FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of Cyltezo is 40 mg every other week with methotrexate.
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine 30 kg ili više Uobičajena doza lijeka Cyltezo je 40 mg svaki drugi tjedan s metotreksatom.
English: Cyltezo is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are
Croatian: Cyltezo je indiciran za liječenje umjerene do teške kronične plak psorijaze u odraslih bolesnika koji su kandidati za sistemsko liječenje.
English: Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
Croatian: Ako bolesnik ne postigne terapijski odgovor unutar 16 tjedana, potrebno je pažljivo razmotriti nastavak liječenja nakon tog razdoblja.
English: Adalimumab is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section
Croatian: Adalimumab je indiciran za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalno
English: Cyltezo is used to treat ulcerative colitis in adults.
Croatian: Cyltezo je namijenjen liječenju ulceroznog kolitisa u odraslih.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Croatian: Treatment Satisfaction Questionnaire - medication [TSQM]; ispitivanja HS-I i HS-II) i fizičko zdravlje, koje se određivalo na temelju rezultata za cjelokupnu fizičku komponentu upitnika SF-36 (ispitivanje HS-I).
English: • acid reflux disease;
Croatian: • infekcije reproduktivnih organa,
English: Cyltezo is used to treat psoriatic arthritis in adults.
Croatian: Cyltezo je namijenjen liječenju psorijatičnog artritisa u odraslih.
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Cyltezo.
Croatian: Kod nezaraznog uveitisa se uz lijek Cyltezo mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: Mood alterations (including depression), anxiety, insomnia
Croatian: • promjene raspoloženja (uključujući depresiju),
English: EU/1/17/1240/008
Croatian: EU/1/17/1240/005 1 napunjena brizgalica EU/1/17/1240/006 2 napunjene brizgalice EU/1/17/1240/007 4 napunjene brizgalice EU/1/17/1240/008 6 napunjenih brizgalica
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Croatian: Djeca, adolescenti i odrasli s artritisom povezanim s entezitisom Djeca i adolescenti u dobi od 6 i više godina, tjelesne težine od 15 kg do manje od 30 kg Cyltezo je dostupan samo u obliku napunjene štrcaljke i napunjene brizgalice od 40 mg.
English: Cyltezo is administered by subcutaneous injection.
Croatian: Cyltezo se primjenjuje supkutanom injekcijom.
English: Patients should be tested for HBV infection before initiating treatment with Cyltezo.
Croatian: Prije početka liječenja lijekom Cyltezo bolesnike je potrebno testirati na HBV infekciju.
English: The blinded period was followed by an open-label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Croatian: Nakon slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano tijekom dodatnih 28 tjedana.
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Croatian: Sigurnost i djelotvornost višestrukih doza adalimumaba su ispitivane u randomiziranim, dvostruko slijepim, placebom kontroliranim kliničkim ispitivanjima u odraslih bolesnika sa srednje teškim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo rezultat od 6 do 12 uz endoskopski podrezultat od
English: The double-blind period was followed by an open-label period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Croatian: Nakon dvostruko slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatna 144 tjedna.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cyltezo 40 mg injection
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Cyltezo 40 mg injekcija adalimumab
English: Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steadystate (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/mL (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/mL (47.7 % CV) with
Croatian: 2 (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom (JIA) u dobi od 4 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene od 20. do 48. tjedna) bila je 5,6 ± 5,6 µg/ml (102% CV) za adalimumab bez istodobne primjene metotreksata i 10,9 ± 5,2 µg/ml (47,7% CV) uz istodobnu primjenu metotreksata.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Croatian: Functional Assessment Of Chronic Illness Therapy, FACIT) zabilježeno je u sva tri ispitivanja u kojima je taj parametar ispitivan
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis
Croatian: Za bolesnika se preporučuje svakodnevno korištenje topikalne antiseptičke tekućine za ispiranje lezija uzrokovanih gnojnim hidradenitisom tijekom
English: Then take your next dose as you would have on your originally scheduled day, had you not
Croatian: Zatim sljedeću dozu ubrizgajte onog dana kada je to prvotno bilo predviđeno, kao da propusta nije bilo.
English: Cyltezo is used to treat moderate to severe plaque psoriasis in adults.
Croatian: Cyltezo je namijenjen liječenju umjerene do teške plak psorijaze u odraslih.
English: • scar;
Croatian: • rak,
English: One 0.8 mL pre-filled syringe contains 40 mg adalimumab.
Croatian: Jedna napunjena brizgalica od 0,8 ml sadrži 40 mg adalimumaba.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week 48).
Croatian: Bolesnici koji su primali placebo imali su promjenu mTSS-a u odnosu na početnu vrijednost (srednja vrijednost ± standardno odstupanje) od 0,8 ± 2,5 (24. tjedan), a bolesnici liječeni adalimumabom 0,0 ± 1,9 (p< 0,001) (48. tjedan).
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF
Croatian: Nisu dostupni odgovarajući podaci o kombiniranom liječenju antivirusnom terapijom i antagonistom TNF-a u svrhu prevencije reaktivacije HBV-a u bolesnika koji su nositelji HBV-a.
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table
Croatian: U ispitivanju RA V, u kojem su obuhvaćeni bolesnici u ranoj fazi reumatoidnog artritisa koji do tada nisu bili liječeni metotreksatom, kombiniranom primjenom adalimumaba i metotreksata tijekom 52 tjedna postignut je brži i statistički značajno bolji ACR odgovor nego uz monoterapiju metotreksatom, odnosno adalimumabom.
English: • inflammations.
Croatian: • gljivične infekcije,
English: Cyltezo 40 mg solution for injection in pre-filled pen Cyltezo 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Croatian: Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici Cyltezo 40 mg otopina za injekciju u napunjenoj brizgalici za jednokratnu primjenu od strane bolesnika koja sadrži napunjenu štrcaljku.
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Croatian: U 79 od 207 bolesnika koji su uzimali adalimumab u dozi od 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 10 godina.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see
Croatian: Oba su ispitivanja pokazala rani i održan učinak adalimumaba na stopu neuspjeha liječenja u odnosu na
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Croatian: , urtikarija, stvaranje modrica (uključujući purpuru), dermatitis (uključujući ekcem), pucanje noktiju, pojačano znojenje (hiperhidroza), alopecija
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Croatian: U 16. tjednu, pozitivan odgovor s obzirom na djelotvornost (npr. PASI 75) postigao je veći broj bolesnika randomiziranih za liječenje adalimumabom u dozi od 0,8 mg/kg nego onih randomiziranih za primanje doze od 0,4 mg/kg svaki drugi tjedan ili za liječenje MTX-om.
English: In monotherapy, some patients who experience a decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Croatian: U slučaju monoterapije, u nekih bolesnika u kojih je došlo do slabljenja odgovora na liječenje lijekom Cyltezo u dozi od 40 mg svaki drugi tjedan može biti korisno povećati doziranje adalimumaba na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: There is little experience from re-administration after more than 8 weeks since the previous dose.
Croatian: Postoji malo podataka o ponovnoj primjeni lijeka Cyltezo kada je prekid liječenja trajao duže od 8 tjedana.
English: If these medicines do not work well enough, you will be given Cyltezo to treat your rheumatoid arthritis.
Croatian: Ako ti lijekovi neće dovoljno dobro djelovati, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek Cyltezo.
English: Results from the overall UC-II study population are shown in Table 28.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 28. Tablica 28 : Odgovor, remisija i cijeljenje sluznice u ispitivanju UC-II (postotak bolesnika)
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Cyltezo.
Croatian: Tijekom liječenja lijekom Cyltezo može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: Cyltezo is administered via subcutaneous injection.
Croatian: Cyltezo se primjenjuje putem supkutane injekcije.
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Croatian: U ispitivanju CD I, 299 bolesnika koji nikad nisu primali liječenje antagonistima TNF-a randomizirani su u jednu od 4 terapijske skupine: placebo u nultom tjednu i nakon 2 tjedna, adalimumab u dozi od 160 mg u nultom tjednu i 80 mg nakon 2 tjedna, adalimumab u dozi od 80 mg u nultom tjednu i 40 mg nakon 2 tjedna, adalimumab u dozi od 40 mg u nultom tjednu i 20 mg nakon 2 tjedna.
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among
Croatian: Limfomi su se javljali u stopi (interval pouzdanosti 95%) od 0,7 (0,2; 2,7) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom, odnosno u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.
English: Cyltezo is administered by injection under the skin (by subcutaneous injection).
Croatian: Cyltezo se primjenjuje potkožnom injekcijom (supkutana injekcija).
English: Cyltezo dose for paediatric patients with Crohn's disease
Croatian: Tablica 4: Doza lijeka Cyltezo za pedijatrijske bolesnike s Crohnovom boleš6 u
English: Should treatment be interrupted, Cyltezo 40 mg every week or 80 mg every other week may be re-introduced
Croatian: Ako liječenje treba privremeno prekinuti, Cyltezo se kasnije može ponovno uvesti u dozi od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan (vidjeti dio 5.1).
English: The recommended dose of Cyltezo for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Croatian: Preporučena doza lijeka Cyltezo za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (Tablica 2).
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s reumatoidnim artritisom i psorijatičnim artritisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 104 tjedna, povišenje razine ALT-a ≥ 3 x GGN (gornja granica normalnog raspona) zabilježeno je u 3,7% bolesnika liječenih adalimumabom i 1,6% bolesnika iz kontrolne skupine.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Psoriasis Area and Severity Index, PASI] ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsko liječenje ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumab-treated patients
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s plak psorijazom, s kontrolnim razdobljem koje je trajalo u rasponu od 12 do 24 tjedna, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 1,8% bolesnika liječenih adalimumabom i 1,8% bolesnika iz
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Croatian: Poremećaji jetre i žuči* vrlo često povišeni jetreni enzimi kolecistitis i kolelitijaza, steatoza jetre, povišeni bilirubin
English: At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Croatian: U 81 od 207 bolesnika koji su uzimali adalimumab u dozi od 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 8 godina.
English: Adalimumab 40 mg eow N = 814 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan, N = 814 n (%)
English: Tell your doctor if you are taking azathioprine or
Croatian: Obavijestite liječnika ako istodobno uz lijek Cyltezo uzimate azatioprin ili merkaptopurin.
English: Taking these results into consideration, Cyltezo is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Croatian: Uzevši to u obzir, preporučuje se primjena lijeka Cyltezo u kombinaciji s metotreksatom, a monoterapija samo u onih bolesnika u kojih primjena metotreksata nije prikladna
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Cyltezo je 40 mg svaki drugi tjedan.
English: • Discard entire Cyltezo pen into “sharps” container.
Croatian: • Zbrinite cjelokupnu brizgalicu lijeka Cyltezo u spremnik za odlaganje oštrih predmeta.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Croatian: neuropatija multipla skleroza, demijelinizirajući poremećaji (npr. optički neuritis, Guillain-Barréov sindrom) oštećenje vida, konjunktivitis, blefaritis, oticanje očiju diplopija
English: If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ako ti lijekovi neće dovoljno dobro djelovati, bit će Vam propisan lijek Cyltezo kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Cyltezo is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: Cyltezo je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih, unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima, nije postignut odgovor ili u bolesnika koji ih ne podnose ili im je takvo liječenje kontraindicirano.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult non-radiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was
Croatian: Nakon supkutane primjene 40 mg adalimumaba svaki drugi tjedan u odraslih bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, srednja vrijednost (± SD) najniže koncentracije u stanju dinamičke ravnoteže u 68. tjednu iznosila je 8,0 ± 4,6 µg/ml.
English: In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
Croatian: U većine je bolesnika postignuti ACR odgovor održan u otvorenom nastavku ispitivanja RA III kada su praćeni do 10 godina.
English: • sensation disorders such as tingling, prickling or numbness; • symptoms of nerve root compression (including low back pain and leg pain);
Croatian: • simptomi kompresije korijena živca (uključujući bolove u donjem dijelu leđa i nozi),
English: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and
Croatian: Tablica 27: Ispitivanje Crohnove bolesti u djece - Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula
English: Cyltezo should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Stoga se u bolesnika s blagim zatajenjem srca (NYHA razred I/II) lijek Cyltezo mora primjenjivati s oprezom.
English: Cyltezo is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom
Croatian: Cyltezo je indiciran za liječenje kroničnog neinfektivnog anteriornog uveitisa u djece u dobi od 2 godine i starije u koje nije postignut zadovoljavajući odgovor na konvencionalno liječenje, koji ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno.
English: Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2)
Croatian: Placebo (N = 28) b 43,3% (13/30) 71,4% (20/28)
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Cyltezo je 40 mg svaki drugi tjedan.
English: Liver failure
Croatian: Tablični popis nuspojava
English: No data are available on the secondary transmission of infection by live vaccines in
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije živim cjepivima u bolesnika liječenih adalimumabom.
English: • Only use each pre-filled syringe for one injection.
Croatian: • Za jednu injekciju upotrijebite jednu napunjenu štrcaljku.
English: The recommended dose of Cyltezo for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U odraslih bolesnika s reumatoidnim artritisom preporučena doza lijeka Cyltezo iznosi 40 mg, a daje se u obliku jednokratne doze svaka dva tjedna putem supkutane injekcije.
English: System Organ Class Frequency
Croatian: Organski sustav
English: * p < 0.05, *** p < 0.001, adalimumab versus placebo
Croatian: * p < 0,05, *** p < 0,001, adalimumab naspram placeba Među svim randomiziranim bolesnicima.
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Croatian: Među bolesnicima liječenima adalimumabom, značajno poboljšanje znakova upale, određeno razinom C-reaktivnog proteina visoke osjetljivosti (hs-CRP) i MR oslikavanjem i sakroilijakalnih zglobova i kralježnice, održalo se do 156., odnosno 104. tjedna.
English: Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients p = 0.015
Croatian: Pedijatrijski odgovori ACR 30/50/70 nakon 48 tjedana liječenja su bili značajno veći nego u skupini koja je uzimala
English: Adalimumab 40 mg eow N = 108 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan, N = 108 n (%)
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Croatian: Doziranje adalimumaba u tih bolesnika utvrđeno je na temelju farmakokinetičkog modeliranja i
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Croatian: Djelotvornost i sigurnost adalimumaba ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima u više od 1500 bolesnika s umjerenom do teškom aktivnom Crohnovom bolešću (indeks aktivnosti Crohnove bolesti [engl.
English: Boehringer Ingelheim Pharma GmbH & Co. KG
Croatian: Boehringer Ingelheim Pharma GmbH & Co.
English: Assessments in SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score high sensitivity C-Reactive Protein (mg/L) Spondyloarthritis Research Consortium of Canada
Croatian: Assessment of SpondyloArthritis international Society) Bath indeks aktivnosti ankilozantnog spondilitisa (engl.
English: Cyltezo is only available as 40 mg pre-filled syringe/pre-filled pen.
Croatian: Lijek Cyltezo dostupan je samo u obliku napunjene štrcaljke/napunjene brizgalice od 40 mg.