natgillin/translations-raw huggingface dataset:
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. t uc
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 vo so bili obravnavani kot neodzivni bolniki.
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
Rezultati obsežnejše študije (VIII) pri 315 bolnikih so pri bolnikih, ki so dobivali Trudexo, pokazali do
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8). rod
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (tabela 8).
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII Reduction of Signs and Symptoms lP
Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII eā
Response ASASa 20 na
Odziv ASASa
Week 2 Week 12 Week 24
2. teden nim
Week 2 Week 12 Week 24
2. teden 12. teden
3% 10% 11%
3% 10%
16%*** 38%*** 35%***
16% *** 38% ***
ASAS 70
ASAS 70 rav
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis
***, ** Statistično značilno pri p < 0, 001, < 0, 01 za vse primerjave med Trudexo in placebom po 2, 12 in 24 tednih
ed b Bath Ankylosing Spondylitis Disease Activity Index
38 a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire
Bolniki, ki so dobivali Trudexo, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu –
ris (ASQoL).
t Ankylosing Spondylitis Quality of Life Questionnaire).
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
me Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji (IX) pri 82 odraslih bolnikih z aktivnim ankilozirajočim
tho placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
pro spondilitisom.
Crohn’ s Disease
Crohnova bolezen
au The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
za Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
478 of the enrolled patients (32%) were defined as having a
Dovoljena
r severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants)
nja je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ ali imunomodulacijskih zdravil; 79% bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
ge corresponding to the population defined in the indication (see section 4.1).
lje Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, CLASSIC I in GAIN.
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications. lon Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
V študiji CLASSIC I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg Trudexe 0. teden in 80 mg vo 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa 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.
V študiji GAIN so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg Trudexe 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
In GAIN, 325 patients who had lost no
Študija ni vključila do
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. t uc
primarno neodzivnih bolnikov in ti tako niso bili dodatno ocenjeni.
Patients in clinical rod
Na 4. teden so bolnike randomizirali na 40 mg eā
Corticosteroid taper was permitted after week 8.
Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida. av
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. lP Me
Indukcija klinične remisije in odziva (odstotek bolnikov)
dic
CLASSIC I:
i
GAIN:
na
ilo
Induction of Clinical Remission and Response (Percent of Patients)
Bolniki, ki še niso dobivali infliksimaba placebo Trudexa Trudexa
Infliximab Naive Patients
Bolniki, ki so že dobivali placebo
GAIN:
n = 166
Placebo Trudexa N=74 80/ 40 mg
160/ 80 mg
Trudexa 160/ 80 m
80/ 40 mg n = 75
Placebo Trudexa N=166 160/ 80 mg
160/ 80 mg n = 76
ed Week 4
4. teden
Clinical response (CR-
Klinični odziv (CR- 100) Zd
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
Vse vrednosti p so za parne primerjave deležev med Trudexo 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.
39 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.
r ge In CHARM, at week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
V študiji CHARM je imelo 4. teden klinični odziv 58% (499/ 854) bolnikov; ti so bili ocenjeni v primarni analizi.
Maintenance of remission and response rates are presented in Table 10.
Rezultati glede klinične
Clinical lon remission results remained relatively constant irrespective of previous TNF antagonist exposure.
t remisije so ostali razmeroma stalni, ne glede na prejšnje prejemanje antagonistov TNF.
Table 10:
me Tabela 10:
Maintenance of Clinical Remission and Response (Percent of Patients) no
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Clinical remission
za Klinični odziv (CR- 100)
for > =90 daysa Week 56 Clinical remission
nja 56. teden Klinična remisija Klinični odziv (CR- 100)
N=170 12%
n = 170 12% 17%
N=172 36%*
n = 172 36% * 41% *
N=157 41%*
n = 157 41% * 48% *
17%
lje
Patients in steroid-free remission for > =90 daysa na
Bolniki v remisiji brez steroidov za ≥ 90 dnia
* p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a i
vo * p < 0, 001 za parne primerjave deležev med Trudexo in placebom ** p < 0, 02 za parne primerjave deležev med Trudexo in placebom do
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week Me
To kaže, da lahko nadaljnje eā
12.
zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
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). av
In CLASSIC I and GAIN, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to
Študiji CLASSIC I in GAIN sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, nim
40 Trudexa 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at weeks 26 and 56 in CHARM as well among the adalimumab treatment groups compared to the placebo group.
randomiziranih na shemi s Trudexo 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 CHARM.
Immunogenicity
Imunogenost ilo
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy
Nastanek protiteles proti adalimumabu spremljata večji očistek in manjša učinkovitost adalimumaba.
There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events.
Med prisotnostjo protiteles proti adalimumabu in neželenimi učinki ni očitne korelacije. rav
In patients not given
V ključnih preskušanjih so protitelesa proti adalimumabu odkrili pri Zd
In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/ 376 subjects (10%)
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.
40 13, 5% (24/ 178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7% (14 od 198 bolnikov).
r ge In patients with ankylosing spondylitis antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
Med bolniki z ankilozirajočim spondilitisom so protitelesa 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. lon In patients with Crohn’ s disease, adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
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%).
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from no
t me Pri bolnikih s Crohnovo boleznijo so identificirali protitelesa proti adalimumabu pri 7 od 269 oseb (2, 6%), ki so bile zdravljene z adalimumabom.
other products is not appropriate.
pro Ker so analize imunogenosti specifične za posamezno zdravilo, primerjava z deleži protiteles pri drugih zdravilih ne pride v poštev.
5.2 Pharmacokinetic properties t
5. 2 Farmakokinetične lastnosti
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab uc
za Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
was slow, with peak serum concentrations being reached about 5 days after administration.
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh raziskav po enem 40 mg odmerku subkutano, je 64%.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg rod
Po enem samem intravenskem odmerku od 0, 25 do 10 mg/ kg so bile koncentracije
subcutaneous dose was 64%.
nja sorazmerne odmerku.
rheumatoid arthritis patients ranged from 31-96% of those in serum.
Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 lje do 96% tistih v serumu.
Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ ml (without na
Po subkutani uporabi 40 mg Trudexe vsak drugi teden pri bolnikih z revmatoidnim artritisom (RA) so vo 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).
concomitant methotrexate) and 8 to 9 µg/ ml (with concomitant methotrexate), respectively.
sorazmerno odmerku po 20, 40 in 80 mg vsak drugi teden in vsak teden subkutano.
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing. i dic
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg Trudexe na 0. teden, ki mu sledi 40 mg Trudexe 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno eā
In patients with Crohn’ s disease, the loading dose of 80 mg Trudexa on week 0 followed by 40 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml during the induction period.
Polnilni odmerek 160 mg Trudexe na 0. teden, ki mu sledi 80 mg Trudexe 2. teden, doseže med obdobjem indukcije najnižjo koncentracijo v serumu približno 12 µg/ ml.
A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Me
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg Trudexe vsak drugi teden, so ugotovili najnižjo av
Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
koncentracijo v stanju dinamičnega ravnovesja približno 7 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 Trudexa every other week.
Analize populacijske farmakokinetike s podatki za več kot 1. 300 bolnikov z revmatoidnim artritisom nim
Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
41 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tiste, ki ni vezan na protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
Trudexa has not been studied in children or in patients with hepatic or renal impairment.
Trudexa ni raziskana pri otrocih in bolnikih z okvaro jeter ali ledvic. ilo
5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti rav
ed Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Neklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Carcinogenicity studies, and standard assessment of
Raziskava embrio- fetalne razvojne toksičnosti/ perinatalnega razvoja je bila narejena pri opicah Zd
au 6.
41 6.
r ge Mannitol Citric acid monohydrate Sodium citrate lon Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 no
me natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid
Sodium hydroxide Water for injections
pro polisorbat 80 natrijev hidroksid voda za injekcije
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. rod
za Zaradi pomanjkanja študij o kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
18 months lP
nja 18 mesecev
6.4 Special precautions for storage
lje 6. 4 Posebna navodila za shranjevanje
Do not freeze. na
Ne zamrzujte. vo 6. 5 Vrsta ovojnine in vsebina do
6.5 Nature and contents of container i
Pakiranja: eā
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use: dic
• 1 napolnjena injekcijska brizga (0, 8 ml sterilne raztopine) z 1 alkoholnim zložencem v pretisnem omotu. • 2 napolnjeni injekcijski brizgi (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v av
Me
pretisnem omotu. • 4 napolnjene injekcijske brizge (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu. nim
• 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
• 6 napolnjenih injekcijskih brizg (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj. ilo
42 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi. rav
ed Queenborough Kent ME11 5EL United Kingdom
Queenborough Kent ME11 5EL Velika Britanija
ris 8.
42 8.
tho EU/ 1/ 03/ 257/ 002 EU/ 1/ 03/ 257/ 003 EU/ 1/ 03/ 257/ 004
EU/ 1/ 03/ 257/ 002 EU/ 1/ 03/ 257/ 003 EU/ 1/ 03/ 257/ 004 EU/ 1/ 03/ 257/ 005
9.
t me 9.
r ge 1 September 2003 10.
pro 1. september 2003
{MM/ YYYY}
za {MM/ LLLL}
uc rod lP i na dic Me
nja lje vo do eā av nim ilo rav Zd
au Solution for injection in pre-filled syringe with needleguard.
Raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar av
44 4.2 Posology and method of administration
44 Za indukcijsko zdravljenje morate Trudexo uporabiti v kombinaciji s kortikosteroidi.
The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. t
Priporočeni odmerek Trudexe pri bolnikih s psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.. av
45 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
45 Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
Trudexa has not been studied in these patient populations.
za Trudexa pri teh populacijah bolnikov še ni bila preskušena.
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4). lon 4.4 Special warnings and precautions for use
Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4. 4). lje Zmerno do hudo srčno popuščanje (razred III/ IV po NYHA) (glejte poglavje 4. 4). vo 4. 4 Posebna opozorila in previdnostni ukrepi
Infections no
Okužbe do
Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Če se pri bolniku pojavi nova resna okužba, je treba uporabo Trudexe prekiniti, dokler okužba ni nim
46 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
46 Pred začetkom zdravljenja s Trudexo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
47 The needle cover of the syringe contains natural rubber (latex).
47 Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
tho In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
pro V kontroliranih delih kliničnih preizkušanj z zaviralci TNF je bilo opaženih več primerov malignomov, vključno z limfomi tako pri bolnikih, ki so prejemali zaviralec TNF, kot pri kontrolnih bolnikih.
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8). lon In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
lje V eksploracijskem kliničnem preskušanju infliksimaba, drugega zdravila proti TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
vaccinations, except for live vaccines.
živih cepiv. rav
Congestive heart failure Me
Kongestivno srčno popuščanje
48 Autoimmune processes
48 Zdravljenje s Trudexo lahko povzroči nastanek avtoimunskih protiteles.
Trudexa has been studied both in rheumatoid arthritis and psoriatic arthritis patients taking Trudexa as uc
Trudexo so raziskali tako pri bolnikih z revmatoidnim artritisom in revmatoidnim artritisom, ki so Trudexo jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
49 However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju s Trudexo.
No studies on the effects on the ability to drive and use machines have been performed.
49 Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
These
t me Trudexo so raziskali pri 5293 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
tho trials included rheumatoid arthritis patients with short term and long standing disease as well as psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease patients.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), psoriatičnim artritisom, ankilozirajočim sponditisom in Crohnovo boleznijo.
au during the controlled period.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, s placebom
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I− IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking
za kontroliranim delom raziskav I– IX, CLASSIC I, GAIN in CHARM, je bil 5, 7% v skupini, ki je prejemala Trudexo, in 5, 3% v kontrolni skupini.
50 Blood and the lymphatic system disorders
Bolezni krvi in limfatičnega sistema
pancytopaenia, idiopathic thrombocytopaenia purpura
pancitopenija, idiopatska trombocitopenična
Endocrine disorders
t me Bolezni endokrinega sistema
au Metabolism and nutrition disorders
Presnovne in prehranske
Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
hipokalemija, zvišanje lipidov, motnje apetita
r
(vključno z anoreksijo), hiperurikemija
ge Psychiatric disorders
Psihiatrične motnje
lon
motnje počutja, anksioznost (vključno z
mood disorders, anxiety (including nervousness and agitation)
za živčnostjo in agitiranostjo)
no
nja parestezijami)
syncope, migraine, tremor, sleep disturbances
sinkopa, migrena, tremor, motnje spanja lje
51
Zd
ris
51
rash, dermatitis and eczema, pruritus, hair loss
izpuščaj, dermatitis in ekcem, srbenje, izpadanje
Uncommon
pro las
lon
občasni
Musculoskeletal,
Bolezni mišično- skeletnega
connective tissue and bone disorders
nja sistema in vezivnega tkiva
disorders
vo
blood creatine phosphokinase increased, activated partial thromboplastin time
zvišanje kreatin fosfokinaze v krvi, podaljšan
prolonged, autoantibodies present
aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
Injection site reactions
Spremembe na mestu injiciranja rav