FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 8 September 2003 Date of latest renewal: 8 September 2008
Croatian: Datum posljednje obnove odobrenja: 8. rujna 2008.
English: Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
Croatian: Humira može biti dostupna i u drugim jačinama i/ili oblicima pakiranja, ovisno o terapijskim potrebama pojedinog bolesnika.
English: Humira can be taken together with:
Croatian: Humira se može primjenjivati istodobno s:
English: Humira is intended for the treatment of the inflammatory diseases described below:
Croatian: Humira je namijenjena liječenju upalnih bolesti opisanih u nastavku:
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Da biste poslušali ili zatražili primjerak ove upute <na Brailleovu pismu>, <u velikom fontu> ili <u obliku audio zapisa>, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Croatian: Klinička remisija je Mayo rezultat ≤ 2 bez podrezultata > 1;
English: Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time.
Croatian: Podaci koji su dobiveni nakon 78. tjedna uglavnom su bili usklađeni s ovim rezultatima, ali se broj uključenih ispitanika smanjio nakon 78.
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Croatian: Provjerite s liječnikom svoga djeteta ili ljekarnikom ako niste sigurni oko nekih uputa ili ako imate dodatnih pitanja.
English: Failure to perform the following steps as described may cause contamination which may lead to infection of your child.
Croatian: Ako sljedeće korake ne provedete kako je opisano, može doći do onečišćenja i posljedično infekcije
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: Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.
Croatian: Držite tijelo napunjene štrcaljke u jednoj ruci, između palca i kažiprsta, kao što biste držali olovku.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Croatian: U svim niže opisanim situacijama potrebno je vrlo pažljivo razmotriti omjer koristi i rizika liječenja.
English: In rare cases, these infections can be life-threatening.
Croatian: U rijetkim slučajevima, te infekcije mogu biti opasne po život.
English: RA study III also had a primary endpoint of changes in quality of life.
Croatian: Primarna mjera ishoda ispitivanja RA III bile su i promjene u kvaliteti života.
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Croatian: Serumske razine matriksnih metaloproteinaza (MMP-1 i MMP-3) koje uzrokuju preoblikovanje tkiva odgovorno za uništenje hrskavice također su se smanjile nakon primjene lijeka Humira.
English: You will then hear a loud ‘click' as the needle is released and you will feel a small prick as the needle advances.
Croatian: Čut ćete glasan ‘klik' od oslobađanja igle i osjetit ćete mali ubod kako igla bude prodirala dalje u kožu.
English: Most patients continued on Humira after the infection resolved.
Croatian: Većina bolesnika nastavila je primjenjivati lijek Humira nakon što je infekcija izliječena.
English: • Do not hold or pull the plunger when removing the needle cover
Croatian: • Nemojte držati ili povući klip dok uklanjate pokrov igle
English: Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication.
Croatian: POLAKO izvucite bijeli klip štrcaljke do 0,1 ml preko propisane doze, ovo je važno za pravilno doziranje i važno radi toga da se spriječi ulaz mjehurića zraka ili zračnih praznina u tekućinu.
English: • It is normal to see 1 or more bubbles in the window
Croatian: • U redu je vidjeti jedan ili više mjehurića zraka u prozorčiću.
English: Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4.
Croatian: Bolesnici s kliničkim odgovorom (smanjenje CDAI rezultata od ≥ 70) u 4. tjednu stratificirani su i analizirani odvojeno od bolesnika bez kliničkog odgovora u 4. tjednu.
English: • neuropathy (disorder of the nerves)
Croatian: • neuropatija (poremećaj živaca)
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through Week 520 (120 months) of open-label treatment.
Croatian: U ispitivanju RA III, kod većine ispitanika koji su postigli poboljšanje fizičke funkcije i nastavili liječenje održano je poboljšanje tijekom 520 tjedana (120 mjeseci) otvorenog liječenja.
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase.
Croatian: Nakon 32 tjedna ili nakon razbuktavanja bolesti bolesnici su mogli biti uključeni u otvoreni produžetak ispitivanja.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Croatian: Indukcija kliničke remisije (definirana kao CDAI < 150) ispitivala se u dva ispitivanja, CD I (CLASSIC I) i CD II (GAIN).
English: The safety and efficacy of Humira in children aged 4-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Humira u djece u dobi od 4 do 17 godina nisu još ustanovljene.
English: Instructions for preparing and giving an injection of Humira
Croatian: Upute za pripremu i davanje injekcije lijeka Humira
English: Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek Humira, a znakovi i simptomi bolesti su se opet pojavili, Humira se može ponovno primijeniti.
English: Hold the pre-filled syringe in one hand.
Croatian: Držite napunjenu štrcaljku u jednoj ruci.
English: HR a CI 95% for HR
Croatian: HRa 95% CI za
English: • On rare occasions, treatment with Humira could result in lupus-like syndrome.
Croatian: • U rijetkim slučajevima liječenje lijekom Humira može dovesti do pojave sindroma sličnog lupusu.
English: The needle will then be covered by the automatic needle guard.
Croatian: Iglu će tada prekriti automatski štitnik za iglu.
English: • Set up the following items on a clean surface, DO NOTtake them out of their individual packaging yet.
Croatian: • Na čistu radnu površinu postavite sljedeći pribor, no još ga NEMOJTE vaditi iz njihovih pojedinačnih pakiranja.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Croatian: • U ispitivanju provedenom u trudnica nije utvrđen povećan rizik od urođenih mana kada su majke primale lijek Humira tijekom trudnoće u odnosu na majke s istom bolešću koje nisu primale lijek Humira.
English: The injection is complete when the yellow indicator stops moving.
Croatian: Ubrizgavanje je potpuno kada se žuti indikator prestane micati.
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Croatian: Stoga se istodobna primjena adalimumaba i anakinre ne preporučuje
English: NA NA 24.0% 58.9%
Croatian: ND ND 24,0% 58,9%
English: Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Croatian: Zbog inhibicije faktora tumorske nekroze α (TNFα), adalimumab primijenjen u trudnoći mogao bi utjecati na normalne imunološke odgovore u novorođenčeta.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4).
Croatian: Oftalmolozima se preporučuje da se posavjetuju s odgovarajućim specijalistom prije nego što započnu liječenje lijekom Humira (vidjeti dio 4.4).
English: • liquid has been frozen or left in direct sunlight
Croatian: • otopina bila zamrznuta ili ako je stajala na izravnoj sunčevoj svjetlosti
English: Germany and
Croatian: Njemačka i
English: Humira works by reducing this inflammation.
Croatian: Humira djeluje tako da smanjuje tu upalu.
English: Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira.
Croatian: Bolesnici su smjeli nastaviti liječenje ispitivanim lijekom nakon 78. tjedna do trenutka kada im je omogućen pristup lijeku Humira.
English: Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button.
Croatian: Skinite bordo zaštitnu kapicu (označena s ‘2') tako da se otkrije bordo obojena tipka za aktivaciju.
English: Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings.
Croatian: Pri dugoročnijem liječenju lijekom Humira u dozi od 40 mg svaki tjedan tijekom 96 tjedana nisu otkriveni novi nalazi povezani sa sigurnošću.
English: Disease flare criteria were defined as a worsening of  30% from baseline in  3 of 6 Pediatric ACR core criteria,  2 active joints, and improvement of  30% in no more than 1 of the 6 criteria.
Croatian: Razbuktavanje bolesti definiralo se kao pogoršanje za ≥ 30% od početnog stanja u ≥ 3 od 6 ključnih kriterija za pedijatrijski ACR, prisutnošću ≥ 2 aktivna zgloba i poboljšanjem za > 30% u najviše 1 od 6 kriterija.
English: The injection is complete when the yellow indicator has stopped moving.
Croatian: Ubrizgavanje je završeno kada se žuti indikator prestane micati.
English: Throw the needle cover away.
Croatian: Bacite pokrov igle.
English: Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Croatian: Liječenje lijekom Humira u dozi od 40 mg svaki tjedan značajno je smanjilo rizik od pogoršanja apscesa i drenirajućih fistula.
English: If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje lijekom Humira, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: At Week 12 and Week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Croatian: U 12. i 24. tjednu, pedijatrijski odgovor ACR30 bio je 93,5%, odnosno 90,0%, što je utvrđeno na temelju zabilježenih podataka.
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira should be carefully considered.
Croatian: Potrebno je pažljivo razmotriti mogući rizik kod primjene kombinacije azatioprina ili 6-merkaptopurina i lijeka Humira.
English: It must be clear and colourless.
Croatian: Otopina mora biti bistra i bezbojna.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.
Croatian: Doza istodobno primijenjenih kortikosteroida može se postupno smanjivati u skladu s kliničkom praksom, počevši dva tjedna nakon započinjanja liječenja lijekom Humira.
English: The frequency of serious infections among Humira treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Croatian: Učestalost ozbiljnih infekcija među bolesnicima liječenima lijekom Humira bila je veća u osoba starijih od 65 godina (3,7%) nego u osoba mlađih od 65 godina (1,5%).
English: Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Croatian: Liječenje lijekom Humira može se započeti u kombinaciji s kortikosteroidima i/ili drugim nebiološkim imunomodulatorima.
English: Humira has not been studied in patients aged less than 2 years.
Croatian: Humira nije ispitivana u bolesnika mlađih od 2 godine.
English: In study UC-II, among those treated with Humira who were in remission at Week 8, 21/41 (51%) were in remission at Week 52.
Croatian: U ispitivanju UC-II, među onima koji su uz lijek Humira bili u remisiji u osmom tjednu, njih 21/41 (51%) bilo je u remisiji u 52. tjednu.
English: Lonza Biologics Porriño,S.L A Relva s/n
Croatian: Lonza Biologics Porriño,S.L
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Croatian: • Držite pakiranje štrcaljke i POLAKO izvucite klip štrcaljke do 0,1 ml preko propisane doze (primjerice, ako je propisana doza 0,5 ml, izvucite klip štrcaljke do 0,6 ml).
English: Active tuberculosis or other severe infections such as sepsis and opportunistic infections (see section 4.4).
Croatian: Aktivna tuberkuloza ili druge teške infekcije, poput sepse, i oportunističke infekcije (vidjeti dio 4.4).
English: Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Croatian: Liječenje lijekom Humira ne smije se započeti u bolesnika s aktivnim infekcijama, uključujući kronične ili lokalizirane infekcije, sve dok se te infekcije ne stave pod kontrolu.
English: Hold the pre-filled pen so that you can see the inspection window.
Croatian: Držite napunjenu brizgalicu tako da možete vidjeti prozorčić.
English: The yellow indicator is part of the plunger of the pre-filled pen.
Croatian: Žuti indikator je dio klipa napunjene brizgalice.
English: The active substance is adalimumab.
Croatian: Djelatna tvar je adalimumab.
English: The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Croatian: Sigurnost lijeka Humira u pedijatrijskih bolesnika s plak psorijazom ocjenjivala se tijekom srednjeg razdoblja od 13 mjeseci.
English: Patients treated with Humira should be given the Patient Reminder Card.
Croatian: Bolesnicima koji se liječe lijekom Humira treba dati Karticu s podsjetnikom za bolesnika.
English: Keep pushing down to prevent the pre-filled pen from moving away from the skin during the injection.
Croatian: Nastavite pritiskati kako biste spriječili odmicanje napunjene brizgalice od kože tijekom ubrizgavanja.
English: Turn the pre-filled pen so that the white arrow points toward the injection site.
Croatian: Okrenite napunjenu brizgalicu tako da je bijela strelica okrenuta prema mjestu ubrizgavanja.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Humira 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 Humira 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: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Croatian: Ove infekcije mogu biti ozbiljne i uključuju tuberkulozu, infekcije uzrokovane virusima, gljivicama, parazitima ili bakterijama, ili druge oportunističke infekcije i sepsu koje, u rijetkim slučajevima, mogu biti opasne po život.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira 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 lijeka Humira u jednoj ili više podskupina pedijatrijske populacije u indikaciji ulceroznog kolitisa, vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomologous 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: Ispitivanje embriofetalne i perinatalne razvojne toksičnosti provedeno na makaki majmunima pri dozama od 0, 30 i 100 mg/kg (9-17 majmuna po skupini) nije pokazalo znakove oštećenja fetusa uslijed primjene adalimumaba.
English: • anakinra
Croatian: • anakinru
English: Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment.
Croatian: Od preostala 364 bolesnika, 269 ocjenjivih bolesnika (74%) sudjelovalo je u otvorenom liječenju adalimumabom tijekom 78 tjedana.
English: If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Humira (vidjeti dio 4.3).
English: Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Croatian: Sažetak sigurnosnog profila Humira je ispitivana u 9506 bolesnika u pivotalnim kontroliranim i otvorenim ispitivanjima tijekom razdoblja do 60 mjeseci ili dulje.
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Croatian: Zbog toga što je analiza imunogenosti specifična za svaki lijek, nije prikladno uspoređivati stope protutijela kod različitih lijekova.
English: Not all presentations or pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti svi oblici i veličine pakiranja.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Croatian: U ispitivanju razvojne toksičnosti kod majmuna nisu zabilježeni znakovi toksičnosti za majku, embriotoksičnosti ni teratogenosti.
English: Side effects may occur at least up to 4 months after the last Humira injection.
Croatian: Nuspojave se mogu javiti tijekom još najmanje 4 mjeseca nakon zadnje injekcije lijeka Humira.
English: Tél: +33 (0) 1 45 60 13 00
Croatian: AbbVie Tél: +33 (0) 1 45 60 13 00
English: There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Croatian: Nema relevantne primjene lijeka Humira u pedijatrijskoj populaciji za indikacije ankilozantnog spondilitisa i psorijatičnog artritisa.
English: In the open-label extension, improvement in the signs and symptoms was maintained with Humira therapy through Week 156.
Croatian: U otvorenom produžetku ispitivanja poboljšanje znakova i simptoma održalo se uz terapiju lijekom Humira do 156. tjedna.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Croatian: Rezultati kliničke remisije održali su se relativno stalnim bez obzira na prethodno liječenje antagonistima TNF
English: The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Croatian: Primarna mjera ishoda ispitivanja bila je klinička remisija u 26. tjednu, definirana kao PCDAI rezultat
English: • On the front of your child's thighs or
Croatian: • prednji dio djetetovih bedara ili
English: • Choose a site on your thigh or stomach.
Croatian: • Izaberite mjesto na bedru ili trbuhu.
English: Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Croatian: Prije početka liječenja lijekom Humira sve bolesnike se mora podvrgnuti pretragama za otkrivanje i aktivnog i neaktivnog (“latentnog“) oblika tuberkuloze.
English: Press the plum activator button and count slowly for 15 seconds.
Croatian: Pritisnite bordo tipku za aktivaciju i polako brojite 15 sekundi.
English: During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Croatian: Tijekom ispitivanja, većina ispitanika je istodobno uzimala metotreksat, a manje njih je prijavilo primjenu kortikosteroida ili NSAIL-a.
English: Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Croatian: Primjena lijeka Humira bez metotreksata rezultirala je povećanim stvaranjem protutijela, povećanim klirensom i smanjenom djelotvornošću adalimumaba (vidjeti dio 5.1).
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78.
Croatian: U 78. tjednu BCVA se ili poboljšao ili održao na istoj razini (pogoršanje za < 5 slova) u 88,6% očiju.
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Croatian: b Bolesnici koji su ispunjavali protokolom utvrđene kriterije za gubitak odgovora ili izostanak poboljšanja morali su prekinuti sudjelovanje u ispitivanjima i vodili su se kao bolesnici bez odgovora
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 u tri ispitivanja bila je 64%.
English: If you use less Humira than you should
Croatian: Ako primijenite manje lijeka Humira nego što ste trebali
English: • severe rash, hives or other signs of allergic reaction • swollen face, hands, feet
Croatian: • težak osip, koprivnjaču ili druge znakove alergijske reakcije • otečeno lice, šake ili stopala
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 je bilo u kliničkoj remisiji dok je 92,0% (46/50) bolesnika i dalje imalo klinički odgovor prema
English: o One 1 ml syringe (1)
Croatian: o Jednu štrcaljku od 1 ml (1)
English: Wash your hands thoroughly.
Croatian: Temeljito operite ruke
English: How do I give my injection?
Croatian: Kako si dati injekciju?
English: 19.3% of patients had continued baseline oral antibiotic therapy during the study.
Croatian: Tijekom ispitivanja, 19,3% bolesnika nastavilo je terapiju oralnim antibioticima koje su uzimali pri uključivanju u ispitivanje.
English: Disease flares at the end of 32 weeks a (n/N)
Croatian: Razbuktavanje bolesti na kraju razdoblja od 32 tjednaa (n/N)
English: Keep this Patient Reminder Card with you or your child.
Croatian: Karticu s podsjetnikom za bolesnika držite kod sebe ili kod svog djeteta.
English: Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8).
Croatian: Zbog toga je potreban dodatan oprez prilikom razmatranja liječenja lijekom Humira u takvih bolesnika (vidjeti dio 4.8).
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Croatian: Otvorena uvodna16 tjedana Pedijatrijski odgovor ACR 30 (n/N)
English: Maintenance Dose Starting at Week 4
Croatian: Doza održavanja počevši od
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Croatian: Infekcije su prvenstveno uključivale nazofaringitis, infekciju gornjeg dišnog sustava i sinusitis.