FrancophonIA/ELRC3.0 huggingface dataset:
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: It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Imraldi.
Croatian: Ako je moguće, preporučuje se da djeca obave sva cijepljenja prema kalendaru cjepljenja za njihovu dob prije započinjanja liječenja lijekom Imraldi.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Imraldi therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Croatian: U bolesnika s neinfektivnim intermedijarnim uveitisom treba provesti neurološku procjenu prije početka liječenja lijekom Imraldi i redovito tijekom liječenja kako bi se utvrdili otprije postojeći ili novorazvijeni demijelinizirajući poremećaji središnjeg živčanog sustava.
English: Table 12 Paed ACR 30 Responses in the JIA study
Croatian: Tablica 12 Pedijatrijski odgovori ACR 30 u ispitivanju kod JIA
English: confidence interval)
Croatian: (95 % interval pouzdanosti)
English: Note: P = Placebo (Number at Risk); H = Adalimumab (Number at Risk).
Croatian: Napomena: P = Placebo (broj bolesnika pod rizikom); H = Adalimumab (broj bolesnika pod rizikom).
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Croatian: Ako bolujete od ankilozantnog spondilitisa ili aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa, prvo će Vam biti propisani drugi lijekovi.
English: You should not take Imraldi with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Croatian: Imraldi se ne smije primjenjivati s lijekovima koji sadrže djelatne tvari anakinru ili abatacept zbog povećanog rizika od ozbiljne infekcije.
English: - If you have moderate or severe heart failure.
Croatian: - Ako bolujete od umjerenog ili teškog zatajenja srca.
English: Very common Leukopenia (including neutropenia and agranulocytosis), anaemia
Croatian: vrlo često leukopenija (uključujući neutropeniju i agranulocitozu),
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
Croatian: Prilagođen OR (kod kojega su uzete u obzir početne razlike) iznosio je 1,10 (95% CI: 0,45 - 2,73) za reumatoidni artritis i Crohnovu bolest zajedno.
English: • autoantibodies present in the blood;
Croatian: • pojava autoprotutijela u krvi;
English: DO NOT touch the tip of the syringe.
Croatian: NE dirajte vrh štrcaljke.
English: • Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe out of the package.
Croatian: • Otvorite prozirno pakiranje tek toliko da bijeli klip štrcaljke bude dostupan, ali ne vadite štrcaljku iz pakiranja.
English: Biogen Finland Oy Puh/Tel: + 358 (0)9 427 041 08
Croatian: Suomi/Finland Biogen Finland Oy Puh/Tel: + 358 (0)9 427 041 08
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Imraldi and contact your doctor immediately since, in rare cases, these reactions can be life-threatening.
Croatian: • Dobijete li alergijske reakcije sa simptomima poput stezanja u prsnom košu, piskanja pri disanju, omaglice, oticanja ili osipa, nemojte više ubrizgavati lijek Imraldi i odmah se javite liječniku, jer te reakcije u rijetkim slučajevima mogu biti opasne po život.
English: Thirty-three (18 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79 %) patients with NSAIDs at baseline.
Croatian: Na početku je 33 bolesnika (18 %) istodobno bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 146 (79 %) NSAIL-ovima.
English: • fatty liver (build up of fat in liver cells);
Croatian: • masna jetra (nakupljanje masti u stanicama jetre);
English: • high blood measurements for lactate dehydrogenase;
Croatian: • visoka razina laktat dehidrogenaze u krvi;
English: • If you have mild heart failure and you are being treated with Imraldi, your heart failure status must be closely monitored by your doctor.
Croatian: • Bolujete li od blagog zatajenja srca, a liječite se lijekom Imraldi, Vaš liječnik mora pomno nadzirati Vaš status zatajenja srca.
English: Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Croatian: U ispitivanje su mogli biti uključeni bolesnici koji prethodno nisu bili liječeni antireumatskim lijekovima koji modificiraju tijek bolesti i oni koji su već dobivali antireumatsku terapiju, pod uvjetom da je ta terapija bila stabilna najmanje 28 dana.
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis, malignancies, other than lymphoma and nonmelanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Croatian: U kontroliranim dijelovima pivotalnih ispitivanja terapije adalimumabom koja su trajala barem 12 tjedana u odraslih bolesnika s umjerenim do teškim aktivnim reumatoidnim artritisom, ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, psorijatičnim artritisom, psorijazom, Crohnovom bolešću, ulceroznim kolitisom i uveitisom, primijećene su zloćudne bolesti, isključujući limfome i nemelanomski rak kože, u stopi od 6,8 (4,4; 10,5) na 1000 bolesnik-godina (interval pouzdanosti 95 %) u 5291 bolesnika liječenog adalimumabom, naspram 6,3 (3,4; 11,8) na 1000 bolesnik-godina u 3444 bolesnika iz kontrolne skupine (medijan trajanja terapije bio je 4,0 mjeseci u bolesnika liječenih adalimumabom i 3,8 mjeseci u kontrolnoj skupini bolesnika).
English: Imraldi 40 mg solution for injection in pre-filled syringe EU/1/17/1216/001
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj štrcaljki EU/1/17/1216/001
English: HS study II
Croatian: Ispitivanje HS II
English: • erythema multiforme (inflammatory skin rash);
Croatian: • multiformni eritem (upalni kožni osip);
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92/349) and 37.8 % (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Croatian: U otvorenom produžetku ispitivanja, među bolesnicima čija je doza zbog PASI odgovora manjeg od 50 % povećana s 40 mg svaka dva tjedna na 40 mg svaki tjedan, odgovor PASI 75 postignut je u 12. tjednu u 26,4 % (92/349) bolesnika i u 24. tjednu u 37,8 % (132/349) bolesnika.
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: Never reuse a syringe.
Croatian: Nikada nemojte ponovno koristiti istu štrcaljku.
English: One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Croatian: Jedno pakiranje sadrži dvije kutije, a svaka sadrži 1 bočicu, 1 praznu sterilnu štrcaljku, 1 iglu, 1 nastavak za bočicu i 2 alkoholna tupfera.
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: 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: 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: • blood in urine;
Croatian: • krv u mokraći;
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7 % and 59.0 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Croatian: Stopa odgovora PASI 75 i PGA rezultata “bez bolesti” i “minimalno” je u tih bolesnika iznosila 74,7 %, odnosno 59,0 % nakon dodatnih 108 tjedana otvorene terapije (ukupno 160 tjedana).
English: • sensation disorders such as tingling, prickling or numbness;
Croatian: • poremećaj osjeta kao što su trnci, bockanje ili utrnulost;
English: There are no clinical trials with adalimumab in adolescent patients with HS.
Croatian: Nisu provedena klinička ispitivanja adalimumaba u adolescentnih bolesnika s gnojnim hidradenitisom.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).
Croatian: Adalimumab je značajno odgodio vrijeme do neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 3, P < 0,0001 iz log-rang testa).
English: When Imraldi 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 Imraldi 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: The safety and efficacy of adalimumab 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 3month trial of systemic antibiotic therapy.
Croatian: Sigurnost i djelotvornost adalimumaba 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: • rheumatoid arthritis,
Croatian: • reumatoidnog artritisa,
English: Imraldi is contraindicated in moderate to severe heart failure (see section 4.3).
Croatian: Primjena lijeka Imraldi je kontraindicirana u bolesnika s umjerenim do teškim zatajenjem srca (vidjeti dio 4.3).
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 21.
Croatian: Stope prestanka uzimanja kortikosteroida ili imunomodulatora prikazane su u Tablici 21.
English: At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 <2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4 % of patients receiving adalimumab monotherapy.
Croatian: Nakon 52 tjedna liječenja, klinička remisija postignuta je u 42,9 % bolesnika liječenih kombinacijom adalimumaba i metotreksata (DAS28 < 2,6) u usporedbi s 20,6 % bolesnika koji su dobivali monoterapiju metotreksatom, odnosno 23,4 % bolesnika koji su dobivali monoterapiju adalimumabom.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX- treated.
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 neMTX).
English: PGA: Clear/minimal a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Croatian: PGA: bez bolesti/minimalno a, b a p < 0,001 adalimumab naspram placeba b p < 0,001 adalimumab naspram metotreksata c p < 0,01 adalimumab naspram placeba d p < 0,05 adalimumab naspram metotreksata
English: - Your doctor will also give you a Patient Reminder Card,which contains important safety information that you need to be aware of before you are given Imraldi and during treatment with Imraldi.
Croatian: Liječnik će Vam dati i karticu s podsjetnikom za bolesnika koja sadrži važne sigurnosne informacije s kojima morate biti upoznati prije i za vrijeme liječenja lijekom Imraldi.
English: Imraldi 40 mg solution for injection in pre-filled pen EU/1/17/1216/005
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj brizgalici EU/1/17/1216/005
English: The combination of Imraldi and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirana terapija lijekom Imraldi i abataceptom se ne preporučuje (vidjeti dio 4.4 “ Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).
Croatian: Adalimumab je značajno odgodio vrijeme do neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 1, P < 0,0001 iz log-rang testa).
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 27.
Croatian: Stope prestanka uzimanja kortikosteroida ili imunomodulatora prikazane su u Tablici 27.
English: Also this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Croatian: Također lijek sadrži manje od 1 mmola natrija (23 mg) po dozi od 0,8 ml, tj. sadrži zanemarivu količinu natrija.
English: • injection site reactions (including pain, swelling, redness or itching);
Croatian: • reakcije na mjestu ubrizgavanja (uključujući bol, oticanje, crvenilo ili svrbež);
English: • Use each pen only once.
Croatian: • Svaku brizgalicu upotrijebite samo jedanput.
English: Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Croatian: Imraldi 40 mg otopina za injekciju u bočici za jednokratnu primjenu (staklo tipa I), s gumenim čepom, aluminijskim zatvaračem i „flip-off“ poklopcem.
English: Imraldi is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Croatian: Imraldi je namijenjen liječenju Crohnove bolesti u odraslih i djece u dobi od 6 do 17 godina.
English: The syringe inside the pen is made from type I glass with a stainless steel needle, a rigid needle shield, a rubber plunger (bromobutyl).
Croatian: Štrcaljka unutar brizgalice načinjena je od stakla tipa I, s iglom od nehrđajućeg čelika s rigidnim štitnikom za iglu i gumenim klipom (bromobutil).
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 17).
English: Percent Change in Total Fingernail NAPSI (%)
Croatian: Postotna promjena ukupnog NAPSI rezultata za psorijazu noktiju na rukama (%)
English: • DO NOT try to put the clear needle cap back on the needle.
Croatian: • NE pokušavajte ponovno staviti prozirnu kapicu na iglu.
English: • Do not use a damaged pen.
Croatian: • Oštećene brizgalice nemojte koristiti.
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: Among patients who were not in response at week 4, 43 % of adalimumab maintenance patients responded by week 12 compared to 30 % of placebo maintenance patients.
Croatian: Među bolesnicima koji u 4. tjednu nisu imali klinički odgovor, 43 % bolesnika koji su primali dozu održavanja adalimumaba imalo je klinički odgovor do 12. tjedna u odnosu na 30 % u skupini bolesnika koji su uzimali placebo kao terapiju održavanja.
English: Imraldi is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Croatian: Imraldi je namijenjen liječenju poliartikularnog juvenilnog idiopatskog artritisa i artritisa povezanog s entezitisom.
English: • Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the syringe as indicated by the arrow in the picture until firm.
Croatian: • Držeći štrcaljku uspravnom, umetnite vrh štrcaljke u žuti spoj za štrcaljku te zakrenite štrcaljku kako pokazuje strelica na donjoj slici, sve dok ne bude čvrsto.
English: Imraldi can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Croatian: Imraldi može usporiti oštećivanje hrskavičnih i koštanih zglobnih struktura uzrokovanih bolešću i poboljšati fizičku funkciju.
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Croatian: Slika 1: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do egzacerbacije u ispitivanju nr-axSpA II
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child.
Croatian: Ako Vaše dijete boluje od KOPB-a , provjerite kod liječnika je li terapija blokatorom TNFα primjerena za Vaše dijete.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Imraldi.
Croatian: Bolesnike treba upozoriti da se odmah obrate liječniku ako se za vrijeme liječenja lijekom Imraldi pojave znakovi i simptomi koji upućuju na krvne diskrazije (npr. stalna vrućica, stvaranje (nastanak) modrica, krvarenje, bljedilo).
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 21).
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Croatian: U analizi u kojoj su se svi bolesnici koji su izašli iz ispitivanja zbog štetnih događaja ili nedostatka djelotvornosti ili kojima je doza povećavana smatrali bolesnicima bez odgovora na terapiju, stopa odgovora PASI 75 i PGA rezultata“bez bolesti” ili “minimalno” nakon dodatnih 108 tjedana otvorene terapije (ukupno 160 tjedana) iznosila je 69,6 %, odnosno
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Croatian: Bolesnicima koji su primili adalimumab kvaliteta života se u 12. tjednu znatno popravila i održala do 24. tjedna prema upitniku SF 36 i upitniku za ocjenu kvalitete života kod ankilozantnog spondilitisa
English: Imraldi is injected under the skin (subcutaneous use).
Croatian: Imraldi se ubrizgava pod kožu (supkutana primjena).
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumab-treated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Croatian: Stopa trudnoća koje su završile najmanje jednim živorođenim djetetom s velikom urođenom manom iznosila je 6/69 (8,7%) među ženama liječenima adalimumabom koje su imale reumatoidni artritis i 5/74 (6,8%) među ženama s reumatoidnim artritisom koje nisu primale liječenje (neprilagođen OR: 1,31; 95% CI: 0,38 - 4,52) te 16/152 (10,5%) među ženama liječenima adalimumabom koje su imale Crohnovu bolest i 3/32 (9,4%) među ženama s Crohnovom bolešću koje nisu primale liječenje (neprilagođen OR: 1,14; 95% CI: 0,31 - 4,16).
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (Creactive 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 adalimumabom 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: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥40 kg (160/80 mg) and 10.6±6.1 µg/ml for patients <40 kg (80/40 mg).
Croatian: Srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u serumu u 4. tjednu bile su 15,7 ± 6,6 µg/ml u bolesnika tjelesne težine ≥ 40 kg (160/80 mg) i 10,6 ± 6,1 µg/ml u bolesnika tjelesne težine < 40 kg (80/40 mg).
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/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 adalimumab u dozi od 40 mg/MTX primjenjivali svaka dva tjedna do 10 godina.
English: Imraldi 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: Imraldi je indiciran 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: Asthma, dyspnoea, cough
Croatian: često astma, dispneja, kašalj