
Croatian: Naknadno se u nekih bolesnika ponovno pojavila reakcija na mjestu primjene injekcije karakterizirana reakcijom kože na najsvježijem mjestu primjene, uz istodobnu pojavu reakcije na prethodnim mjestima primjene injekcije.
English: Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy.
Croatian: Drugo ispitivanje nije zabilježilo povećani rizik od urođenih mana kada je majka primala etanercept tijekom trudnoće.
English: For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities.
Croatian: U bolesnika sa psorijatičnim artritisom koji zahvaća više zglobova Benepali može poboljšati sposobnost obavljanja uobičajenih dnevnih aktivnosti.
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Croatian: Recite svom liječniku ako primijetite bilo kakve promjene u izgledu kože ili izrasline na koži.
English: ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
Croatian: Učestalost odgovora ACR 20 i 50 bila je veća u bolesnika liječenih etanerceptom tijekom 3 i 6 mjeseci nego u bolesnika liječenih placebom (ACR 20: etanercept 62% i 59%, placebo 23% i 11% nakon 3 odnosno 6 mjeseci; ACR 50: etanercept 41% i 40%, placebo 8% i 5% nakon 3, odnosno 6 mjeseci; p < 0,01 etanercept u odnosu na placebo u svim vremenskim točkama za ACR 20 i ACR 50 odgovore).