FrancophonIA/ELRC3.0 huggingface dataset:
English: 6 pre-filled syringes 6 alcohol pads
Croatian: 6 napunjenih štrcaljki 6 alkoholnih tupfera
English: Table 23 Maintenance of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 23 Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Croatian: Slika 1: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u ispitivanju liječenja uveitisa u djece
English: Set the package down with the clear side of the package facing up.
Croatian: Odložite pakiranje tako da prozirna strana bude gore.
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Croatian: 1 pakiranje s 2 kutije, od kojih svaka sadrži: jednu bočicu (s 0,8 ml sterilne otopine), 1 praznu sterilnu štrcaljku za injekciju, 1 iglu, 1 nastavak za bočicu i 2 alkoholna tupfera.
English: 2 pre-filled syringes 2 alcohol pads
Croatian: 2 napunjene brizgalice 2 alkoholna tupfera
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 The usual dose of Imraldi is 20 mg every other week with methotrexate.
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 Uobičajena doza lijeka Imraldi je 20 mg svaki drugi tjedan s metotreksatom.
English: Imraldi 40 mg solution for injection in pre-filled syringe adalimumab
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: Leukaemia1) Not known Hepatosplenic T-cell lymphoma1),
Croatian: rijetko leukemija nepoznato hepatosplenični T-stanični limfom karcinom Merkelovih stanica (neuroendokrini karcinom kože)
English: • anxiety;
Croatian: • utrnulost;
English: interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Croatian: Nuspojava manje često plućna embolija intersticijska plućna bolest, kronična opstruktivna plućna bolest, pneumonitis pleuralna efuzija rijetko plućna fibroza
English: • Gently set the vial with vial adapter down on your clean work surface.
Croatian: • Pažljivo odložite bočicu s nastavkom na Vašu čistu radnu površinu.
English: A 40 mg pre-filled syringe and pre-filled pen are available for patients to administer a full 40 mg dose.
Croatian: Za bolesnike kojima je potrebno primijeniti punu dozu od 40 mg dostupne su napunjena štrcaljka i napunjena brizgalica od 40 mg.
English: • Peel the cover off the vial adapter package but do not take out the vial adapter.
Croatian: • Skinite pokrov s pakiranja nastavka za bočicu, ali nemojte vaditi nastavak.
English: solution for injection 1 vial
Croatian: otopina za injekciju 1 bočica
English: Your child's doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Croatian: Djetetov liječnik možda će propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: • Press plunger slowly:
Croatian: • Polako pritisnite klip:
English: Syringe disposal
Croatian: Prekid terapije
English: Methotrexate should be continued during treatment with Imraldi.
Croatian: Za vrijeme liječenja lijekom Imraldi treba nastaviti primjenu metotreksata.
English: Total Sharp Score
Croatian: p-vrijednost ukupan zbroj bodova prema Sharpu
English: * p<0.05, ***p<0.001, adalimumab versus placebo a
Croatian: * P < 0,05, ***P < 0,001, adalimumab naspram placeba a Među svim randomiziranim bolesnicima.
English: Hold the syringe steady and press the plunger all the way down.
Croatian: Pridržavajući štrcaljku u mjestu potisnite klip do kraja.
English: It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Croatian: Ako je bolovalo ili boluje od ozbiljne srčane bolesti, važno je da to kažete liječniku (pogledajte dio „Upozorenja i mjere opreza“).
English: If you dropped your pen with the cap OFF, do not use it.
Croatian: Ako Vam brizgalica ispadne BEZ štitnika za iglu, nemojte je upotrijebiti.
English: Adults with hidradenitis suppurativa
Croatian: Odrasli s gnojnim hidradenitisom
English: Very common Elevated liver enzymes Uncommon Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Croatian: Poremećaji jetre i žuči* vrlo često povišeni jetreni enzimi manje često kolecistitis i kolelitijaza, steatoza jetre, povišen bilirubin rijetko hepatitis reaktivacija hepatitisa B autoimuni hepatitis nepoznato zatajenje jetre
English: • Keep the syringe out of the sight and reach of children.
Croatian: • Štrcaljku čuvajte izvan pogleda i dohvata djece.
English: In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Croatian: A bolesnici su primali placebo ili adalimumab u početnoj dozi od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim u dozi od 40 mg svaki tjedan, počevši od 4. tjedna pa sve do 11. tjedna.
English: 4 pre-filled syringes 4 alcohol pads
Croatian: 4 napunjene brizgalice 4 alkoholna tupfera
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 12 godina u ovoj indikaciji.
English: If your child takes Imraldi the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih vrsta raka može se povećati ako Vaše dijete prima lijek Imraldi.
English: See leaflet for further information.
Croatian: Za više podataka pogledajte uputu o lijeku.
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Croatian: ≥ 18 godina koji nisu učinkovito odgovorili na prethodnu terapiju metotreksatom u dozi od 12,5 do 25 mg ili koji nisu podnosili metotreksat u dozi od 10 mg jednom tjedno.
English: Your child's doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Croatian: Djetetov liječnik može propisati i početnu dozu od 80 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: This medicinal product contains 20 mg sorbitol in each pre-filled syringe/pre-filled pen.
Croatian: Ovaj lijek sadrži 20 mg sorbitola u jednoj napunjenoj štrcaljki/napunjenoj brizgalici.
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 nego
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Croatian: Ps II (CHAMPION) - Rezultati djelotvornosti nakon 16 tjedana
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Croatian: • Ako je Vaše dijete ranije bolovalo od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: Adolescent hidradenitis suppurativa
Croatian: Adolescentni gnojni hidradenitis (Hidradenitis suppurativa)
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: Adult hidradenitis suppurativa
Croatian: Gnojni hidradenitis odraslih
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and
Croatian: S povećanjem koncentracija adalimumaba povećavale su se i stope odgovora PASI 75 i PGA rezultata 'bez bolesti' ili 'minimalno', u oba slučaja uz sličan prividan EC50 od približno 4,5 μg/ml (95% CI: 0,4-47,6 odnosno 1,9-10,5).
English: Time to Treatment Failure At or After Week 2 in Study UV II
Croatian: Vrijeme do neuspjeha liječenja u 2. tjednu ili nakon njega u ispitivanju UV II Primarna analiza (ITT)
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Croatian: (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s artritisom povezanim s entezitisom u dobi od 6 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene u 24. tjednu) bila je 8,8 ± 6,6 µg/ml za adalimumab bez istodobne primjene metotreksata i 11,8 ± 4,3 µg/ml uz istodobnu primjenu metotreksata.
English: Adalimumabb N=113
Croatian: N = 113
English: pruritus
Croatian: Nuspojava
English: Pull off the clear needle cap
Croatian: Skinite prozirni štitnik igle
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, terapiju adalimumabom 40 mg svaka dva tjedna nastavilo je 114 od 207 bolesnika koji su bili randomizirani u skupinu koja je primala adalimumab 40 mg svaki drugi tjedan.
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: • reproductive tract infections;
Croatian: • infekcije reproduktivnih organa;
English: In monotherapy, some patients who experience a decrease in their response to Imraldi 40 mg every other week dosing 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 Imraldi u dozi od 40 mg svaki drugi tjedan možda će biti korisno povećati doziranje adalimumaba na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Teл.
Croatian: (engl.
English: • You might get infections more easily while you are receiving Imraldi treatment.
Croatian: • Dok primate lijek Imraldi, možete biti podložniji infekcijama.
English: Imraldi 40 mg/0.8 ml solution for injection
Croatian: NAZIV LIJEKA Imraldi 40 mg/0,8 ml otopina za injekciju
English: Imraldi 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 Imraldi ne smije se nastaviti.
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, kroz 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: - The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Croatian: - Drugi sastojci su, natrijev citrat, citratna kiselina hidrat, histidin, histidinklorid hidrat, sorbitol,
English: There is no button on your pre-filled pen.
Croatian: Napunjena brizgalica nema tipku za okidanje.
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Imraldi.
Croatian: Nakon uzimanja lijeka Imraldi može se javiti osjećaj da se prostorija vrti (vrtoglavica) te smetnje vida.
English: 4 pre-filled pens 4 alcohol pads
Croatian: 4 napunjene štrcaljke 4 alkoholna tupfera
English: Uncommon Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Croatian: često rak kože, isključujući melanom (uključujući bazocelularni karcinom i karcinom skvamoznih stanica), benigne neoplazme manje često limfom**, novotvorine na solidnim organima (uključujući rak dojke, novotvorine na plućima i štitnjači), melanom**
English: 506 (62.2)b a Percent of patients achieving PASI 75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
Croatian: PGA: bez bolesti/minimalno b a Postotak bolesnika s rezultatom PASI 75 izražen kao stopa prilagođena istraživačkom centru b p < 0,001, adalimumab naspram placeba
English: There is no relevant use of adalimumab in children aged less than 2 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 2 godine u ovoj indikaciji.
English: The recommended dose of Imraldi for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Croatian: Preporučena doza lijeka Imraldi za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 5).
English: Table 6 Undesirable Effects
Croatian: Tablica 6 Nuspojave
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: 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 svaki drugi tjedan.
English: Pull off needle cap
Croatian: Skinite štitnik igle
English: The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Croatian: Uobičajena početna doza je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg.
English: Imraldi 40 mg solution for injection in pre-filled syringe is supplied as a 0.8 ml clear and colourless solution.
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj brizgalici dolazi kao 0,8 ml bistre i bezbojne otopine.
English: The recommended Imraldi 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 Imraldi 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: If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40-mg injections in 1 day) followed by 40 mg two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, djetetov liječnik može propisati početnu dozu od 80 mg (u obliku dvije injekcije od 40 mg u 1 danu) i zatim 40 mg nakon dva tjedna.
English: a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders
Croatian: Bolesnici koji su ispunjavali protokolom utvrđene kriterije za gubitak odgovora ili izostanak poboljšanja morali su prekinuti ispitivanja i vodili su se kao bolesnici bez odgovora
English: Autoantibodies Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies
Croatian: U ispitivanjima (I - V) kod reumatoidnog artritisa, uzorci seruma bolesnika u više su vremenskih točaka testirani na prisutnost autoprotutijela.
English: Most ALT
Croatian: Tijekom razdoblja
English: The recommended dose of Imraldi 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 Imraldi 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: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Croatian: • Ako ste ranije bolovali od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: pJIA II
Croatian: (vidjeti dio 4.2). pJIA II
English: Adalimumab Δ Censored Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Croatian: Napomena: P = Placebo (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]); A = Adalimumab (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]).
English: Confirm completion & dispose
Croatian: Provjerite da je ubrizgavanje dovršeno i bacite
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (VIAL PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (PAKIRANJE BOČICE)
English: The recommended Imraldi 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 Imraldi 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: Placebo (treatment withdrawal) N = 73
Croatian: Placebo (ukidanje liječenja)
English: The recommended dose of Imraldi 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 Imraldi je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) i zatim 40 mg nakon dva tjedna.
English: • Keep your syringe in its carton, and away from light.
Croatian: • Štrcaljku držite u njenoj kutiji, zaštićenu od svjetla.
English: ANNEX II
Croatian: Tablica 22
English: Some patients who experience decrease in their response to Imraldi 40 mg every other week may benefit from an increase in dosage to 40 mg Imraldi every week or 80 mg every other week.
Croatian: U nekih bolesnika u kojih dođe do slabljenja odgovora na terapiju Imraldi u dozi od 40 mg svaki drugi tjedan možda će biti korisno povećati doziranje na 40 mg lijeka Imraldi svaki tjedan ili 80 mg svaki drugi tjedan.
English: • ear infections;
Croatian: • infekcije uha;
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: paleness.
Croatian: Imraldi.
English: This medicinal product contains 20 mg sorbitol in each pre-filled syringe.
Croatian: Ovaj lijek sadrži 20 mg sorbitola u jednoj napunjenoj brizgalici.
English: • haematoma (a solid swelling with clotted blood);
Croatian: • podljev krvi (čvrsta oteklina sa zgrušanom krvi);
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: The usual dose for adults with non-infectious uveitis is an 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: Uobičajena doza za odrasle s nezaraznim uveitisom je 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: This medicinal product contains 20 mg sorbitol in each vial.
Croatian: Ovaj lijek sadrži 20 mg sorbitola u jednoj bočici.
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later.
Croatian: Uobičajen režim doziranja za gnojni hidradenitis je početna doza od 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 kojih se dva tjedna kasnije primjenjuje doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: • rash;
Croatian: • osip;
English: There is no relevant use of adalimumab in children aged below 6 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 6 godina u ovoj indikaciji.
English: 40 mg, or placebo every other week for 12 weeks.
Croatian: Placebo Adalimumab 40 mg svaki drugi tjedan
English: Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Croatian: Ako bolesnik ne postigne terapijski odgovor unutar 16 tjedana, nastavak liječenja nakon tog razdoblja potrebno je pomno razmotriti.