natgillin/translations-raw huggingface dataset:
The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko medianega časa do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
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.
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Poročali so tudi o melanomu in karcinomu Merklovih celic pri bolnikih, zdravljenih s TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
Contains 2 cartons and each carton contains:
Vsebuje 2 škatli, vsaka od njiju pa vsebuje:
In rare cases, these infections may be life-threatening.
Te okužbe so lahko v redkih primerih smrtno nevarne.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Cilj adalimumaba je beljakovina, ki ji pravimo tumorje nekrotizirajoči faktor ali TNFα, katere ravni so zvišane pri zgoraj navedenih vnetnih boleznih.
• Set up the following items on a clean surface, DO NOT take them out of their individual packaging yet.
• Na čisto površino pripravite sledeče enote zdravila in jih NE JEMLJITE iz njihove posamezne ovojnine:
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Imraldi cannot be excluded (see section 4.8).
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Imraldi, ni mogoče izključiti (glejte poglavje 4.8).
The proportions of subjects with PaedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ali soli zlata.
solution for injection Contains 2 cartons each for a single injection only
raztopina za injiciranje Vsebuje 2 škatli, od katerih je vsaka samo za eno injiciranje
• Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
• Držite ovojnino brizge in POČASI potegnite beli nosilec bata ven, tako da je 0,1 ml preko predpisanega odmerka (če je npr. predpisani odmerek 0,5 ml, potegnite beli nosilec bata do 0,6 ml).
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM1 with an IC50 of 0.1-0.2 nM).
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in
You should continue to inject Imraldi for as long as your doctor has told you.
Nadaljevati morate z injiciranjem zdravila Imraldi tako dolgo, kot vam je naročil zdravnik.
People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rakom, ki prizadene limfatični sistem) in levkemijo (rakom, ki prizadene kri in kostni mozeg).
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba
The needle might be dirty or damaged.
Možno je namreč, da je igla onesnažena ali poškodovana.
4) Dose Preparation
4) Priprava odmerka
Wait 15-30 minutes for your pre-filled syringe to reach to room temperature, which helps reduce your pain during injection.
Počakajte 15-30 minut, da napolnjena injekcijska brizga doseže sobno temperaturo, saj to pomaga zmanjšati bolečino med injiciranjem.
Patients should be tested for HBV infection before initiating treatment with Imraldi.
Bolnike je treba pred začetkom zdravljenja z zdravilom Imraldi testirati na okužbo s HBV.
Choose an injection site & clean skin
Izberite mesto za injiciranje in očistite kožo
Do not use this medicine after the expiry date which is stated on the label of the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na škatli poleg oznake “Uporabno do”.
Study nr-axSpA I evaluated patients with active nr-axSpA.
Študija nr-axSpA I je proučila bolnike z aktivnim nr-axSpA.
- If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
- če imate hudo okužbo, vključno s tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
Then lift your thumb to let the needle retract into the body of the syringe.
Nato dvignite palec, da bo igla zdrsnila v ohišje injekcijske brizge.
Should treatment be interrupted, Imraldi may be re-introduced as appropriate.
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Imraldi znova uvesti, kakor je primerno.
Vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Učinki, povezani z vidom, niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Sočasna uporaba adalimumaba z drugimi biološkimi DMARDS (tj. anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij.
Imraldi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Imraldi is indicated.
Zdravljenje z zdravilom Imraldi mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Imraldi indicirano.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Imraldi should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Imraldi nemudoma prekiniti in uvesti ustrezno zdravljenje.
Your doctor may recommend temporary discontinuation of Imraldi.
Zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Imraldi.
If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Če je predpisani odmerek 0,5 ml, potegnite beli nosilec bata ven do 0,6 ml.
If you forget to give yourself an injection, you should inject the next dose of Imraldi as soon as you remember.
Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Imraldi injicirati, čim se spomnite.
Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
upoštevanjem teh ugotovitev je adalimumab priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Odmerjanje adalimumaba pri teh bolnikih je bilo določeno na podlagi farmakokinetičnega modeliranja in simulacije (glejte poglavje 5.2).
Following 3 years of adalimumab therapy, 75 % (301/402) continued to be in clinical remission per partial Mayo score.
Po 3 letih zdravljenja z adalimumabom jih je 75 % (301/402) ostalo v klinični remisiji po delni oceni Mayo.
Your child's symptoms may return upon stopping treatment.
Otrokovi simptomi se lahko po prenehanju zdravljenja povrnejo.
• While holding the vial, push the white plunger rod all the way down.
• Medtem ko držite vialo, potisnite beli nosilec bata do konca dol.
Among patients whose adalimumab treatment was withdrawn at week 12 in studies HS-I and HS-II, the
Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in
Table 16 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih
Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Številke so bile v korist adalimumaba za večino podrezultatov s statistično značilno povprečno razliko za splošni vid, očesno bolečino, vid na blizu, duševno zdravje in skupen rezultat v študiji UV I ter za splošni vid in duševno zdravje v študiji UV II.
c Based on rank analysis d Joint Space Narrowing
c na podlagi analize rangov d zožitev sklepne špranje
DO NOT push the white plunger rod past the dose position.
NE POTISNITE belega nosilca bata preko položaja za odmerek.
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10 % (60 % of patients) and BSA<10 % and ≥5 % (40 % of patients)).
Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) ter telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Adalimumab so raziskali pri 9.506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
Antibiotics may be continued during treatment with Imraldi if necessary.
Med zdravljenjem z zdravilom Imraldi lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 26.
If you forget to give your child an injection, you should inject the Imraldi dose as soon as you remember.
Če svojemu otroku pozabite dati injekcijo, morate odmerek zdravila Imraldi injicirati, čim se spomnite.
• Pop off the white plastic cap from the vial to see the top of the vial stopper.
• Odstranite belo plastično zaporko z viale, da bo viden zgornji del zamaška viale.
Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Bolniki, zdravljeni z adalimumabom, so imeli statistično pomembno zmanjšanje tveganja novega izbruha bolezni v začetnih 12. tednih zdravljenja.
Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where adalimumab was given for at least an additional 108 weeks.
Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili lahko vključeni v odprto podaljšano preskušanje, v katerem so adalimumab prejemali vsaj še dodatnih 108 tednov.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Zdravilo Imraldi se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let, in artritisa, povezanega z entezitisom, pri otrocih in mladostnikih, starih od 6 do 17 let.
This medicinal product contains 20.0 mg sorbitol.
To zdravilo vsebuje 20,0 mg sorbitola.
Steroid-free remission for ≥ 90 daysa
Remisija brez steroidov za ≥ 90 dnia
The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo adalimumaba:
At week 12 and week 24, PaedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
12. teden je bil odziv Paed ACR 30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Imraldi je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
This injection should not be mixed in the same syringe or vial with any other medicine.
Raztopine ne smete v isti brizgi ali viali mešati z nobenim drugim zdravilom.
a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor b 2-sided P value from log rank test c NE = not estimable.
a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem b 2-stranska vrednost p testa log-rank c NE = ni mogoče oceniti.
The active ingredient in Imraldi, adalimumab, is a monoclonal antibody.
Učinkovina v zdravilu Imraldi, adalimumab, je monoklonsko protitelo.
Follow this instruction guide carefully, and soon you will develop a routine for injecting confidently.
Natančno se ravnajte po teh navodilih in kmalu boste povsem obvladali postopek injiciranja.
Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda
Portugal Biogen Portugal Sociedade Farmacêutica,
• serious infections
• resne okužbe
• Place the syringe on your clean work surface.
• Položite brizgo na čisto delovno površino.
Ped ACR 30 response (n/N)
Odziv »Paed ACR« 30 (n/N)
Place the container on your work surface.
Položite vsebnik za odpadke na delovno površino.
Hidradenitis Suppurativa Clinical Response (HiSCR)a
Klinični odziv pri hidradenitis suppurativa (HiSCR)a
• intestinal perforation;
• intestinalna perforacija;
hepatic steatosis,
jetrna steatoza,
Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Slika 2 Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Zdravilo Imraldi je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
Place greenbase, press down, and hold
Zeleno osnovo položite na kožo, pritisnite navzdol in držite
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z zdravilom adalimumab, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS < 1,3).
The primary efficacy endpoint in both studies was ´time to treatment failure´.
Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah "čas do neuspeha zdravljenja".
Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Študija nr-axSpA II je bila študija prenehanja zdravljenja pri bolnikih z aktivnim nr-axSpA, ki so med zdravljenjem z zdravilom adalimumab v odprti fazi zdravljenja dosegli remisijo.
In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
V odprtem podaljšanju študije revmatoidnega artritisa III se je večina bolnikov, ki so se odzvali na ACR, odzivala še naprej v času sledenja do 10 let.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Imraldi.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila Imraldi.
If you press the syringe plunger slowly, it may make your injection more comfortable.
Če bat injekcijske brizge potiskate počasneje, bo injiciranje morda manj neprijetno.
506 (62.2)b a Percent of patients achieving PASI 75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
506 (62,2)b a Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center b p < 0,001, adalimumab v primerjavi s placebom
• Imraldi can be used during breast-feeding.
• Zdravilo Imraldi se lahko uporablja med dojenjem.
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQIDermatology Life Quality Index).
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Imraldi.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom Imraldi natančno kontrolirati glede okužb, vključno s tuberkulozo.
Do not remove the needle cap before you are ready to inject.
Pokrovček za iglo odstranite šele, ko ste pripravljeni na injiciranje.
There is limited experience in the initiation of treatment with Imraldi alone.
O začetku zdravljenja samo z zdravilom Imraldi so izkušnje omejene.
What Imraldi looks like and contents of the pack
Izgled zdravila Imraldi in vsebina pakiranja
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.
Patients participating in studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Bolniki, vključeni v študiji HS-I in HS-II, so bili primerni za vključitev v odprto podaljšano študijo, pri kateri so prejemali 40 mg adalimumaba vsak teden.
PASI 75b PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
PGA: čisto/minimalnoc a MTX = metotreksat b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Vsi bolniki so ob začetku študije prejeli 2-tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
If new areas of damaged skin appear during or after therapy or if existing marks or areas of damage change appearance, tell your doctor.
Če se med zdravljenjem ali po njem pojavijo nova področja poškodovane kože ali če se spremeni videz obstoječih znamenj ali poškodovanih področij, morate to povedati zdravniku.
After proper training in injection technique, patients may self-inject with Imraldi if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo Imraldi lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
This includes any possible side effects not listed in this leaflet (See section 4).
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
• In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi.
• Poleg tega so pri bolnikih, zdravljenih z zdravilom Imraldi, opazili primere nemelanomskega kožnega raka.
Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenem z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF-36) v študiji HS-I).
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated patients.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini.
Improvement in health-related quality of life and physical function was maintained during the openlabel extension through week 156.
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
• facial oedema associated with allergic reactions;
• edem obraza, povezan z alergijskimi reakcijami;