FrancophonIA/ELRC3.0 huggingface dataset:
English: Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Hefiya se može davati i kao monoterapija ako bolesnik ne podnosi metotreksat ili kada kontinuirana primjena metotreksata nije prikladna.
English: Dosing regimen
Croatian: Režim doziranja
English: If you forget to use Hefiya
Croatian: Ako ste zaboravili primijeniti lijek Hefiya
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Croatian: U bolesnika koji su postigli PASI 75 ili PGA rezultat 'bez bolesti' ili 'minimalno', liječenje je prekinuto tijekom razdoblja do najviše 36 tjedana te se pratio gubitak kontrole bolesti (tj. pogoršanje PGA
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Croatian: Primijećena stopa nemelanomskih tumora kože je približno 9,6 na 1000 bolesnik-godina, a limfoma 1,3 na 1000 bolesnik-godina.
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Croatian: Najčešće prijavljene nuspojave su infekcije (kao nazofaringitis, infekcija gornjih dišnih putova i sinusitis), reakcije na mjestu primjene (eritem, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
English: Your healthcare provider should show you how to prepare and inject Hefiya properly using the pre-filled pen before you use it for the first time.
Croatian: Vaš zdravstveni radnik treba Vam pokazati kako ispravno pripremiti i ubrizgati lijek Hefiya napunjenom brizgalicom prije prve uporabe.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Croatian: Merkelovih stanica su također prijavljeni u bolesnika liječenih antagonistima TNF-a, uključujući adalimumab (vidjeti dio 4.8).
English: Approximately 40 % of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Croatian: Oko 40% bolesnika u ispitivanju UC-II nije imalo uspjeha s prethodnim liječenjem antagonistom
English: For patients who stayed on their randomised therapy, the mean (± SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 µg / ml for the Standard Dose group and 3.5 ± 2.2 µg / ml for the Low Dose group.
Croatian: U bolesnika koji su nastavili terapiju na koju su randomizirani, srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u 52. tjednu bile su 9,5 ± 5,6 µg/ml za skupinu koja je primala standardnu dozu i 3,5 ± 2,2 µg/ml za skupinu koja je primala nisku dozu.
English: Based on the observed data approach, 222 (80.4 %) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Croatian: Prema pristupu utemeljenom na opaženim podacima, u 222 (80,4%) bolesnika bolest je bila u mirovanju (bez aktivnih upalnih lezija, stupanj prema broju stanica u prednjoj očnoj komori ≤ 0,5+, stupanj prema zamućenju staklovine ≤ 0,5+) uz istodobnu primjenu steroida u dozi od ≤ 7,5 mg na dan, dok je u njih 184 (66,7%) bolest bila u mirovanju bez primjene steroida.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Hefiya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Croatian: U bolesnika s neinfektivnim intermedijarnim uveitisom treba provesti neurološku procjenu prije početka liječenja lijekom Hefiya i redovito tijekom liječenja kako bi se utvrdili otprije postojeći ili novorazvijeni demijelinizirajući poremećaji središnjeg živčanog sustava.
English: • autoantibodies present in the blood;
Croatian: • pojava autoprotutijela u krvi,
English: Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Croatian: Ozbiljne alergijske reakcije, uključujući anafilaksu, prijavljivane su nakon primjene adalimumaba.
English: Your healthcare provider should show you how to prepare and inject Hefiya properly using the pre-filled syringe before you use it for the first time.
Croatian: Vaš zdravstveni radnik treba Vam pokazati kako ispravno pripremiti i ubrizgati lijek Hefiya napunjenom štrcaljkom prije prve uporabe.
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab.
Croatian: Među bolesnicima koji nisu imali uspjeha s prethodnim liječenjem antagonistima TNF-a remisiju je u 52. tjednu postiglo 3% u skupini koja je primala placebo i 10% u skupini koja je primala adalimumab.
English: Among those, 154 patients (90.6 %) had ACR 20 responses; 127 patients (74.7 %) had ACR 50 responses; and 102 patients (60.0 %) had ACR 70 responses.
Croatian: Među njima su 154 bolesnika (90,6%) imala odgovor ACR 20, 127 bolesnika (74,7%) odgovor ACR 50, a 102 bolesnika (60,0%) odgovor ACR 70.
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age
Croatian: Djeca i adolescenti s kroničnim nezaraznim uveitisom u dobi od 2 i više godina
English: * p < 0.05, *** p < 0.001, adalimumab versus placebo a among all randomised patients.
Croatian: * p < 0,05, *** p < 0,001, adalimumab naspram placeba a među svim randomiziranim bolesnicima.
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
Croatian: • stvaranje proširenja u stijenci velike arterije, upala vena i stvaranje ugruška, zatvaranje krvnih žila,
English: • Do not give Hefiya to children with paediatric Crohn's disease below the age of 6 years.
Croatian: • Nemojte davati Hefiya djeci s Chronovom bolesti mlađoj od 6 godina.
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi leukemije u bolesnika liječenih antagonistima TNF-a.
English: The active ingredient in Hefiya, adalimumab, is a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Hefiya, adalimumab, monoklonsko je protutijelo.
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 adalimumab, 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 nakon 33. tjedna pri ponovnoj randomizaciji dodijeljen placebo, u usporedbi s 5% bolesnika koji su nastavili uzimati adalimumab (p<0,001), uočen je „gubitak primjerenog odgovora“ (PASI rezultat nakon 33. i u ili prije 52. tjedna 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: For the safety and health of you and others, the pens must never be re-used.
Croatian: Radi zdravlja i sigurnosti kako Vas tako i drugih osoba, igle i korištene brizgalice ne smiju se nikada ponovno koristiti.
English: Hefiya is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Croatian: Hefiya se koristi i za liječenje teške plak psorijaze u djece i adolescenata u dobi od 4 do 17 godina u kojih lijekovi koji se primjenjuju na kožu i liječenje UV zračenjem nisu djelovali jako dobro ili nisu prikladne.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Croatian: Primarni ishod ispitivanja RA I, II i III te sekundarni ishod ispitivanja RA IV bio je postotak bolesnika u kojih je postignut terapijski odgovor ACR 20 nakon 24, odnosno 26 tjedana liječenja.
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Croatian: U eksploracijskom kliničkom ispitivanju primjene drugog antagonista TNF-a, infliksimaba, u bolesnika s umjerenom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB), prijavljen je veći broj zloćudnih bolesti, uglavnom na plućima ili glavi i vratu, u bolesnika liječenih infliksimabom nego u bolesnika u kontrolnoj skupini.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Hefiya therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Croatian: Ako imate reumatoidni artritis i ne dobivate metotreksat zajedno s lijekom Hefiya, Vaš liječnik može odlučiti dati Vam 40 mg adalimumaba svaki tjedan ili 80 mg svaki drugi tjedan.
English: Patients were then re-treated with adalimumab 0.8 mg / kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Croatian: Bolesnici su zatim ponovno započeli liječenje adalimumabom u dozi od 0,8 mg/kg svaki drugi tjedan tijekom dodatnih 16 tjedana, a stope odgovora primijećene tijekom ponovnog liječenja bile su slične onima prethodno zabilježenima tijekom razdoblja dvostruko slijepog liječenja: odgovor PASI 75 postiglo je 78,9% (15 od 19 ispitanika), a PGA rezultat 'bez bolesti' ili 'minimalno' njih 52,6% (10 od 19 ispitanika).
English: Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Croatian: Hefiya je indiciran za liječenje umjerene do teške kronične plak psorijaze u odraslih bolesnika koji su kandidati za sistemsko liječenje.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Croatian: U otvorenoj uvodnoj fazi ispitivanja bolesnici su podijeljeni u dvije skupine, jedna koja je uzimala metotreksat (označena s MTX) i ona koja nije (označena s ne
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Hefiya.
Croatian: Obavijestite liječnika ako istodobno uz lijek Hefiya uzimate azatioprin ili merkaptopurin.
English: Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Croatian: karcinom Merkelovih stanica (neuroendokrini karcinom kože)1)
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: Srednja početna vrijednost PASI rezultata u svih ispitanih skupina 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: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and / or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, reakcije na mjestu primjene (eritem i/ili svrbež, krvarenje, bol ili oticanje) pojavile su se u 12,9% bolesnika liječenih adalimumabom u usporedbi sa 7,2% bolesnika koji su dobivali placebo ili aktivni kontrolni lijek.
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Croatian: Sve p-vrijednosti odnose se na sparene usporedbe udjela uz adalimumab naspram placeba * p < 0,001 ** p < 0,01
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 adalimumab / methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab 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 ukupnog zbroja bodova prema Sharpu ≤0,5) bio je značajno veći u skupini liječenoj kombinacijom adalimumaba i metotreksata (63,8% odnosno 61,2%) u usporedbi sa skupinom koja je dobivala monoterapiju metotreksatom (37% odnosno 33,5%, p < 0,001) i monoterapiju adalimumabom (50,7%, p < 0,002 odnosno 44,5%, p < 0,001).
English: Check the green indicator fills the window (see Figure J):
Croatian: Provjerite je li zeleni indikator ispunio prozorčić (vidjeti Sliku J): • To znači da je lijek ubrizgan.
English: Figure A: Hefiya pre-filled syringe with needle guard and add-on finger flange
Croatian: Slika A: Napunjena štrcaljka lijeka Hefiya sa štitnikom za iglu i dodanim hvatištem za prste
English: MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX
Croatian: MTX = metotreksat b p=0,027, adalimumab 0,8 mg/kg naspram MTX-a c p=0,083, adalimumab 0,8 mg/kg naspram MTX-a
English: Adults with Crohn's disease
Croatian: Odrasli s Crohnovom bolešću
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hefiya.
Croatian: Ako je moguće, preporučuje se da djeca prime sva predviđena cjepiva za njihovu dob prije početka liječenja lijekom Hefiya.
English: Do not remove the cap until you are ready to inject.
Croatian: Ne skidajte zatvarač dok niste spremni za primjenu injekcije.
English: Maintenance of remission and response rates are presented in table 24.
Croatian: Održavanje remisije i stope kliničkog odgovora nalaze se u tablici 24.
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Croatian: Djelotvornost adalimumaba ocjenjivala se u randomiziranom, dvostruko slijepom, kontroliranom ispitivanju provedenom u 114 pedijatrijskih bolesnika u dobi od 4 ili više godina s teškom kroničnom plak psorijazom (koja se definirala kao PGA rezultat od ≥ 4 ili zahvaćenost površine tijela od > 20% ili zahvaćenost površine tijela od > 10% s vrlo debelim lezijama ili PASI rezultat od ≥ 20 ili ≥ 10 uz klinički značajnu zahvaćenost lica, genitalija ili šaka/stopala) u kojih bolest nije bila dovoljno dobro kontrolirana topikalnom terapijom i helioterapijom ili fototerapijom.
English: Table 20 paediatric plaque psoriasis efficacy results at 16 weeks
Croatian: Tablica 20 Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Croatian: Dva tjedna kasnije (29. dan) liječenje se nastavlja dozom od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Croatian: To su bili pretežito nazofaringitis, infekcija gornjeg dišnog sustava i sinusitisa.
English: N (%)
Croatian: N neuspjeh N (%)
English: The patients improved following discontinuation of therapy.
Croatian: Ti su se bolesnici oporavili nakon prekida liječenja.
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja antagonista TNF-a zabilježeno je više slučajeva zloćudnih bolesti, uključujući i limfome, u bolesnika liječenih antagonistima TNF-a nego u kontrolnoj skupini.
English: • Look at the expiration date (EXP) on your pen.
Croatian: • Provjerite rok valjanosti (EXP) na brizgalici.
English: Axial spondyloarthritis
Croatian: Aksijalni spondiloartritis
English: Before your injection
Croatian: Prije primjene injekcije
English: It is recommended that you use an antiseptic wash daily on the affected areas.
Croatian: Preporučuje se da zahvaćena područja svakodnevno ispirete antiseptičkom tekućinom.
English: 506 (62.2)b a percent of patients achieving PASI75 response was calculated as centreadjusted rate b p<0.001, adalimumab vs. placebo
Croatian: 506 (62,2)b a postotak bolesnika s rezultatom PASI 75 izražen kao stopa prilagođena istraživačkom centru b p<0,001, adalimumab naspram placeba
English: Hefiya dose for patients with polyarticular juvenile idiopathic arthritis
Croatian: Doza lijeka Hefiya za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Croatian: Bolesnici koji su neprekidno primali adalimumab su do 68. tjedna pokazali statistički značajno veće poboljšanje znakova i simptoma aktivnog nr-axSpA u usporedbi s bolesnicima kojima je terapija ukinuta tijekom dvostruko slijepog razdoblja ispitivanja (Tablica 15).
English: • do not open the outer box until you are ready to use the pen.
Croatian: • ne otvarate vanjsku kutiju dok niste spremni za korištenje brizgalice.
English: • adults with non-infectious uveitis with inflammation affecting the back of the eye.
Croatian: • odraslih osoba s nezaraznim uveitisom kod kojega upala zahvaća stražnji dio oka
English: • leukaemia (cancer affecting the blood and bone marrow);
Croatian: • leukemija (rak koji zahvaća krv i koštanu srž),
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab-treated patients.
Croatian: Endoskopska ispitivanja intestinalne mukoze pokazala su znakove zacjeljivanja sluznice u bolesnika liječenih adalimumabom.
English: If these medicines do not work well enough, you will be given Hefiya.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, bit će Vam propisan lijek Hefiya.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and / or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Croatian: Sigurnost i djelotvornost adalimumaba također se ispitivala u odraslih bolesnika s umjerenom do teškom kroničnom plak psorijazom i istodobnom psorijazom šaka i/ili stopala koji su bili kandidati za sistemsku terapiju u randomiziranom, dvostruko slijepom ispitivanju (Psoriasis Study III).
English: Physicians should exercise caution when considering the use of Hefiya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Croatian: Liječnici trebaju oprezno razmotriti liječenje lijekom Hefiya u bolesnika s ponavljajućim infekcijama u anamnezi ili podležećim stanjima koja pogoduju razvoju infekcija u bolesnika, uključujući istodobnu primjenu imunosupresivnih lijekova.
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated non-infectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u randomiziranom, dvostruko maskiranom, kontroliranom ispitivanju provedenom u 90 pedijatrijskih bolesnika u dobi od 2 do < 18 godina koji su imali aktivan neinfektivni anteriorni uveitis povezan s JIA i koji su bili refraktorni na najmanje 12 tjedana liječenja metotreksatom.
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Croatian: U ispitivanju nr-axSpA I ocjenjivali su se bolesnici koji su imali aktivan nr-axSpA.
English: Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Croatian: Psorijatični artritis je upalna bolest zglobova povezana sa psorijazom.
English: • diverticulitis (inflammation and infection of the large intestine);
Croatian: • divertikulitis (upala i infekcija debelog crijeva),
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6 % (5 / 192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Croatian: U ispitivanju faze III adalimumaba u pedijatrijskih bolesnika s Chronovom bolešću, koje je ocijenilo djelotvornost i sigurnost dvaju režima terapije održavanja dozom prilagođenom tjelesnoj težini nakon indukcijske terapije prilagođene tjelesnoj težini do 52 tjedna liječenja, povišenje ALT-a ≥ 3 x GGN javilo se u 2,6% (5/192) bolesnika, od kojih je njih četvero na početku liječenja bilo izloženo istodobnoj terapiji imunosupresivima.
English: • Do not freeze the syringes.
Croatian: • Ne zamrzavati štrcaljke.
English: The following side effects have been observed with adalimumab:
Croatian: Dolje opisane nuspojave uočene su pri primjeni adalimumaba:
English: RA Study IIa**
Croatian: Ispitivanje RA IIa**
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, stopa infekcija bila je 1,51 po bolesnikgodini u bolesnika liječenih adalimumabom, odnosno 1,46 po bolesnik-godini u bolesnika koji su primali placebo ili aktivni kontrolni lijek.
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Croatian: Rezultati većeg ispitivanja (AS I), u kojem je sudjelovalo 315 bolesnika, pokazali su statistički značajno poboljšanje znakova i simptoma ankilozantnog spondilitisa u bolesnika koji su primali adalimumab u odnosu na bolesnike koji su primali placebo.
English: In these trials, 11.9 % of patients treated with adalimumab and 8.1 % of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Croatian: U tim ispitivanjima, u 11,9% bolesnika liječenih adalimumabom i 8,1% bolesnika koji su primali placebo i aktivni kontrolni lijek i koji su prije početka liječenja imali negativan titar antinuklearnih protutijela zabilježen je pozitivan titar nakon 24 tjedna primjene lijeka.
English: • Carefully pull the needle cap straight off to remove it from the syringe (see Figure G).
Croatian: • Pažljivo povucite zatvarač s igle da biste ga skinuli sa štrcaljke (vidjeti Sliku G).
English: 20, 25 and 40 mg
Croatian: 20, 25 i 40 mg
English: • increased uric acid in the blood;
Croatian: • povećana razina mokraćne kiseline u krvi,
English: Asthma, dyspnoea, cough
Croatian: Astma, dispneja, kašalj