natgillin/translations-raw huggingface dataset:
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
Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Prekinitve sodelovanja zaradi razlogov, ki niso bili posledica neuspeha zdravljenja so bile cenzurirane ob prekinitvi RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
Low Dose 20/10 mg eow N = 95
Majhni odmerek 20/10 mg vsak drugi teden n = 95
COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje
There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Adalimumab ni namenjen za uporabo pri otrocih, starih manj kot 4 leta, za to indikacijo.
In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumab-treated patients
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week 48).
Sprememba je bila (povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
Cyltezo is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Cyltezo kontraindicirano (glejte poglavje 4.3).
• shortness of breath;
• predrtje črevesja;
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
A 40 mg pre-filled syringe/pre-filled pen is available for patients to administer a full 40 mg dose.
Za dajanje polnega 40 mg odmerka je bolnikom na voljo 40 mg napolnjena injekcijska
The recommended dose of Cyltezo is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Priporočeno odmerjanje zdravila Cyltezo je začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
Keep the pre-filled syringe/pre-filled pen in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo/napolnjeni injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The recommended Cyltezo dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Cyltezo pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciran v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciran v obliki dveh 40 mg injiciranj v enem dnevu).
• 1 pre-filled syringe (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
• 1 napolnjena injekcijska brizga (0,8 ml sterilne raztopine) v pretisnem omotu, z 2 alkoholnima
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Cyltezo cannot be excluded (see section 4.8).
Tveganja za razvoj hepatospleničnega T-celičnega limfoma pri bolnikih, ki dobivajo zdravilo Cyltezo, ni mogoče
How to use Cyltezo
Ne uporabljajte zdravila Cyltezo
In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of
Pri odraslih bolnikih z uveitisom je uvajalni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil srednjo koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
Following subcutaneous administration of 40 mg of adalimumab every other week in adult non-radiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was
Po subkutanem apliciranju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z neradiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja v 68. tednu 8,0 ± 4,6 μg/ml.
Efficacy Response in Placebo-Controlled Study nr-axSpA I
Preglednica 14: Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I Dvojno slepa
No data are available on the secondary transmission of infection by live vaccines in
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z adalimumabom, ni.
In monotherapy, some patients who experience a decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Cyltezo 40 mg vsak drugi teden, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden ali 80 mg vsak drugi teden.
The recommended dose of Cyltezo for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Priporočeni odmerek zdravila Cyltezo za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
If you are unsure, contact your doctor.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
If something goes wrong with the injection, do not use another Cyltezo pen.
Če injiciranje ne poteka tako, kot bi bilo treba, ne uporabite drugega peresnika zdravila
Some patients who experience decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg Cyltezo every week or 80 mg every other week.
Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Cyltezo 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Cyltezo na 40 mg vsak teden ali 80 mg vsak drugi teden.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement
Če se bolniku stanje po 12. tednih ne izboljša, je pred podaljšanjem zdravljenja na več kot 12 tednov potreben natančen ponoven premislek.
p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c.
Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
The recommended dose of Cyltezo for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Priporočeni začetni odmerek zdravila Cyltezo za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
Your doctor may recommend temporary discontinuation of Cyltezo.
Odločil se bo, ali lahko dobivate zdravilo Cyltezo.
4.3 Contraindications
6.4 Posebna navodila za shranjevanje
The recommended Cyltezo induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Cyltezo med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
tuberkulozo in oportunistične okužbe, kongestivno srčno popuščanje, demielinizirajoče
Room spinning sensation (vertigo) and vision disturbances may occur after taking Cyltezo.
Po dajanju zdravila Cyltezo se lahko pojavita vrtoglavica (vertigo) in poslabšanje vida.
NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Adalimumab ni namenjen za uporabo pri otrocih, starih manj kot 6 let, za to indikacijo.
“Sharps” container (not included)
Vsebnik za ostre predmete (ni priložen)
Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week.
Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Cyltezo je 40 mg vsak drugi teden.
• Discard Cyltezo pre-filled syringe into “sharps” container.
• Napolnjeno injekcijsko brizgo zdravila Cyltezo vrzite v vsebnik za ostre predmete.
Cyltezo 40 mg solution for injection in pre-filled syringe Each 0.8 mL single dose pre-filled syringe contains 40 mg of adalimumab.
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
40 mg every week or 80 mg every other week
10 mg vsak drugi teden 20 mg vsak drugi teden 20 mg vsak drugi teden 40 mg vsak drugi teden
Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week.
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Cyltezo je 40 mg vsak drugi teden.
EU/1/17/1240/008
EU/1/17/1240/005 1 napolnjen injekcijski peresnik EU/1/17/1240/006 2 napolnjena injekcijska peresnika EU/1/17/1240/007 4 napolnjeni injekcijski peresniki EU/1/17/1240/008 6 napolnjenih injekcijskih peresnikov
If your doctor considers that methotrexate is inappropriate,
Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Cyltezo dobivate samo.
Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Preglednica 28: Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov) placebo adalimumab 40 mg vsak drugi teden
Cyltezo therapy should not be continued in patients failing to respond within this time period.
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Cyltezo ni priporočljivo nadaljevati.
• 1 pre-filled pen (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
• 1 napolnjen injekcijski peresnik (0,8 ml sterilne raztopine) v pretisnem omotu, z 2 alkoholnima
Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Preglednica 17: Študija pri psoriazi I (REVEAL) - rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
Adalimumab treated patients showed statistically significant improvements at week 26 compared with
Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
The combination of Cyltezo and anakinra is not recommended (see section 4.4 “Concurrent administration of
Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
• severe rash, hives or other signs of allergic reaction;
Poiščite urgentno zdravniško pomoč, če opazite kaj od naslednjega: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
Cyltezo 40 mg solution for injection in pre-filled syringe
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
• You might get infections more easily while you are receiving Cyltezo treatment.
• Med zdravljenjem z zdravilom Cyltezo se lahko poveča dovzetnost za okužbe.
Cyltezo dose for paediatric patients with uveitis
Preglednica 5: Odmerjanje zdravila Cyltezo pri pediatričnih bolnikih z uveitisom
Table 6:
Slika 3:
Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3.441 bolnikov, zdravljenih z adalimumabom.
In patients with ulcerative colitis, 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.
Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
Talk to your doctor or pharmacist before using Cyltezo Allergic reaction
Pred začetkom uporabe zdravila Cyltezo se posvetujte z zdravnikom ali farmacevtom.
There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Adalimumab ni namenjen za uporabo pri otrocih, mlajših od 12 let, za to indikacijo.
Cyltezo is intended for the treatment of the inflammatory diseases described below: • Polyarticular juvenile idiopathic arthritis,
Zdravilo Cyltezo je namenjeno za zdravljenje vnetnih bolezni, ki so opisane spodaj:
Preclinical data on postnatal toxicity of adalimumab are not available (see
Predkliničnih podatkov o poporodni toksičnosti adalimumaba ni (glejte poglavje 5.3).
• facial oedema associated with allergic reactions;
• artritisa, povezanega z entezitisom,
Cyltezo can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease.
Zdravilo Cyltezo lahko zmanjša število vozličev in ognojkov, ki jih imate.
coccidioidomycosis or blastomycosis are endemic.
nesteroidnih protivnetnih zdravil ali analgetikov.
• Do not inject through clothes.
• Napolnjenih injekcijskih brizg NE vrzite med gospodinjske odpadke.
The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Običajni začetni odmerek za odrasle z luskavico (psoriazo) je 80 mg (dve 40 mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.