natgillin/translations-raw huggingface dataset:
In RA study III, where Humira 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 so strukturno prizadetost sklepov ocenjevali rentgenografsko.
Humira/ methotrexate patients demonstrated significantly less radiographic
Okvaro so izrazili kot spremembo modificirane celotne Sharpove ocene (“ Total Sharp Score (TSS) ”) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
71 progression than patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Pri bolnikih, ki so dobivali Humiro in metotreksat, je bilo po 6 in 12 mesecih (glejte tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
Among those, 66 patients showed no progression of structural damage defined by a change in the TSS of zero or less..
Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj.
other
Celotna Sharpova ocena
week
2, 7
2.6 (1.4, 3.8) 1.6 (0.9, 2.2)
Ocena erozij Ocena ZSŠd a metotreksat b
< <
1, 6 1, 0
0.001c 0.001
0, 0 0, 1
0.9 (0.3, 1.4)
1, 6 (0, 9, 2, 2) 0, 9 (0, 3, 1, 4)
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp Score (see Table 6).
V študiji pri revmatoidnem artritisu V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte tabelo 6).
Humira
vrednost
Humira/ MTX
vrednost
n=274
n = 268
n=268
vrednost
(95%
pb
(95%
pc
confidence interval)
Sharpova ocena
Total Sharp Score
ocena erozij
5.7 (4.2-7.3)
3, 7 (2, 7- 4, 7) 1, 7 (1, 0- 2, 4)
Erosion score JSN score a
seštevek JSN a
72 Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at Week 52 in RA study III.
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji pri revmatoidnem artritisu III vnaprej določena primarna končna točka po 52 tednih.
In RA study III, improvement in physical function was maintained through Week 260 (60 months) of open-label treatment.
72 V študiji pri revmatoidnem artritisu III se je izboljšanje telesne funkcije in kakovosti življenja ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
73 Table 8 Ped ACR Responses in the JIA study
73 Tabela 8 Odzivi » Pediatric ACR (Ped ACR) « v študiji pri juvenilnem idiopatskem artritisu
Double Blind
Dvojno slepa
Median time to disease flare a
Srednji čas do širjenja bolezni
Psoriatic arthritis Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Uporabo Humire 40 mg vsak drugi teden so pri bolnikih z zmernim do zelo aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
74 Table 9 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov)
PsA Study I
Študija pri psoriatičnem artritisu I
PsA Study II
Študija pri psoriatičnem
Response
artritisu II
N=162
placebo n = 49
N=151
Humira n = 51
N=49
16% np
N=51
39% * np
14% 15%
4% 6%
58%*** 57%***
36% *** 39% ***
16% N/ A
2% np
39%* N/ A
25% *** np
Week 12 Week 24 ACR 70
ACR 70
4% 6%
12. teden
36%*** 39%***
1%
2% N/ A
2
25%*** N/ A
0% *** 0%
Humira 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 Humira 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 s Humiro (po 48 tednih).
Improved physical function continued during the open label extension up to Week 136. Ankylosing spondylitis Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Humiro 40 mg vsak drugi teden so ocenili v dveh randomiziranih 24- tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa – Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6, 3), ki se niso odzvali ustrezno na konvencionalno terapijo.
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Preiskovanci (n = 215, 54, 7%), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
75 Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali Humiro, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
75 Table 10– Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
Tabela 10 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
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 Humira 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.
76 skupin: placebo 0. in 2. teden, 160 mg Humire 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.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira 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 Humire 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
Maintenance of clinical remission was evaluated in CD Study I(CHARM).
Vzdrževanje klinične remisije je ocenjevala študija pri Crohnovi bolezni III (CHARM).
At week 4 patients were
V študiji pri Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
76 randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Na 4. teden so bolnike randomizirali na 40 mg vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
All p-values are pairwise * p < 0.001 ** p < 0.01
Vse vrednosti p so za parne primerjave deležev med Humiro in placebom. * p < 0, 001 ** p < 0, 01
In CD Study II, at Week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58% (499/ 854) bolnikov; ti so bili ocenjeni v primarni analizi.
77 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Among patients who were not in response at Week 4, 43% of Humira maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Med bolniki, ki so bili 4. teden brez odziva, se je do 12. tedna odzvalo 43% tistih, ki so vzdrževalno dobivali Humiro, in 30% tistih, ki so vzdrževalno dobivali placebo.
78 by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
78 nadaljnjim povečanjem odmerka skozi 12 tednov do največjega odmerka 25 mg, ali začetni odmerek 80 mg Humire in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
Table 13 Ps Study I (REVEAL) Efficacy Results at 16 Weeks
Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Humira 40 mg placebo vsak 2. teden n = 398 n = 814 n (%) n (%) 578 (70, 9) b a
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 and were evaluated at 12 weeks after dose escalation, 59/ 243 (24.3%) of patients regained PASI 75 response.
79 V odprti podaljšani študiji je odziv PASI 75 znova doseglo 59 od 243 (24, 3%) bolnikov, ki so jim zaradi odziva PASI pod 50 odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden ter so jih ocenili 12 tednov po povečanju odmerka.
79 Immunogenicity
Imunogenost
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) the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ mL (102 %CV) Humira monotherapy and 10.9 ± 5.2 µg/ mL (47.7% CV) with concomitant methotrexate.
80 Po uporabi 24 mg/ m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom je bila povprečna najnižja koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med monoterapijo s Humiro 5, 6 ± 5, 6 µg/ ml (koeficient variacije 102%) in med uporabo z metotreksatom 10, 9 ± 5, 2 µg/ ml (koeficient variacije 47, 7%).
80 In patients with Crohn’ s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira 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 Humire na 0. teden, ki mu sledi 40 mg Humire 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno 5, 5 μg/ ml.
6.4 Special precautions for storage
24 mesecev 81 6. 4 Posebna navodila za shranjevanje
Do not freeze.
Ne zamrzujtr.
81 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needleguard for hospital and caregiver use.
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno uporabo, opremljeni s ščitnikom za iglo, za zdravniško in bolnišnično uporabo.
1 pre-filled syringe with needleguard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.
1 napolnjena injekcijska brizga s ščitnikom za iglo (0, 8 ml sterilne raztopine) v pretisnem omotu in 1 alkoholni zloženec.
HUMIRA 40 mg solution for injection does not contain preservatives; therefore, any unused product or waste material should be disposed of in accordance with local requirements.
Humira 40 mg raztopina za injiciranje ne vsebuje konzervanzov, zato neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
En 0, 8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba.
Clear solution for injection in pre-filled pen.
Bistra raztopina za injiciranje v napolnjenem injekcijskem peresniku.
 the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
 the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Ankylosing spondylitis
Z rentgenskim slikanjem je bilo dokazano, da Humira upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5. 1) in izboljša telesno funkcijo.
83 Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
83 Ankilozirajoči spondilitis
Psoriatic arthritis and ankylosing spondylitis
84 Psoriatični artritis in ankilozirajoči spondilitis
The recommended dose of Humira for patients with psoriatic arthritis or ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek Humire pri bolnikih s psoriatičnim artritisom ali ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
84 For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Dosegljivi podatki za vse navedene indikacije kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
85 4.3 Contraindications
85 4. 3 Kontraindikacije
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, coccidiodomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Opportunistic infections).
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja s Humiro 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).
Serious Infections:
Resne okužbe:
Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal viral, or other opportunistic infections such as listeriosis, and pneumocystis have been reported in patients receiving Humira.
Pri bolnikih, ki so dobivali Humiro, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, virusnih in drugih oportunističnih okužb, npr. listerioza in pnevmocistična okužba.
86 If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
86 Če sumite na latentno tuberkulozo, se posvetujte z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
These infections have not consistently been recognised in patient taking TNF-blockers and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšne okužbe se pri uporabnikih zaviralcev TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
87 reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
V pomarketinškem obdobju so po uporabi Humire v zelo redkih primerih poročali o resnih alergijskih reakcijah, vključno z anafilaksijo.
In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, -NK-cells, monocyte/ macrophages, and neutrophils.
V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih s Humiro, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/ makrofagov ali nevtrofilcev.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNFantagonists.
Pri uporabi antagonistov TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in
88 Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih s Humiro, ni.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Za bolnike s poliartikularnim juvenilnim idiopatskim artritisom je priporočljivo, da pred začetkom zdravljenja s Humiro opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
See section 4.5).
Zato kombinacija adalimumaba in anakinre ni priporočena (glejte poglavje 4. 5).
4.5 Interaction with other medicinal products and other forms of interaction
89 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Antibody formation was lower when Humira was given together with methotrexate in comparison with use as
Če je bila Humira uporabljena skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Humira see (Section 4.8).
Po dajanju Humire se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4. 8).
Humira was studied in 6,593patients in controlled and open label trials for up to 60 months.
Humiro so raziskali pri 6593 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
Adverse events at least possibly causally-related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common
90 Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v ključnih študijah, so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/ 10), pogosti (≥1/ 100 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100) in redki (≥1/ 10. 000 do < 1/ 1. 000) v tabeli 1 spodaj.
91 System Organ Class Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Gastrointestinal disorders
91 Organski sistem Bolezni prebavil
92 System Organ Class Infections and infestations
Infekcijske in parazitske bolezni
Neoplasms benign, malignant and unspecified
92 Organski sistem Benigne, maligne in neopredeljene novotvorbe
skin papilloma
Neželeni učinki papilom na koži
93 Injection site reactions
Spremembe na mestu injiciranja
In the pivotal controlled trials, the rate of infection was 1.58per patient year in the Humira treated patients and 1.42 per patient year in the placebo and active control-treated patients.
V ključnih kontroliranih preskušanjih je bil delež okužb 1, 58 na bolnik- leto med bolniki, ki so dobivali Humiro, in 1, 42 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
In controlled and open label studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
93 invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
During the controlled portions of pivotal Humira trials at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.9 (3.5, 9.9) per 1,000 patient-years among 3,853 Humira treated patients versus a rate of 4.3 (1.8, 10.4) per 1,000 patient-years among 2,183 control patients (median duration of treatment was 5.5 months for Humira and 3.9 months for control-treated patients).
V kontroliranih delih ključnih preskušanj Humire, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom, Crohnovo boleznijo in psoriazo so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95% interval zaupanja) 5, 9 (3, 5, 9, 9) na 1000 bolnik- let med 3853 bolniki, ki so dobivali Humiro, in 4, 3 (1, 8, 10, 4) na 1000 bolnik- let med 2183 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 5, 5 meseca in pri drugih 3, 9 meseca).
The rate (95% confidence interval) of lymphomas was 0.8 (0.2, 3.3) per 1000 patient-years among Humira-treated patients and 0.9 (0.1, 6.1) per 1,000 patient-years among control patients.
Delež (95% interval zaupanja) limfomov je bil 0, 8 (0, 2, 3, 3) na 1000 bolnik- let med bolniki, ki so dobivali Humiro, in 0, 9 (0, 1, 6, 1) na 1000 bolnik- let v kontrolni skupini bolnikov.
94 Autoantibodies
Avtoprotitelesa
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (RA study V), elevations of ALT were more common in the combination arm (Humira / methotrexate) compared to the methotrexate monotherapy arm or the Humira monotherapy arm.
V preskušanju pri juvenilnem idiopatskem artritisu je bilo zvišanj transaminaz
In the JIA trial the few transaminase elevations were small and similar in the placebo and adalimumab exposed patients, and mostly occurred in combination with methotrexate.
94 malo in so bila podobna pri bolnikih, izpostavljenih placebu in adalimumabu; večinoma so se pojavila med kombinirano uporabo z metotreksatom.
Psoriasis clinical trials: in controlled psoriasis clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo
Klinične študije pri psoriazi: zvišanje ALT je bilo v kontroliranih kliničnih preskušanjih pri psoriazi podobno pri bolnikih, ki so dobivali adalimumab, in tistih, ki so dobivali placebo.
Adverse Reaction intestinal perforation reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis, Guillain-Barré syndrome)
demielinizirajoče bolezni (npr. optični nevritis, Bolezni živčevja Guillain- Barréjev sindrom)
95 4.9 Overdose
4. 9 Preveliko odmerjanje
Mechanism of action
95 Mehanizem delovanja
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis
Pri pacientih s poliartikularnim juvenilnim idiopatskim artritisom so opazili tudi naglo znižanje koncentracij CRP.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had anineffective response to methotrexate at doses of 12.5 to 25 mg or have
Študija pri revmatoidnem artritisu III je ocenila 619 bolnikov z zmerno do zelo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12, 5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.