natgillin/translations-raw huggingface dataset:
Maintenance of clinical remission was evaluated in CD Study III (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.
22 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.
Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at week 4.
Bolnike s kliničnim odzivom (znižanje CDAI ≥ 70) 4. teden so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva 4. teden.
Corticosteroid taper was permitted after Week 8.
Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida.
CD Study I and CD Study II induction of remission and response rates are presented in Table 11.
Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje tabela 11.
Table 11 Induction of Clinical Remission and Response (Percent of Patients) Week 4
Indukcija klinične remisije in odziva (odstotek bolnikov)
CD Study I:
Študija pri Crohnovi bolezni I:
Infliximab Naive Patients Placebo Humira Humira N=74 80/ 40 mg 160/ 80 m N = 75 g N=76
Bolniki, ki še niso dobivali infliksimaba placebo Humira Humira n = 74 80/ 40 mg 160/ 80 mg
CD Study II:
Študija pri Crohnovi bolezni II:
Infliximab Experienced Patients Placebo Humira N=166 160/ 80 mg N=159
Bolniki, ki so že dobivali infliksimab placebo Humira n = 166 160/ 80 mg
12% 24% 36%* **
12% 24% 49% **
7% 21%*
7% 38% **
Clinical response (CR- 100)
Klinični odziv (CR- 100)
All p-values are pairwise comparisons of proportions for Humira versus placebo * p < 0.001 ** p < 0.01
Vse vrednosti p so za parne primerjave deležev med Humiro in placebom. * p < 0, 001 ** p < 0, 01
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by Week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
Z indukcijskima shemama 160/ 80 mg in 80/ 40 mg so do 8. tedna ugotovili podobne deleže remisij; neželeni učinki so bili pogostejši v skupini s shemo 160/ 80 mg.
In CD Study III, 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.
Of those in clinical response at Week 4, 48% had been previously exposed to other anti-TNF therapy.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48% predhodno dobilo drugo terapijo proti TNF.
Maintenance of remission and response rates are presented in Table 12.
Vzdrževanje remisije in deleže odziva prikazuje tabela 12.
23 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
40 mg Humira
40 mg Humire
every other week
vsak drugi teden
Week 26 Clinical remission Clinical response (CR-100)
26. teden Klinična remisija Klinični odziv (CR- 100)
N=170 17% 27%
= 170 17% 27%
N=172 40%* 52%*
n = 172 40% * 52% *
N=157 47%* 52%*
n = 157 47% * 52% *
Patients in steroid-free remission for > =90 daysa
Bolniki v remisiji brez steroidov za ≥ 90 dnia
Week 56 Clinical remission Clinical response (CR-100)
Klinična remisija Klinični odziv (CR- 100)
* p < 0.001 for Humira versus placebo pairwise comparisons of proportions ** p < 0.02 for Humira versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
* p < 0, 001 za parne primerjave deležev med Humiro in placebom ** p < 0, 02 za parne primerjave deležev med Humiro in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide.
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.
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Zdravljenje prek 12. tedna ni prineslo značilno več odzivov (glejte poglavje 4. 2).
In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Študiji pri Crohnovi bolezni I in II sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi s Humiro 80/ 40 mg in 160/ 80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
Psoriasis The safety and efficacy of Humira 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 Humire 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 terapijo ali fototerapijo.
73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
73% bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko terapijo ali fototerapijo.
In period A, patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
V obdobju A so bolniki dobivali placebo ali Humiro v začetnem odmerku 80 mg in potem 40 mg vsak drugi teden, začenši en teden po začetnem odmerku.
After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B and received open-label 40 mg Humira every other week.
Po 16 tednih zdravljenja so bolniki, ki so dosegli odziv PASI vsaj 75 (izboljšanje ocene PASI za vsaj 75% glede na izhodišče), vstopili v obdobje B, med katerim so odprto dobivali 40 mg Humire vsak drugi teden.
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 Humira 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 Humire vsak drugi teden ali placebo.
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician’ s Global Assessment (PGA) score ranged from “ moderate” (53% of subjects included) to “ severe” (41%) to “ very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18, 9, izhodiščna zdravnikova globalna ocena (PGA – Physician' s Global Assessment) pa je segala od "zmerne" (53% vključenih preiskovancev) do "hude" (41%) in "zelo hude" (6%).
Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira versus methotrexate and placebo in 271 patients.
Študija pri psoriazi II (CHAMPION) je primerjala učinkovitost in varnost Humire z metotreksatom in placebom pri 271 bolnikih.
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to Week 12, with a maximum dose of 25 mg or an initial dose of 80 mg Humira followed
Bolniki so dobivali placebo, začetni odmerek 7, 5 mg metotreksata z
24 by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
24 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.
There are no data available comparing Humira and MTX beyond 16 weeks of therapy.
Podatkov za primerjavo Humire in metotreksata med več kot 16- tedenskim zdravljenjem ni.
Patients receiving MTX who achieved a ≥ PASI 50 response at Week 8 and/ or 12 did not receive further dose increases.
Bolnikom, ki so dobivali metotreksat in so 8. in/ ali 12. teden dosegli odziv PASI ≥ 50, odmerka niso več povečevali.
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “ mild” (< 1%) to “ moderate” (48%) to “ severe” (46%) to “ very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19, 7, izhodiščna PGA pa je segala od "blage" (< 1%), "zmerne" (48%) in "hude" (46%) do "zelo hude" (6%).
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 13 and 14).
V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte tabeli 13 in 14).
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
Clear/ minimal a
PASI ≥ 75 PASI 100 PGA: čisto/ minimalno a
163 (20.0)b 506 (62.2)b
163 (20, 0) b 506 (62, 2) b
Percent of patients achieving PASI75 response was calculated as center- adjusted rate b p < 0.001, Humira vs. placebo
Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center b p < 0, 001, Humira v primerjavi s placebom
Table 14 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Študija pri psoriazi II (CHAMPION) Rezultati učinkovitosti po 16 tednih Humira 40 mg
MTX
n = 53
Humira 40 mg eow
n = 110
N=53 n (%)
n = 108
Clear/ minimal a
n (%) 86 (79, 6) a, b
p < 0.01 Humira vs. placebo d p < 0.05 Humira vs. methotrexate
p < 0, 001 Humira v primerjavi s placebom b p < 0, 001 Humira v primerjavi z metotreksatom c p < 0, 01 Humira v primerjavi s placebom d p < 0, 05 Humira v primerjavi z metotreksatom
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 Humira, 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).
"Izguba ustreznega odziva" je bila opredeljena kot takšna ocena PASI po 33. tednu in 52. teden ali pred njim, da je bil odziv PASI < 50 glede na izhodišče, s porastom PASI vsaj 6 točk v primerjavi s 33. tednom.
Of the patients who lost adequate response after re-randomization to placebo who then enrolled into the open- label extension trial, 38% (25/ 66) and 55% (36/ 66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Med bolniki, ki so izgubili ustrezen odziv ob ponovni randomizaciji na placebo med podaljšanim odprtim preskušanjem, je po 12 tednih ponovne terapije PASI 75 znova doseglo 38% (25/ 66), po 24 tednih pa 55% (36/ 66) bolnikov.
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
V študiji I so v primerjavi s placebom ugotovili tudi značilno izboljšanje telesne in duševne komponente ocene SF- 36.
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.
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.
25 Immunogenicity
25 Imunogenost
Patients in RA Studies I, II and III were tested at multiple timepoints for anti-adalimumab antibodies during the 6 to 12 month period.
Pri bolnikih v študijah pri revmatoidnem artritisu I, II in III so v obdobju od 6 do 12 mesecev ob različnih časih večkrat določali protitelesa proti adalimumabu.
In the pivotal trials, anti-adalimumab antibodies were identified in 58/ 1053 (5.5%) patients treated with adalimumab, compared to 2/ 370 (0.5%) on placebo.
V ključnih preskušanjih so protitelesa proti adalimumabu odkrili pri 58/ 1053 (5, 5%) bolnikov, zdravljenih z adalimumabom, in pri 2/ 370 (0, 5%), ki so dobivali placebo.
In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 12, 4%, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 0, 6%.
In patients with polyarticular juvenile idiopathic arthritis, adalimumab antibodies were identified in 27/ 171 subjects (15.8%) treated with adalimumab.
Med bolniki s poliartikularnim juvenilnim idiopatskim artritisom so protitelesa proti adalimumabu ugotovili pri 27/ 171 (15, 8%) tistih, ki so dobivali adalimumab.
In patients not given concomitant methotrexate, the incidence was 22/ 86 (25.6%), compared to 5/ 85 (5.9%) when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 22/ 86 (25, 6%) bolnikov, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 5/ 85 (5, 9%) bolnikov.
In patients with psoriatic arthritis, anti-adalimumab antibodies were identified in 38/ 376 subjects (10%) treated with adalimumab.
Med bolniki s psoriatičnim artritisom so protitelesa proti adalimumabu ugotovili pri 38/ 376 (10%) tistih, ki so dobivali adalimumab.
In patients not given concomitant methotrexate, the incidence was 13.5% (24/ 178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13, 5% (24/ 178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7% (14 od 198 bolnikov).
In patients with ankylosing spondylitis anti-adalimumab antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
Med bolniki z ankilozirajočim spondilitisom so protitelesa proti adalimumabu ugotovili pri 17/ 204 (8, 3%) tistih, ki so dobivali adalimumab.
In patients not given concomitant methotrexate, the incidence was 16/ 185 (8.6%), compared to 1/ 19 (5.3%) when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 16/ 185 (8, 6%), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 1/ 19 (5, 3%).
In patients with Crohn’ s disease, anti-adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
Pri bolnikih s Crohnovo boleznijo so identificirali protitelesa proti adalimumabu pri 7 od 269 oseb (2, 6%), ki so bile zdravljene z adalimumabom.
In patients with psoriasis, anti-adalimumab antibodies were identified in 77/ 920 subjects (8.4%) treated with adalimumab monotherapy.
Med bolniki s psoriazo so protitelesa proti adalimumabu ugotovili pri 77 od 920 preiskovancev (8, 4%), ki so dobivali monoterapijo z adalimumabom.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh študij po enem 40 mg odmerku subkutano, je 64%.
After single intravenous doses ranging from 0.25 to 10 mg/ kg, concentrations were dose proportional.
Po enem samem intravenskem odmerku od 0, 25 do 10 mg/ kg so bile koncentracije sorazmerne odmerku.
After doses of 0.5 mg/ kg (~40 mg), clearances ranged from 11 to 15 ml/ hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half- life was approximately two weeks.
Po odmerkih 0, 5 mg/ kg (~40 mg) je bil očistek od 11 do 15 ml/ uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
Following subcutaneous administration of 40 mg of Humira 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 Humire 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).
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Najnižje koncentracije adalimumaba v serumu v stanju dinamičnega ravnovesja so naraščale približno sorazmerno odmerku po 20, 40 in 80 mg subkutano vsak drugi teden in vsak teden.
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.
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%).
26 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.
26 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.
A loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
Polnilni odmerek 160 mg Humire na 0. teden, ki mu sledi 80 mg Humire 2. teden, doseže med obdobjem indukcije najnižjo koncentracijo v serumu približno 12 μg/ ml.
Mean steady-state trough levels of approximately 7 µg/ ml were observed in Crohn’ s disease patients who received a maintenance dose of 40 mg Humira every other week.
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg Humire vsak drugi teden, so ugotovili najnižjo koncentracijo v stanju dinamičnega ravnovesja približno 7 μg/ ml.
In patients with psoriasis, the mean steady-state trough concentration was 5 µg/ mL during adalimumab 40 mg every other week monotherapy treatment.
Pri bolnikih s psoriazo je bila povprečna najnižja koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 μg/ ml.
Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Analize populacijske farmakokinetike s podatki za več kot 1. 300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
Humira has not been studiedin patients with hepatic or renal impairment.
Humira ni raziskana pri bolnikih z okvaro jeter ali ledvic.
An embryo-foetal developmental toxicity/ perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/ kg (9-17 monkeys/ group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Raziskava embrio- fetalne razvojne toksičnosti/ perinatalnega razvoja je bila narejena pri opicah Cynomologous z odmerki 0, 30 in 100 mg/ kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
Mannitol Citric acid monohydrate Sodium citrate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 Sodium hydroxide Water for injections.
manitol citronska kislina monohidrat natrijev citrat natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid polisorbat 80 natrijev hidroksid voda za injekcije
27 6.5 Nature and contents of container
27 6. 5 Vrsta ovojnine in vsebina
Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Humira 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe in pouch and 2 alcohol pads, all in a blister.
1 viala (0, 8 ml sterilne raztopine), 1 prazna sterilna injekcijska brizga v vrečki in 2 alkoholna zloženca, vse v pretisnem omotu.
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 konzervansov, zato neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Queenborough Kent ME11 5EL United Kingdom
Queenborough Kent ME11 5EL Velika Britanija
Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Ena 0, 8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
Clear solution for injection in pre-filled syringe.
Bistra raztopina za injiciranje v napolnjeni injekcijski brizgi.
(see section 5.1).
Humiro je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne zdravljenje z metotreksatom ni primerno (glejte poglavje 5. 1).
29 Ankylosing spondylitis
29 Ankilozirajoči spondilitis
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease or psoriasis.
Zdravljenje s Humiro mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa Crohnove bolezni ali psoriaze.
In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv na Humiro zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
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.
30 Psoriatični artritis in ankilozirajoči spondilitis Priporočeni odmerek Humire pri bolnikih s psoriatičnim artritisom ali ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.