FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cyltezo 40 mg injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Cyltezo 40 mg injekcija adalimumab subkutana uporaba
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.
Slovenian: • Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNFα, so bili primeri rakov, ki niso bili limfomi.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Cyltezo.
Slovenian: Priporočljivo je, da med zdravljenjem z zdravilom Cyltezo bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
English: Radiographic Mean Changes at Week 52 in RA Study V MTX n=257 confidence interval)
Slovenian: Povprečne rentgenografske spremembe po 52 tednih študije adalimumab/ MTX n = 268 (95-% interval zaupanja)
English: ACR Responses in RA Study V (percent of patients)
Slovenian: Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1-0.4 mg/kg weekly (up to 25 mg).
Slovenian: Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do največ 40 mg), 0,4 mg/kg vsak drugi teden (do največ 20 mg) ali 0,1 - 0,4 mg/kg metotreksata na teden (do največ
English: Cyltezo dose for patients with enthesitis-related arthritis
Slovenian: Preglednica 2: Odmerjanje zdravila Cyltezo pri bolnikih z artritisom, povezanim z entezitisom
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Slovenian: Med temi kožnimi raki je bil delež (95-% interval zaupanja) ploščatoceličnega karcinoma 2,7 (1,4; 5,4) 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.
English: The recommended dose of Cyltezo for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Slovenian: Priporočeni odmerek zdravila Cyltezo pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Cyltezo is an initial dose of 40 mg, followed by 40 mg one week later.
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Cyltezo je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
English: Keep this
Slovenian: Pritisnite in držite
English: Cyltezo 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
Slovenian: Zdravilo Cyltezo je indicirano za zdravljenje kroničnega, neinfekcijskega, anteriornega uveitisa pri pediatričnih bolnikih, starejših od 2 let, ki se niso ustrezno odzvali ali ne prenašajo konvencionalnega zdravljenja, ali pri katerih konvencionalno zdravljenje ni primerno.
English: • Gently remove cap by pulling it straight off. Do not touch needle or let needle touch anything.
Slovenian: Ne dotikajte se igle, prav tako se z iglo ničesar ne dotikajte.
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Razpoložljivi podatki kažejo, da je klinični odziv ponavadi dosežen v 12 tednih zdravljenja.
English: In the OL LI phase all patients received 24 mg/m² up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Slovenian: V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) adalimumaba vsak drugi teden.
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Slovenian: *** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom
English: Adalimumab has not been studied in patients aged less than 2 years.
Slovenian: Raziskave z adalimumabom pri bolnikih, mlajših od 2 let, niso bile izvedene.
English: Cyltezo is used to treat rheumatoid arthritis in adults.
Slovenian: Zdravilo Cyltezo se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
English: 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.
Slovenian: 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.
English: (See section 4.5).
Slovenian: (glejte podatke za odrasle bolnike v poglavju 5.1).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: 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.
Slovenian: Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
English: • allergic reactions (including seasonal allergy);
Slovenian: • alergijske reakcije (vključno s sezonskimi alergijami); • spremenljivo razpoloženje (vključno z depresijo);
English: 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
Slovenian: 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).
English: • Do not reuse a used pre-filled syringe.
Slovenian: • Napolnjene injekcijske brizge ne uporabite znova.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your
Slovenian: 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.
English: 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
Slovenian: 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.
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Slovenian: V kliničnih preskušanjih so bile redke resne alergijske reakcije, povezane z adalimumabom.
English: 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
Slovenian: • 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;
English: The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the
Slovenian: Varnostni profil za bolnike z uveitisom, ki so bili vsak drugi teden zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
English: 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
Slovenian: 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**
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: • 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
Slovenian: • otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: Adalimumab 40 mg every other week N = 70
Slovenian: adalimumab 40 mg vsak drugi teden n = 70
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
Slovenian: 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.
English: Cyltezo is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are
Slovenian: Zdravilo Cyltezo je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Slovenian: Ankilozirajoči spondilitis, aksialni spondiloartritis brez radiografskega dokaza za AS in psoriatični
English: 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.
Slovenian: 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).
English: b.
Slovenian: S
English: 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.
Slovenian: 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
English: Check with your doctor before you receive any vaccines.
Slovenian: Preden opravite kakršno koli cepljenje, se posvetujte z zdravnikom.
English: RA study III also had a primary endpoint of changes in quality of life.
Slovenian: Študija revmatoidnega artritisa III je imela kot primarni opazovani dogodek tudi spremembe
English: 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.
Slovenian: 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.
English: Inflammation
Slovenian: Cepljenja
English: Efficacy results
Slovenian: Neželeni učinki
English: The recommended Cyltezo dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Slovenian: Priporočeni odmerek zdravila Cyltezo pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: Cyltezo 40 mg solution for injection in pre-filled pen EU/1/17/1240/006
Slovenian: 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
English: Cyltezo may be available as a pre-filled syringe and/or a pre-filled pen.
Slovenian: Zdravilo Cyltezo je lahko na voljo v napolnjeni injekcijski brizgi in/ali napolnjenem injekcijskem peresniku.
English: 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.
Slovenian: 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.
English: Paediatric CD Study PCDAI Clinical Remission and Response
Slovenian: Preglednica 26: Študija Crohnove bolezni pri pediatričnih bolnikih - PCDAI klinična remisija
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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 Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 40 mg Adalimumab every other week
Slovenian: placebo 40 mg adalimumaba vsak drugi teden
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab
Slovenian: Pri podaljšanih študijah brez placeba se je pri zdravljenju z adalimumabom izboljšanje znakov in
English: Adalimumab 40 mg weekly N = 70
Slovenian: adalimumab 40 mg vsak teden n = 70
English: 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.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko njegov zdravnik odmerek poveča na 40 mg vsak teden ali 80 mg vsak drugi teden.
English: Ped ACR 30 Responses in the JIA study
Slovenian: Odzivi Ped ACR 30 v študiji pri juvenilnem idiopatskem artritisu
English: Cyltezo is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo Cyltezo se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: Cyltezo is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo Cyltezo se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: 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.
Slovenian: 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.
English: Double-Blind Response at Week 12
Slovenian: 4. teden Klinična remisija 12 % 24 %
English: Cyltezo is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Cyltezo se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: - Not applicable.
Slovenian: - Navedba smiselno ni potrebna.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose
Slovenian: Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Non-infectious uveitis in adults and children Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Cyltezo works by
Slovenian: Neinfekcijski uveitis je vnetna bolezen, ki prizadene določene dele očesa.
English: Cyltezo should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo Cyltezo uporabljati previdno.
English: In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment
Slovenian: Izkušenj z adalimumabom pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega
English: CD Study II: Infliximab Experienced Patients
Slovenian: Študija pri Crohnovi bolezni II: bolniki, ki so že dobivali infliksimab placebo n = 74
English: 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
Slovenian: 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 %).
English: Cyltezo dose for patients with polyarticular juvenile idiopathic arthritis
Slovenian: Preglednica 1: Odmerek zdravila Cyltezo pri bolnikih s poliartikulatnim juvenilnim idiopatskim
English: Note: P = Placebo (Number at Risk (flared)); A = adalimumab (Number at Risk (flared)).
Slovenian: Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = adalimumab (število rizičnih preiskovancev (zagon bolezni)).