natgillin/translations-raw huggingface dataset:
Cyltezo is used to treat rheumatoid arthritis in adults.
Zdravilo Cyltezo se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Concurrent administration of biologic DMARDS or TNF-antagonists Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
V kliničnih študijah s sočasno uporabo anakinre in etanercepta, drugega antagonista TNF, so opazili hude okužbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
(See section 4.5).
(glejte podatke za odrasle bolnike v poglavju 5.1).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
It is recommended that the conduct and results of these tests are recorded in the patient alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
• allergic reactions (including seasonal allergy);
• alergijske reakcije (vključno s sezonskimi alergijami); • spremenljivo razpoloženje (vključno z depresijo);
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
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Cyltezo ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
• Do not reuse a used pre-filled syringe.
• Napolnjene injekcijske brizge ne uporabite znova.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your
Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okužbe, o tem takoj obvestite zdravnika.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi adalimumaba in azatioprina/6-merkaptopurina opazili večjo incidenco malignih in resnih z okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z adalimumabom.
Serious allergic reactions associated with adalimumab were rare during clinical trials.
V kliničnih preskušanjih so bile redke resne alergijske reakcije, povezane z adalimumabom.
o Expiration date on pen or carton has passed o Medication is cloudy, discoloured, frozen, or contains flakes or particles o Pen appears cracked, damaged, or leaking
• Peresnika zdravila Cyltezo NE uporabite, če: ○ je datum roka uporabnosti peresnika ali škatle potekel; ○ je zdravilo motno, obarvano, zamrznjeno ali vsebuje kosmiče ali delce; ○ je peresnik videti počen, poškodovan ali pušča;
The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the
Varnostni profil za bolnike z uveitisom, ki so bili vsak drugi teden zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
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 paronihijo, celulitisom, impetigom, nekrotizirajočim fasciitisom in herpesom zostrom), okužbe ušes, okužbe ustne votline (vključno s herpesom simpleksom, ustnim herpesom in okužbami zob), okužbe rodil (vključno z vulvovaginalno mikotično okužbo), okužbe sečil (vključno s pielonefritisom), glivične okužbe, okužbe sklepov nevrološke okužbe (vključno z virusnim meningitisom), oportunistične okužbe in tuberkuloza (vključno s kokidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium), bakterijske okužbe, okužbe oči, divertikulitis karcinom kože, razen melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor limfom**, novotvorbe na parenhimskih organih (vključno z rakom dojk, novotvorbo na pljučih in novotvorbo na ščitnici), melanom**
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
V študiji pri Crohnovi bolezni I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumaba 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
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 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg) Kliničnih preskušanjih z adalimumabom pri mladostnikih s HS ni. Odmerjanje adalimumaba pri teh bolnikih je bilo določeno na podlagi farmakokinetičnega modeliranja in simulacije (glejte
Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
2 (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
• Adults with non-infectious uveitis with inflammation affecting the back of the eye • Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the
• otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
Cyltezo is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Cyltezo je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo
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).