FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose of Imraldi is 20 mg every other week with methotrexate.
Croatian: Uobičajena doza lijeka Imraldi je 20 mg svaki drugi tjedan s metotreksatom.
English: Concurrent administration of biologic DMARDS or TNF-antagonists
Croatian: Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a
English: 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 terapiju aktivnim lijekom, ponovno su randomizirani u razdoblju C tako da su tijekom dodatnih 19 tjedana primali ili adalimumab 40 mg svaki drugi tjedan ili placebo.
English: • polyarticular juvenile idiopathic arthritis,
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa,
English: Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger, a plunger rod, a safe-shield body, a finger flange and 2, 2, 4 or 6 alcohol pads enclosed in packs respectively.
Croatian: Imraldi je dostupan u pakiranjima koja sadrže 1, 2, 4 ili 6 napunjenih štrcaljki (staklo tipa I) s iglom od nehrđajućeg čelika, čvrstim štitnikom za iglu, gumenim klipom, potisnikom klipa, zaštitnim tijelom i uporištem za prste za uporabu od strane bolesnika te s 2, 2, 4,odnosno 6 alkoholnih tupfera priloženih u pakiranju.
English: Placebo/MTXa
Croatian: Placebo/MTX
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥3 × ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika u dobi od 4 do 17 godina s poliartikularnim juvenilnim idiopatskim artritisom i u bolesnika u dobi od 6 do 17 godina s artritisom povezanim s entezitisom, povišenje ALT-a ≥ 3 × GGN zabilježeno je u 6,1 % bolesnika liječenih adalimumabom i 1,3 % bolesnika iz kontrolne skupine.
English: If you press the syringe plunger slowly, it may make your injection more comfortable.
Croatian: Sporim potiskivanjem klipa štrcaljke uštrcavanje može biti manje neugodno.
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Croatian: Među njima je njih 86 (75,4 %), 72 (63,2 %) odnosno 41 (36 %) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
English: If these medicines do not work well enough, you will be given Imraldi to treat your rheumatoid arthritis.
Croatian: Ukoliko ovi lijekovi ne djeluju dovoljno dobro, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek Imraldi.
English: The recommended dose of Imraldi is an initial dose of 20 mg, followed by 20 mg one week later.
Croatian: Preporučeno doziranje lijeka Imraldi je početna doza od 20 mg, a zatim 20 mg nakon tjedan dana.
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 adalimumab supkutano kroz dodatna 144 tjedna.
English: Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Imraldi je indiciran za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u 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: Table 17 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Croatian: Tablica 17 Ispitivanje Ps I (REVEAL) - Rezultati djelotvornosti nakon 16 tjedana
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
Croatian: U odraslih bolesnika sa psorijazom, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže bila je 5 μg/ml tijekom primjene monoterapije dozom adalimumaba od 40 mg svaki drugi tjedan.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, and hidradenitis suppurativa after treatment with adalimumab.
Croatian: U bolesnika s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovom bolešću, ulceroznim kolitisom i gnojnim hidradenitisom primijećeno je naglo smanjenje razina CRP-a nakon liječenja adalimumabom.
English: Imraldi 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 therapy (see sections 5.1 and 5.2).
Croatian: Imraldi 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: • If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Imraldi.
Croatian: • Ako se Vaše dijete mora podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, molimo recite svom liječniku da prima lijek Imraldi.
English: Ulcerative Colitis
Croatian: Ulcerozni kolitis
English: • mouth infections (including tooth infections and cold sores);
Croatian: • infekcije usne šupljine (uključujući infekcije zuba i herpes);
English: Depending on your response, your doctor may increase the dose frequency to 20 mg every week.
Croatian: Ovisno o odgovoru na liječenje, liječnik Vam može povećati doziranje na 20 mg svaki tjedan.
English: Week 26 Week 52
Croatian: 26. tjedan 52. tjedan
English: For paediatric use.
Croatian: Za primjenu u pedijatriji.
English: Patients demonstrating a Paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Croatian: Bolesnici koji su u 16. tjednu pokazali pedijatrijski odgovor ACR 30 (American College of Rheumatology 30) mogli su biti randomizirani u dvostruko slijepu fazu ispitivanja i primiti ili 24 mg/m adalimumaba, do maksimalne doze od 40 mg, ili placebo, svaki drugi tjedan kroz 32 tjedna ili do egzacerbacije bolesti.
English: Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Croatian: Dermatology Life Quality Index, DLQI), u usporedbi s placebom (ispitivanja I i II) i u usporedbi s MTX-om (ispitivanje II).
English: What you need to know before you use Imraldi Do not use Imraldi
Croatian: Što je Imraldi i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Imraldi
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18).
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan, stopa HiSCR-a zabilježena u 36. tjednu bila je veća u onih bolesnika koji su nastavili primati adalimumab svaki tjedan nego u bolesnika kojima je učestalost doziranja smanjena na jednom svaki drugi tjedan ili onih kojima je liječenje ukinuto (vidjeti Tablicu 18).
English: The usual dose of Imraldi is 40 mg every other week with methotrexate.
Croatian: Uobičajena doza lijeka Imraldi je 40 mg svaki drugi tjedan s metotreksatom.
English: • Pick up the syringe with the needle pointing up.
Croatian: • Podignite štrcaljku tako da igla pokazuje prema gore.
English: Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Croatian: ***, **Statistički značajno uz p < 0,001, p < 0,01 za sve usporedbe adalimumaba s placebom u 2., 12. i 24. tjednu a Procjena kod ankilozantnog spondilitisa (engl.
English: • While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand.
Croatian: • Dok još držite štrcaljku uspravno za dio s označenim volumenima, uklonite nastavak bočice s bočicom tako što ćete odviti nastavak drugom rukom.
English: Adalimumab 40 mg eow N=814 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan, N = 814 n (%)
English: Never reuse a pen.
Croatian: Nikada nemojte ponovno koristiti istu brizgalicu.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Croatian: Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje tijekom kojeg su bolesnici primali 24 mg/m tjelesne površine adalimumaba do maksimalne doze od 40 mg svaki drugi tjedan supkutano tijekom najviše 192 dodatna tjedna.
English: The recommended dose of Imraldi is 20 mg every other week.
Croatian: Preporučena doza lijeka Imraldi je 20 mg svaki drugi tjedan.
English: Table 14 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Croatian: Tablica 14 Ispitivanje Ps I (REVEAL) - Rezultati djelotvornosti nakon 16 tjedana
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Croatian: U bolesnika s poliartikularnim JIA u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i starijih i tjelesne težine manje od 15 kg, nakon primjene 24 mg/m adalimumaba srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže bila je 6,0 ± 6,1 µg/ml (101 % CV) za adalimumab bez istodobne primjene metotreksata i 7,9 ± 5,6 µg/ml (71,2 % CV) uz istodobnu primjenu metotreksata.
English: Table 7 ACR Responses in Placebo Controlled Trials (Percent of Patients)
Croatian: Tablica 7 ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika)
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Croatian: U ispitivanju CD II, 325 bolesnika koji su izgubili odgovor ili nisu podnosili terapiju infliksimabom randomizirani su u dvije skupine: jedna je primila 160 mg adalimumaba u nultom tjednu i 80 mg adalimumaba dva tjedna kasnije, a druga skupina je primila placebo u u nultom tjednu i 2. tjednu.
English: Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Croatian: Među njima je njih 64 (79,0 %), 56 (69,1 %), odnosno 43 (53,1 %) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
English: Leukocytosis, thrombocytopenia Uncommon Idiopathic thrombocytopenic purpura Rare
Croatian: anemija često leukocitoza, trombocitopenija manje često idiopatska trombocitopenična purpura rijetko pancitopenija
English: Adalimumab 40 mg eow N=108 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan, N = 108 n (%)
English: If this dose does not work well enough, your child's doctor may increase the dose frequency to 20 mg every week.
Croatian: Ako ova doza nije dovoljno djelotvorna, djetetov liječnik može povećati doziranje na 20 mg svaki tjedan.
English: • migraine;
Croatian: • glavobolja;
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22).
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan, stopa HiSCR-a zabilježena u 36. tjednu bila je veća u onih bolesnika koji su nastavili primati adalimumab svaki tjedan nego u bolesnika kojima je učestalost doziranja smanjena na jednom svaki drugi tjedan ili onih kojima je liječenje ukinuto (vidjeti Tablicu 22).
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥3 × ULN occurred in 2.4 % of adalimumab-treated patients and 2.4 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 80 mg u nultom tjednu, nakon kojih slijede doze od 40 mg svaki drugi tjedan, počevši od 1. tjedna) u odraslih bolesnika s uveitisom u trajanju do 80 tjedana, uz medijan izloženosti od 166,5 dana u bolesnika liječenih adalimumabom te 105,0 dana u bolesnika iz kontrolne skupine, povišenja razine ALT-a ≥ 3 × GGN zabilježena su u 2,4 % bolesnika liječenih adalimumabom i 2,4 % bolesnika iz kontrolne skupine.
English: Adult Crohn's disease
Croatian: Crohnova bolest odraslih
English: Absorption and distribution Following the administration of 24 mg/m
Croatian: Nakon primjene 24 mg/m
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: BROJE(VI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: (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 steady-state (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 concomitant methotrexate.
Croatian: (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: 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: U ovoj otvorenoj uvodnoj fazi ispitivanja svi bolesnici su primali 24 mg/m adalimumab do maksimalne doze od 40 mg adalimumaba, svaki drugi tjedan kroz 16 tjedana.
English: The recommended Imraldi dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Croatian: Preporučena doza lijeka Imraldi za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Imraldi.
Croatian: Za vrijeme liječenja lijekom Imraldi može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: Imraldi is used to treat ulcerative colitis in adults.
Croatian: Imraldi je namijenjen liječenju ulceroznog kolitisa u odraslih.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥3 × ULN occurred in 0.3 % of adalimumabtreated patients and 0.6 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim 40 mg svaki tjedan, počevši od 4. tjedna) u bolesnika s gnojnim hidradenitisom, uz kontrolno razdoblje u trajanju od 12 do 16 tjedana, povišenja razine ALT-a ≥ 3 × GGN zabilježena su u 0,3 % bolesnika liječenih adalimumabom i 0,6 % bolesnika iz kontrolne skupine.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 μg/ml.
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: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Imraldi.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom Imraldi zbog moguće pojave infekcija, uključujući tuberkulozu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mg/0,8 ml
English: Table 9 ACR Responses in Placebo Controlled Trials (Percent of Patients)
Croatian: Tablica 9 ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika)
English: RA study Ia**
Croatian: Ispitivanje RA I
English: Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Croatian: U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, Imraldi se može primijeniti i bez prethodnog liječenja metotreksatom.
English: • Keep the special container out of the sight and reach of children at all times.
Croatian: • Ovaj poseban spremnik uvijek čuvajte izvan pogleda i dohvata djece.
English: • high blood measurements for white blood cells;
Croatian: • visoka razina bijelih krvnih stanica;
English: Imraldi is used to treat psoriatic arthritis in adults.
Croatian: Imraldi je namijenjen liječenju psorijatičnog artritisa u odraslih.
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Croatian: Ispitivanjem PsA I u trajanju od 24 tjedna obuhvaćeno je 313 odraslih bolesnika koji nisu ostvarili odgovarajući odgovor na prethodno liječenje nesteroidnim protuupalnim lijekovima.
English: Hold the white plunger rod in and turn the vial and syringe upside down.
Croatian: Držite bijeli klip štrcaljke pritisnutim te preokrenite bočicu i štrcaljku.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Croatian: ***, ** Statistički značajno kod p < 0,001 odnosno p < 0,01 za sve usporedbe lijeka adalimumab s placebom.
English: In adolescent patients with inadequate response to Imraldi 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 s neodgovarajućim odgovorom na 40 mg lijeka Imraldi svaki drugi tjedan, može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: • While holding the vial adapter firmly, insert the syringe tip into the vial adapter and twist the syringe clockwise with one hand until firm.
Croatian: • Dok čvrsto držite nastavak bočice, umetnite vrh štrcaljke u nastavak i jednom rukom zakrenite štrcaljku u smjeru kazaljke na satu da bude čvrsto.
English: The recommended dose of Imraldi 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 Imraldi iznosi 40 mg adalimumaba, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Croatian: Važno je da prije bilo kakvog cijepljenja djeteta obavijestite liječnika svog djeteta i druge zdravstvene radnike o tome da ste u trudnoći primali lijek Imraldi (za više informacija o cjepivima pogledajte dio „Upozorenja i mjere opreza“).
English: Imraldi 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: U kombinaciji s metotreksatom, Imraldi je indiciran za: - liječenje umjereno teškog do teškog oblika reumatoidnog artritisa u aktivnoj fazi u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti,
English: • 40 mg at week 0 and 20 mg at week 2
Croatian: • 40 mg u nultom tjednu i 20 mg u drugom tjednu
English: • feeling weak or tired;
Croatian: • osjećaj slabosti ili umora;
English: • shortness of breath;
Croatian: • nedostatak zraka;
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 × ULN occurred in 1.8% of adalimumab-treated patients and 1.8 % of control-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 × GGN zabilježena su u 1,8 % bolesnika liječenih adalimumabom i 1,8 % bolesnika iz kontrolne skupine.
English: Imraldi is used to treat moderate to severe plaque psoriasis in adults.
Croatian: Imraldi je namijenjen liječenju umjerene do teške plak psorijaze u odraslih.
English: Table 9 Radiographic Mean Changes Over 12 Months in RA Study III
Croatian: Tablica 9 Srednje vrijednosti promjena radioloških nalaza tijekom 12 mjeseci u ispitivanju RA III
English: OL-LI 16 weeks
Croatian: Otvorena uvodna - 16 tjedana
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Imraldi.
Croatian: U rijetkim je slučajevima u bolesnika koji su uzimali lijek Imraldi uočen specifičan i težak oblik limfoma.
English: The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.
Croatian: Uobičajena početna doza je 40 mg, nakon čega poslije dva tjedna slijedi doza od 20 mg.
English: • adolescent hidradenitis suppurativa,
Croatian: • gnojnog hidradenitisa adolescenata,
English: SPARCCh MRI Sacroiliac Jointsd,i
Croatian: MR sakroilijakalnih zglobova d,i
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of
Croatian: Djelotvornost i sigurnost adalimumaba ocjenjivale su se u randomiziranim, dvostruko slijepim,
English: Adalimumab 80/40 mg N=75
Croatian: Adalimumab 80/40 mg
English: P Valueb
Croatian: P vrijednost1
English: Imraldi 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: Imraldi 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 konvencionalnu terapiju (vidjeti dio 5.1).
English: Imraldi is administered by subcutaneous injection.
Croatian: Imraldi se primjenjuje supkutanom injekcijom.