FrancophonIA/ELRC3.0 huggingface dataset:
English: Imraldi 40 mg solution for injection in pre-filled syringe Imraldi 40 mg solution for injection in pre-filled pen
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj štrcaljki Imraldi 40 mg otopina za injekciju u napunjenoj brizgalici
English: • pulmonary fibrosis (scarring of the lung);
Croatian: • plućna fibroza (ožiljci na plućima);
English: Keep the pre-filled syringe or pre-filled pen in outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku ili napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Croatian: 40 mg svaki drugi tjedan Adalimumab nije ispitivan u bolesnika s artritisom povezanim s entezitisom mlađih od 6 godina.
English: • cancer
Croatian: • rak
English: If these medicines do not work well enough, you will be given Imraldi to reduce the signs and symptoms of your disease.
Croatian: Ukoliko ovi lijekovi ne djeluju dovoljno dobro, bit će Vam propisan lijek Imraldi kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Week 12 Week 24
Croatian: 12. tjedan 24. tjedan
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively.
Croatian: Nakon supkutane primjene adalimumaba u dozi od 40 mg svaka dva tjedna u odraslih bolesnika s reumatoidnim artritisom srednje vrijednosti najniže koncentracije lijeka u stanju dinamičke ravnoteže bile su približno 5 μg /ml (bez istodobne primjene metotreksata), odnosno 8 do 9 μg/ml (uz metotreksat).
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Croatian: Radiološki nalazi u bolesnika liječenih kombinacijom adalimumaba i metotreksata pokazali su znatno sporiju progresiju strukturnih oštećenja zglobova nego u bolesnika liječenih samo metotreksatom tijekom 6 i 12 mjeseci (vidjeti Tablicu 9).
English: You will be instructed by your child's doctor or his/her assistant on the technique of injection and the amount to give to your child. Do not attempt to give your child an injection until you are sure that you understand how to prepare and give the injection.
Croatian: Ne pokušavajte dati injekciju djetetu dok niste sigurni da posve razumijete kako je prirediti i ubrizgati.
English: Your doctor should test you for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Croatian: Imraldi može u nositelja virusa reaktivirati infekciju HBV-om.
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 control patients.
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: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Croatian: Klinički se odgovor obično postiže unutar 12 tjedana liječenja.
English: The recommended dose of Imraldi is an initial dose of 40 mg, followed by 40 mg one week later.
Croatian: Preporučeno doziranje lijeka Imraldi je početna doza od 40 mg, a zatim 40 mg nakon tjedan dana.
English: Imraldi 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: Imraldi 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 conventional therapy is inappropriate.
Croatian: Imraldi 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: Table 1 Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Croatian: Tablica 1 Doza lijeka Imraldi za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom
English: Adalimumabb/ MTXc
Croatian: Adalimumab / MTXc
English: The recommended dose of Imraldi is 40 mg every other week.
Croatian: Preporučena doza lijeka Imraldi je 40 mg svaki drugi tjedan.
English: How to inject with your pre-filled pen Gather supplies
Croatian: Kako ubrizgavati pomoću napunjene brizgalice
English: solution for injection 1 pre-filled syringe 2 alcohol pads
Croatian: otopina za injekciju 1 napunjena brizgalica 2 alkoholna tupfera
English: • There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Croatian: • U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNFα blokatore, zabilježeni su slučajevi i drugačijih oblika raka osim limfoma.
English: Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of Imraldi 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 Imraldi je 40 mg svaki drugi tjedan s metotreksatom.
English: Hold the syringe on the graduated area and pull the syringe from its package.
Croatian: Štrcaljku držite za dio s označenim volumenima i izvucite je iz pakiranja.
English: Table 11 Radiographic Mean Changes Over 12 Months in RA Study III
Croatian: Tablica 11 Srednje vrijednosti promjena radioloških nalaza tijekom 12 mjeseci u ispitivanju RA III
English: N=53 n (%)
Croatian: n (%)
English: The recommended dose of Imraldi for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U bolesnika s ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza ASa te u bolesnika sa psorijatičnim artritisom preporučena doza lijeka Imraldi iznosi 40 mg adalimumaba, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Croatian: Za vrijeme liječenja adalimumabom može doći do stvaranja protutijela na adalimumab.
English: If you take 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 primjenjujete lijek Imraldi.
English: Taking these results into consideration, adalimumab 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 da se adalimumab daje u kombinaciji s metotreksatom, a monoterapija samo u onih bolesnika u kojih primjena metotreksata nije prikladna
English: 6 months 12 months ACR 70
Croatian: 6 mjeseci 12 mjeseci
English: Table 10 Radiographic Mean Changes at Week 52 in RA Study V
Croatian: Tablica 10 Srednje vrijednosti promjena radioloških nalaza nakon 52 tjedna u ispitivanju RA V
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Croatian: Radiološki nalazi u bolesnika liječenih kombinacijom adalimumaba i metotreksata pokazali su znatno sporiju progresiju strukturnih oštećenja zglobova nego u bolesnika liječenih samo metotreksatom tijekom 6 i 12 mjeseci (vidjeti Tablicu 11).
English: • fungal infections;
Croatian: • gljivične infekcije;
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: • inflammation of the eyelid and eye swelling;
Croatian: • upala očnog kapka i oticanje oka;
English: Table 22 Induction of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 22 Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in Period B.
Croatian: A bili randomizirani za primanje placeba je u razdoblju B dodijeljeno liječenje adalimumabom u dozi od 40 mg svaki tjedan.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza ankilozantnog spondilitisa upalne su bolesti kralježnice.
English: • abdominal (belly) pain;
Croatian: • bol u abdomenu (trbuhu);
English: Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Croatian: Stevens-Johnsonov sindrom angioedem kutani vaskulitis lihenoidne kožne reakcije nepoznato pogoršanje simptoma dermatomiozitisa
English: Imraldi is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Croatian: Imraldi se koristi za liječenje gnojnog hidradenitisa u adolescenata u dobi od 12 godina i starijih.
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 1.9-10.5, respectively).
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: Table 2 Imraldi Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Croatian: Tablica 2 Doza lijeka Imraldi za bolesnike s artritisom povezanim s entezitisom
English: • low blood measurements for red blood cells;
Croatian: • niska razina crvenih krvnih stanica;
English: Imraldi is administered via subcutaneous injection.
Croatian: Lijek Imraldi se primjenjuje supkutanom injekcijom.
English: years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Croatian: Ispitivanje RA I obuhvatilo je 271 bolesnika s umjereno teškim do teškim aktivnim reumatoidnim artritisom u dobi od 18 godina i starijih u kojih prethodna terapija barem jednim antireumatskim lijekom koji modificira tijek bolesti nije bila uspješna, u kojih nije bio dovoljno djelotvoran metotreksat u dozi od 12,5 do 25 mg (10 mg ako bolesnik ne podnosi metotreksat) jednom tjedno i u kojih je doza metotreksata bila konstantno 10 do 25 mg jednom tjedno.
English: Erosion Score JSNd Score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Croatian: d rezultat ametotreksat razlike 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: Table 24 Maintenance of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 24 Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ovisno o odgovoru na terapiju, Vaš liječnik Vam može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: The recommended dose of Imraldi for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Croatian: Preporučena doza lijeka Imraldi u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom, u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 1).
English: Table 20 Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Croatian: Tablica 20 Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: Children and adolescents with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg The recommended dose of Imraldi is 20 mg every other week.
Croatian: Djeca i adolescenti s poliartikularnim juvenilnim idiopatskim artritisom Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine od 10 kg do manje od 30 kg Preporučena doza lijeka Imraldi je 20 mg svaki drugi tjedan.
English: Adult plaque psoriasis
Croatian: Plak psorijaza odraslih
English: Induction Dose
Croatian: Indukcijska doza
English: Table 3 Imraldi Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Croatian: Tablica 3 Doza lijeka Imraldi za pedijatrijske bolesnike s plak psorijazom Tjelesna težina bolesnika
English: Vertigo and visual impairment may occur following administration of Imraldi (see section 4.8).
Croatian: Nakon primjene lijeka Imraldi mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: The recommended dose of Imraldi for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Croatian: Preporučena doza lijeka Imraldi za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (Tablica 2).
English: There is no relevant use of Imraldi in children aged less than 4 years for this indication.
Croatian: Nema relevantne primjene lijeka Imraldi u djece mlađe od 4 godine u ovoj indikaciji.
English: • low blood measurements for calcium;
Croatian: • niska razina kalcija u krvi;
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: Sigurnost i djelotvornost adalimumaba ispitivala se u odraslih bolesnika s kroničnom plak psorijazom (zahvaćeno ≥ 10 % površine tijela i rezultat prema ljestvici za ocjenjivanje zahvaćenosti kože i težine kliničke slike PASI ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: Imraldi 40 mg/0.8 ml injection adalimumab
Croatian: Imraldi 40 mg/0,8 ml otopina za injekciju adalimumab
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 ×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 × GGN (gornja granica normalnog raspona) zabilježeno je u 3,7 % bolesnika liječenih adalimumabom i 1,6 % bolesnika iz kontrolne skupine.
English: Imraldi 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: Imraldi 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: If you dropped your syringe with the cap OFF, do not use it.
Croatian: Ako Vam štrcaljka ispadne BEZ štitnika za iglu, nemojte je upotrijebiti.
English: Inspect medicine & expiration date
Croatian: Pregledajte lijek i rok valjanosti
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Croatian: Slika 3: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u ispitivanju liječenja uveitisa u djece
English: SPARCC MRI Spined,j a Assessments in SpondyloArthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Croatian: N = 91 za placebo i N = 87 za adalimumab f C-reaktivni protein visoke osjetljivosti (engl. high sensitivity C-Reactive Protein) (mg/l)
English: A 40 mg pre-filled pen and a 40 mg pre-filled syringe are also available for patients to administer a full 40 mg dose.
Croatian: Za bolesnike kojima je potrebno primijeniti punu dozu od 40 mg također su dostupne napunjena brizgalica od 40 mg i napunjena štrcaljka od 40 mg.
English: • low blood measurements for white blood cells;
Croatian: • niska razina bijelih krvnih stanica;
English: • low blood measurements for phosphate;
Croatian: • niska razina fosfata u krvi;
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako kod svoga djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti djetetovog liječnika ili ljekarnika.
English: Seek medical attention urgently if you notice any of the following:
Croatian: Primijetite li išta od dolje navedenog, odmah potražite liječničku pomoć:
English: Table 13 Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Croatian: Tablica 13 Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Croatian: Tablica 14 Djelotvornost u placebom kontroliranom ispitivanju nr axSpA I
English: The recommended Imraldi 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 Imraldi je 80 mg u nultom tjednu, nakon čega slijedi 40 mg svaki drugi tjedan počevši od prvog tjedna supkutanom injekcijom.
English: HS study I
Croatian: Ispitivanje HS I
English: Table 12 Radiographic Mean Changes at Week 52 in RA Study V
Croatian: Tablica 12 Srednje vrijednosti promjena radioloških nalaza nakon 52 tjedna u ispitivanju RA V
English: • While holding the vial, push the white plunger rod all the way down.
Croatian: • Dok držite bočicu, stisnite klip štrcaljke do kraja.
English: - If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati lijek Imraldi Nemojte primjenjivati lijek Imraldi - Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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: Dermatology Life Quality Index [DLQI]; ispitivanja HS-I i HS-II), opće zadovoljstvo bolesnika farmakološkim liječenjem, koje se određivalo upitnikom za ocjenjivanje zadovoljstva farmakološkim liječenjem (engl.
English: Your doctor will decide if your child should receive Imraldi.
Croatian: Liječnik će odlučiti trebate li Vaše dijete primiti lijek
English: Imraldi is given by injection under the skin (by subcutaneous injection).
Croatian: Imraldi se primjenjuje potkožnom injekcijom (supkutana injekcija).
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Croatian: Ankilozantni spondilitis, aksijalni spondiloartritis bez radiološkog dokaza AS-a te psorijatični artritis
English: • hidradenitis suppurativa,
Croatian: • gnojnog hidradenitisa,
English: Week 4
Croatian: 24. tjedan
English:  2 pre-filled pens, each with 1 alcohol pad  4 pre-filled pens, each with 1 alcohol pad  6 pre-filled pens, each with 1 alcohol pad
Croatian: Pakiranja s:  1 napunjenom brizgalicom s 2 alkoholna tupfera  2 napunjene brizgalice, svaka s 1 alkoholnim tupferom  4 napunjene brizgalice, svaka s 1 alkoholnim tupferom  6 napunjenih brizgalica, svaka s 1 alkoholnim tupferom
English: Discontinuation of Immunomodulators2
Croatian: Prekinuti imunomodulatori2
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza ankilozantnog spondilitisa
English: Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Croatian: Doza lijeka Imraldi za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom
English: * p <0.001 for adalimumab versus placebo pairwise comparisons of proportions
Croatian: *** p < 0,001 za sve usporedbe adalimumaba s placebom
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration
Croatian: Poremećaji metabolizma i prehrane vrlo često povišena razina lipida često hipokalijemija, povišene razine mokraćne kiseline, abnormalna razina natrija u krvi, hipokalcijemija, hiperglikemija, hipofosfatemija, dehidracija
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 The recommended dose of Imraldi is 20 mg every other week.
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 Preporučena doza lijeka Imraldi je 20 mg svaki drugi tjedan.
English: • numbness;
Croatian: • svrbež;
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Imraldi 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 Imraldi je 40 mg svaki drugi tjedan.
English: The recommended dose of Imraldi is an 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: Preporučeno doziranje lijeka Imraldi je 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: The safety and efficacy of adalimumab were assessed in over 1,500 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 Chronove bolesti [engl.