FrancophonIA/ELRC3.0 huggingface dataset:
English: The active ingredient in Humira, adalimumab, is a human monoclonal antibody.
Croatian: Djelatna tvar u lijeku Humira, adalimumab, ljudsko je monoklonsko protutijelo.
English: The safety and efficacy of Humira were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Croatian: Sigurnost i djelotvornost lijeka Humira ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima i jednom otvorenom produžetku ispitivanja u odraslih bolesnika s umjerenim do teškim gnojnim hidradenitisom (Hidradenitis suppurativa, HS) koji nisu podnosili sistemske antibiotike, koji su imali kontraindikacije za njihovu primjenu ili nisu postigli zadovoljavajući odgovor na liječenje sistemskim antibioticima tijekom najmanje 3 mjeseca.
English: Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Croatian: Radiološke su pretrage pokazale da Humira usporava brzinu progresije oštećenja zglobova i poboljšava fizičku funkciju kada se daje u kombinaciji s metotreksatom.
English: • Do not recycle or throw the pre-filled pen in the household waste
Croatian: • Nemojte reciklirati niti bacati napunjenu brizgalicu u kućni otpad.
English: • severe rash, hives or other signs of allergic reaction
Croatian: • težak osip, koprivnjaču ili druge znakove alergijske reakcije
English: Table 12 Ped ACR 30 Responses in the JIA study
Croatian: Tablica 12 Pedijatrijski odgovori ACR 30 u ispitivanju kod JIA
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg Humira was administered every other week.
Croatian: Nakon završetka oba ispitivanja, 383 bolesnika uključena su u otvoreni produžetak ispitivanja u kojem su dobivala 40 mg lijeka Humira svaki drugi tjedan.
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Croatian: Tijekom liječenja starijih osoba mora se obratiti posebna pažnja na mogući rizik od infekcije.
English: The safety profile for patients with uveitis treated with Humira every other week was consistent with the known safety profile of Humira.
Croatian: Sigurnosni profil lijeka Humira u bolesnika s uveitisom liječenih svaki drugi tjedan bio je u skladu s poznatim sigurnosnim profilom lijeka Humira.
English: ≥30% Reduction in Skin Pain
Croatian: Smanjenje kožne boli za
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA
English: • Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira.
Croatian: • Vaše dijete i njegov liječnik moraju obratiti posebnu pozornost na znakove infekcije tijekom liječenja lijekom Humira.
English: Children and adolescents from 2 years of age weighing less than 30 kg The usual dose of Humira is 20 mg every other week with methotrexate.
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine manje od 30 kg Uobičajena doza lijeka Humira je 20 mg svaki drugi tjedan s metotreksatom.
English: Grey Cap 1 White Needle Sleeve White Arrow
Croatian: Humira napunjena brizgalica Siva kapica 1 Bijela navlaka za iglu Bijela strelica
English: Fever, bruising, bleeding or looking pale
Croatian: Vrućica, nastanak modrica, krvarenje ili bljedilo
English: If you have active tuberculosis, do not use Humira.
Croatian: Ako imate aktivnu tuberkulozu, nemojte primjenjivati lijek Humira.
English: • multiple sclerosis
Croatian: • multipla skleroza
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given (see section
Croatian: Ako bolesnik nakon primjene lijeka Humira razvije simptome koji upućuju na sindrom nalik lupusu i pozitivan je na protutijela usmjerena protiv dvolančane DNK, terapija lijekom Humira ne smije se nastaviti (vidjeti dio 4.8).
English: • Make sure the liquid is clear and colourless
Croatian: • Provjerite da li je otopina bistra i bezbojna
English: The decision to stop using Humira should be discussed with your doctor.
Croatian: Odluku o prekidu primjene lijeka Humira potrebno je raspraviti sa svojim liječnikom.
English: • Humira can be used during breast-feeding.
Croatian: • Humira se može primjenjivati tijekom dojenja.
English: 2) Choosing and preparing an injection site
Croatian: 2) Odabir i priprema mjesta za ubrizgavanje
English: NA NA 4.5% 23.2% RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks 40 mg Humira administered every other week MTX = methotrexate **p < 0.01, Humira versus placebo
Croatian: ND ND 4,5% 23,2% a Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon 24 tjedna i nakon 52 tjedna b 40 mg lijeka Humira primijenjenog svaki drugi tjedan c MTX = metotreksat **p<0,01, Humira u usporedbi s placebom
English: 5) Injecting Humira
Croatian: 5) Ubrizgavanje lijeka Humira
English: What the Humira pre-filled syringe with automatic needle guard looks like and contents of the pack
Croatian: Kako napunjena štrcaljka lijeka Humira s automatskim štitnikom za iglu izgleda i sadržaj pakiranja
English: Cap 2
Croatian: Kapica 2
English: • DO NOT set the syringe down at any time after the clear needle cap is off.
Croatian: • Ni u kojem trenutku NE odlažite štrcaljku nakon što je prozirna kapica skinuta.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA
English: Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Croatian: Ako liječenje treba privremeno prekinuti, Humira se kasnije može ponovno uvesti u dozi od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan (vidjeti dio 5.1).
English: You should not take Humira with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Croatian: Humira se ne smije primjenjivati s drugim lijekovima koji sadrže djelatne tvari anakinru ili abatacept zbog povećanog rizika od ozbiljne infekcije.
English: • Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the age of 2
Croatian: • Ne primjenjujte lijek Humira djeci s poliartikularnim juvenilnim idiopatskim artritisom mlađoj od 2 godine.
English: Psoriasis Study III (REACH) compared the efficacy and safety of Humira versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Croatian: U ispitivanju Psoriasis Study III (REACH) uspoređivale su se djelotvornost i sigurnost lijeka Humira u odnosu na placebo u 72 bolesnika s umjerenom do teškom kroničnom plak psorijazom i psorijazom šaka i/ili stopala.
English: In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
Croatian: U pivotalnim ispitivanjima, protutijela na adalimumab nađena su u 5,5% (58/1053) bolesnika koji su primali adalimumab u odnosu na 0,5% (2/370) bolesnika koji su primali placebo.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST NA SPREMNIKU
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year vs. 0.22 per patient year.
Croatian: Broj hospitalizacija zbog bilo kojeg uzroka u skupini liječenoj adalimumabom bio je 0,18 po bolesnik-godini u odnosu na 0,26 po bolesnik-godini u skupini koja je primala placebo, a odgovarajuće vrijednosti za hospitalizaciju povezanu s ulceroznim kolitisom bile su
English: Patients in rheumatoid arthritis studies I, II and III were tested at multiple time points for anti-adalimumab antibodies during the 6 to 12 month period.
Croatian: U bolesnika u ispitivanjima kod reumatoidnog artritisa I, II i III, između 6. i 12. mjeseca terapije u više vremenskih točaka vršene su pretrage kako bi se utvrdila prisutnost protutijela na adalimumab.
English: When Humira therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Croatian: Kad se uvodi liječenje lijekom Humira može se primijeniti udarna doza od 40 mg za bolesnike tjelesne težine < 30 kg ili 80 mg za bolesnike tjelesne težine ≥ 30 kg tjedan dana prije početka terapije održavanja.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Croatian: Nakon 52 i 104 tjedna liječenja, postotak bolesnika bez progresije bolesti (promjena početnog ukupnog zbroja bodova prema Sharpu ≤0,5) bio je značajno veći u skupini liječenoj kombinacijom lijeka Humira i metotreksata (63,8% odnosno 61,2%) u usporedbi sa skupinom koja je dobivala monoterapiju metotreksatom (37,4% odnosno 33,5%, p < 0,001) i monoterapiju lijekom Humira (50,7%, p < 0,002 odnosno 44,5%, p < 0,001).
English: • sensation of heart beating rapidly
Croatian: • osjećaj brzog kucanja srca
English: • Your doctor should test your child for HBV.
Croatian: • Liječnik treba provjeriti ima li Vaše dijete HBV.
English: If your child stops using Humira
Croatian: Ako Vaše dijete prestane uzimati lijek Humira
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where Humira was given for at least an additional 108 weeks.
Croatian: Bolesnici koji su sudjelovali u svim ispitivanjima faze II i III kod psorijaze ispunili su kriterije za uključivanje u otvoreni produžetak ispitivanja, gdje se Humira primjenjivala još najmanje dodatnih
English: A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Croatian: Jedna napunjena štrcaljka ili napunjena brizgalica lijeka Humira može se čuvati na temperaturama do maksimalno 25°C u trajanju do 14 dana.
English: 1 sterile injection syringe 1 sterile needle
Croatian: 1 sterilna štrcaljka za injekciju 1 sterilna igla
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Croatian: rezultata u svim ispitanim skupinama iznosila je 19,7, a početni PGA rezultat kretao se u rasponu od „blagog“ (< 1%), preko „umjerenog“ (48%) do „teškog“ (46%) i „vrlo teškog“ (6%).
English: Check the expiry (EXP) date.
Croatian: Provjerite rok valjanosti (Rok valjanosti, EXP).
English: Hold the grey body of the pre-filled pen with one hand.
Croatian: Jednom rukom držite sivo tijelo brizgalice.
English: Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici/blisteru/kutiji iza oznake „Rok valjanosti“ili „EXP“.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
Croatian: • Stevens-Johnsonov sindrom (rani simptomi uključuju malaksalost, vrućicu, glavobolju i osip)
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Croatian: koji je uključivao i distalne interfalangealne zglobove (tj. nije jednak TSS-u korištenom u ispitivanjima kod reumatoidnog artritisa).
English: Patients were randomised to receive a single dose of Humira 40 mg/0.8 ml or Humira 40 mg/0.4 ml, followed by a single injection of the opposite treatment at their next dose.
Croatian: Bolesnici su bili randomizirani za primanje jednokratne doze lijeka Humira od 40 mg/0,8 ml ili 40 mg/0,4 ml, nakon koje su pri sljedećoj primjeni primili jednu injekciju suprotne doze.
English: In people who carry HBV, Humira can cause the virus to become active again.
Croatian: U nositelja HBV-a, Humira može uzrokovati ponovno aktiviranje virusa.
English: • Do not remove the Grey or Plum-coloured Caps while allowing Humira to reach room temperature
Croatian: • Nemojte uklanjati sivu i bordo kapicu dok lijek Humira postiže sobnu temperaturu.
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Croatian: Potrebno je pažljivo ponovno razmotriti koristi i rizike nastavka liječenja lijekom u dozi od 40 mg jednom tjedno ili 80 mg svaki drugi tjedan u bolesnika u kojih nije postignut zadovoljavajući odgovor nakon povećanja doziranja (vidjeti dio 5.1).
English: RA studies VI and VII each evaluated 60 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Croatian: U ispitivanjima RA VI i VII ocjenjivano je po 60 bolesnika s umjereno teškim do teškim aktivnim reumatoidnim artritisom u dobi od ≥18 godina.
English: Week 4
Croatian: 4. tjedna
English: Contains 2 cartons each for a single injection only Each carton contains:
Croatian: Otopina za injekciju Sadrži 2 kutije, svaka je samo za jednokratnu injekciju
English: After treatment with Humira, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Croatian: Nakon liječenja lijekom Humira u bolesnika s reumatoidnim artritisom primijećeno je naglo snižavanje razina reaktanata akutne faze upale (C-reaktivni protein [CRP] i brzina sedimentacije eritrocita [SE]) i serumskih citokina (IL-6) u usporedbi s početnim vrijednostima.
English: Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Croatian: Smanjenje kožne boli uzrokovane gnojnim hidradenitisom ocjenjivalo se uz pomoć brojčane ocjenske ljestvice u bolesnika koji su pri uključivanju u ispitivanje imali početni rezultat od 3 ili više na ljestvici od
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Croatian: Među bolesnicima u kojih je nastupio gubitak primjerenog odgovora nakon ponovne randomizacije u skupinu koja je primala placebo, a koji su potom uključeni u otvoreni produžetak ispitivanja, odgovor PASI 75 ponovno je postignut u 38% (25/66) bolesnika nakon 12 tjedana terapije, odnosno u 55% (36/66) bolesnika nakon 24 tjedna terapije.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26.
Croatian: Primarna mjera ishoda ispitivanja RA I, II i III te sekundarna mjera ishoda ispitivanja RA IV bio je postotak bolesnika u kojih je postignut terapijski odgovor ACR 20 nakon 24 odnosno 26 tjedana liječenja.
English: • elevated liver enzymes
Croatian: • povišena razina jetrenih enzima
English: Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Croatian: Humira nije ispitivana u bolesnika s artritisom povezanim s entezitisom mlađih od 6 godina.
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Croatian: Nakon primjene doza od 0,5 mg/kg (~40 mg) klirens je bio u rasponu od 11 do 15 ml/sat, a volumen raspodjele (Vss) je iznosio od 5 do 6 litara.
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Croatian: 1 bočicu (0,8 ml sterilne otopine), 1 praznu sterilnu štrcaljku za injekciju, 1 iglu, 1 nastavak za bočicu i 2 jastučića natopljena alkoholom.
English: • Ulcerative colitis
Croatian: • ulceroznog kolitisa
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Croatian: Raspodjela bolesnika prema dobi te minimalnoj i maksimalnoj dozi i medijanu doze tijekom ove faze prikazan je u Tablici 11.
English: • If you are over 65 years you may be more susceptible to infections while taking Humira.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka
English: Number of patients at Baseline n (%)
Croatian: Početni broj bolesnika, n (%)
English: In patients with moderate to severe hidradenitis suppurativa, anti-adalimumab antibodies were identified in 10/99 subjects (10.1%) treated with adalimumab.
Croatian: U bolesnika s umjerenim do teškim gnojnim hidradenitisom, protutijela na adalimumab nađena su u 10/99 ispitanika (10,1%) liječenih adalimumabom.
English: • vertigo (feeling of dizziness or spinning)
Croatian: • vrtoglavica (osjećaj omaglice ili vrtnje)
English: Talk to your doctor or pharmacist before using Humira.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Humira.
English: • Keep pushing the pre-filled pen down firmly against the injection site until the injection is complete.
Croatian: • Nastavite čvrsto pritiskati napunjenu brizgalicu na mjestu ubrizgavanja dok ubrizgavanje nije završeno.
English: • When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.
Croatian: • Kada ste sigurni da ste pričvrstili nastavak za bočicu, maknite pakiranje s nastavka.
English: DO NOT rub the injection site.
Croatian: Mjesto ubrizgavanja ne trljajte.
English: Do not rub the injection site.
Croatian: Mjesto ubrizgavanja NE trljajte.
English: Erythema multiforme Stevens-Johnson syndrome angioedema cutaneous vasculitis lichenoid skin reaction
Croatian: ožiljci rijetko multiformni eritem1), Stevens-Johnsonov sindrom1), angioedem1), kutani vaskulitis1) lihenoidne kožne reakcije1)
English: Tel: +46 (0)8 684 44 600
Croatian: AbbVie AB Tel: +46 (0)8 684 44 600
English: • moderate to severe chronic plaque psoriasis in adults and
Croatian: • umjerene do teške kronične plak psorijaze u odraslih i
English: The combination of Humira and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirana terapija lijekom Humira i anakinrom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.
Croatian: Paediatric CD Study) nastavilo je sudjelovanje u otvorenom dugotrajnom produžetku ispitivanja.
English: Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Croatian: Humira je indicirana za liječenje neinfektivnog intermedijarnog, posteriornog i panuveitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na kortikosteroide, kojima je potrebna poštedna primjena kortikosteroida ili u kojih liječenje kortikosteroidima nije prikladno.
English: Among patients whose Humira treatment was withdrawn at Week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of Humira 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Croatian: Među bolesnicima kojima je liječenje lijekom Humira ukinuto u12. tjednu u ispitivanjima HS-I i HSII, stopa HiSCR-a zabilježena 12 tjedana nakon ponovnog uvođenja lijeka Humira u dozi od 40 mg svaki tjedan vratila se na razine slične onima prije prekida liječenja (56,0%).
English: Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.
Croatian: Artritis povezan s entezitisom je upalna bolest zglobova i područja na kojima se tetive spajaju na kost.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of Humira/MTX was administered every other week up to 10 years.
Croatian: Po završetku prva 52 tjedna, 457 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem su se Humira u dozi od 40 mg/MTX primjenjivali svaka dva tjedna do 10 godina.
English: The syringe or pen must be protected from light, and discarded if not used within the 14-day period.
Croatian: Štrcaljku ili brizgalicu mora se zaštiti od svjetlosti i zbrinuti ako se ne iskoristi unutar 14 dana.
English: The conduct and results of these tests should be recorded on your child's Patient Reminder Card.
Croatian: Provođenje i rezultati ovih pretraga moraju se zabilježiti na Kartici s podsjetnikom za bolesnika Vašeg djeteta.
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
Croatian: U ispitivanju Psoriasis Study I, u 28% bolesnika s odgovorom PASI 75 kojima je u 33. tjednu pri ponovnoj randomizaciji dodijeljen placebo, u usporedbi s 5% bolesnika koji su nastavili primjenjivati lijek Humira (p<0,001), uočen je „gubitak primjerenog odgovora“ (PASI rezultat nakon 33. tjedna te u 52. tjednu ili prije njega koji je rezultirao odgovorom < PASI 50 u odnosu na početak terapije, uz porast PASI rezultata za najmanje 6 bodova u odnosu na 33. tjedan).
English: Doses of 20 or 40 mg of Humira were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Croatian: Humira u dozi od 20 ili 40 mg primjenjivala se supkutanom injekcijom ili svaki drugi tjedan naizmjenično s placebom (jedan tjedan Humira, drugi tjedan placebo), ili svaki tjedan tijekom 26 tjedana; placebo se primjenjivao svaki tjedan tijekom istog razdoblja.
English: Reports of serious allergic reactions including anaphylaxis have been received following Humira administration.
Croatian: Ozbiljne alergijske reakcije, uključujući anafilaksiju, prijavljivane su nakon primjene lijeka Humira.
English: Puh/Tel: +358 (0)10 2411 200
Croatian: AbbVie Oy Puh/Tel: +358 (0)10 2411 200
English: What you need to know before you use Humira
Croatian: Što morate znati prije nego počnete primjenjivati lijek Humira
English: The highest frequency seen among the various indications has been included.
Croatian: Navedena je najviša primijećena kategorija učestalosti neovisno o indikaciji.
English: • With one hand, gently grasp the cleaned areas of skin and hold firmly
Croatian: • Jednom rukom nježno primite očišćene dijelove kože i čvrsto ih držite
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 7.
Croatian: Raspodjela bolesnika prema dobi te minimalnoj i maksimalnoj dozi i medijanu doze tijekom ove faze prikazan je u Tablici 7.