FrancophonIA/ELRC3.0 huggingface dataset:
English: Thirty-three (18%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Slovenian: 33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
English: The window turns yellow When the injection is done
Slovenian: Ko je injiciranje končano, postane okence rumeno.
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year versus 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year versus 0.22 per patient year.
Slovenian: Število hospitalizacij iz vseh razlogov v skupini, zdravljeni z adalimumabom, je bilo 0,18 na bolnikov-let proti 0,26 na bolnikov-let v placebo skupini.
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, 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.
Slovenian: V eksploracijskem kliničnem preskušanju infliksimaba, drugega antagonista 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.
English: • 160 mg at week 0 and 80 mg at week 2
Slovenian: • 160 mg v 0. tednu in 80 mg v 2.tednu
English: AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
Slovenian: Pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo je zvečano osnovno tveganje za limfome in levkemijo, kar komplicira oceno tveganja.
English: • Adults with non-infectious uveitis with inflammation affecting the back of the eye.
Slovenian: • odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa.
English: AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Slovenian: Rentgensko slikanje je pokazalo, da zdravilo AMGEVITA upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
English: If you have mild heart failure and you are being treated with AMGEVITA, your heart failure status must be closely monitored by your doctor.
Slovenian: • Če imate blago srčno popuščanje in se zdravite z zdravilom AMGEVITA, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your rheumatoid arthritis.
Slovenian: Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo AMGEVITA.
English: K. Examine the injection site.
Slovenian: K. Preglejte mesto injiciranja.
English: CD study II: infliximab experienced patients
Slovenian: Študija pri Crohnovi bolezni II: Bolniki, ki so že dobivali infliksimab
English: Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).
Slovenian: Eno pakiranje vsebuje 1, 2, 4 ali 6 40 mg napolnjenih injekcijskih brizg (z modrim batom brizge).
English: AMGEVITA is administered every other week via subcutaneous injection.
Slovenian: Zdravilo AMGEVITA se odmerja vsak drugi teden v obliki subkutane injekcije.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNFα) inhibitors.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje-nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04.
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Slovenian: Če je s 40 mg vsak teden ali 80 mg vsak drugi teden dosežen zadosten odziv na zdravljenje, se lahko odmerek pozneje zmanjša na 40 mg vsak drugi teden.
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Slovenian: Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of AMGEVITA should be promptly discontinued.
Slovenian: Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of AMGEVITA for patients with polyarticular juvenile idiopathic arthritis, from 2 years of age is based on body weight (table 1).
Slovenian: Pediatrična populacija Juvenilni idiopatski artritis Poliartikularni juvenilni idiopatski artritis od 2. leta starosti Priporočeni odmerek zdravila AMGEVITA pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: AMGEVITA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
English: By Week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Slovenian: Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so neprekinjeno prejemali adalimumab v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
English: Statistically and clinically significant improvements from baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Slovenian: Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kvalitete življenja (vključno z IMPACT III) glede na začetek študije.
English: Make sure the medicine in the syringe is clear and colourless to slightly yellow.
Slovenian: Prepričajte se, da je zdravilo v brizgi bistro in brezbarvno do rahlo rumenkasto.
English: AMGEVITA Dose for Paediatric Patients with Crohn's disease
Slovenian: Odmerjanje zdravila AMGEVITA pri pediatričnih bolnikih s Crohnovo boleznijo
English: Multipack: 6 (3 packs of 2) pre-filled syringes.
Slovenian: Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week (eow).
Slovenian: Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg adalimumaba vsak drugi teden.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Slovenian: • sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo,
English: LIST OF EXCIPIENTS Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Slovenian: SEZNAM POMOŽNIH SNOVI Ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
English: Table 29.
Slovenian: Preglednica 29.
English: Marketing Authorisation Holder Amgen Europe B.V.
Slovenian: Imetnik dovoljenja za promet Amgen Europe B.V.
English: The combination of AMGEVITA and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Slovenian: Kombinacija zdravila AMGEVITA in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
English: Table 23.
Slovenian: Preglednica 23.
English: Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres) wide.
Slovenian: Kožno gubo čvrsto držite med palcem in prsti, da nastane približno 5 centimetrov široka površina.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Slovenian: Pri 84% preiskovancev, ki so dobivali adalimumab in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
English: Week 26 Placebo-controlled
Slovenian: teden Kontrolirana s placebom
English: ● Do not remove the needle cap until you are ready to inject.
Slovenian: ● Ne odstranjujte pokrovčka igle, dokler niste pripravljeni za injiciranje.
English: • oral infections (including tooth infections and cold sores);
Slovenian: • okužbe ustne votline (vključno z okužbami zob in ocvirki);
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Slovenian: Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okužbe, to takoj povejte zdravniku.
English: Keep AMGEVITA in the outer carton in order to protect from light.
Slovenian: Zdravilo AMGEVITA shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v 0. tednu, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating AMGEVITA therapy.
Slovenian: Za pediatrične bolnike je priporočljivo, da pred začetkom zdravljenja z zdravilom AMGEVITA opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
English: 40 mg adalimumab every other week
Slovenian: 40 mg adalimumaba vsak drugi teden
English: - The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Slovenian: - Pomožne snovi so ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
English: Used plunger rod Finger flange
Slovenian: Uporabljen bat Oprijemalo za prste
English: ACR responses in placebo-controlled trials (percent of patients)
Slovenian: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: Radiographic mean changes over 12 months in RA study III
Slovenian: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
English: Children and adolescents with plaque psoriasis
Slovenian: Otroci in mladostniki z luskavico (psoriazo) v plakih
English: Table 28.
Slovenian: Preglednica 28.
English: Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).
Slovenian: Eno pakiranje vsebuje 1 20 mg napolnjeno injekcijsko brizgo za enkratno uporabo (z rumenim batom brizge).
English: Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Slovenian: pogosti astma, dispneja, kašelj občasni pljučni embolizem intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralna efuzija1)
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX
Slovenian: V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Slovenian: Delež (95 % interval zaupanja) nemelanomskih kožnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
English: Radiographic mean changes at week 52 in RA study V
Slovenian: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: ● Put the used AMGEVITA syringe in a sharps disposal container immediately after use.
Slovenian: ● Uporabljen napolnjen injekcijski peresnik nemudoma po injiciranju dajte v vsebnik za ostre odpadke.
English: If you forget to use AMGEVITA
Slovenian: Če ste pozabilli uporabiti zdravilo AMGEVITA
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z adalimumabom in pri 2,4 % bolnikov v kontrolni skupini.
English: ● Do not remove the needle cap from the syringe until you are ready to inject.
Slovenian: ● Ne odstranjujte pokrovčka igle z brizge, dokler niste pripravljeni za injiciranje.
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with AMGEVITA.
Slovenian: Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom AMGEVITA ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
English: The recommended dose of AMGEVITA for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Slovenian: Priporočeni odmerek zdravila AMGEVITA pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so dobivali adalimumab, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, kot so npr. listerioza, legioneloza in pnevmocistična okužba.
English: Step 2: Get ready E. Pull the needle cap straight out and away from your body when you are ready to inject.
Slovenian: 2. korak: Pripravite se E. Ko ste pripravljeni na injiciranje, potegnite rumeni pokrovček igle naravnost s peresnika.
English: ● Plaster
Slovenian: ● Obliž
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitislike psoriatic arthropathy due to the small number of patients studied.
Slovenian: Zaradi majhnega števila proučenih bolnikov ni dovolj dokazov o učinkovitosti adalimumaba pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79% CV).
Slovenian: Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih so bile srednje ± SD koncentracije adalimumaba v stanju dinamičnega ravnovesja približno 7,4 ± 5,8 µg/ml (79 % KV).
English: In the open-label extension of RA study V, the mean change from baseline at year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Slovenian: V odprtem podaljšanju študije revmatoidnega artritisa V je bila povprečna sprememba celotne Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z adalimumabom in kombinacijo adalimumab/metotreksat, glede na izhodišče 10,8, 9,2 oz. 3,9.
English: Adalimumab has not been studied in patients aged less than 2 years.
Slovenian: Raziskave z adalimumabom pri bolnikih mlajših od 2 let niso bile izvedene.
English: • It is important that you tell your baby's doctors and other health care professionals about your AMGEVITA use during your pregnancy before the baby receives any vaccine.
Slovenian: • Pomembno je, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo AMGEVITA, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi").
English: 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%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Slovenian: V odprti podaljšani študiji je odziv PASI 75 v 12. oziroma 24. tednu doseglo 26,4 % (92/349) oziroma 37,8 % (132/349) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
English: AMGEVITA is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
English: • injection site reactions (including pain, swelling, redness or itching);
Slovenian: • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem);
English: Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
Slovenian: b izhodišče je določeno kot izhodišče odprte faze, ko imajo bolniki aktivno bolezen.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (psoriasis study III).
Slovenian: Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 20 mg injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE AMGEVITA 20 mg injekcija adalimumab s.c.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET
English: Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Slovenian: Bolniki, ki so 16. teden dosegli odziv »Pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m2 (do največ 40 mg) ali placebo.
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Slovenian: 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 adalimumaba 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
English: If you do not respond well enough to these medicines, you will be given AMGEVITA.
Slovenian: Če se na ta zdravila ne boste dovolj dobro odzivali, boste dobili zdravilo AMGEVITA.