FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelbromida).
English: How to take Clopidogrel Teva Pharma B.V.
Croatian: Kako uzimati Klopidogrel Teva Pharma B.V.
English: • Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin.
Croatian: • oticanje u ustima ili kožne poremećaje kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: Deutschland ratiopharm GmbH Tel: +49 731 402 02
Croatian: Tél/Tel: +49 731 402 02
English: Vascular disorders
Croatian: Pretrage trombocita
English: Film-coating
Croatian: NAČIN IZDAVANJALIJEKA
English: Inflammation of the blood vessels, decrease in blood pressure Yellowing of the skin and whites of the eyes (jaundice) Bleeding in the lungs, throat, stomach or bowels, abdomen or joints Bleeding of post-operative wounds or other serious bleeds Severe abdominal pain with or without back pain, pain in the joints and muscular pain Diarrhoea
Croatian: Poremećaji probavnog sustava gastrointestinalno krvarenje, proljev, bol u trbuhu, dispepsija ulkus želuca i dvanaesnika, gastritis, povraćanje, mučnina, konstipacija, flatulencija retroperitonealno krvarenje gastrointestinalno i retroperitonealno krvarenje s fatalnim ishodom, pankreatitis, kolitis (uključujući ulcerozni ili limfocitni kolitis), stomatitis
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Croatian: U studiji CLARITY, uočeno je ukupno povećanje krvarenja u grupi koja je primala klopidogrel uz ASK u odnosu na skupinu koja je uzimala placebo uz ASK.
English: There was an excess of intracranial bleeding in the clopidogrel
Croatian: • krvarenje u trbušnoj šupljini
English: Push the tablet out
Croatian: Istisnuti tabletu.
English: How to store Clopidogrel Teva Pharma B.V.
Croatian: Kako čuvati Klopidogrel Teva Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets
Croatian: NAZIV LIJEKA Klopidogrel Teva Pharma B.V 75 mg filmom obložene tablete
English: Tel.: +36 1 288 64 00
Croatian: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: Warnings and precautions Tell your doctor before you start to take this medicine if:
Croatian: Prije nego što počnete uzimati ovaj lijek, obavijestite svojega liječnika:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel oral use
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Klopidogrel Teva Pharma B.V. 75 mg filmom obložene tablete klopidogrel
English: - Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Croatian: - Blisteri djeljivi na jedinične doze koji sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 filmom obloženih tableta.
English: Ulcers in the stomach and small intestine, nausea, vomiting, constipation, flatulence (wind) and inflammation of the stomach leading to sickness, loss of appetite and discomfort after eating Reduction in blood platelets which makes bleeding or bruising more likely Blood disorders including a reduction in the number of white blood cells which makes infections more likely.
Croatian: • Ulkus želuca i tankog crijeva, povraćanje, mučnina, zatvor, nadutost (vjetrovi) i upala želuca koja uzrokuje mučninu, gubitak apetita i neugodu nakon jela
English: The recommended dose is one 75 mg tablet per day which should be swallowed with water or another liquid.
Croatian: Preporučena doza je jedna tableta od 75 mg jednom na dan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE blistera (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 filmom obloženih tableta)
English: • Diarrhoea, abdominal pain, indigestion or heartburn
Croatian: • proljev, bol u trbuhu, loša probava ili žgaravica.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Klopidogrel Teva Pharma B.V. sadrži laktozu Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite mu se prije uzimanja ovog lijeka.
English: - Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Croatian: - Blisteri s odvojivom folijom djeljivi na jedinične doze koji sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 filmom obloženih tableta.
English: • Non-steroidal anti-inflammatory medicines (used to treat painful inflammatory conditions of the joints or muscles).
Croatian: • nesteroidne protuupalne lijekove, koji se obično primjenjuju za liječenje bolnih i/ili upalnih stanja mišića ili zglobova, primjerice ibuprofen, diklofenak i meloksikam,
English: Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 21 476 75 50
Croatian: Tel: (351) 21 476 75 50
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Croatian: PODACI KOJE NAJMANJE MORA SADRŽAVATI BLISTER ILI STRIP (BLISTER 14 x1, 28 x1,30x1, 50x1, 84 x1, 90x1 ili 100x1 filmom obloženih tableta)
English: Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.
Croatian: Portugal Teva Pharma - Produtos Farmacêuticos Lda
English: 1 of 1
Croatian: 500 IU
English: Further information on RoActemra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/RoActemra.
Croatian: Više informacija o lijeku RoActemra nalazi se na internetskim stranicama Agencije:ema.europa.eu/medicines/human/EPAR/RoActemra.
English: Patients were allowed to continue treatment with methotrexate during the study.
Croatian: Bolesnicima je bilo dopušteno nastaviti liječenje metotreksatom tijekom ispitivanja.
English: Cytokine release syndrome (CRS)
Croatian: Sindrom oslobađanja citokina (CRS)
English: All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.
Croatian: Svi bolesnici također su liječeni kortikosteroidom, no to je liječenje prekinuto nakon postupnog smanjenja doze u razdoblju od 6 ili 12 mjeseci.
English: By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.
Croatian: Sprječavajući vezivanje interleukina-6 na njegove receptore, tocilizumab smanjuje upalu i ostale simptome tih bolesti.
English: The pack will also include a patient alert card with key safety information for patients.
Croatian: Paket će također sadržavati karticu s upozorenjima za bolesnike koja sadržava važne informacije o sigurnosti primjene.
English: RoActemra received a marketing authorisation valid throughout the EU on 16 January 2009.
Croatian: Lijek RoActemra dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. siječnja 2009.
English: What measures are being taken to ensure the safe and effective use of RoActemra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka RoActemra?
English: Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine' called interleukin-6.
Croatian: Tocilizumab se veže na receptor za glasničku molekulu ili „citokin” naziva interleukin-6.
English: RoActemra is a medicine used to treat:
Croatian: RoActemra je lijek koji se primjenjuje u liječenju:
English: RoActemra must not be used in patients who have an active, severe infection.
Croatian: Lijek RoActemra ne smije se primjenjivati u bolesnika koji imaju aktivne i ozbiljne infekcije.
English: Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years.
Croatian: Gotovo 4 000 bolesnika iz tih pet ispitivanja poslije je sudjelovalo u ispitivanjima kojima su proučavani dugoročni učinci liječenja lijekom RoActemra, a rezultati su pokazali da se odgovor na lijek RoActemra zadržava barem dvije godine.
English: The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions.
Croatian: Najozbiljnije nuspojave su ozbiljne infekcije, komplikacije divertikulitisa (bolest koja zahvaća crijeva) i reakcije preosjetljivosti (alergijske reakcije).
English: The company that markets RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra.
Croatian: Tvrtka koja proizvodi lijek RoActemra mora svim liječnicima za koje se očekuje da će propisivati lijek dostaviti edukacijski paket koji sadržava važne informacije o sigurnosti i ispravnoj primjeni lijeka RoActemra.
English: The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days of the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines.
Croatian: Glavna mjera učinkovitosti bio je broj bolesnika u kojih je CRS izliječen u roku od 14 dana nakon prve doze lijeka RoActemra i kojima nisu bile potrebne više od dvije doze lijeka kao ni dodatno liječenje osim kortikosteroidnih lijekova.
English: Other information about RoActemra:
Croatian: Ostale informacije o lijeku RoActemra:
English: What is RoActemra and what is it used for?
Croatian: Što je RoActemra i za što se primjenjuje?
English: Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek RoActemra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and CRS.
Croatian: Taj je glasnik uključen u nastajanje upale i prisutan je u visokim koncentracijama u bolesnika s reumatoidnim artritisom, sistemskim juvenilnim idiopatskim artritisom, juvenilnim idiopatskim poliartritisom, arteritisom divovskih stanica i CRS-om.
English: RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure).
Croatian: Lijek RoActemra može se također primjenjivati u odraslih i djece u dobi od 2 godine i starije za liječenje teškog ili po život opasnog sindroma oslobađanja citokina (CRS, stanja koje može prouzročiti mučninu, povraćanje, bol i nizak krvni tlak).
English: Juvenile idiopathic polyarthritis
Croatian: Juvenilni idiopatski poliartritis
English: Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.
Croatian: Liječnici moraju pozorno pratiti javljaju li se u bolesnika znakovi infekcije tijekom liječenja te moraju oprezno propisivati lijek RoActemra u bolesnika koji imaju učestale ili dugotrajne infekcije, odnosno bolesti koje mogu povećati rizik od infekcija, kao što su divertikulitis ili dijabetes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati radi sigurne i učinkovite primjene lijeka RoActemra također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of RoActemra are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka RoActemra kontinuirano se prate.
English: The European Medicines Agency decided that RoActemra's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi od lijeka RoActemra nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u Europskoj uniji.
English: RoActemra can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition.
Croatian: RoActerma se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju relevantnog stanja.
English: What are the risks associated with RoActemra?
Croatian: Koji su rizici povezani s lijekom RoActemra?
English: Why is RoActemra authorised in the EU?
Croatian: Zašto je lijek RoActemra odobren u EU-u?
English: One year after starting treatment, 56% of patients treated with RoActemra once a week did not have symptoms compared with 14% patients receiving placebo.
Croatian: Jednu godinu nakon početka liječenja, 56 % bolesnika liječenih lijekom RoActemra jednom tjedno nije imalo simptome, u usporedbi s 14 % bolesnika koji su primali placebo.
English: One of the studies, which involved 1,196 patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to 2 years, when compared with the combination of placebo and methotrexate.
Croatian: U jednom od ispitivanja kojim je bilo obuhvaćeno 1 196 bolesnika također se pokazalo da je kombinacija lijeka RoActemra i metotreksata nakon razdoblja do dvije godine usporila oštećenje zglobova i poboljšala fizičke funkcije, u usporedbi s kombinacijom placeba i metotreksata.
English: An overview of RoActemra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku RoActemra i zašto je odobren u EU-u
English: The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), headache, hypertension (high blood pressure) and abnormal liver function tests.
Croatian: Najčešće nuspojave lijeka RoActemra (javljaju se u najviše 1 na 10 bolesnika) su infekcije gornjih dišnih putova (infekcije nosa i grla), nazofaringitis (upala nosa i grla), glavobolja, hipertenzija (visoki krvni tlak) i abnormalni rezultati testova jetrene funkcije.
English: For more information about using RoActemra, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka RoActemra pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3,000 patients.
Croatian: U trima od tih ispitivanja lijek RoActemra uspoređen je s placebom kao dodatak neuspješnom liječenju konvencionalnim lijekovima za liječenje reumatoidnog artritisa u ukupno više od 3 000 bolesnika.
English: In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate.
Croatian: U četvrtom ispitivanju, kojim je bilo obuhvaćeno 498 bolesnika koji nisu primjereno odgovorili na inhibitore TNF-a, bolesnici koji su primali lijek RoActemra s metotreksatom imali su otprilike devet puta više izgleda za odgovor od onih koji su primali placebo s metotreksatom.
English: Results showed that patients adding RoActemra were around 4 times more likely to respond to treatment than those adding placebo.
Croatian: Rezultati su pokazali da su bolesnici kojima je u terapiju dodan lijek RoActemra imali otprilike četiri puta više izgleda odgovoriti na terapiju od onih kojima je dodan placebo.
English: RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.
Croatian: Lijek RoActemra primjenjuje se i za liječenje odraslih s arteritisom divovskih stanica, bolesti uslijed koje otiču arterije (obično u glavi).
English: In the first study, RoActemra was more effective than placebo in treating rheumatoid arthritis: after 6 months of treatment with RoActemra, 61% of patients responded to treatment compared with 32% on placebo.
Croatian: U prvom ispitivanju lijek RoActemra bio je učinkovitiji od placeba u liječenju reumatoidnog artritisa: nakon šest mjeseci liječenja lijekom RoActemra, 61 % bolesnika odgovorilo je na liječenje, u usporedbi s 32 % bolesnika koji su uzimali placebo.
English: • children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.
Croatian: • djece u dobi od 2 godine i starije s juvenilnim idiopatskim poliartritisom kod koje liječenje metotreksatom nije bilo dovoljno uspješno.
English: Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions.
Croatian: Ispitivanjima je utvrđeno da je lijek RoActemra učinkovit u smanjenju simptoma nekoliko oblika upalnih stanja.
English: RoActemra given by infusion was considered to be effective at treating severe CRS based on a review of data from 66 patients who experienced this condition after they were given CAR-T cell medicines to treat a blood cancer.
Croatian: Lijek RoActemra primijenjen u obliku infuzije ocijenjen je učinkovitim u liječenju teškog oblika CRS-a na temelju pregleda podataka o 66 bolesnika u kojih je nastupilo to stanje nakon što su primili lijekove na bazi CAR-T stanica radi liječenja raka krvi.
English: • adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
Croatian: • odraslih osoba s teškim oblikom reumatoidnog artritisa koji se pogoršava u bolesnika koji nisu prethodno liječeni metotreksatom;
English: • adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated;
Croatian: • odraslih osoba s aktivnim reumatoidnim artritisom umjerenog do teškog stupnja u kojih prethodne terapije antireumaticima koji modificiraju tijek bolesti (DMARD-ovi), kao što su metotreksat ili lijekovi poznati kao inhibitori faktora nekroze tumora (TNF), nisu bile uspješne ili ih bolesnici nisu dobro podnijeli;
English: The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months.
Croatian: Drugim ispitivanjem, u kojem je uspoređen lijek RoActemra primijenjen injekcijom pod kožu i u obliku infuzije, pokazalo se da lijek RoActemra koji se primjenjuje injekcijom pod kožu nije manje učinkovit u postizanju reakcije nakon šest mjeseci.
English: RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein.
Croatian: Lijek RoActemra dostupan je kao otopina koja se ubrizgava pod kožu i kao koncentrat za pripremu otopine za intravensku infuziju (drip).
English: How does RoActemra work?
Croatian: Kako djeluje RoActemra?
English: The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body.
Croatian: Djelatna tvar lijeka RoActemra je tocilizumab, monoklonsko protutijelo, vrsta bjelančevina koja prepoznaje i veže se na određeno ciljno mjesto (antigen) u tijelu.
English: Out of 51 patients who had CRS after being given the CAR-T cell medicine tisagenlecleucel, 39 responded to treatment with RoActemra (76.5%), while 8 out 15 patients (53.3%) who had CRS after being given axicabtagene ciloleucel responded.
Croatian: Od 51 bolesnika koji su imali CRS nakon što su primili lijek na bazi CAR-T stanica naziva tisagenlekleucel, njih 39 odgovorilo je na terapiju lijekom RoActemra (76,5 %), dok je među bolesnicima koji su imali CRS nakon što su primili aksikaptagen ciloleucel odgovorilo njih 8 od 15 (53,3 %).
English: • children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;
Croatian: • djece u dobi od 1 godine i starije s aktivnim sistemskim juvenilnim idiopatskim artritisom kod koje druge terapije (protuupalnim lijekovima NSAID-ovima i kortikosteroidima) nisu bile dovoljno djelotvorne;
English: In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo.
Croatian: U tom je ispitivanju 85 % (64 od 75) bolesnika liječenih lijekom RoActemra odgovorilo na liječenje te više nije imalo vrućicu nakon tri mjeseca, u usporedbi s 24 % (9 od 37) bolesnika koji su primali placebo.
English: The fifth study involving 673 patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.
Croatian: U petom ispitivanju, kojim su bila obuhvaćena 673 bolesnika, utvrđeno je da su bolesnici koji su primali lijek RoActemra kao monoterapiju imali više izgleda za odgovor od onih koji su uzimali metotreksat kao monoterapiju.
English: RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well.
Croatian: Lijek RoActemra primijenjen injekcijom pod kožu ispitan je u dvama ispitivanjima kojima je bilo obuhvaćeno 1 918 bolesnika s reumatoidnim artritisom umjerenog do teškog stupnja u kojih prethodno liječenje DMARD-om nije bilo uspješno.
English: In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving 112 children in whom treatment with NSAID and corticosteroids did not work well enough.
Croatian: U slučaju sistemskog juvenilnog idiopatskog artritisa, lijek RoActemra primljen infuzijom uspoređen je s placebom u jednom glavnom ispitivanju kojim je bilo obuhvaćeno 112 djece u koje liječenje NSAIDom i kortikosteroidima nije bilo dovoljno uspješno.
English: Another study involving 51 children from 1 year of age showed that RoActemra given by injection under the skin had a similar distribution in the body and effect on the disease to that previously seen with RoActemra given by infusion.
Croatian: Drugo ispitivanje koje je obuhvatilo 51 dijete u dobi od godinu dana i starije pokazalo je da se lijek RoActemra, primijenjen injekcijom pod kožu, na sličan način raspoređuje u tijelu te ima sličan učinak na bolest onome prethodno dokazanom u liječenju lijekom RoActemra putem infuzije.
English: For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4,000 adults.
Croatian: Za liječenje reumatoidnog artritisa umjerenog do teškog stupnja u kojem drugi lijekovi nisu bili uspješni, lijek RoActemra primljen putem infuzije ispitan je u pet glavnih ispitivanja kojima je ukupno bilo obuhvaćeno više od 4 000 odraslih osoba.
English: RoActemra, on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate.
Croatian: Lijek RoActemra, primijenjen kao monoterapija ili u kombinaciji s metotreksatom, uspoređen je s placebom (prividnim liječenjem) u kombinaciji s metotreksatom.