FrancophonIA/ELRC3.0 huggingface dataset:
English: Ankylosing Spondylitis Disease Activity Score Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Croatian: c Rezultat za aktivnost ankilozantnog spondilitisa d Djelomično razbuktavanje bolesti definiralo se kao ASDAS rezultat ≥ 1,3, ali < 2,1 pri dva uzastopna posjeta.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije živim cjepivima u bolesnika liječenih lijekom Humira.
English: Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
Croatian: Slučajevi pogoršanja kongestivnog zatajenja srca također su prijavljeni i u bolesnika liječenih lijekom Humira.
English: You will see a yellow indicator move into the window during the injection.
Croatian: Vidjet ćete da se tijekom ubrizgavanja žuti indikator pomiče u prozorčić.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako se pojavi anafilaktička reakcija ili kakva druga ozbiljna alergijska reakcija, primjenu lijeka Humira treba odmah obustaviti i započeti odgovarajuću terapiju.
English: Humira is available in other strengths and presentations.
Croatian: Humira je dostupna i u drugim jačinama i oblicima pakiranja.
English: • For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Croatian: • Na primjer, ako je propisana doza 0,5 ml, NE gurajte klip štrcaljke preko položaja od 0,5 ml.
English: Carriers of HBV who require treatment with Humira 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 Humira mora se pomno pratiti zbog moguće pojave znakova i simptoma aktivne HBV infekcije tijekom cijelog trajanja terapije te nekoliko mjeseci nakon njezina prekida.
English: Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Croatian: Djelovanje lijeka Humira ispitivano je u više od 3000 bolesnika u svim kliničkim ispitivanjima kod reumatoidnog artritisa (RA).
English: You may notice a spot of blood at the injection site.
Croatian: Moguća je pojava oskudnog krvarenja na mjestu ubrizgavanja.
English: With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and hold firmly (see below).
Croatian: Slobodnom rukom nježno primite dovoljno veliko područje očišćene kože za ubrizgavanje i čvrsto držite (pogledajte dolje).
English: • tuberculosis
Croatian: • tuberkulozu
English: Should treatment be interrupted, Humira may be re-introduced as appropriate.
Croatian: Ako liječenje treba privremeno prekinuti, Humira se kasnije po potrebi može ponovno uvesti.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 0,8 ml, odnosno zanemarive količine natrija.
English: Dose + 0.1 ml
Croatian: Doza + 0,1 ml
English: No clinical data are available on the use of a Humira loading dose in children < 6 years of age (see section 5.2).
Croatian: Nisu dostupni klinički podaci o primjeni udarne doze lijeka Humira u djece u dobi od < 6 godina (vidjeti dio 5.2).
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Croatian: Sličan odgovor protutijela na standardno 23-valentno pneumokokno cjepivo i trovalentno cjepivo protiv gripe zamijećen je u ispitivanju 226 odraslih ispitanika s reumatoidnim artritisom koji su primali adalimumab ili placebo.
English: Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike u kojih se za vrijeme liječenja lijekom Humira razviju nove infekcije potrebno je pozorno pratiti i podvrgnuti kompletnoj dijagnostičkoj procjeni.
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Croatian: Bolesnici u kojih nije bilo odgovora nakon prve doze isključeni su iz daljnjeg tijeka ispitivanja i stoga ti bolesnici nisu bili dalje procjenjivani.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne često otežano cijeljenje
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Humira.
Croatian: U nekih bolesnika koji su bili uspješno liječeni zbog aktivne tuberkuloze, za vrijeme liječenja lijekom Humira ponovno se razvila tuberkuloza.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged),
Croatian: često poremećaji koagulacije i krvarenja (uključujući produljenje aktiviranog parcijalnog tromboplastinskog vremena),
English: The recommended Humira dose is up to a maximum of 40 mg per dose.
Croatian: Preporučena doza lijeka Humira iznosi do najviše 40 mg po dozi.
English: With your other hand, pull the grey cap (1) straight off, check that the small black needle cover of the syringe has been removed with the cap, then discard cap.
Croatian: Drugom rukom povucite sivu kapicu (1), provjerite da je zajedno s kapicom uklonjen i mali crni pokrov igle na štrcaljki i bacite kapicu.
English: The safety and efficacy of Humira in children aged 4-17 years have been established for plaque psoriasis.
Croatian: Sigurnost i djelotvornost lijeka Humira u djece u dobi od 4 do 17 godina ustanovljene su za plak psorijazu.
English: Treatment with Humira may result in the formation of autoimmune antibodies.
Croatian: Liječenje lijekom Humira može dovesti do razvoja autoimunih protutijela.
English: • melanoma
Croatian: • melanom
English: • high blood pressure
Croatian: • visok krvni tlak
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
Croatian: 26. tjedan 52. tjedan 1 p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: The efficacy and safety of Humira were assessed in five randomised, double-blind and well-controlled studies.
Croatian: Djelotvornost i sigurnost lijeka Humira ocijenjena je u pet randomiziranih, dvostruko slijepih, dobro kontroliranih ispitivanja.
English: At Week 16, a statistically significantly greater proportion of patients who received Humira achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Croatian: U 16. tjednu je statistički značajno veći udio bolesnika koji su primali lijek Humira postigao PGA rezultat „bez bolesti“ ili „gotovo bez bolesti“ za šake i/ili stopala u usporedbi s bolesnicima koji su primali placebo (30,6% u odnosu na 4,3% [P = 0,014]).
English: Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Croatian: Razbuktavanje bolesti definiralo se kao ASDAS rezultat ≥ 2,1 pri dva uzastopna posjeta u razmaku od četiri tjedna.
English: The primary endpoint in RA studies VI and VII was injection site pain immediately after injection as measured by a 0-10 cm VAS.
Croatian: Primarna mjera ishoda u ispitivanjima RA VI i VII bila je bol na mjestu injiciranja neposredno nakon injekcije, ocijenjena prema VAS ljestvici od 0-10 cm.
English: If there are more than a few drops of liquid on the injection site, contact your doctor, nurse or pharmacist.
Croatian: Ako se na mjestu ubrizgavanja nalazi više od nekoliko kapi tekućine, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Humira, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom Humira mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: Patients in steroid-free remission for >=90 days
Croatian: Bolesnici u remisiji bez primjene steroida >= 90 danaa
English: The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Croatian: Postotak bolesnika liječenih lijekom Humira u kojih je postignut terapijski odgovor ACR 20, 50 i 70 bio je podjednak u ispitivanjima RA I, II i III.
English: Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Croatian: U kliničkim ispitivanjima kod svih indikacija, bolesnici s povišenim razinama ALT-a nisu imali simptome i u većini slučajeva povišenje je bilo prolazno i povuklo se s nastavkom liječenja.
English: Humira is used to treat
Croatian: Humira se koristi za liječenje
English: You should continue to inject Humira for as long as your doctor has told you.
Croatian: Lijek Humira morate nastaviti primjenjivati onoliko dugo koliko Vam je propisao Vaš liječnik.
English: Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks.
Croatian: Bolesnici koji su dovršili ispitivanja UV I i UV II zadovoljavali su kriterije za uključivanje u nekontrolirani dugoročni produžetak ispitivanja čije je planirano vrijeme trajanja bilo 78 tjedana.
English: • severe infection in the blood (sepsis)
Croatian: • tešku infekciju krvi (sepsa)
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Croatian: Nisu provedena ispitivanja kancerogenog potencijala ni standardna procjena toksičnosti za plodnost i postnatalne toksičnosti adalimumaba zbog nepostojanja odgovarajućih modela za protutijelo s ograničenom križnom reaktivnošću s TNF-om glodavaca i stvaranja neutralizirajućih protutijela u glodavaca.
English: Worsening of symptoms of dermatomyositis1)
Croatian: nepoznato pogoršanje simptoma dermatomiozitisa1)
English: You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Croatian: Zabilježite datum kada ste štrcaljku prvi put izvadili iz hladnjaka i datum nakon kojega je morate baciti.
English: There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and no stillbirths or malignancies were reported.
Croatian: Nije bilo velikih razlika između žena liječenih adalimumabom i onih koje ga nisu primale s obzirom na sekundarne mjere ishoda - spontane pobačaje, manje urođene mane, prijevremeni porođaj, porođajnu veličinu i ozbiljne ili oportunističke infekcije, a nije prijavljeno nijedno mrtvorođenje ni zloćudna bolest.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with Humira, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Croatian: Među 68 bolesnika kod kojih je došlo do razbuktavanja bolesti u skupini u kojoj je terapija ukinuta, 65 bolesnika primilo je 12 tjedana spasonosne terapije lijekom Humira, od kojih je njih 37 (56,9%) ponovno postiglo remisiju bolesti (ASDAS rezultat < 1,3) 12 tjedana nakon ponovnog započinjanja otvorenog liječenja.
English: Your child's symptoms may return if you stop using Humira.
Croatian: Simptomi Vašeg djeteta mogu se vratiti ako prestane primjenjivati lijek Humira.
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Croatian: Djelotvornost adalimumaba je u tih bolesnika bila smanjena u odnosu na bolesnike koji nisu prethodno bili liječeni antagonistima TNF-a.
English: Surgery or dental procedure
Croatian: Kirurški ili stomatološki zahvat
English: Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.
Croatian: Liječenje lijekom Humira moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja je Humira indicirana.
English: During treatment with Humira, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Croatian: Tijekom liječenja lijekom Humira potrebno je optimizirati druge istodobno primijenjene terapije (npr. kortikosteroide i/ili imunomodulatore).
English: TREATMENT FAILURE RATE (%)
Croatian: STOPA NEUSPJEHA LIJEČENJA(%)
English: If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Croatian: Ako Vaš liječnik procijeni da je metotreksat neprikladan, Humira se može davati samostalno.
English: Humira contains the active substance adalimumab.
Croatian: Humira sadrži djelatnu tvar adalimumab.
English: REMINDER STICKERS TEXT (included in pack)
Croatian: TEKST NA NALJEPNICI ZA PODSJETNIK (uključeno u pakiranje)
English: • If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Croatian: • Ako je Vaša kći trudna, misli da bi mogla biti trudna ili planira imati dijete, obratite se njezinu liječniku za savjet o primjeni ovog lijeka.
English: Humira/MTX 40 mg every other week
Croatian: Humira/MTX 40 mg svaka dva tjedna
English: Of 342 subjects originally randomized to Humira monotherapy or Humira/methotrexate combination therapy who entered the openlabel extension study, 171 subjects completed 10 years of Humira treatment.
Croatian: Od 342 ispitanika izvorno randomizirana za monoterapiju lijekom Humira ili liječenje kombinacijom lijeka Humira i metotreksata koji su ušli u otvoreni produžetak ispitivanja, 171 ispitanik završio je 10 godina liječenja lijekom Humira.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8).
Croatian: Rizik od pojave hepatospleničnog T-staničnog limfoma u bolesnika liječenih lijekom Humira ne može se isključiti (vidjeti dio 4.8).
English: Improved physical function continued during the open label extension up to Week 136.
Croatian: Poboljšana fizička funkcija održala se i u otvorenom produžetku ispitivanja do 136. tjedna.
English: Throw the cap away.
Croatian: Bacite kapicu.
English: 2) Preparing the Humira dose for injection
Croatian: 2) Priprema doze lijeka Humira za ubrizgavanje
English: In rheumatoid arthritis, methotrexate is continued while using Humira.
Croatian: Kod reumatoidnog artritisa, primjena metotreksata se nastavlja za vrijeme uzimanja lijeka Humira.
English: If you use more Humira than you should
Croatian: Ako primijenite više lijeka Humira nego što ste trebali
English: • If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako je Vaše dijete alergično na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: AbbVie AB
Croatian: AbbVie SA
English: Do not press the plum activator button until you are ready to inject.
Croatian: Nemojte pritisnuti bordo tipku za aktivaciju dok niste spremni za ubrizgavanje.
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: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Croatian: U razdoblju kada je terapija bila ukinuta, simptomi psorijaze su se s vremenom vratili, uz medijan vremena do relapsa od oko 5 mjeseci (pogoršanje na PGA rezultat “umjereno” ili gore).
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
Croatian: • oportunističke infekcije (uključujući tuberkulozu i druge infekcije do kojih dolazi kod slabljenja otpornosti na bolest)
English: Humira 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: Humira 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: If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Humira provider for a replacement.
Croatian: Ako ste bijeli klip štrcaljke sasvim izvukli iz štrcaljke, bacite štrcaljku i obratite se dobavljaču lijeka Humira radi zamjene.
English: Antibiotics may be continued during treatment with Humira if necessary.
Croatian: Ako je potrebno, primjena antibiotika može se nastaviti i tijekom liječenja lijekom Humira.
English: Humira contains sodium
Croatian: Humira sadrži natrij
English: You and your doctor should pay special attention to signs of infection while you are being treated with Humira.
Croatian: I Vi i Vaš liječnik morate obratite posebnu pažnju na znakove infekcije dok se liječite lijekom Humira.
English: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section
Croatian: Sigurnost preporučene doze adalimumaba u adolescentnoj populaciji s gnojnim hidradenitisom temelji se na sigurnosnom profilu adalimumaba u drugim indikacijama i u odraslih i u pedijatrijskih bolesnika pri sličnoj ili većoj učestalosti doziranja (vidjeti dio 5.2).
English: Choose a site on your thigh or stomach
Croatian: Izaberite mjesto na bedru ili trbuhu.
English: Results from the overall UC-II study population are shown in Table 18.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 18.
English: TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including GuillainBarré syndrome.
Croatian: U rijetkim su slučajevima antagonisti TNF-a, uključujući lijek Humira, bili povezani s pojavom novih ili pogoršanjem postojećih kliničkih simptoma i/ili radioloških dokaza demijelinizirajuće bolesti središnjeg živčanog sustava, uključujući multiplu sklerozu i optički neuritis, i periferne demijelinizirajuće bolesti, uključujući Guillain-Barréov sindrom.
English: Patients treated with Humira usually experienced improvement in haematological signs of chronic inflammation.
Croatian: Bolesnici liječeni lijekom Humira obično pokazuju poboljšanje hematoloških znakova kronične upale.
English: Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection.
Croatian: Nastavite pritiskati i držati napunjenu brizgalicu pod stalnim pritiskom na mjestu oko 10
English: You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.
Croatian: Zabilježite datum kada ste brizgalicu prvi put izvadili iz hladnjaka i datum nakon kojega je morate baciti.
English: Contents of the pack and other information Injecting Humira
Croatian: Sadržaj pakiranja i druge informacije Što Humira sadrži
English: In patients with moderately to severely active paediatric Crohn's disease, the rate of anti-adalimumab antibody development in patients receiving adalimumab was 3.3%.
Croatian: U bolesnika s umjerenim do teškim oblikom aktivne Crohnove bolesti, stopa stvaranja protutijela na adalimumab u bolesnika koji su primali adalimumab bila je 3,3%.
English: Humira is administered every other week via subcutaneous injection.
Croatian: Humira se primjenjuje svaki drugi tjedan supkutanom injekcijom.
English: Your doctor will decide if you should receive Humira.
Croatian: Liječnik će odlučiti trebate li primiti lijek Humira.
English: The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study.
Croatian: Primarna mjera ishoda za djelotvornost bio je udio bolesnika kod kojih nije došlo do razbuktavanja bolesti do 68. tjedna ispitivanja.
English: Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Humira se može davati i kao monoterapija ako bolesnik ne podnosi metotreksat ili kada nastavak terapije metotreksatom nije prikladan.
English: • haematoma (collection of blood outside of blood vessels)
Croatian: • hematom (nakupljanje krvi izvan krvnih žila)
English: • allergic reactions (including seasonal allergy)
Croatian: • alergijske reakcije (uključujući sezonsku alergiju)
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 post-Baseline visits
Croatian: 2 Imunosupresivna terapija mogla se obustaviti samo u 26. tjednu ili kasnije, prema slobodnoj procjeni ispitivača ako je ispitanik ispunio kriterij kliničkog odgovora 3 definirano kao zatvaranje svih fistula iz kojih se na početku cijedio sadržaj, održano kroz barem 2 uzastopna posjeta nakon početka liječenja
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Other opportunistic infections).
Croatian: U bolesnika koji su bili izloženi tuberkulozi ili bolesnika koji su putovali u područja visokog rizika od tuberkuloze ili endemskih mikoza, kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza, prije započinjanja liječenja treba razmotriti rizike i koristi liječenja lijekom Humira (vidjeti Druge oportunističke infekcije).
English: Among patients who were at least partial responders at Week 12, and who received continuous weekly Humira therapy, the HiSCR rate at Week 48 was 68.3% and at Week 96 was 65.1%.
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor i koji su nastavili terapiju lijekom Humira svaki tjedan, stopa HiSCR-a u 48. tjednu iznosila je 68,3%, a u 96. tjednu 65,1%.
English: Hold the pre-filled syringe in one hand between the finger grip and the needle cover.
Croatian: Držite napunjenu štrcaljku u jednoj ruci između hvatišta za prste i pokrova igle.
English: The Humira pre-filled pen is available in packs containing:
Croatian: Napunjena brizgalica lijeka Humira dostupna je u pakiranjima koja sadrže:
English: A total of 233 PASI 75 responders at Week 16 and Week 33 received continuous Humira therapy for 52 weeks in Psoriasis Study I, and continued Humira in the open-label extension trial.
Croatian: Ukupno su 233 bolesnika s odgovorom PASI 75 u 16. i 33. tjednu primala kontinuiranu terapiju lijekom Humira kroz 52 tjedna u ispitivanju Psoriasis Study I te su nastavila s primanjem lijeka Humira u otvorenom produžetku ispitivanja.
English: 1) Setting up
Croatian: 1) Priprema
English: Mark your calendar with the stickers provided to remind you of the date for your next dose.
Croatian: Priloženim naljepnicama označite na svome kalendaru datum kada trebate primiti sljedeću dozu.