natgillin/translations-raw huggingface dataset:
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %). 
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna zdravnikova globalna ocena (PGA - Physician's Global Assessment) pa je segala od "zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).
Table 14 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks 
Študija pri psoriazi I (REVEAL) - rezultati učinkovitosti po 16 tednih Placebo
Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24. 
Ob zdravljenju z adalimumabom so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF 36 (Short Form Health Survey).
The recommended dose of Imraldi is 40 mg every other week. 
Priporočeni odmerek zdravila Imraldi je 40 mg vsak drugi teden.
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Imraldi. 
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Imraldi ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje telesne mase, nekoliko zvišano telesno temperaturo).
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 8). 
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 8).
If you use less Imradi than you should 
Če ste uporabili manjši odmerek zdravila Imraldi, kot bi smeli
Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (<40 kg or ≥40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score >30. 
Adalimumab je bil ocenjen v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti uvodnega in vzdrževalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 kg ali ≥ 40 kg) pri 192 pediatričnih bolnikih med 6. in 17.
Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections 
pogosti sistemske okužbe (vključno s sepso, kandidiazo in gripo), črevesne okužbe (vključno z virusnim gastroenteritisom), okužbe kože in mehkih tkiv (vključno z zanohtnico, celulitisom, impetigom, nekrotizirajočim fasciitisom in herpes zostrom), okužbe ušes, okužbe ustne votline (vključno s herpesom simpleksom, ustnim herpesom in okužbami zob), okužbe reproduktivnega trakta (vključno z vulvovaginalno mikotično okužbo), okužbe urinarnega trakta (vključno s pielonefritisom), glivične okužbe, okužbe sklepov občasni okužbe centralnega živčevja (vključno z virusnim meningitisom), oportunistične okužbe in tuberkuloza (vključno s kokcidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium),
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥40 kg, and 80 mg and 40 mg, respectively, for subjects <40 kg. 
Vsi bolniki so prejeli odprto uvodno zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg v tem vrstnem redu bolniki z < 40 kg.
Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase 
Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Imraldi. 
Med zdravljenjem z zdravilom Imraldi je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study 
Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
Week 2 Week 12 Week 24 
2. teden 12. teden 24. teden
Adalimumab 40 mg weekly N = 70 
40 mg adalimumaba vsak teden N = 70
Very common Elevated liver enzymes Uncommon Cholecystitis and cholelithiasis, 
zelo pogosti zvišani jetrni encimi občasni vnetje žolčnika in holelitiaza,
All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52. 
V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami adalimumaba izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
Anti-adalimumab antibodies may develop during adalimumab treatment. 
Med zdravljenjem z adalimumabom lahko pride do razvoja protiteles proti adalimumabu.
- The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20 and water for injections. 
- Druge sestavine zdravila so natrijev citrat, citronska kislina monohidrat, histidin, histidinijev klorid monohidrat, sorbitol, polisorbat 20 in voda za injekcije.
If this dose does not work well enough, your child's doctor may increase the dose frequency to 20 mg every week. 
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik vašemu otroku poveča pogostnost odmerjanja na 20 mg vsak teden.
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. 
V študiji revmatoidnega artritisa I je bilo ocenjeno 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
What you need to know before your child uses Imraldi 3. 
Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Imraldi
Carriers of HBV who require treatment with Imraldi should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. 
Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Imraldi, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
Table 7 ACR Responses in Placebo Controlled Trials (Percent of Patients) 
Odziv po ACR v preskušanjih, kontroliranih s placebom (odstotek bolnikov)
* p<0.05, ***p<0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 
* p < 0,05, ***p < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki b Med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži
RA study IIa** 
Študija revmatoidnega artritisa IIa**
Table 25 Maintenance regimen 
Vzdrževalni režim
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. 
Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1), 
pogosti poslabšanje ali pojav psoriaze (vključno s palmoplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom),
4 pre-filled pens 4 alcohol pads 
4 alkoholni zloženci
Week 26 Placebo-Controlled 
Kontrolirana s placebom26.
Table 10 Radiographic Mean Changes at Week 52 in RA Study V 
Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks 
Študija pri psoriazi II (CHAMPION) - rezultati učinkovitosti po 16 tednih Placebo
Absorption and distribution Following the administration of 24 mg/m 
Po uporabi 24 mg/m
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 10). 
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. 
Običajni začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
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. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 × ULN pojavilo pri 1,8 % bolnikov,
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. 
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
Imraldi is given by injection under the skin (by subcutaneous injection). 
Zdravilo Imraldi se daje v obliki injekcije pod kožo (subkutana uporaba).
There is no relevant use of Imraldi in children aged less than 4 years for this indication. 
Uporaba zdravila Imraldi pri otrocih, starih manj kot 4 leta, za to indikacijo ni primerna.
104 Week 42.8% 36.9% 59.0% <0.001 <0.001 0.162 
52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104. teden 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162
Placebo/MTXa 
Placebo/MTXadalimumab/MTX
Muscle spasms (including blood creatine phosphokinase increased) 
Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti mišičnoskeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Imraldi is used to treat ulcerative colitis in adults. 
Zdravilo Imraldi se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
EU/1/17/1216/005 1 pre-filled pen EU/1/17/1216/006 2 pre-filled pens EU/1/17/1216/007 4 pre-filled pens EU/1/17/1216/008 6 pre-filled pens 
EU/1/17/1216/005 1 napolnjen injekcijski peresnik EU/1/17/1216/006 2 napolnjena injekcijska peresnika EU/1/17/1216/007 4 napolnjeni injekcijski peresniki EU/1/17/1216/008 6 napolnjenih injekcijskih peresnikov
The recommended Imraldi dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). 
Priporočeni odmerek zdravila Imraldi pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
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. 
Za bolnike sta na voljo tudi 40 mg napolnjen injekcijski peresnik in 40 mg napolnjena injekcijska brizga za apliciranje polnega 40 mg odmerka.
Imraldi is used to treat psoriatic arthritis in adults. 
Zdravilo Imraldi se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
The patients received 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks. 
Bolniki so vsaj 24 tednov prejemali adalimumab v odmerku 24 mg/m telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
I − V. In these trials, 11.9 % of patients treated with adalimumab and 8.1% of placebo and active control treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24. 
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
The recommended dose of Imraldi for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). 
Priporočeni odmerek zdravila Imraldi pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised doubleblind study (Psoriasis study III). 
Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (študija pri psoriazi III).
Your doctor should test you for HBV. Imraldi can reactivate HBV infection in people who carry this virus. 
Zdravilo Imraldi lahko pri nosilcih HBV reaktivira okužbo s HBV.
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 
12. tedna ni prineslo značilno več odzivov (glejte poglavje 4.2).
This risk may increase if his/her lung function is impaired. 
Tveganje je lahko večje, če ima vaš otrok okvarjeno delovanje pljuč.
Caring for your pre-filled syringe 
Skrb za vaš napolnjen injekcijski peresnik
104 Week 56.0% 49.3% 69.4% 0.002 <0.001 0.140 
52. teden 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043 104. teden 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
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. 
Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg Običajni odmerek zdravila Imraldi je 20 mg vsak drugi teden z metotreksatom.
In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 µg/mL. 
Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečne koncentracije v stanju dinamičnega ravnovesja približno 8 do 10 μg/ml.
Dosing Regimen 
Režim odmerjanja
arrhythmia, congestive heart failure 
Neželeni učinki kongestivno srčno popuščanje redki zastoj srca
NEVER pull past the 0.9 ml position regardless of prescribed dose. 
Ne glede na predpisani odmerek pa nosilca bata NIKOLI ne potegnite preko položaja 0,9 ml.
Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections. 
Pomožne snovi: natrijev citrat, citronska kislina monohidrat, histidin, histidinijev klorid monohidrat, sorbitol, polisorbat 20 in voda za injekcije.
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. 
Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimumaba v serumu pred naslednjim odmerkom približno 7 do 8 μg/ml v 2. tednu in v 4. tednu.
DO NOT use if the liquid is not clear or not free of particles. 
Zdravila NE UPORABLJAJTE, če je tekočina motna ali vsebuje kosmiče ali delce.
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. 
Dvojno slepi periodi je sledila odprta perioda, v kateri so bolniki prejemali 40 mg adalimumaba vsak drugi teden subkutano do dodatnih
Discontinuation of Imraldi therapy should be considered in patients with confirmed significant haematologic abnormalities. 
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Imraldi.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. 
Zdravilo Imraldi se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
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. 
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila Imraldi je 40 mg vsak drugi teden z metotreksatom.
Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. 
Glede na vaš odziv vam bo zdravnik lahko povečal odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Hepatitis reactivation of hepatitis B1) 
zvišana vrednost bilirubina v krvi redki hepatitis reaktivacija hepatitisa B avtoimunski hepatitis1)
Imraldi 40 mg injection adalimumab SC 
Imraldi 40 mg injekcija adalimumab s.c.
• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; 
• znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi,
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Imraldi should be considered prior to initiating therapy (see Other opportunistic infections). 
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Imraldi pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Druge oportunistične okužbe).
Amongst those who responded (Paediatric ACR 30) at week 24 (n=27 out of 30 patients), the Paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period. 
od 30 bolnikov), se je odziv Paediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks. 
Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali zdravilo adalimumab 40 mg vsak drug teden vsaj 12 tednov.
Low Dose 20/10 mg eow P value1 
Majhni odmerek 20/10 mg vsak P vrednost1
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment. 
Pri odraslih bolnikih s psoriazo je bila povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 μg/ml.
If your child gets any side effects, talk to your child's doctor or pharmacist. 
Če vaš otrok opazi katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom svojega otroka ali farmacevtom.
Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. 
Zdravilo Imraldi je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem,
114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or PASI ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy. 
zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
 Avoid skin that's sore, bruised, scarred, scaly, or has red patches. 
 Izogibajte se injiciranja na mestih, kjer je koža boleča, zabrazgotinjena ali luskasta ali pa so na njej modrice ali rdeče lise.
Imraldi is administered via subcutaneous injection. 
Zdravilo Imraldi se uporablja kot subkutana injekcija.
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %). 
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna ocena PGA pa je segala od "zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).