natgillin/translations-raw huggingface dataset:
Tell your doctor if you are taking azathioprine or
Obvestite zdravnika, če prejemate azatioprin ali merkaptopurin sočasno z
Patients who maintained ≥ PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg adalimumaba vsak drugi teden ali placebo.
Adalimumab has not been studied in patients with hepatic or renal impairment
Adalimumaba niso proučili pri bolnikih z okvaro jeter ali ledvic.
When adalimumab therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Na začetku zdravljenja z adalimumabom se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorjenekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04.
Cyltezo is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Zdravilo Cyltezo se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis pri odraslih.
Cyltezo is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Zdravilo Cyltezo je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Med vzdrževalnim zdravljenjem, je mogoče kortikosteroide postopoma zmanjšati v skladu s
o Expiration date on pre-filled syringe or carton has passed o Medication is cloudy, discolored, frozen, or contains flakes or particles o Pre-filled syringe appears cracked, damaged, or leaking o Pre-filled syringe has already been used o Pre-filled syringe has been left in direct light
• Napolnjene injekcijske brizge NE uporabite, če: ○ je datum roka uporabnosti napolnjene injekcijske brizge ali škatle potekel; ○ je zdravilo motno, obarvano, zamrznjeno ali vsebuje kosmiče ali delce; ○ je napolnjena injekcijska brizga videti počena, poškodovana ali pušča; ○ je bila napolnjena injekcijska brizga že uporabljena; ○ je bila napolnjena injekcijska brizga izpostavljena neposredni sončni svetlobi.
In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3 % of adalimumab-treated patients
V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v 0. tednu, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis,
The recommended Cyltezo induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Priporočena shema odmerjanja zdravila Cyltezo med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
The Cyltezo pre-filled syringe is made of glass.
Napolnjena injekcijska brizga z zdravilom Cyltezo je iz stekla.
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92/349) and 37.8 % (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
V odprti podaljšani študiji je odziv PASI 75 v 12. oziroma 24. tednu doseglo 26,4 % (92/349) oziroma 37,8 % (132/349) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
Cyltezo 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 Cyltezo 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, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that
Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi adalimumaba 40 mg enkrat na teden raven kliničnega odziva (HiSCR) vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
O neprekinjenem zdravljenju po 16. tednu je treba skrbno premisliti pri bolniku, ki se v tem obdobju
Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po presoji raziskovalca, če je bolnik izpolnjeval kriterije kliničnega odziva.
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 double-blind 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).
The Cyltezo pre-filled syringe is a single-use syringe that delivers a pre-set dose of medication.
Zdravilo Cyltezo napolnjena injekcijska brizga je injekcijska brizga za enkratno uporabo, s katero dovajate vnaprej določen odmerek zdravila.
Adolescent hidradenitis suppurativa
Hidradenitis suppurativa pri mladostnikih
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 80 mg vsak drugi teden.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 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
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA, Physician's Global Assessment) ≥ 4 ali > 20 % 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.
• haematoma (a solid sweling with clotted blood);
• hematom (trda oteklina s strjeno krvjo);
p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann
Patients demonstrating a Paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m² up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Bolniki, ki so 16. teden dosegli odziv "Pediatric ACR" 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m2 (do največ 40 mg) ali placebo.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
V študiji pri Crohnovi bolezni II so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg adalimumaba 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
If these medicines do not work well enough, you will be given Cyltezo to treat your rheumatoid arthritis.
Če ta zdravila pri vas ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Cyltezo.
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Varnost in učinkovitost adalimumaba so v randomiziranih, dvojno slepih študijah raziskali pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze (PASI, Psoriasis Area and Severity Index) ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg/m² , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 μg/mL (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 μg/mL (71.2 % CV) with concomitant methotrexate.
Pri bolnikih s poliartikularnim JIA, starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
Anti-adalimumab antibodies may develop during adalimumab treatment.
Med zdravljenjem z adalimumabom lahko nastajajo protitelesa proti adalimumabu.
Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Preglednica 15: Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II Dvojno slepa
Patients were randomised to receive either 24 mg/m² body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m2 telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg
Cyltezo can slow down the damage to the cartilage and bone of the joints caused by the disease and improve
Zdravilo Cyltezo lahko upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša
Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Delni zagon bolezni ocena spondiloartritičnega mednarodnega združenja (Assessment of Spondyloarthritis international Society) izhodišče je določeno kot izhodišče odprte faze, ko imajo bolniki aktivno bolezen ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease
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 adalimumab 40 mg vsak drug teden subkutano do dodatnih 144 tednov.
In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno
Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of
V povezavi z jemanjem adalimumaba so poročali tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
Carriers of HBV who require treatment with Cyltezo 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 Cyltezo, 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.
The inner part of the cap of the syringe (the needle cover) contains natural rubber (latex).
Notranji del pokrovčka injekcijske brizge (pokrovček igle) vsebuje naravni kavčuk (lateks).
Cyltezo dose for paediatric patients with Crohn's disease
Preglednica 4: Odmerjanje zdravila Cyltezo pri pediatričnih bolnikih s Crohnovo boleznijo
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/mL (without concomitant methotrexate) and 8 to 9 μg/mL (with concomitant methotrexate), respectively.
Po subkutani uporabi 40 mg adalimumab vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 μg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 μg/ml (s sočasno uporabo metotreksata).
Visual impairment, conjunctivitis, blepharitis, eye swelling
motnje vidnega zaznavanja, konjunktivitis, blefaritis, otekanje oči občasni diplopija
• Discard entire Cyltezo pen into “sharps” container.
• Celoten peresnik z zdravilom Cyltezo vrzite v vsebnik za ostre predmete.
In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 µg/mL during adalimumab 40 mg every week treatment.
Najnižja koncentracija pred naslednjim odmerkom v stanju dinamičnega ravnovesja je bila približno 8 do 10 µg/ml med 12. tednom in 36. tednom pri zdravljenju z odmerkom 40 mg adalimumaba vsak teden.
If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your disease.
Če ta zdravila ne bodo delovala dovolj dobro, boste dobili zdravilo Cyltezo za zmanjšanje znakov in simptomov vaše bolezni.
In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Uporabo adalimumaba 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni po BASDAI] je bila 6,4 pri bolnikih zdravljenih z adalimumabom in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s
The recommended dose of Cyltezo for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Cyltezo za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between
***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in
• Do not give Cyltezo to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
• Zdravila Cyltezo ne smete dati otrokom s poliartikularnim juvenilnim idiopatskim artritisom, če
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Običajni odmerek za odrasle z revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis in za bolnike s psoriatičnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku.
The needle cover of the syringe contains natural rubber (latex).
Pokrovček za iglo na injekcijski brizgi vsebuje naravni kavčuk (lateks).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cyltezo 40 mg injection
IME ZDRAVILA IN POT(I) UPORABE Cyltezo 40 mg injekcija adalimumab subkutana uporaba
• 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.
• 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.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Cyltezo.
Priporočljivo je, da med zdravljenjem z zdravilom Cyltezo bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
Radiographic Mean Changes at Week 52 in RA Study V MTX n=257 confidence interval)
Povprečne rentgenografske spremembe po 52 tednih študije adalimumab/ MTX n = 268 (95-% interval zaupanja)
ACR Responses in RA Study V (percent of patients)
Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
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).
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
Cyltezo dose for patients with enthesitis-related arthritis
Preglednica 2: Odmerjanje zdravila Cyltezo pri bolnikih z artritisom, povezanim z entezitisom
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.
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.
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).
Priporočeni odmerek zdravila Cyltezo pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
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.
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.
Keep this
Pritisnite in držite
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
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.
• Gently remove cap by pulling it straight off. Do not touch needle or let needle touch anything.
Ne dotikajte se igle, prav tako se z iglo ničesar ne dotikajte.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Razpoložljivi podatki kažejo, da je klinični odziv ponavadi dosežen v 12 tednih zdravljenja.
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.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) adalimumaba vsak drugi teden.
*** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
*** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom
Adalimumab has not been studied in patients aged less than 2 years.
Raziskave z adalimumabom pri bolnikih, mlajših od 2 let, niso bile izvedene.