FrancophonIA/ELRC3.0 huggingface dataset:
English: Component of a multipack, cannot be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: Adalimumab is available in other strengths and presentations.
Croatian: Adalimumab je dostupan i u drugim jačinama i oblicima pakiranja.
English: See “8.
Croatian: Vidjeti “8.
English: • increased sweating;
Croatian: • povećano znojenje,
English: Concomitant stable doses of one non-biologic immunosuppressant were permitted.
Croatian: Bila je dopuštena istodobna primjena stabilnih doza jednog nebiološkog imunosupresiva.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and / or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Croatian: Istodobne stabilne doze aminosalicilata, kortikosteroida i/ili imunomodulatora bile su dozvoljene te je 80% bolesnika nastavilo uzimati barem jedan od ovih lijekova.
English: p value*
Croatian: p vrijednost*
English: • The recommended injection site is the front of your thighs.
Croatian: • Preporučeno mjesto primjene je prednja strana bedara.
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Croatian: Klinički odgovor (CR-100) se održao u 102 odnosno 233 bolesnika.
English: ACR response
Croatian: ACR odgovor
English: Hefiya can also be given alone.
Croatian: Hefiya se može primjenjivati i sam.
English: The highest frequency seen among the various indications has been included.
Croatian: Uključene su one najučestalije primijećene kod različitih indikacija.
English: This includes any possible side effects not listed in this leaflet (see section 4).
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi (pogledajte dio 4).
English: Significant response was first observed at week 2 and maintained through 24 weeks (table 13).
Croatian: To se poboljšanje prvi put uočilo u drugom tjednu i održalo se 24 tjedna (tablica 13).
English: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost adalimumaba u djece u dobi od 4 do 17 godina nije ustanovljena.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Croatian: * detaljnije informacije mogu se pronaći u dijelovima 4.3, 4.4 i 4.8 ** uključujući otvorene produžetke ispitivanja uključujući podatke iz spontanog prijavljivanja Gnojni hidradenitis (Hidradenitis suppurativa)
English: Figure C: Safety Checks before injection
Croatian: Slika C: Sigurnosne provjere prije injekcije
English: The primary efficacy endpoint in both studies was ‘time to treatment failure'.
Croatian: Primarna mjera ishoda za djelotvornost u oba ispitivanja bilo je 'vrijeme do neuspjeha liječenja'.
English: >32 weeks
Croatian: >32 tjedna
English: No dose adjustment is required.
Croatian: Nije potrebno prilagođavati dozu.
English: 88 and 189 patients, respectively, continued to be in clinical remission.
Croatian: 88 odnosno 189 bolesnika nastavilo je biti u kliničkoj remisiji.
English: Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Croatian: Dostupni podaci upućuju na to da je ponovno uvođenje adalimumaba nakon prekida od 70 dana ili duže rezultiralo jednako jakim kliničkim odgovorom i sličnim sigurnosnim profilom kao i primjena prije prekida terapije.
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Croatian: HR za adalimumab naspram placeba iz regresije proporcionalnih hazarda, uz liječenje kao faktor.
English: In RA study III, these improvements were maintained throughout 52 weeks.
Croatian: U ispitivanju RA III to se poboljšanje održalo 52 tjedna.
English: The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.
Croatian: Predviđene razine izloženosti ukazuju na to da u odsutnosti metotreksata udarna doza može dovesti do početnog povećanja sistemske izloženosti.
English: Serious infections
Croatian: Ozbiljne infekcije
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju ispitivanja toksičnosti pojedinačne doze, toksičnosti ponovljenih doza i genotoksičnosti.
English: • inject Hefiya 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Croatian: • ubrizgate Hefiya 15-30 minuta nakon vađenja iz hladnjaka radi ugodnije injekcije.
English: If you are unsure, contact your doctor.
Croatian: Ako niste sigurni, obratite se svom liječniku.
English: Check with your doctor before you receive any vaccines.
Croatian: Posavjetujte se sa svojim liječnikom prije nego primite bilo kakvo cjepivo.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard.
Croatian: • Nemojte ubrizgavati lijek u područja na kojima je koža osjetljiva, s modricama, crvena, ljuskasta ili tvrda.
English: Instructions for use
Croatian: Upute za uporabu
English: Radiographic response
Croatian: Radiografski odgovor
English: Detailed instructions on how to inject Hefiya are provided in section 7, “Instructions for use”.
Croatian: Detaljne informacije kako ubrizgavati Hefiya nalaze se u dijelu 7, “Upute za uporabu”.
English: By attaching to TNFα, Hefiya blocks its action and reduces the inflammation in these diseases.
Croatian: Vezivanjem za TNFα, Hefiya blokira njegovo djelovanje i smanjuje upalni proces kod tih bolesti.
English: Tuberculosis (TB)
Croatian: Tuberkuloza (TBC)
English: joints and other organ systems);
Croatian: zglobova i drugih organa),
English: This medicine is subject to additional monitoring.
Croatian: Ovaj je lijek pod dodatnim praćenjem.
English: Corticosteroid taper was permitted after week 8.
Croatian: Postupno smanjenje doze kortikosteroida bilo je dopušteno nakon 8 tjedana.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.
Croatian: Na interpretaciju podataka mogu utjecati metodološka ograničenja ispitivanja, uključujući malu veličinu uzorka i dizajn koji nije uključivao randomizaciju.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet o primjeni ovog lijeka.
English: The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.
Croatian: Primarni ishod ispitivanja bio je klinička remisija u 26. tjednu, definirana kao PCDAI rezultat ≤ 10.
English: 4 to 7 years
Croatian: 4 do 7 godina
English: • swollen face, hands, feet;
Croatian: • otečeno lice, šake, stopala,
English: Table 25 maintenance regimen patient weight low dose standard dose
Croatian: Tablica 25 Režim održavanja tjelesna težina bolesnika niska doza standardna doza
English: Results from the overall UC-II study population are shown in table 28.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u tablici 28.
English: The primary endpoint was ‘time to treatment failure'.
Croatian: Primarna mjera ishoda bilo je 'vrijeme do neuspjeha liječenja'.
English: Table 21 efficacy results at 12 weeks, HS studies I and II
Croatian: Tablica 21 Rezultati djelotvornosti u 12. tjednu, ispitivanja HS I i II
English: b 2-sided p value from log rank test.
Croatian: b Dvostrana p-vrijednost iz log rang testa.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Croatian: • U ispitivanju provedenom u trudnica nije utvrđen povećan rizik od urođenih mana kada su majke primale adalimumab tijekom trudnoće u odnosu na majke s istom bolešću koje nisu primale adalimumab.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Croatian: Smatra se da psorijazu uzrokuje problem s imunološkim sustavom tijela, zbog kojega se povećava proizvodnja kožnih stanica.
English: If you have Crohn's disease you will first be given other medicines.
Croatian: Ako bolujete od Crohnove bolesti, prvo će Vam biti propisani drugi lijekovi.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Croatian: Ovaj rijedak oblik T-staničnog limfoma ima izrazito agresivan tijek i uglavnom je smrtonosan.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Croatian: Bolesnici iz ispitivanja UC-I i UC-II imali su mogućnost prijeći u otvoreni dugotrajni produžetak ispitivanja (UC III).
English: Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Croatian: Među 250 ispitanika koji su dovršili otvoreni produžetak ispitivanja, poboljšanja fizičke funkcije održala su se tijekom 10 godina liječenja.
English: • night sweats;
Croatian: • noćno znojenje,
English: You may cover the injection site with a small adhesive bandage, if needed.
Croatian: Možete prekriti mjesto primjene malim flasterom ako je potrebno.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Croatian: Adalimumab također modulira biološke odgovore koje inducira ili regulira TNF, uključujući promjene u razinama adhezijskih molekula koje su odgovorne za migraciju leukocita (ELAM-1, VCAM-1 i ICAM-1 s IC50 od 0,1-0,2 nM).
English: disease flares at the end of 32 weeksa (n/N)
Croatian: reaktivacija bolesti pri kraju razdoblja od 32 tjednaa (n/N)
English: Figure C: needle guard is not activated - the syringe is ready for use
Croatian: Slika C: štitnik igle nije aktiviran - štrcaljka je spremna za uporabu
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Croatian: Adalimumab se specifično veže za TNF (faktor tumorske nekroze) i neutralizira biološku funkciju TNF-a blokirajući njegovu interakciju s površinskim staničnim TNF-receptorima p55 i p75.
English: Concomitant antibiotic use was not allowed during the study.
Croatian: Tijekom ispitivanja nije bila dopuštena istodobna primjena antibiotika.
English: o The syringe is ready for use (see Figure C).
Croatian: o Štrcaljka je spremna za uporabu (vidjeti Sliku C).
English: 20 weeks
Croatian: 20 tjedana
English: In Figure A, the pen is shown with the cap removed.
Croatian: Na Slici A, brizgalica je prikazana s uklonjenim zatvaračem.
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Croatian: U slučaju kada je potreban brži odgovor na liječenje, imajući na umu da rizik od nuspojava može biti veći kod primjene više indukcijske doze, može se primijeniti sljedeća doza:
English: Ask your doctor or pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svoga liječnika ili ljekarnika kako baciti lijekove koje više ne koristite.
English: Alternatively, if a patient has stopped Hefiya and signs and symptoms of disease recur, Hefiya may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek Hefiya, a znakovi i simptomi bolesti su se opet pojavili, Hefiya se može ponovno primijeniti.
English: 117 / 276 patients from CD study I and 272 / 777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Croatian: 117/276 bolesnika iz ispitivanja CD I i 272/777 bolesnika iz ispitivanja CD II i III praćeno je tijekom najmanje 3 godine otvorene terapije adalimumabom.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a long-term and often painful inflammatory skin disease.
Croatian: Gnojni hidradenitis (koji se ponekad naziva inverznim aknama) je dugotrajna i često bolna upalna bolest kože.
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Croatian: Serumske razine matriksnih metaloproteinaza (MMP-1 i MMP-3) koje uzrokuju preoblikovanje tkiva odgovorno za uništenje hrskavice također su se smanjile nakon uzimanja adalimumaba.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Croatian: • Recite svom liječniku ako ste nositelj virusa hepatitisa B (HBV), ako imate aktivnu HBV infekciju ili mislite da biste se mogli zaraziti HBV-om.
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Croatian: Odgovarajući udio bolesnika bez radiografske progresije iznosio je 31,3%, 23,7% odnosno 36,7%.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)*
English: If you forget to give yourself an injection, you should inject the next dose of Hefiya as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju, sljedeću dozu lijeka Hefiya morate primijeniti čim to primijetite.
English: TIME (WEEKS)
Croatian: VRIJEME (TJEDNI)
English: Clinical results were assessed for induction of remission at week 8 and for maintenance of remission at week 52.
Croatian: Klinički rezultati ocjenjivali se se radi određivanja indukcije remisije u osmom tjednu i održavanja remisije u 52. tjednu.
English: After proper training in injection technique, patients may self-inject with Hefiya if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka Hefiya ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi.
English: The first received placebo injections every week for 52 weeks.
Croatian: Prva je dobivala injekcije placeba svaki tjedan tijekom 52 tjedna.
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Croatian: U nekim rijetkim slučajevima, osobito ako uzimate druge lijekove koji potiskuju imunološki sustav, reaktivacija HBV infekcije može biti opasna po život.
English: • impotence;
Croatian: • impotencija,
English: • Additional risk minimisation measures The Patient Reminder Cards (adult and paediatric) contain the following key elements:
Croatian: • Dodatne mjere minimizacije rizika Kartice s podsjetnikom za bolesnike sadrže sljedeće ključneelemente:
English: • if you have moderate or severe heart failure.
Croatian: • Ako bolujete od umjerenog ili teškog zatajenja srca.
English: • Hold the syringe as shown (see Figure I).
Croatian: • Držite štrcaljku kako je prikazano (vidjeti Sliku I).
English: RA study III also had a primary endpoint of changes in quality of life.
Croatian: Primarni ishod ispitivanja RA III bile su i promjene u kvaliteti života.
English: Most patients continued on adalimumab after the infection resolved.
Croatian: Većina bolesnika nastavila je primjenjivati adalimumab nakon što je infekcija izliječena.
English: If re-treatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje adalimumabom, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Croatian: Nema dostupnih podataka o usporedbi adalimumaba i MTX-a za razdoblje terapije duže od 16 tjedana.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Croatian: Farmakoterapijska skupina: Imunosupresivi, Inhibitori faktora tumorske nekroze alfa (TNF-α), ATK oznaka: L04AB04
English: Moderate to severe heart failure (NYHA class III / IV) (see section 4.4).
Croatian: Umjereno do teško zatajenje srca (NYHA razred III/IV) (vidjeti dio 4.4).
English: The conduct and results of these tests should be recorded on your Patient Reminder Card.
Croatian: Provođenje i rezultati ovih pretraga moraju se zabilježiti na Vašoj Kartici s podsjetnikomza bolesnika.
English: A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Croatian: Prospektivno prikupljeni podaci o velikom broju trudnoća izloženih adalimumabu (približno 2100) koje su završile živorođenjem s poznatim ishodom, uključujući više od 1500 trudnoća izloženih tijekom prvog tromjesečja, ne ukazuju na povećanu stopu malformacija u novorođenčeta.
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg / kg, which is approximately 15 times the recommended dose.
Croatian: Najveća ispitivana doza bila je višestruka intravenska doza od 10 mg/kg, koja je oko 15 puta veća od preporučene doze.
English: • Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Croatian: • Držite klip pritisnut do kraja dok držite štrcaljku na istom mjestu 5 sekundi.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Croatian: Odmah recite svom liječniku ako se pojave simptomi kao što su promjene vida, slabost u rukama ili nogama ili utrnulost ili trnci u bilo kojem dijelu tijela.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Croatian: Adalimumab je rekombinantno humano monoklonsko protutijelo koje se proizvodi u stanicama jajnika kineskog hrčka.
English: b patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders.
Croatian: b bolesnici koji su ispunjavali protokolom utvrđene kriterije za gubitak odgovora ili izostanak poboljšanja morali su prekinuti ispitivanja i vodili su se kao bolesnici bez odgovora
English: In CD study III, at week 4, 58 % (499 / 854) of patients were in clinical response and were assessed in the primary analysis.
Croatian: U 4. tjednu ispitivanja CD III 58% bolesnika (499/854) imalo je klinički odgovor i bilo je uvršteno u primarnu analizu.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je adalimumab, djeluju na imunološki sustav te njihova primjena može utjecati na obranu tijela od infekcija i raka.
English: You may first be given other medicines.
Croatian: prvo ćete dobiti druge lijekove.
English: Your doctor may decide to stop treatment.
Croatian: Možda će odlučiti prekinuti terapiju.
English: • Check the green indicator fills the window and has stopped moving (see Figure I).
Croatian: • Provjerite je li zeleni indikator ispunio prozorčić i prestao se micati (vidjeti Sliku I).
English: • Using a circular motion, clean the injection site with an alcohol wipe.
Croatian: • Kružnim pokretima očistite mjesto primjene alkoholnim tupferom.
English: Mean exposure in all adalimumab population was 762 days.
Croatian: Srednja vrijednost izloženosti u cjelokupnoj populaciji liječenoj adalimumabom iznosila je 762 dana.
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Croatian: Ako se sumnja na latentnu tuberkulozu, potrebno je konzultirati liječnika s iskustvom u liječenju tuberkuloze.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Hefiya.
Croatian: Karticu s podsjetnikomza bolesnika držite kod sebe tijekom Vašeg liječenja i 4 mjeseca nakon ubrizgavanja zadnje injekcije lijeka Hefiya Vama (ili Vašem djetetu).
English: In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Croatian: U ispitivanju UV II, statistički značajne razlike primijećene su samo za oštrinu vida, ali su druge komponentne brojčano bile u korist adalimumaba.
English: Figure D: needle guard is activated - do not use o In this configuration the needle guard is
Croatian: Slika D: štitnik igle je aktiviran - ne koristiti o U ovoj konfiguraciji štitnik igle NIJE
English: Adalimumab should only be used during pregnancy if clearly needed.
Croatian: Adalimumab se tijekom trudnoće smije primjenjivati samo ako je to posve neophodno.
English: 40 mg every other week in combination with methotrexate
Croatian: 40 mg svaki drugi tjedan u kombinaciji s metotreksatom
English: discontinued corticosteroids
Croatian: prekinuti kortikosteroidi
English: − The active substance is adalimumab.
Croatian: Djelatna tvar je adalimumab.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži adalimumab u jednoj ili više podskupina pedijatrijske populacije u indikaciji ulceroznog kolitisa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Croatian: Zvjezdica (*) u stupcu 'Organski sustav' znači da se detaljnije informacije mogu pronaći u dijelovima 4.3, 4.4 i 4.8.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in table 25.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u tablici 25.
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in table 27.
Croatian: Stope prestanka uzimanja kortikosteroida ili imunomodulatora prikazane su u tablici 27.
English: primary analysis (ITT) placebo adalimumab time to treatment failure at or after week 2 in study UV II
Croatian: primarna analiza (ITT) placebo adalimumab vrijeme do neuspjeha liječenja u 2. tjednu ili nakon njega u ispitivanju UV II
English: The primary endpoint was the birth prevalence of major birth defects.
Croatian: Primarna mjera ishoda bila je prevalencija velikih (major) urođenih mana pri porođaju.
English: Keep Hefiya and all medicines out of the reach of children.
Croatian: Čuvati Hefiya i sve lijekove izvan dohvata djece.