FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age Children and adolescents from 2 years of age weighing less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Croatian: Djeca i adolescenti s kroničnim nezaraznim uveitisom u dobi od 2 i više godina Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine manje od 30 kg Cyltezo je dostupan samo u obliku napunjene štrcaljke i napunjene brizgalice od 40 mg.
English: Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Croatian: Tablica 17: Ispitivanje Ps I (REVEAL) - Rezultati djelotvornosti nakon 16 tjedana Placebo N = 398 n (%)
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions
Croatian: Klinički odgovor je postignut ako je ostvareno smanjenje Mayo rezultata u odnosu na početne vrijednosti od ≥ 3 boda i ≥ 30%, uz smanjenje podrezultata rektalnog krvarenja [engl. rectal bleeding subscore, RBS] od ≥ 1 ili apsolutni RBS od 0 ili
English: Your doctor will decide if you should
Croatian: OD LIJEKA, AKO JE POTREBNO
English: Preclinical data on postnatal toxicity of adalimumab are not available (see
Croatian: Nisu dostupni pretklinički podaci o postnatalnoj toksičnosti
English: The recommended dose of Cyltezo for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: Uobičajena doza u odraslih osoba oboljelih od reumatoidnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez radiološkog dokaza AS-a te u bolesnika sa psorijatičnim artritisom iznosi 40 mg adalimumaba, a primjenjuje se kao pojedinačna doza svaki drugi tjedan.
English: Name and address of the manufacturer(s) responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim International GmbH
English: Package leaflet: Information for the patient Cyltezo 40 mg solution for injection in pre-filled syringe Adalimumab
Croatian: Uputa o lijeku: Informacije za bolesnika Cyltezo 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: No dose recommendations can be made.
Croatian: Nije potrebno prilagođavati dozu.
English: 40 mg every week or 80 mg every other week
Croatian: 10 mg svaki drugi tjedan 20 mg svaki drugi tjedan 20 mg svaki drugi tjedan 40 mg svaki drugi tjedan
English: • haematoma (a solid sweling with clotted blood);
Croatian: • modrice (tvrda oteklina sa zgrušanom krvi),
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of
Croatian: • Ako ste ranije bolovali od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: Leukocytosis, thrombocytopenia
Croatian: leukemija hepatosplenični T-stanični limfom
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Croatian: Bath Ankylosing Spondilitis Disease Activity Index, BASDAI)] bila je 6,4 u skupini bolesnika koji su primali adalimumab i 6,5 u skupini koja je primala placebo) koji nisu imali zadovoljavajući odgovor na ≥ 1 NSAIL-a ili ga nisu podnosili ili su imali kontraindikaciju za primjenu NSAIL-a.
English: Package leaflet: Information for the patient Cyltezo 40 mg solution for injection in pre-filled pen Adalimumab
Croatian: Uputa o lijeku: Informacije za bolesnika Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: The usual Cyltezo dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (as two 40 mg injections in one day) at week 2 and thereafter 40 mg every other week.
Croatian: Uobičajena doza lijeka Cyltezo za odrasle bolesnike s ulceroznim kolitisom je 160 mg (4 injekcije od 40 mg u jednom danu ili 2 injekcije od 40 mg u dva uzastopna dana) u nultnom tjednu i 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) u drugom tjednu te potom 40 mg svaki drugi tjedan.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži učinak, liječnik Vam može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan u dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Croatian: U ispitivanju UC-I, 390 bolesnika koji nikad nisu primali liječenje antagonistima TNF-a randomizirani su tako da primaju ili placebo u nultom tjednu i u drugom tjednu, adalimumab u dozi od 160 mg u nultom tjednu i 80 mg u drugom tjednu ili adalimumab u dozi 80 mg u nultom tjednu i 40 mg u drugom tjednu.
English: Vertigo and visual impairment may occur following administration of Cyltezo (see section 4.8).
Croatian: Nakon primjene lijeka Cyltezo mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 4 godine za ovu indikaciju.
English: • dyspepsia (indigestion, bloating, heart burn);
Croatian: • dispepsija (loša probava, nadutost, žgaravica),
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period.
Croatian: Tijekom razdoblja indukcije u bolesnika s ulceroznim kolitisom, nakon udarne doze od 160 mg adalimumaba u nultom tjednu i zatim 80 mg u drugom tjednu postignute su najniže serumske koncentracije adalimumaba od oko 12 μg/ml.
English: Cyltezo 40 mg solution for injection in pre-filled syringe
Croatian: Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici
English: 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Croatian: Placebo/MTXAdalimumab/MTX (95% interval pouzdanosti p-vrijednost razlike između metotreksata i adalimumaba s obzirom na promjene ukupnog zbroja bodova na razini intervala suženje zglobnih prostora (eng.
English: Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement
Croatian: U slučaju da niti nakon 12 tjedana nema poboljšanja, potrebno je pomno razmotriti nastavak liječenja takvog bolesnika.
English: • sensation of heart beating irregularly such as skipped beats; • heart problems that can cause shortness of breath or ankle swelling;
Croatian: • osjećaj da srce kuca nepravilno, primjerice, preskakanje otkucaja,
English: The recommended dose of Cyltezo for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Croatian: Preporučena doza lijeka Cyltezo za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 5).
English: In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Croatian: U 4. tjednu ispitivanja CD I i CD II, u bolesnika koji su randomizirani za primanje adalimumaba u dozi od 80/40 mg i adalimumaba u dozi od 160/80 mg došlo je do statistički značajnog poboljšanja ukupnog rezultata prema upitniku o upalnoj bolesti crijeva (engl.
English: There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 6 godina za ovu indikaciju.
English: The recommended Cyltezo dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Croatian: Preporučen režim doziranja lijeka Cyltezo za odrasle bolesnike s gnojnim hidradenitisom je početna doza od 160 mg prvoga dana (primijenjena u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon koje slijedi doza od 80 mg dva tjedna kasnije, 15. dana (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: Your symptoms may return upon
Croatian: Simptomi se mogu vratiti nakon prestanka liječenja.
English: Cyltezo may have a minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Lijek Cyltezo može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Croatian: U dva dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja, tijekom 24 tjedna ispitivano je djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna u 393 bolesnika s aktivnim ankilozantnim spondilitisom (srednja početna vrijednost aktivnosti bolesti [engl.
English: Distribution of patients by age and adalimumab dose received during the OL LI phase
Croatian: Tablica 11: Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Cyltezo 40 mg solution for injection in pre-filled syringe Each 0.8 mL single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: The recommended dose of Cyltezo for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Preporučena doza lijeka Cyltezo u odraslih bolesnika s uveitisom je početna doza od 80 mg, nakon koje slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: In the OL LI phase all patients received 24 mg/m² up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Croatian: 2 adalimumaba do maksimalne doze od 40 mg adalimumaba, svaki drugi tjedan tijekom 16 tjedana.
English: Cyltezo can also be used to treat severe, active and progressive rheumatoid arthritis without previous
Croatian: U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, Cyltezo se može primijeniti i bez prethodnog liječenja metotreksatom.
English: There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u bolesnika mlađih od 2 godine za ovu indikaciju.
English: • impotence;
Croatian: • migrena,
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Croatian: U slučaju postojanja potrebe za bržim odgovorom na liječenje, ono se može početi dozom od 160 mg u nultom tjednu (primijenjenom u obliku četiri injekcije od 40 mg u jednom danu ili u obliku dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjenom u obliku dvije injekcije od 40 mg u jednom danu), uz napomenu da je rizik od razvoja nuspojava veći prilikom
English: Cyltezo therapy should not be continued in patients failing to respond within this time period.
Croatian: U bolesnika u kojih u ovom razdoblju ne bude odgovora, liječenje lijekom Cyltezo ne treba nastaviti.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) :
English: A 40 mg pre-filled syringe/pre-filled pen is available for patients to administer a full 40 mg dose.
Croatian: Za primjenu pune doze od 40 mg dostupna je napunjena štrcaljka/napunjena brizgalica od 40 mg.
English: Patient weight Low dose
Croatian: Tjelesna težina bolesnika
English: NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen
Croatian: Cyltezo 40 mg otopina za injekciju u napunjenoj štrcaljki Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Croatian: , aritmija, kongestivno zatajenje srca zastoj srca hipertenzija, navale crvenila, hematomi manje često aneurizma aorte, okluzije arterijskih žila, tromboflebitis
English: The Cyltezo pre-filled syringe is a single-use syringe that delivers a pre-set dose of medication.
Croatian: Napunjena štrcaljka lijeka Cyltezo Napunjena štrcaljka lijeka Cyltezo je štrcaljka za jednokratnu primjenu koja oslobađa gotovu dozu
English: The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Croatian: Druga je dobivala 20 mg adalimumaba svaki tjedan tijekom 52 tjedna, dok je treća skupina svaki drugi tjedan naizmjenično dobivala 40 mg adalimumaba ili injekcije placeba.
English: Of 207 patients who were randomised to adalimumab 40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for 5 years.
Croatian: Kroz 5 godina, liječenje adalimumabom u dozi od 40 mg svaka dva tjedna nastavilo je 114 od 207 bolesnika koji su bili randomizirani u skupinu koja je primala adalimumab u dozi od 40 mg svaki drugi tjedan.
English: • 1 pre-filled syringe (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
Croatian: • 1 napunjena brizgalica (0,8 ml sterilne otopine) u blisteru, s 2 jastučića natopljena alkoholom.
English: Beyond 16 weeks, patients with inadequate response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Cyltezo u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, može biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Adalimumab has not been studied in these patient populations.
Croatian: Nije ispitivano djelovanje adalimumaba u tim populacijama bolesnika te se ne mogu dati preporuke za
English: Seventy-nine (20.1 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4 %) patients with glucocorticoids.
Croatian: Bath Ankylosing Spondilitis Disease Activity Index, BASDAI] bila je 6,3 u svim skupinama) koji nisu imali adekvatan odgovor na konvencionalnu terapiju. 79 bolesnika (20,1%) istodobno je bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 37 bolesnika (9,4%) glukokortikoidima.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with
Croatian: U bolesnika liječenih adalimumabom prijavljeni su rijetki slučajevi hepatospleničnog T-staničnog limfoma nakon stavljanja lijeka u promet.
English: Abdominal pain, nausea and vomiting
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: Cyltezo 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
Croatian: Cyltezo je indiciran 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: The recommended Cyltezo induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Croatian: Preporučena indukcijska doza lijeka Cyltezo u odraslih bolesnika s umjerenim do teškim ulceroznim kolitisom je 160 mg u nultom tjednu (primijenjena u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Croatian: Nakon završetka oba ispitivanja, 383 bolesnika uključeno je u otvoreni nastavak ispitivanja u kojem su dobivali adalimumab u dozi od
English: The combination of Cyltezo and anakinra is not recommended (see section 4.4 “Concurrent administration of
Croatian: Kombinirano liječenje lijekom Cyltezo i anakinrom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: Cyltezo 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear to slightly opalescent solution of 40 mg adalimumab.
Croatian: Cyltezo 40 mg otopina za injekciju (injekcija) u napunjenoj brizgalici dolazi u obliku 0,8 ml sterilne bistre do blago zamućene otopine 40 mg adalimumaba.
English: If you take Cyltezo the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora se može povećati ako primjenjujete lijek Cyltezo.
English: • elevated bilirubin measurement (liver blood test).
Croatian: • visoka razina leukocita (bijelih krvnih stanica),
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later.
Croatian: Uobičajena početna doza za Crohnovu bolest je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg svaka dva tjedna.
English: Keep the pre-filled syringe/pre-filled pen in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku/napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 µg/mL at week 2 and week 4.
Croatian: Nakon primjene adalimumaba u dozi od 160 mg u nultom tjednu i 80 mg u 2. tjednu u odraslih bolesnika s gnojnim hidradenitisom, najniže koncentracije adalimumaba u serumu u 2. i 4. tjednu iznosile su približno 7 do 8 µg/ml.
English: • Only use each pre-filled pen for one injection.
Croatian: • Za jednu injekciju upotrijebite jednu napunjenu brizgalicu.
English: Patients were randomised to receive either 24 mg/m² body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Croatian: 2 tjelesne površine adalimumaba do maksimalne doze od 40 mg ili placebo svaki drugi tjedan tijekom 12 tjedana.
English: Cyltezo in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Croatian: ▪ liječenje umjereno teškog do teškog oblika reumatoidnog artritisa u aktivnoj fazi u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti, uključujući metotreksat, nije postignut zadovoljavajući odgovor.
English: Patients who maintained ≥ PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Croatian: A bili randomizirani za liječenje aktivnim lijekom, ponovno su randomizirani u razdoblju C tako da su tijekom dodatnih 19 tjedana primali ili adalimumab u dozi od 40 mg svaki drugi tjedan ili placebo.
English: Leukaemia
Croatian: , karcinom
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/mL during the induction period.
Croatian: Tijekom razdoblja indukcije u bolesnika s Crohnovom bolešću, nakon udarne doze od 80 mg adalimumaba u nultom tjednu i zatim 40 mg u drugom tjednu postignute su najniže serumske koncentracije adalimumaba od oko 5,5 μg/ml, odnosno 12 μg/ml ako je udarna doza bila 160 mg adalimumaba u nultom tjednu i zatim 80 mg u drugom tjednu.
English: p-value p-value p-value
Croatian: Dvostrana P-vrijednost iz log rang testa.
English: The recommended dose of Cyltezo for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Croatian: U odraslih bolesnika preporučena početna doza lijeka Cyltezo je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: • abnormal blood measurements for sodium;
Croatian: • razina natrija u krvi izvan urednih vrijednosti,
English: The patient information pack should contain:
Croatian: Paket s informacijama za bolesnika mora sadržavati: Uputu o lijeku s informacijama za bolesnika.
English: • flushing;
Croatian: • dehidracija,
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Croatian: Adalimumab je u 12. tjednu, u odnosu na početne vrijednosti, pokazao statistički značajno veće poboljšanje ukupnog rezultata HAQ-S i rezultata za fizičku komponentu (engl.
English: • Adults with non-infectious uveitis with inflammation affecting the back of the eye • Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the
Croatian: • djece u dobi od 2 i više godina s kroničnim nezaraznim uveitisom kod kojega upala zahvaća
English: This may cause severe allergic reactions in patients sensitive to latex.
Croatian: Unutarnji dio zatvarača (poklopac igle) na štrcaljki sadrži prirodnu gumu (lateks), što može uzrokovati teške alergijske reakcije u bolesnika osjetljivih na lateks.
English: The primary efficacy endpoint was the proportion of patients with no flare by week 68 of the study.
Croatian: Primarna mjera ishoda za djelotvornost bio je udio bolesnika kod kojih nije došlo do egzacerbacije do
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Croatian: Nakon drugog tjedna, bolesnici u obje skupine liječene adalimumabom primali su