FrancophonIA/ELRC3.0 huggingface dataset:
English: Humira was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Croatian: Djelotvornost i sigurnost lijeka Humira ispitivane su u multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju indukcijske terapije i terapije održavanja dozama ovisnim o tjelesnoj težini (< 40 kg ili ≥ 40 kg) u 192 pedijatrijska ispitanika u dobi između (i uključujući) 6 i 17 godina s umjerenom do teškom Crohnovom bolešću (engl.
English: There is little experience from re-administration after more than 8 weeks since the previous dose.
Croatian: Postoji malo podataka o ponovnoj primjeni lijeka Humira kad je prekid terapije trajao duže od 8 tjedana.
English: • Do not use the pre-filled syringe if it has been dropped or crushed
Croatian: • Nemojte upotrijebiti napunjenu štrcaljku ako je pala ili se slomila
English: • hearing loss, buzzing
Croatian: • gubitak sluha, zujanje
English: • erythema multiforme (inflammatory skin rash)
Croatian: • multiformni eritem (upalni kožni osip)
English: You will be instructed by your doctor or his/her assistant on the technique of self-injection.
Croatian: U tehniku samostalnog ubrizgavanja uputit će Vas liječnik ili njegov/njezin pomoćnik.
English: Humira 40 mg every other week N = 70
Croatian: Humira 40 mg svaki drugi tjedan N = 70
English: DO NOT use if the liquid is cloudy, discoloured or has flakes or particles in it.
Croatian: NE koristite lijek ako je otopina zamućena, obojena ili sadrži pahulje ili čestice.
English: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Croatian: Reumatoidni artritis, psorijatični artritis, ankilozantni spondilitis ili aksijalni spondiloartritis bez radiološkog dokaza ankilozantnog spondilitisa Dob ili tjelesna težina
English: 6) Throwing away supplies
Croatian: 6) Odlaganje pribora u otpad
English: Tel + 385 (0)1 5625 501
Croatian: AbbVie d.o.o. Tel + 385 (0)1 5625 501
English: • If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor.
Croatian: • Bolujete li od blagog zatajenja srca, a liječite se lijekom Humira, liječnik mora pomno nadzirati status zatajenja srca.
English: Do not try to touch the needle housed in the barrel.
Croatian: Ne pokušavajte dirati iglu koja se nalazi u cijevi.
English: • At least 3 cm from your child's last injection site
Croatian: • barem 3 cm od mjesta na kojem je djetetu ubrizgana prethodna injekcija
English: The safety and efficacy of Humira were assessed in two randomized, double-blind placebo-controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Croatian: Sigurnost i djelotvornost lijeka Humira ocjenjivale su se u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja, provedena u bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a (nr-axSpA).
English: Hold the pre-filled syringe with the needle facing up.
Croatian: Držite napunjenu štrcaljku s iglom okrenutom prema gore.
English: Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Croatian: Bolesnici koji primaju lijek Humira mogu istodobno primiti cjepiva, ali ne živa cjepiva.
English: Your doctor may recommend temporary discontinuation.
Croatian: Liječnik može preporučiti privremeni prekid terapije lijekom
English: Table 7 Distribution of patients by age and adalimumab dose received during the OL LI phase
Croatian: Tablica 7 Raspodjela bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: • heart problems that can cause shortness of breath or ankle swelling
Croatian: • problemi sa srcem koji mogu uzrokovati nedostatak zraka ili oticanje zglobova
English: • Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.
Croatian: • Recite svom liječniku ako je Vaše dijete nekada imalo infekcije koje su se ponavljale ili druga stanja koja povećavaju rizik od infekcija.
English: Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients p = 0.015 c p = 0.031
Croatian: 14 tjedana a Pedijatrijski odgovori ACR 30/50/70 nakon 48 tjedana bili su značajno veći nego u skupini koja je uzimala placebo bp=0,015 cp=0,031
English: • lung diseases causing shortness of breath (including inflammation)
Croatian: • bolest pluća koja uzrokuje nedostatak zraka (uključujući upalu)
English: Week 12 Week 24
Croatian: 2. tjedan 12. tjedan 24. tjedan
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at Week 0 and 80 mg at Week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Croatian: Svi ispitanici su primali otvorenu indukcijsku terapiju u dozi određenoj prema njihovoj početnoj tjelesnoj težini: 160 mg u nultom tjednu i 80 mg u drugom tjednu za ispitanike tjelesne težine ≥ 40 kg, odnosno 80 mg i 40 mg za ispitanike tjelesne težine < 40 kg.
English: In patients with non-radiographic axial spondyloarthritis, anti-adalimumab antibodies were identified in 8/152 subjects (5.3%) who were treated continuously with adalimumab.
Croatian: U bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, protutijela na adalimumab pronađena su u 8/152 ispitanika (5,3%) koji su bili kontinuirano liječeni adalimumabom.
English: In adult patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.
Croatian: U odraslih bolesnika s neinfektivnim uveitisom, protutijela na adalimumab nađena su u 4,8% (12/249) bolesnika liječenih adalimumabom.
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Croatian: Ispitivanje RA V obuhvatilo je 799 odraslih bolesnika s umjerenim do teškim aktivnim ranim reumatoidnim artritisom (srednja vrijednost trajanja bolesti kraća od 9 mjeseci) koji do tada nisu bili liječeni metotreksatom.
English: The safety and efficacy of Humira was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Croatian: I i II) u djece s aktivnim poliartikularnim ili poliartikularnim tijekom juvenilnog idiopatskog artritisa i raznim vrstama početka JIA (najčešće negativni reumatoidni faktor ili pozitivni poliartritis i prošireni oligoartritis).
English: Humira can slow down the damage to the joints caused by the disease and can help them move more freely.
Croatian: Humira može usporiti oštećenje zglobova uzrokovano bolešću i može poboljšati njihovu pokretljivost.
English: Injecting Humira
Croatian: Ubrizgavanje lijeka Humira
English: If a faster response is required, your child's doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik Vašeg djeteta može propisati prvu dozu od 160 mg, nakon koje dva tjedna kasnije slijedi doza od 80 mg.
English: The recommended dose of Humira is 20 mg every other week.
Croatian: Preporučena doza lijeka Humira je 20 mg svaki drugi tjedan.
English: Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Croatian: Humira je indicirana za liječenje aktivnog i progresivnog psorijatičnog artritisa u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti nije postignut zadovoljavajući odgovor.
English: In patients not given concomitant methotrexate, the incidence was 25.6% (22/86) compared to 5.9% (5/85) when adalimumab was used as add-on to methotrexate.
Croatian: U bolesnika koji nisu istodobno primali metotreksat incidencija je bila 25,6% (22/86), u usporedbi s 5,9% (5/85) u bolesnika koji su primali adalimumab uz metotreksat.
English: • With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
Croatian: • Dok je nastavak još u prozirnom pakiranju, pričvrstite ga za čep bočice tako da ga pritisnete prema dolje sve dok nastavak ne sjedne na svoje mjesto.
English: Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Humira je indicirana za liječenje umjerenog do teškog oblika aktivnog ulceroznog kolitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), ili u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with Humira.
Croatian: U bolesnika s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovom bolešću, ulceroznim kolitisom i gnojnim hidradenitisom također je primijećeno naglo smanjenje razina CRP-a nakon liječenja lijekom Humira.
English: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among Humira-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Croatian: Stopa nemelanomskih tumora kože (interval pouzdanosti od 95%) bila je 8,8 (6,0; 13,0) na 1000 bolesnik-godina u bolesnika liječenih lijekom Humira, odnosno 3,2 (1,3; 7,6) na 1000 bolesnik-godina u kontrolnoj skupini bolesnika.
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
Croatian: • abnormalno raspadanje mišića • sistemski eritemski lupus (uključujući upalu kože, srca, pluća, zglobova i drugih organskih sustava)
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa u odraslih bolesnika koji nisu bili prethodno liječeni metotreksatom.
English: • At least 3 cm from your last injection site
Croatian: • Barem 3 cm od mjesta na kojem je ubrizgana prethodna injekcija
English: With automatic needle guard
Croatian: Sadrži automatski štitnik za iglu
English: (injection) Clear, colourless solution.
Croatian: Otopina za injekciju. (injekcija) Bistra, bezbojna otopina.
English: • nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome 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 koji može uzrokovati slabost mišića, abnormalne osjete, trnce u rukama i gornjem dijelu tijela),
English: A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom Humira potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: Week 12 Week 24 ASAS 70 Week 2
Croatian: 2. tjedan 12. tjedan 24. tjedan ASAS 70
English: • moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.
Croatian: • umjerenog do teškog oblika gnojnog hidradenitisa u adolescenata u dobi od 12 do 17 godina.
English: Humira is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Croatian: Humira je namijenjena liječenju djece u dobi od 2 i više godina s kroničnim nezaraznim uveitisom kod kojega upala zahvaća prednji dio oka.
English: Then give your child's next dose as you would have on the originally scheduled day, had you not forgotten a dose.
Croatian: Zatim sljedeću dozu ubrizgajte djetetu onda kada je to prvotno bilo predviđeno, kao da niste zaboravili dozu.
English: • Only use each pre-filled syringe for one injection.
Croatian: • Svaku brizgalicu koristite samo za jednu injekciju.
English: Maintenance of remission and response rates are presented in Table 14.
Croatian: Stope održavanja remisije i stope odgovora nalaze se u Tablici 14.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)
Croatian: Adolescentni gnojni hidradenitis (u dobi od 12 i više godina, tjelesne težine najmanje 30 kg)
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).
Croatian: Potrebno je periodički ocjenjivati koristi i rizike kontinuiranog dugotrajnog liječenja (vidjeti podatke za odrasle u dijelu 5.1).
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/ml (79% CV).
Croatian: Nakon supkutano primijenjene doze od 0,8 mg/kg (do maksimalno 40 mg) svaki drugi tjedan u pedijatrijskih bolesnika s kroničnom plak psorijazom, srednja vrijednost ± SD najniže koncentracije adalimumaba u stanju dinamičke ravnoteže iznosila je približno 7,4 ± 5,8 µg/ml (79% CV).
English: Patients should be tested for HBV infection before initiating treatment with Humira.
Croatian: Bolesnike je potrebno prije početka terapije lijekom Humira testirati na HBV infekciju.
English: PROBABILITY OF NO FLARE
Croatian: VJEROJATNOST DA NEĆE DOĆI DO RAZBUKTAVANJA
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Croatian: Žene reproduktivne dobi trebaju razmotriti korištenje odgovarajuće kontracepcije kako bi spriječile trudnoću i trebale bi je nastaviti koristiti još najmanje pet mjeseci nakon posljednje doze lijeka Humira.
English: Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Croatian: Pomoćne tvari: manitol, citratna kiselina hidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid i voda za injekcije.
English: • leukaemia (cancer affecting the blood and bone marrow)
Croatian: • leukemija (rak koji zahvaća krv i koštanu srž)
English: All p-values are pairwise comparisons of proportions for Humira versus placebo p < 0.001 p < 0.01
Croatian: Sve p-vrijednosti odnose se na sparene usporedbe udjela uz lijek Humira naspram placeba * p < 0,001 ** p < 0,01
English: • autoantibodies present in the blood
Croatian: • pojava autoprotutijela u krvi
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
Croatian: Ako Vaše dijete boluje od KOPB-a ili puno puši, provjerite kod liječnika je li terapija blokatorom TNF primjerena za Vaše dijete.
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 obrambenog sustava organizma),
English: Humira 40 mg/0.8 ml solution for injection
Croatian: Humira 40 mg/0,8 ml otopina za injekciju
English: With automatic needle guard.
Croatian: Sadrži automatski štitnik za iglu.
English: • Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Croatian: • Recite svom liječniku ako Vaše dijete živi ili putuje u područja gdje su vrlo česte gljivične infekcije (primjerice histoplazmoza, kokcidioidomikoza ili blastomikoza).
English: • methotrexate
Croatian: • metotreksatom
English: Please check with your doctor before you receive any vaccines.
Croatian: Posavjetujte se sa svojim liječnikom prije nego primite bilo kakvo cjepivo.
English: 40 mg Humira every week
Croatian: Humira 40 mg svaki tjedan
English: RA Study I a**
Croatian: Ispitivanje RA Ia**
English: In study UC-II, 248 patients received 160 mg of Humira at Week 0, 80 mg at Week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Croatian: U ispitivanju UC-II, 248 bolesnika primalo je lijek Humira u dozi od 160 mg u nultom tjednu, 80 mg u drugom tjednu i zatim 40 mg svaka dva tjedna, a 246 bolesnika primalo je placebo.
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/ml (47.7% CV) with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m2 (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom (JIA) u dobi od 4 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene od 20. do 48. tjedna) bila je 5,6 ± 5,6 µg/ml (102% CV) za adalimumab bez istodobne primjene metotreksata i 10,9 ± 5,2 µg/ml (47,7% CV) uz istodobnu primjenu metotreksata.
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: Način i put primjene
English: • cancer that affects the lymph system;
Croatian: • rak koji zahvaća limfni sustav,
English: Take one dose tray containing a pre-filled pen of Humira from the refrigerator.
Croatian: Uzmite iz hladnjaka jedan blister koji sadrži napunjenu brizgalicu lijeka Humira Ne tresite i ne ispuštajte napunjenu brizgalicu.
English: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Humira je indicirana za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u adolescenata u dobi od 12 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa (vidjeti dijelove 5.1 i 5.2).
English: STEP 4
Croatian: KORAK 4
English: After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.
Croatian: Nakon završetka ubrizgavanja, možete vatom ili komadom gaze pritisnuti mjesto ubrizgavanja.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom Humira zbog moguće pojave infekcija, uključujući tuberkulozu.
English: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Humira je indicirana za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u odraslih i adolescenata u dobi od 12 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa (vidjeti dijelove 5.1 i 5.2).
English: At Week 12, a significantly higher proportion of patients treated with Humira versus placebo achieved HiSCR.
Croatian: U 12. tjednu HiSCR je postigao značajno veći udio bolesnika liječenih lijekom Humira naspram onih koji su primali placebo.
English: Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Croatian: Humira se koristi za liječenje gnojnog hidradenitisa u adolescenata u dobi od 12 godina i starijih.
English: At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Croatian: Nakon 52 tjedna liječenja, klinička remisija (DAS28 [CRP] <2,6) postignuta je u 42,9% bolesnika liječenih kombinacijom lijeka Humira i metotreksata u usporedbi s 20,6% bolesnika koji su dobivali monoterapiju metotreksatom, odnosno 23,4% bolesnika koji su dobivali monoterapiju lijekom Humira.
English: STEP 7
Croatian: KORAK 7
English: Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.
Croatian: Jedno pakiranje sadrži 1, 2, 4 ili 6 napunjenih štrcaljki za uporabu od strane bolesnika s 1, 2, 4, odnosno
English: • Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
Croatian: • Recite svom liječniku ako ste ranije imali infekcije koje su se ponavljale ili druga stanja koja povećavaju rizik od infekcija.
English: Assessment of SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score mean change from baseline n=91 placebo and n=87 Humira high sensitivity C-Reactive Protein (mg/L) n=73 placebo and n=70 Humira Spondyloarthritis Research Consortium of Canada n=84 placebo and Humira n=82 placebo and n=85 Humira ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between Humira and placebo.
Croatian: Spondyloarthritis Research Consortium of Canada) i n=84 za placebo i lijek Humira j n=82 za placebo i n=85 za lijek Humira ***, **, * Statistički značajno kod p<0,001, p<0,01 odnosno p<0,05, za sve usporedbe lijeka Humira s placebom.
English: This study evaluated the efficacy of Humira 40 mg every other week/methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Croatian: mg lijeka Humira svaka dva tjedna/metotreksat), monoterapije lijekom Humira (40 mg svaka dva tjedna) te monoterapije metotreksatom na smanjenje simptoma i znakova te brzinu progresije oštećenja zglobova kod reumatoidnog artritisa.
English: How to store Humira
Croatian: Kako primjenjivati lijek Humira
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patientyears among control patients.
Croatian: Od tih tumora kože, karcinom skvamoznih stanica javljao se (interval pouzdanosti od 95%) uz stopu od 2,7 (1,4; 5,4) na 1000 bolesnik-godina u bolesnika liječenih lijekom Humira i stopu od 0,6 (0,1; 4,5) na 1000 bolesnikgodina u kontrolnoj skupini.
English: • trouble breathing, swallowing
Croatian: • otežano disanje, gutanje
English: Do not use Humira:
Croatian: Nemojte primjenjivati lijek Humira:
English: Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Croatian: Ne dirajte bordo tipku za aktivaciju sve dok niste spremni za ubrizgavanje jer će se time lijek izbaciti van.