FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Idacio Do not use Idacio - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Idacio is available as a vial, a pre-filled syringe and a pre-filled pen.
Croatian: Idacio je dostupan u obliku bočice, napunjene štrcaljke i/ili napunjene brizgalice.
English: When needed (for example when you are travelling), Idacio may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), lijek Idacio može se čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da je zaštitite od svjetlosti.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific 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: Table 13: Paediatric plaque psoriasis efficacy results at 16 weeks MTXa
Croatian: Tablica 13: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: 1.4 You will also need following supplies that are not included in the kit:
Croatian: Štrcaljka Upozorenje: Ne upotrebljavajte u slučaju oštećenja 1.4 Bit će vam potreban i sljedeći pribor koji nije uključen u set:
English: Step 3 Check the Pre-filled Syringe
Croatian: 3. korak Provjerite štrcaljku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Idacio 40 mg/0.8 mL injection adalimumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Idacio 40 mg/0,8 ml injekcija adalimumab s.c.
English: Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTXa
Croatian: Tablica 20: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Croatian: Adolescenti u dobi od 12 do 17 godina, tjelesne težine 30 kg ili više
English: - 2 pre-filled pens, with 2 alcohol pads - 6 pre-filled pens, with 6 alcohol pads
Croatian: Pakiranja od: - 2 napunjene brizgalice, s 2 jastučića natopljena alkoholom - 6 napunjenih brizgalica, sa 6 jastučića natopljena alkoholom
English: The recommended dose of Idacio 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 adalimumaba iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: When needed (for example when you are travelling), a single Idacio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), jedna Idacio napunjena brizgalica može se čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da je zaštitite od svjetlosti.
English: Table 21 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Croatian: Tablica 21 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
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
English: If your child has mild heart failure and is being treated with Idacio, his/her heart failure status must be closely monitored by your doctor.
Croatian: • Ako je Vaše dijete bolovalo ili boluje od ozbiljne srčane bolesti, važno je da to kažete svome liječniku Boluje li od blagog zatajenja srca, a liječi se lijekom Idacio, liječnik mora pomno nadzirati status zatajenja srca..
English: If these medicines do not work well enough, you will be given Idacio to treat your rheumatoid arthritis.
Croatian: Ukoliko ti drugi lijekovi ne djeluju dovoljno dobro, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek Idacio.
English: Idacio 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: Idacio 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 kod bolesnika koji ih ne podnose ili im je takva terapija kontraindicirana.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Djelovanje adalimumaba ispitivano je u bolesnika s reumatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom i psorijatičnim artritisom koji su dobivali adalimumab kao monoterapiju i u onih koji su istodobno uzimali i metotreksat.
English: Methotrexate should be continued during treatment with Idacio.
Croatian: Za vrijeme liječenja lijekom Idacio treba nastaviti primjenu metotreksata.
English: • If needed, for example when traveling, the Idacio Vial Kit can be stored at room temperature for up to 14 days.
Croatian: • Ako je potrebno, primjerice dok ste na putu, Idacio set s bočicom može se čuvati na sobnoj temperaturi do 14 dana.
English: If you do not respond well enough to these medicines, you will be given Idacio to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ako na njih ne reagirate dovoljno dobro, u svrhu smanjenja znakova i simptoma Crohnove bolesti bit će Vam propisan lijek Idacio.
English: Corticosteroids or other medicines that influence the immune system may be continued while using Idacio.
Croatian: Kod nezaraznog uveitisa se uz lijek Idacio mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: The recommended dose of Idacio for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Croatian: Preporučena doza lijeka Idacio za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (Tablica 2).
English: Ped ACR 30 response (n/N)
Croatian: Faza Otvorena uvodna16 tjedana Pedijatrijski odgovor ACR 30 (n/N)
English: Table 27 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Croatian: Tablica 27 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Idacio.
Croatian: Za vrijeme liječenja lijekom Idacio može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: Solution for injection 2 pre-filled syringes 2 alcohol pads 6 pre-filled syringes 6 alcohol pads
Croatian: Otopina za injekciju 2 napunjene štrcaljke 2 jastučića natopljena alkoholom 6 napunjenih štrcaljki 6 jastučića natopljena alkoholom
English: Idacio 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Croatian: Idacio 40 mg/0,8 ml otopina za injekciju za pedijatrijsku uporabu adalimumab
English: Idacio 40 mg/0.8 mL solution for injection (injection) for paediatric use is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Croatian: Idacio 40 mg/0,8 ml otopina za injekciju (injekcija) za pedijatrijsku uporabu dolazi kao sterilna bistra, bezbojna otopina s 40 mg adalimumaba u 0,8 ml otopine.
English: The recommended Idacio 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 Idacio 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 kao 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: The recommended Idacio 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 Idacio 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: Solution for injection 2 pre-filled pens 2 alcohol pads 6 pre-filled pens 6 alcohol pads
Croatian: Otopina za injekciju 2 napunjene brizgalice 2 jastučića natopljena alkoholom 6 napunjenih brizgalica 6 jastučića natopljena alkoholom
English: Erosion 3.7 (2.7-4.7) 1.7 (1.0-2.4) JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Croatian: 104 tjedna 28,4% 28,1% ap-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa bp-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa cp-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U test
English: There is insufficient evidence of the efficacy of Idacio in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Croatian: Zbog premalog broja bolesnika uključenih u ispitivanje, nema dovoljno dokaza o djelotvornosti adalimumaba u liječenju bolesnika s psorijatičnom artropatijom sličnoj ankilozantnom spondilitisu.
English: Idacio is administered by injection under the skin (by subcutaneous injection).
Croatian: Idacio se primjenjuje potkožnom injekcijom (supkutana injekcija).
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg solution for injection in pre-filled syringe Idacio 40 mg solution for injection in pre-filled pen
Croatian: Idacio 40 mg otopina za injekciju u napunjenoj štrcaljki Idacio 40 mg otopina za injekciju u napunjenoj brizgalici
English: Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Croatian: <0,001c rezultat za eroziju JSNd rezultat ametotreksat brazlike između metotreksata i adalimumaba s obzirom na promjene ukupnog zbroja bodova na razini intervala pouzdanosti od 95% cna osnovi analize ranga dsuženje zglobnih prostora (eng.
English: At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Croatian: U četvrtom su tjednu bolesnici na temelju tjelesne težine randomizirani u omjeru 1:1 u skupinu koja je dobivala standardnu dozu (40/20 mg svaki drugi tjedan) ili nisku dozu (20/10 mg svaki drugi tjedan) kao terapiju održavanja.
English: Adalimumab 40 mg weekly N = 70
Croatian: adalimumab 40 mg svaki tjedan N = 70
English: - The active substance is adalimumab.
Croatian: Što Idacio sadrži - Djelatna tvar je adalimumab.
English: Liver failure1)
Croatian: vaskulitis rijetko anafilaksa1)
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Croatian: ND ND 4,5% 23,2% a Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon
English: Discontinuation of immunomodulators2
Croatian: Prekinuti imunomodulatori2
English: • If needed, for example when traveling, a single pre-filled pen can be stored at room temperature for up to 14 days.
Croatian: • Ako je potrebno, primjerice dok ste na putu, jedna napunjena brizgalica može se čuvati na sobnoj temperaturi do 14 dana.
English: Note: P# = Placebo (Number of events/Number at risk); A# = Adalimumab (number of events/Number at risk).
Croatian: Napomena: P# = Placebo (broj događaja/broj bolesnika pod rizikom); A# = Adalimumab (broj događaja/broj bolesnika pod rizikom).
English: • Keep the Idacio pre-filled pen out of the reach of children.
Croatian: • Čuvajte Idacio napunjenu brizgalicu izvan dohvata i pogleda djece.
English: The recommended Idacio dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Croatian: Preporučena doza lijeka Idacio je 80 mg u nultom tjednu, nakon koje se primjenjuje doza od 40 mg svaki drugi tjedan, počevši od prvog tjedna, supkutanom injekcijom.
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Croatian: - infekcije, uključujući tuberkulozu - rak - problemi živčanog sustava - cijepljenje
English: Idacio 40 mg solution for injection in pre-filled syringe adalimumab
Croatian: Idacio 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: In adolescent patients with inadequate response to Idacio 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Croatian: U adolescentnih bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Idacio u dozi od 40 mg svaki drugi tjedan, može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: If you have mild heart failure and you are being treated with Idacio, your heart failure status must be closely monitored by your doctor.
Croatian: • Ako ste bolovali ili bolujete od ozbiljne srčane bolesti, važno je da to kažete svome liječniku Bolujete li od blagog zatajenja srca, a liječite se lijekom Idacio, liječnik mora pomno nadzirati status zatajenja srca..
English: • Store the pre-filled syringe in its original box to protect it from light.
Croatian: • Čuvajte napunjenu brizgalicu u originalnoj kutiji radi zaštite od svjetlosti.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in one 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: 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: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE/LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ŠTRCALJKI
English: Read carefully these entire instructions before using your Idacio Vial kit.
Croatian: Pažljivo pročitajte cijele upute prije upotrebe Idacio seta s bočicom.
English: Idacio 40 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Croatian: Idacio 40 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: 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: Početna doza 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see section
Croatian: Potrebno je periodički ocjenjivati koristi i rizike kontinuiranog dugotrajnog liječenja (vidjeti dio 5.1).
English: Your child is advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection.
Croatian: Preporučuje se da za vrijeme korištenja lijeka Idacio Vaše dijete ne ostane trudno, te da još barem 5 mjeseci nakon posljednje injekcije lijeka Idacio koristi odgovarajuću kontracepciju.
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg/0.8 mL solution for injection for paediatric use
Croatian: Idacio 40 mg/0,8 ml otopina za injekciju za pedijatrijsku uporabu
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ova doza ne djeluje dovoljno dobro, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Croatian: Početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), a zatim 40 mg svaki drugi tjedan, počevši tjedan dana kasnije.
English: 6 months 13.3% 65.1% 19.1% 12 months NA
Croatian: 52 tjedna 62,6% 54,4%
English: The recommended dose of Idacio 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 Idacio 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: Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase Age group
Croatian: Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Steroid-free remission for ≥ 90 days a
Croatian: Bolesnici u remisiji bez primjene steroida ≥ 90 danaa
English: Contents of the pack and other information What Idacio contains
Croatian: Kako čuvati lijek Idacio Sadržaj pakiranja i druge informacije Upute za uporabu
English: Vertigo and visual impairment may occur following administration of Idacio (see section 4.8).
Croatian: Nakon primjene lijeka Idacio mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: Table 15 Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N=53 n (%)
Croatian: Tablica 15 Ispitivanje Ps II (CHAMPION) Rezultati djelotvornosti u 16. tjednu
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Početna doza od 80 mg (u obliku dvije injekcije u jednom danu), nakon čega slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: Response RA Study Ia**
Croatian: Ispitivanje RA Ia**
English: Paraesthesias (including hypoaesthesia), migraine, nerve root compression
Croatian: vrlo često glavobolja često parestezije (uključujući hipoesteziju), migrena, kompresija korijena živca manje često cerebrovaskularni događaj1),
English: The recommended dose of Idacio 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 Idacio je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: Total sharp score
Croatian: pvrijednost ukupan zbroj bodova prema Sharpu
English: The recommended dose of Idacio for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Croatian: Preporučena doza lijeka Idacio za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 5).
English: 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,
English: Your healthcare provider should show you how to prepare and inject Idacio properly using the pre-filled syringe before you use it for the first time.
Croatian: Prije nego što primijenite ovaj lijek prvi puta, Vaš zdravstveni radnik Vam mora pokazati kako se Idacio ispravno priprema i primjenjuje koristeći napunjenu brizgalicu.
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 AS-a, prvo će Vam biti dani drugi lijekovi, no ukoliko ti drugi lijekovi ne djeluju dovoljno dobro, bit će Vam propisan lijek Idacio kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Some patients who experience decrease in their response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg Idacio every week or 80 mg every other week.
Croatian: U nekih bolesnika u kojih dođe do slabljenja odgovora na terapiju Idaciom u dozi od 40 mg svaki drugi tjedan možda će biti korisno povećati doziranje na 40 mg lijeka Idacio svaki tjedan ili 80 mg svaki drugi tjedan.
English: Note: P = Placebo (number at risk); A = Adalimumab (number at risk).
Croatian: Napomena: P = Placebo (broj bolesnika pod rizikom); A = Adalimumab (broj bolesnika pod rizikom).
English: Idacio 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Croatian: Idacio 40 mg otopina za injekciju (injekcija) u napunjenoj brizgalici dolazi kao sterilna bistra, bezbojna otopina s 40 mg adalimumaba u 0,8 ml otopine.