natgillin/translations-raw huggingface dataset:
Cyltezo 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. 
Zdravilo Cyltezo je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Adalimumab 40 mg every other week N = 70 
adalimumab 40 mg vsak drugi teden n = 70
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 
Delež (95-% interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1.000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1.000 bolnikov-let v kontrolni skupini bolnikov.
Cyltezo is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are 
Zdravilo Cyltezo je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis 
Ankilozirajoči spondilitis, aksialni spondiloartritis brez radiografskega dokaza za AS in psoriatični
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).
b. 
S
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
Check with your doctor before you receive any vaccines. 
Preden opravite kakršno koli cepljenje, se posvetujte z zdravnikom.
RA study III also had a primary endpoint of changes in quality of life. 
Študija revmatoidnega artritisa III je imela kot primarni opazovani dogodek tudi spremembe
Cyltezo 40 mg solution for injection in pre-filled pen Cyltezo 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. 
Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, namenjeno uporabi za bolnika, vsebuje napolnjeno injekcijsko brizgo.
Inflammation 
Cepljenja
Efficacy results 
Neželeni učinki
The recommended Cyltezo dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). 
Priporočeni odmerek zdravila Cyltezo pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
Cyltezo 40 mg solution for injection in pre-filled pen EU/1/17/1240/006 
EU/1/17/1240/001 1 napolnjena injekcijska brizga EU/1/17/1240/002 2 napolnjeni injekcijski brizgi EU/1/17/1240/003 4 napolnjene injekcijske brizge EU/1/17/1240/004 6 napolnjenih injekcijskih brizg
Cyltezo may be available as a pre-filled syringe and/or a pre-filled pen. 
Zdravilo Cyltezo je lahko na voljo v napolnjeni injekcijski brizgi in/ali napolnjenem injekcijskem peresniku.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen. 
Otroci, mladostniki in odrasli s poliartikularnim juvenilnim idiopatskim artritisom Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg Zdravilo Cyltezo je na voljo le v obliki 40 mg napolnjene injekcijske brizge in napolnjenega injekcijskega peresnika.
Paediatric CD Study PCDAI Clinical Remission and Response 
Preglednica 26: Študija Crohnove bolezni pri pediatričnih bolnikih - PCDAI klinična remisija
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 Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen. 
Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg Zdravilo Cyltezo je na voljo le v obliki 40 mg napolnjene injekcijske brizge in napolnjenega injekcijskega peresnika.
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/m2 telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen. 
Otroci, mladostniki in odrasli z artritisom, povezanim z entezitisom Otroci in mladostniki, starejši od 6 let, ki tehtajo od 15 kg do manj kot 30 kg Zdravilo Cyltezo je na voljo le v obliki 40 mg napolnjene injekcijske brizge in napolnjenega injekcijskega peresnika.
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.
40 mg Adalimumab every other week 
placebo 40 mg adalimumaba vsak drugi teden
In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab 
Pri podaljšanih študijah brez placeba se je pri zdravljenju z adalimumabom izboljšanje znakov in
Adalimumab 40 mg weekly N = 70 
adalimumab 40 mg vsak teden n = 70
If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. 
Če ta odmerek ne deluje dovolj dobro, lahko njegov zdravnik odmerek poveča na 40 mg vsak teden ali 80 mg vsak drugi teden.
Ped ACR 30 Responses in the JIA study 
Odzivi Ped ACR 30 v študiji pri juvenilnem idiopatskem artritisu
Cyltezo is used to treat psoriatic arthritis in adults. 
Zdravilo Cyltezo se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
Cyltezo is used to treat ulcerative colitis in adults. 
Zdravilo Cyltezo se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of Cyltezo is 40 mg every other week with methotrexate. 
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila Cyltezo je 40 mg vsak drugi teden z metotreksatom.
Double-Blind Response at Week 12 
4. teden Klinična remisija 12 % 24 %
Cyltezo is used to treat moderate to severe plaque psoriasis in adults. 
Zdravilo Cyltezo se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
- Not applicable. 
- Navedba smiselno ni potrebna.
NAME OF THE MARKETING AUTHORISATION HOLDER 
Imetnik dovoljenja za promet z zdravilom
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose 
Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Non-infectious uveitis in adults and children Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Cyltezo works by 
Neinfekcijski uveitis je vnetna bolezen, ki prizadene določene dele očesa.
Cyltezo should be used with caution in patients with mild heart failure (NYHA class I/II). 
Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo Cyltezo uporabljati previdno.
In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment 
Izkušenj z adalimumabom pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega
CD Study II: Infliximab Experienced Patients 
Študija pri Crohnovi bolezni II: bolniki, ki so že dobivali infliksimab placebo n = 74
Following the administration of 24 mg/m² (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 steadystate (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 
2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
Cyltezo dose for patients with polyarticular juvenile idiopathic arthritis 
Preglednica 1: Odmerek zdravila Cyltezo pri bolnikih s poliartikulatnim juvenilnim idiopatskim
Note: P = Placebo (Number at Risk (flared)); A = adalimumab (Number at Risk (flared)). 
Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = adalimumab (število rizičnih preiskovancev (zagon bolezni)).
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.
No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients 
Pri 60 pediatričnih bolnikih z uveitisom, ki so bili med preskušanji z adalimumabom izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively. 
Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z adalimumabom in kombinacijo adalimumab/metotreksat, glede na izhodišče 10,8, 9,2 oz. 3,9.
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of non-melanoma skin cancer prior to and during treatment with Cyltezo. 
Pred zdravljenjem z zdravilom Cyltezo in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
The recommended dose of adalimumab for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). 
Poliartikularni juvenilni idiopatski artritis od 2. leta starosti Priporočeni odmerek adalimumaba za bolnike s poliartikularnim juvenilnim idiopatskim artritisom, stare 2 leti in več, temelji na telesni masi (preglednica 1).
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be 
Pri otrocih in mladostnikih, zdravljenih z antagonisti TNF, ni mogoče izključiti tveganja nastanka malignomov.
Cyltezo may have a minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Cyltezo ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Patients who experience insufficient response may benefit from an increase in dosage: • < 40 kg: 
Pri bolnikih, ki se ne odzovejo zadostno, se lahko odmerek poveča: Navedba smiselno ni potrebna.
It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. 
Pomembno je, da obvestite zdravnika, če doživite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
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.
Improvement in health-related quality of life and physical function was maintained during the open-label 
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
In adolescent patients with inadequate response to Cyltezo 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered. 
Pri mladostnikih z nezadostnim odzivom na zdravilo Cyltezo 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali 80 mg vsak drugi teden.
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. 
Polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, doseže med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
PRILOGA II A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
Cyltezo dose for paediatric patients with plaque psoriasis 
Preglednica 3: Odmerjanje zdravila Cyltezo pri pediatričnih bolnikih s psoriazo v plakih
Adalimumab 40 mg eow N = 814 n (%) 
adalimumab 40 mg vsak 2. teden n = 814 n (%)
Cyltezo is only available as 40 mg pre-filled syringe/pre-filled pen. 
Zdravilo Cyltezo je na voljo le v obliki 40 mg napolnjene injekcijske brizge/napolnjenega injekcijskega peresnika.
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients) 
Preglednica 16: Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom
The recommended dose of Cyltezo for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). 
Priporočeni odmerek zdravila Cyltezo pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
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 Cyltezo should be considered prior to initiating therapy (see Other opportunistic infections). 
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Cyltezo 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 Oportunistične okužbe).
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. 
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 5,5 µg/ml.
If a faster effect is required your doctor may prescribe 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 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week. 
Če je potreben hitrejši učinek, vam zdravnik lahko predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije na en dan ali dve 40 mg injekciji dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
The recommended dose of Cyltezo for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). 
Priporočeni odmerek zdravila Cyltezo pri bolnikih z artritisom, povezanim z entezitisom, stare 6 let in več, temelji na telesni masi (preglednica 2).
The usual Cyltezo dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (as two 40 mg injections in one day) at week 2 and thereafter 40 mg every other week. 
Običajni odmerek zdravila Cyltezo pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva) 0. teden in 80 mg (kot dve 40 mg injekciji v enem dnevu) 2. teden, nato pa 40 mg vsak drugi teden.
Cardiac disorders* Common 
Srčne bolezni*
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 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 x zgornja normalna meja (ULN, Upper Limits of Normal) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
System Organ Class Frequency 
Organski sistem
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems. 
Pomembno je, da obvestite zdravnika, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
Adalimumab 40 mg eow N = 108 n (%) 
adalimumab 40 mg vsak 2. teden n = 108 n (%)
In Psoriasis Study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33). 
V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov, ki so še naprej dobivali adalimumab (p < 0,001).
p-value p-value p-value 
a Vrednost Vrednost p
One 0.8 mL pre-filled syringe contains 40 mg adalimumab. 
En 0,8 ml napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
Cyltezo is administered via subcutaneous injection. 
Zdravilo Cyltezo se uporablja kot subkutana injekcija.
• low blood measurements for phosphate; 
• nizke krvne vrednosti za trombocite;
Discontinuation of Cyltezo 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 Cyltezo.
If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your Crohn's disease. 
Če ta zdravila ne bodo delovala dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo
Cyltezo is administered every other week via subcutaneous injection. 
Zdravilo Cyltezo se aplicira vsak drugi teden v obliki
Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen. 
Zdravilo Cyltezo je na voljo le v obliki 40 mg napolnjene injekcijske brizge in napolnjenega injekcijskega peresnika.
Cyltezo contains sodium 
Shranjevanje zdravila Cyltezo
Should treatment be interrupted, Cyltezo 40 mg every week or 80 mg every other week may be re-introduced 
Če je potrebno zdravljenje prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Cyltezo z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) 
alacebo (n = 28) b 43,3 % (13/30) 71,4 % (20/28)
Name and address of the manufacturer(s) responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim International GmbH
Beyond 16 weeks, patients with inadequate response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. 
Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Cyltezo 40 mg vsak drugi teden, koristi povečanje odmerka na 40 mg vsak teden ali 80 mg vsak drugi teden.
* p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions 
* p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom
• scar; 
• srbenje;
Cyltezo 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear to slightly opalescent solution of 40 mg adalimumab. 
Zdravilo Cyltezo 40 mg raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi je na voljo kot sterilna 0,8 ml bistra do rahlo opalescentna raztopina 40 mg adalimumaba.
Mean exposure in all adalimumab population was 762 days. 
Povprečna izpostavljenost v vseh populacijah z adalimumabom je bila 762 dni.Tekom vseh treh študij so bolniki dnevno uporabljali topikalno antiseptično čistilno tekočino.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis 
Ankilozirajoči spondilitis in aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči
If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later. 
Če je potreben hitrejši odziv, lahko zdravnik vašega otroka predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Vertigo and visual impairment may occur following administration of Cyltezo (see section 4.8). 
Po dajanju zdravila Cyltezo se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
Cyltezo 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 
Zdravilo Cyltezo je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
Hidradenitis Suppurativa Clinical Response 
Klinična remisija Klinični odziv