FrancophonIA/ELRC3.0 huggingface dataset:
English: Kromeya can also be given alone.
Croatian: Kromeya se može primjenjivati i sam.
English: If retreatment with Kromeya is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje lijekom Kromeya, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: Week 52 Fistula remission3
Croatian: 52. tjedan Remisija fistula
English: Your child's symptoms may return upon stopping treatment.
Croatian: Simptomi se Vašem djetetu mogu vratiti nakon prestanka primjene.
English: Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Croatian: Nakon 3 godine terapije adalimumabom, 75% (301/402) je i dalje bilo u kliničkoj remisiji prema djelomičnom Mayo rezultatu.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Croatian: Poliartikularni juvenilni idiopatski artritis i artritis povezan s entezitisom upalne su bolesti zglobova koje se uglavnom prvi puta javljaju u djetinjstvu.
English: 2.3 Check the liquid to make sure that : The liquid is clear, colorless, and free of particles.
Croatian: 2.3 Provjerite tekućinu kako biste bili sigurni u sljedeće: • tekućina je bistra, bezbojna i ne sadrži čestice.
English: The European Medicines Agency has deferred the obligation to submit the results of 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: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Croatian: Udio ispitanika s pedijatrijskim odgovorom ACR50/70/90 u 12. i 24. tjednu bio je 90,3%/61,3%/38,7%, odnosno 83,3%/73,3%/36,7%.
English: Via delle Magnolie 15 Loc. frazione Zona Industriale 70026 - Modugno (BA) Italy
Croatian: Via delle Magnolie 15 Loc. frazione Zona Industriale 70026 - Modugno (BA) Italija
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Croatian: Djelotvornost i sigurnost adalimumaba ocijenjena je u pet randomiziranih, dvostruko slijepih, dobro kontroliranih ispitivanja.
English: 5.4 Hold the syringe like a pencil with the pink needle safety cover pointing up
Croatian: 5.4 Držite štrcaljku kao olovku, tako da ružičasti sigurnosni pokrov za iglu pokazuje prema gore.
English: After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in clinical response per PCDAI.
Croatian: Nakon 5 godina terapije adalimumabom, 74,0% (37/50) od 50 bolesnika koji su ostali u ispitivanju i dalje su bili u kliničkoj remisiji dok je 92,0% (46/50) bolesnika nastavilo imati klinički odgovor prema PCDAI.
English: 1.1 Remove the Kromeya Vial Kit from the refrigerator.
Croatian: 1.1 Izvadite Kromeya set s bočicom iz hladnjaka.
English: Administration of Kromeya should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Primjena lijeka Kromeya mora se obustaviti ako bolesnik razvije novu ozbiljnu infekciju ili sepsu te je potrebno započeti odgovarajuću antimikrobnu ili antifungalnu terapiju sve dok se infekcija ne stavi pod kontrolu.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Kromeya should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako se pojavi anafilaktička reakcija ili kakva druga ozbiljna alergijska reakcija, primjenu lijeka Kromeya treba odmah obustaviti i započeti odgovarajuću terapiju.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Croatian: Koncentracije adalimumaba u sinovijalnoj tekućini nekolicine bolesnika s reumatoidnim artritisom iznosile su 31-96% koncentracija u serumu.
English: Warning: Do not detach the pink needle safety cover from the yellow connector.
Croatian: Upozorenje: Nemojte odvajati ružičasti sigurnosni pokrov za iglu od žutog priključka.
English: Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Croatian: Via delle Magnolie 15 I-70026 Modugno (Bari) Italija
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Kromeya (see section 4.4).
Croatian: Oftalmolozima se preporučuje da se posavjetuju s odgovarajućim specijalistom prije nego što započnu liječenje lijekom Kromeya (vidjeti dio 4.4).
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Croatian: Adalimumab je značajno smanjio rizik od neuspjeha liječenja za 75% u odnosu na placebo, što pokazuje omjer hazarda (HR = 0,25 [95% CI: 0,12; 0,49]).
English: NA 4.5% 23.2%
Croatian: ND ND 4,5% 23,2%
English: 5.1 Choose an injection site on:
Croatian: 5.1 Odaberite mjesto injiciranja na:
English: • Do not use the Kromeya pre-filled syringe if it has been dropped or crushed, as the pre-filled syringe may be broken even if you cannot see the break.
Croatian: • Nemojte primjenjivati Kromeya napunjenu štrcaljku ako vam je ispala ili je zdrobljena jer napunjena štrcaljka može biti razbijena čak i ako ne vidite oštećeno mjesto.
English: Following the administration of 24 mg/m
Croatian: Nakon primjene 24 mg/m
English: >32 weeks 14 weeks a
Croatian: 14 tjedana a
English: ASAS partial remission BASDAI
Croatian: ASAS djelomična remisija BASDAI
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Croatian: Ako se za vrijeme liječenja ili nakon njega na koži jave nova područja oštećene kože ili ako se postojeći znakovi ili područja oštećenja promijene, javite se svom liječniku.
English: • WATCH the syringe plunger to make sure it moves all the way down to the bottom (Figure P).
Croatian: • GLEDAJTE klip brizgalice kako biste se uvjerili da se spušta skroz do dna (slika P).
English: Open your sharps container so it is ready.
Croatian: Otvorite spremnik za oštre predmete tako da bude spreman.
English: Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive postBaseline visits
Croatian: Imunosupresivna terapija mogla se obustaviti samo u 26. tjednu ili kasnije, prema slobodnoj procjeni ispitivača ako je ispitanik ispunio kriterije kliničkog odgovora definirano kao zatvaranje svih fistula iz kojih se na početku cijedio sadržaj, održano kroz barem 2 uzastopna posjeta nakon početka liječenja
English: Before Injection
Croatian: Prije injektiranja
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Kromeya, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom Kromeya mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Croatian: • imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće kao stanje koje se zove sarkoidoza),
English: • Hold the -pre-filled pen so that you can see the transparent syringe housing.
Croatian: • Držite napunjenu brizgalicu tako da možete vidjeti prozirno kućište štrcaljke.
English: 8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure V).
Croatian: 8.1 Da biste lakše zapamtili kada i gdje trebate dati sljedeću injekciju, trebate bilježiti datume i mjesta na koja ste primijenili injekciju (slika V).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije često otežano cijeljenje
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Croatian: Melanom i karcinom Merkelovih stanica su također prijavljeni u bolesnika liječenih antagonistima TNF-a, uključujući adalimumab (vidjeti dio 4.8).
English: Warning: Do not remove the needle cap until you are ready to inject.
Croatian: Upozorenje: Nemojte skidati poklopac igle sve dok niste spremni za injiciranje lijeka.
English: • Do not try to activate the clear needle guard before injecting.
Croatian: • Nemojte pokušavati aktivirati prozirni štitnik igle prije injiciranja.
English: Treatment with Kromeya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Croatian: Liječenje lijekom Kromeya ne smije se započeti u bolesnika s aktivnim infekcijama, uključujući kronične ili lokalizirane infekcije, sve dok se te infekcije ne stave pod kontrolu.
English: Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Croatian: Liječenje lijekom Kromeya može se započeti u kombinaciji s kortikosteroidima i/ili drugim nebiološkim imunomodulatorima.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double−blind, placebo−controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Croatian: Slični trendovi (ne svi statistički značajni) viđeni su i u manjem, randomiziranom, dvostruko slijepom ispitivanju kontroliranom placebom AS II, u kojem su sudjelovala 82 odrasla bolesnika s aktivnim ankilozantnim spondilitisom.
English: Open your sharps disposal container so it is ready to use.
Croatian: Otvorite spremnik za oštre predmete tako da bude spreman za upotrebu.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Croatian: Bolesnici su i dalje uzimali stabilne doze NSAIL-a i/ili prednizona (≤0,2 mg/kg/dan ili najviše 10 mg/dan).
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Croatian: U bolesnika s Crohnovom bolešću primijećeno je smanjenje broja stanica u debelom crijevu koje eksprimiraju markere upale, uključujući i značajno sniženje ekspresije TNFα.
English: After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional.
Croatian: Nakon pojedinačnih intravenskih doza koje su se kretale od 0,25 do 10 mg/kg, koncentracije su bile proporcionalne dozi.
English: • The expiration date on the syringe has passed.
Croatian: • rok valjanosti na štrcaljki je istekao.
English: Thus additional caution should be exercised in considering Kromeya treatment of these patients (see section 4.8).
Croatian: Zbog toga je potreban dodatan oprez prilikom razmatranja liječenja lijekom Kromeya u takvih bolesnika (vidjeti dio 4.8).
English: Warning: If you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches.
Croatian: Upozorenje: Ako imate psorijazu, ne injicirajte u lezije ili crvene, zadebljane, uzdignute ili ljuskaste mrlje.
English: • Made of a heavy-duty plastic;
Croatian: • izrađen od izdržljive plastike;
English: Shaking can damage the pre-filled syringe and the medicine.
Croatian: Tresenje može oštetiti napunjenu štrcaljku i lijek.
English: • hair loss;
Croatian: • gubitak kose,
English: - if your child has moderate or severe heart failure.
Croatian: • ako Vaše dijete boluje od umjerenog ili teškog zatajenja srca.
English: Kromeya is used to treat:
Croatian: Kromeya je namijenjena liječenju:
English: Injector body
Croatian: Tijelo injektora
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Croatian: Među bolesnicima koji su prekinuli sudjelovanje u ispitivanju prije 78. tjedna, njih 11% to je učinilo zbog nuspojava, a njih 5% zbog nedovoljno dobrog odgovora na liječenje adalimumabom.
English: Warning: Do not blow on or touch the injection site after cleaning.
Croatian: Upozorenje: Nemojte puhati na ili dodirivati mjesto injiciranja nakon što ga očistite.
English: • the lot number (on vial label).
Croatian: • broj serije (na naljepnici bočice).
English: You should continue to inject Kromeya for as long as your doctor has told you.
Croatian: Nastavite injicirati lijek Kromeya onoliko dugo koliko Vam kaže liječnik.
English: 6.3 Gently push the white plunger rod all the way down until the syringe is empty.
Croatian: 6.3 Lagano potisnite bijeli štapić klipa do kraja prema dolje tako da se štrcaljka isprazni.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Kromeya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu profilakse tuberkuloze također treba razmotriti prije početka liječenja lijekom Kromeya u bolesnika s nekoliko faktora rizika ili sa značajnim faktorima rizika od tuberkuloze unatoč negativnom nalazu na tuberkulozu i u bolesnika s latentnom ili aktivnom tuberkulozom u anamnezi u kojih se ne može utvrditi adekvatan tijek liječenja.
English: In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Croatian: U nekim rijetkim slučajevima, osobito ako Vaše dijete uzima druge lijekove koji potiskuju imunološki sustav, reaktivacija HBV infekcije može biti opasna po život.
English: • The glass syringe is not cracked or broken (Figure H).
Croatian: • Staklena štrcaljka nije napukla ili oštećena (slika H).
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Placebo/MTXAdalimumab/MTX (95% confidence interval b)
Croatian: Placebo/MTXAdalimumab/MTX (95% interval pouzdanosti b)
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Croatian: Prosječna apsolutna bioraspoloživost adalimumaba procijenjena nakon primjene jednokratne supkutane doze od 40 mg bila je 64% u tri ispitivanja.
English: Table 13 Efficacy responses in placebo-controlled AS Study - Study I reduction of signs and symptoms
Croatian: Tablica 13 Djelotvornost u placebom kontroliranom ispitivanju kod AS-a - ispitivanje I Smanjenje znakova i simptoma
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Croatian: • poremećaji živaca (kao upala očnog živca i Guillain-Barréov sindrom, stanje koje može uzrokovati slabost mišića, abnormalne osjete, trnce u rukama i gornjem dijelu tijela),
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Croatian: • Vrlo se rijetko javljaju određene vrste tumora u djece i odraslih liječenih adalimumabom ili nekim drugim TNFα blokatorom.
English: • Kromeya pre-filled syringe has a clear needle guard that covers the needle after the injection is complete.
Croatian: • Kromeya napunjena štrcaljka ima proziran štitnik igle koji pokriva iglu nakon dovršenog injiciranja.
English: Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Croatian: Od ukupno 417 ispitanika uključenih u nekontrolirani dugoročni produžetak ispitivanja UV I i UV II, 46 ispitanika nije zadovoljavalo kriterije (npr. kod njih su se razvile komplikacije kao posljedica dijabetičke retinopatije, zbog operacije katarakte ili vitrektomije) i stoga nisu bili uključeni u primarnu analizu djelotvornosti.
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Croatian: • rak, uključujući rak koji zahvaća limfni sustav (limfom) i melanom (oblik raka kože),
English: Before initiation of therapy with Kromeya, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Croatian: Prije početka liječenja lijekom Kromeya sve bolesnike se mora podvrgnuti pretragama za otkrivanje i aktivnog i neaktivnog (“latentnog“) oblika tuberkuloze.
English: If you use less Kromeya than you should
Croatian: Ako primijenite manje lijeka Kromeya nego što ste trebali
English: • Can be closed with a tight-fitting, puncture-resistant lid; that will keep sharps from coming out,
Croatian: • može se zatvoriti poklopcem koji čvrsto prianja i otporan je na ubode te će spriječiti ispadanje oštrih predmeta,
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Croatian: Važno je da liječniku kažete jeste li ikada bolovali od tuberkuloze, odnosno jeste li bili u bliskom doticaju s nekim tko je od nje bolovao.
English: • Hold the syringe firmly without moving it, at the same angle (Figure R).
Croatian: • Čvrsto držite štrcaljku bez pomicanja pod istim kutom (slika R).
English: Mood alterations (including depression), anxiety, insomnia
Croatian: Psihijatrijski poremećaji često promjene raspoloženja (uključujući depresiju), anksioznost, nesanica
English: Shaking can cause damage.
Croatian: Tresenje ih može oštetiti.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Croatian: Kvaliteta života vezana uz zdravlje i fizička funkcija ocjenjivale su se uz pomoć upitnika HAQ-S i SF36.
English: Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Croatian: Slika 2: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega (ispitivanje UV II)
English: • Lift the pre-filled pen from your skin (Figure Q).
Croatian: • Podignite brizgalicu s Vaše kože (slika Q).
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Croatian: Ispitivanja embriofetalne i perinatalne razvojne toksičnosti provedena na makaki majmunima s dozama od 0, 30 i 100 mg/kg (9-17 majmuna u skupini) nisu pokazala znakove oštećenja fetusa uslijed primjene adalimumaba.
English: Carriers of HBV who require treatment with Kromeya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje HBV-a u kojih je nužna primjena lijeka Kromeya mora se pomno pratiti zbog moguće pojave znakova i simptoma aktivne HBV infekcije tijekom cijelog trajanja terapije te nekoliko mjeseci nakon njezina prekida.
English: 8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure T).
Croatian: 8.1 Da biste lakše zapamtili kada i gdje trebate dati sljedeću injekciju, trebate bilježiti datume i mjesta na koja ste primijenili injekciju (slika T).
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Croatian: Poboljšanje kvalitete života vezane uz zdravlje i fizičke funkcije održalo se tijekom otvorenog produžetka ispitivanja do 156. tjedna.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije primjene ovog lijeka.
English: These infections have not consistently been recognised in patients taking TNFantagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Croatian: Ove infekcije nisu uvijek bile prepoznate u bolesnika koji su primali antagoniste TNF-a, što je rezultiralo kašnjenjem s primjerenim liječenjem i ponekad dovelo do smrtnog ishoda.
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Croatian: Kromeya je namijenjena liječenju poliartikularnog juvenilnog idiopatskog artritisa u djece i adolescenata u dobi od 2 do 17 godina i artritisa povezanog s entezitisom u djece i adolescenata u dobi od 6 do 17 godina.
English: 4.2 Choose a different site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.
Croatian: 4.2 Svaki put odaberite drugo mjesto (barem 2,5 centimetra dalje od prethodnog mjesta injiciranja) kako biste smanjili crvenilo, nadraženost i druge probleme s kožom.
English: Radiographic response
Croatian: Radiološki odgovor
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase.
Croatian: Nakon 32 tjedna, odnosno nakon egzacerbacije bolesti, bolesnici su mogli biti uključeni u otvoreni produžetak ispitivanja.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Croatian: Dostupni podaci pokazuju da se klinički odgovor obično postiže unutar 12 tjedana liječenja.
English: If you use more Kromeya than you should
Croatian: Ako primijenite više lijeka Kromeya nego što ste trebali
English: TREATMENT FAILURE RATE (%)
Croatian: STOPA NEUSPJEHA LIJEČENJA (%)
English: If active tuberculosis is diagnosed, Kromeya therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Kromeya (vidjeti dio 4.3).
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Croatian: • hepatosplenični T-stanični limfom (rijetki rak krvi često sa smrtnim ishodom),
English: 6.2 Pinch the skin
Croatian: 6.2 Uhvatite kožu u nabor
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Croatian: Oko 40% bolesnika u ispitivanju UC-II nije imalo uspjeha s prethodnim liječenjem antagonistom TNF-a infliksimabom.