FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare interstitial lung disease, pneumonitis Common nausea Uncommo ascites, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis, dyspepsia, abdominal distension, oropharyngeal dryness
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja rijetko intersticijska upala pluća, pneumonitis često mučnina manje često ascites, gastrointestinalne ulceracije i perforacije, upala gastrointestinalnog trakta (na različitim mjestima), stomatitis, dispepsija, distenzija abdomena, suha usta i ždrijelo
English: Administration of Cimzia should be discontinued if a patient develops a new serious infection until the infection is controlled.
Croatian: Ako bolesnik razvije novu tešku infekciju, primjenu Cimzije treba prekinuti dok infekcija ne bude pod kontrolom.
English: Cimzia 200 mg + MTXPlacebo + MTX Mean Difference mTSS
Croatian: Cimzia 200 mg + MTXPlacebo + MTX Srednja razlika mTSS
English: • vertigo (dizziness)
Croatian: • vrtoglavica (omaglica)
English: Lonza AG
Croatian: Sandoz GmbH Lonza AG
English: • When ready, remove the needle cap by pulling it firmly downwards.
Croatian: • Kad ste spremni, povucite zatvarač igle čvrsto prema dolje da biste ga skinuli.
English: Rare blood uric acid increased
Croatian: Pretrage rijetko povećane razine urične kiseline u krvi
English: No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia.
Croatian: U bolesnika koji primaju Cimziju nema podataka o odgovoru na cijepljenje živim cjepivima niti o sekundarnom prijenosu infekcije nakon primjene živog cjepiva.
English: Cimzia 200 mg + MTX every 2 weeks
Croatian: Cimzia 200 mg + MTX svaka 2 tjedna
English: Rare cholelithiasis Common rash Uncommo alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail and nail bed disorders
Croatian: Poremećaji jetre i žuči rijetko kolelitijaza često osip manje često alopecija, nova pojava ili pogoršanje psorijaze (uključujući pustularnu psorijazu dlanova i stopala) i s njom povezana stanja, dermatitis i ekcem, poremećaj žlijezda znojnica, kožni vrijed, fotoosjetljivost, akne, promjene boje kože, suha koža, poremećaji noktiju i ležišta nokta
English: Do not use this medicine if the solution is discoloured, cloudy or if you can see particles in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je otopina promijenila boju, ako je mutna ili ako vidite čestice u njoj.
English: How Cimzia will be given
Croatian: Kako će Vam se dati Cimzia
English: • axial spondyloarthritis (including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
Croatian: • aksijalnog spondiloartritisa (uključujući ankilozantni spondilitis i aksijalni spondiloartritis bez radiografskih dokaza za ankilozantni spondilitis),
English: The percentage of ACR 20 responders was clinically relevant for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit after baseline through Week 24 (nominal p≤0.001 at each visit).
Croatian: Postotak bolesnika s ACR 20 odgovorom bio je klinički relevantan za skupine liječene s 200 mg Cimzije svaka 2 tjedna i s 400 mg Cimzije svaka 4 tjedna u usporedbi s placebo skupinom pri svakoj posjeti nakon početka liječenja pa do 24. tjedna (nominalno p≤0,001 pri svakoj posjeti).
English: Cimzia-treated patients reported greater improvements compared to placebo in the Hospital Anxiety and Depression Scale (HADS)-D.
Croatian: Bolesnici liječeni Cimzijom prijavili su veća poboljšanja u usporedbi s placebom mjereno prema bolničkoj ljestvici tjeskobe i depresije (eng.
English: At Week 52, patients treated with Cimzia showed a clinical meaningful improvement in the MASES compared to placebo (LS mean change from baseline -2.4; -0.2 respectively).
Croatian: U 52. tjednu bolesnici liječeni Cimzijom pokazali su klinički značajno poboljšanje na ljestvici MASES u usporedbi s placebom (srednja vrijednost promjene dobivena metodom najmanjih kvadrata u odnosu na početno stanje -2,4 odnosno -0,2).
English: NA = not available *p≤0.05, Cimzia vs placebo **p<0.001, Cimzia vs placebo
Croatian: NA = nije dostupno *p≤0,05, Cimzia naspram placeba **p<0,001, Cimzia naspram placeba
English: Table 12: Clinical response in CIMPACT study at Week 12 and Week 16 Week 12
Croatian: Tablica 12: Klinički odgovor u ispitivanju CIMPACT u 12. tjednu i u 16. tjednu 12. tjedan
English: Uncommo electrolyte imbalance, dyslipidaemia, appetite disorders, weight change
Croatian: Endokrini poremećaji rijetko poremećaji u radu štitnjače manje često neravnoteža elektrolita, dislipidemija, poremećaji apetita, promjene tjelesne težine
English: • eye and eyelid inflammation, vision disturbances, problems with tears
Croatian: • upala oka i očnog kapka, smetnje vida, smetnje suzenja
English: The dose-dispenser cartridges may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Croatian: Ulošci za dozator mogu se čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 10 dana, zaštićeni od svjetlosti.
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol (see section 4.8).
Croatian: U bolesnika liječenih TNF-antagonistima uključujući certolizumabpegol prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
English: Uncommo asthma and related symptoms, pleural effusion and symptoms, respiratory tract congestion and inflammation, cough
Croatian: Učestalost Nuspojave manje često astma i s njom povezani simptomi, pleuralni izljev i prateći simptomi, kongestija i upala dišnih puteva, kašalj
English: Inhibition of radiographic progression was further maintained up to Week 216 for the patients who remained in the study.
Croatian: U bolesnika koji su ostali u istraživanju, inhibicija radiografske progresije održala se do 216. tjedna.
English: PASI75 and PGA at Week 16 were key secondary endpoints.
Croatian: Ključne sekundarne mjere ishoda bile su PASI 75 i PGA u 16. tjednu.
English: The efficacy and safety of Cimzia were assessed in two placebo-controlled studies (CIMPASI-1 and CIMPASI-2) and one placebo- and active-controlled study (CIMPACT) in patients ≥18 years of age with moderate to severe chronic plaque psoriasis for at least 6 months.
Croatian: Djelotvornost i sigurnost Cimzije procijenjeni su u dva placebom kontrolirana ispitivanja (CIMPASI1 i CIMPASI-2) i jednom ispitivanju s kontrolom placebom i aktivnim lijekom (CIMPACT) u bolesnika u dobi od ≥18 godina s umjerenom do teškom kroničnom plak psorijazom tijekom najmanje 6 mjeseci.
English: Week 12 Week 24 ASAS40(c,d)
Croatian: 12. tjedan 24. tjedan ASAS 40(c,d)
English: This will help reduce discomfort when injecting.
Croatian: To traje 30 minuta, a pomoći će ublažiti nelagodu pri injiciranju.
English: You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:
Croatian: Drugi lijekovi i Cimzia Ako uzimate sljedeće lijekove za liječenje reumatoidnog artritisa, NE smijete primjenjivati Cimziju:
English: Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.
Croatian: Bolesnici liječeni Cimzijom u usporedbi s placebom izvijestili su o značajnom poboljšanju produktivnosti na poslu i u domaćinstvu a vezanoj uz aksijalni spondiloartritis, kao što je objavljeno u Anketi radne produktivnosti.
English: 982 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Croatian: 982 400 mg (tjedan 0,2,4) s MTX-om 200 mg ili 400 mg svaka 2 tjedna s MTXom
English: The dose-dispenser cartridge is also referred to as “medication”.
Croatian: Uložak za dozator naziva se još i „uložak”.
English: • skin cancers, pre-cancerous skin lesions
Croatian: • zloćudni tumori kože, prekancerozne kožne lezije
English: Etanercept 50 mg BiW N=170
Croatian: Etanercept 50 mg dvaput tjedno N=170
English: Paediatric malignancy
Croatian: Pedijatrijske maligne bolesti
English: • plaque psoriasis
Croatian: • plak psorijaze.
English: One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Croatian: Napunjena štrcaljka volumena jedan ml (staklo tipa I) s klipom štrcaljke (brombutilna guma) koja sadrži 200 mg certolizumabpegola.
English: In an integrated analysis of CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every other week, the maintenance response rates at Week 48 were 98.0% and 87.5%, respectively.
Croatian: U integriranoj analizi ispitivanja CIMPASI-1 i CIMPASI-2, kod bolesnika koji su u 16. tjednu imali odgovor PASI 75 i primali Cimziju po 400 mg svaka 2 tjedna ili Cimziju po 200 mg svaki drugi tjedan, stope odgovora u održavanju u 48. tjednu bile su 98,0% odnosno 87,5%.
English: How Cimzia is given
Croatian: Kako se daje Cimzia
English: Over the course of the entire study (up to 192 weeks), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.6% (4.8% had transient formation and an additional 4.8% had persistent formation of antibodies to Cimzia).
Croatian: Tijekom čitavog istraživanja (do 192 tjedna), ukupan postotak bolesnika kod kojih su barem jednom otkrivena protutijela na Cimziju iznosio je 9,6% (u 4,8% njih stvaranje protutijela na Cimziju bilo je prolazno, dok je u dodatnih 4,8% bilo trajno).
English: • nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation,
Croatian: • smetnje živaca u ekstremitetima uključujući utrnulost, trnce, osjećaj vrućine, omaglice, nevoljno drhtanje
English: • injection site reactions
Croatian: • reakcije na mjestu injiciranja lijeka
English: • rash or itching
Croatian: • osip ili svrbež
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Croatian: Napunjenu brizgalicu čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: Patients received loading doses of Cimzia 400 mg at weeks 0, 2, and 4 followed by Cimzia 200 mg every 2 weeks during the initial open label period.
Croatian: Bolesnici su primili udarnu dozu od 400 mg Cimzije u 0., 2. i 4. tjednu nakon čega je slijedilo 200 mg Cimzije svaka 2 tjedna tijekom početnog otvorenog razdoblja.
English: In 2 long-term (up to 5 years of exposure) open-label studies, the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 13% (8.4% of the overall patients had transient formation of antibodies and an additional 4.7% had persistent formation of antibodies to Cimzia).
Croatian: U dva dugotrajna (do 5 godina izloženosti) otvorena ispitivanja, ukupan postotak bolesnika s detektabilnim protutijelima na Cimziju u najmanje jednom navratu bio je 13% (8,4% od ukupnog broja bolesnika imalo je prolazno stvaranje protutijela i dodatnih 4,7% imalo je dugotrajno stvaranje protutijela na Cimziju).
English: The total content (1 ml) of the dose-dispenser cartridge should be administered using the electromechanical injection device ava for a subcutaneous injection only.
Croatian: Ukupan sadržaj (1 ml) uloška za dozator smije se primijeniti samo supkutanom injekcijom uz pomoć elektromehaničkog uređaja za injekciju pod nazivom „ava”.
English: The pre-filled syringe contains 200 mg of certolizumab pegol.
Croatian: Napunjena štrcaljka sadrži 200 mg certolizumabpegola.
English: • Do not remove the cap until you are ready to inject.
Croatian: • Nemojte ukloniti zatvarač dok niste spremni za injiciranje.
English: One ml pre-filled pen (AutoClicks) containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Croatian: Napunjena brizgalica (AutoClicks) volumena jedan ml (staklo tipa I) s klipom brizgalice (brombutilna guma) koja sadrži 200 mg certolizumabpegola.
English: Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6-month period
Croatian: Klinički značajan odgovor definiran je kao dostizanje odgovora ACR 70 pri svakom ocjenjivanju u neprekidnom razdoblju kroz 6 mjeseci p-vrijednosti po Waldu navedene su za usporedbu liječenja koristeći logističku regresiju uz faktore za liječenje i regiju.
English: Over the course of the entire study (up to 4 years of exposure), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 17.3% (8.7% had transient formation and an additional 8.7% had persistent formation of antibodies to Cimzia).
Croatian: Tijekom čitavog istraživanja (do 4 godine izloženosti), ukupan postotak bolesnika kod kojih su barem jednom otkrivena protutijela na Cimziju iznosio je 17,3% (u 8,7% njih stvaranje protutijela na Cimziju bilo je prolazno, dok je u dodatnih 8,7% bilo trajno).
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1.59 per patient-year for placebo-treated patients.
Croatian: U placebom kontroliranim kliničkim istraživanjima psorijaze stopa incidencije novih slučajeva infekcija među svim bolesnicima liječenih Cimzijom bila je 1,37 po bolesnik-godini, odnosno u skupini koja je primala placebo 1,59 po bolesnik-godini.
English: N/A (a) Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Cimzia administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (c) In subjects with at least 3% psoriasis BSA at Baseline
Croatian: N/A (a) Cimzia primijenjena svaka 2 tjedna s prethodnom udarnom dozom od 400 mg u 0., 2. i 4. tjednu (b) Cimzia primijenjena svaka 4 tjedna s prethodnom udarnom dozom od 400 mg u 0., 2. i 4. tjednu (c) U ispitanika s barem 3% površine tijela zahvaćene psorijazom na početku liječenja
English: 619 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Croatian: 619 400 mg (tjedan 0,2,4) s MTX-om 200 mg ili 400 mg svaka 2 tjedna s MTXom
English: • flu-like symptoms, chills, altered temperature perception, night sweats, flushing
Croatian: • simptomi nalik gripi, zimica, poremećaj osjeta temperature, noćno znojenje, crvenilo kože
English: • prolonged coagulation (clotting) test times
Croatian: • produženo vrijeme u testovima koagulacije (zgrušavanja krvi)
English: • Allow the AutoClicks pre filled pen(s) to reach room temperature.
Croatian: • Prije injiciranja pričekajte da se napunjene brizgalice AutoClicks ugriju na sobnu temperaturu.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: • This is followed by a maintenance dose of 200 mg every 2 weeks, or 400 mg every 2 weeks as instructed by your physician.
Croatian: • Zatim slijedi doza održavanja od 200 mg svaka 2 tjedna ili 400 mg svaka 2 tjedna prema uputama liječnika.
English: No adverse effects were seen on maternal well-being or female fertility, embryo-foetal and peri- and post-natal reproductive indices in rats using a rodent antirat TNFα PEGylated Fab' (cTN3 PF) following sustained TNFα suppression.
Croatian: Primjenom glodavcima prilagođenog pegiliranog Faba na TNFα štakora (cTN3 PF) nisu zabilježene nuspojave na zdravstveno stanje majke ili plodnost ženke, embrio-fetalne te perinatalne i postnatalne reproduktivne indekse u štakora nakon produžene TNFα supresije.
English: Patients receiving concomitant NSAIDs and conventional DMARDs were 72.6% and 70.2% respectively.
Croatian: 72,6% odnosno 70,2% bolesnika je istodobno primalo NSAIL-e odnosno konvencionalne DMARD-e.
English: • two AutoClicks pre-filled pens of solution, and
Croatian: • dvije otopinom napunjene brizgalice (AutoClicks) i
English: Comprehensive instructions for the preparation and administration of Cimzia in a dose-dispenser cartridge are given in the package leaflet and in the user manual provided with the electromechanical injection device ava.
Croatian: Opsežne upute za pripremu i primjenu Cimzije u ulošku za dozator dane su u uputi o lijeku i korisničkom priručniku koji dolazi s „ava” elektromehaničkim uređajem za injekciju.
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia pre-filled pen.
Croatian: Do sada nije otkriven antigenski protein lateksa u uklonjivom zaštitnom poklopcu na igli napunjene brizgalice Cimzia.
English: Erosion score
Croatian: Zbroj erozija
English: Patients were randomized to receive placebo, or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4), or Cimzia 400 mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 12.
Croatian: Bolesnici su randomizirani za primanje placeba ili Cimzije u dozi od 200 mg svaka 2 tjedna (nakon udarne doze Cimzia 400 mg u 0., 2. i 4. tjednu) ili Cimzije 400 mg svaka 2 tjedna do 16. tjedna ili etanercept 50 mg dvaput tjedno, do 12. tjedna.
English: The efficacy and safety of Cimzia were assessed in one multicenter, randomized, double-blind, placebo-controlled trial (AS001) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months as defined by the Assessment of Spondyloarthritis International Society (ASAS) Classification Criteria for axial spondyloarthritis.
Croatian: Djelotvornost i sigurnost Cimzije ocjenjivana je tijekom barem 3 mjeseca u jednom multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom istraživanju (AS001) u 325 bolesnika ≥18 godina s pojavom aktivnog aksijalnog spondiloartritisom u odrasloj dobi kako je definirano klasifikacijskim kriterijima Međunarodnog društva za ocjenu spondiloartritisa (ASAS, engl.
English: • reduce the signs and symptoms of your disease,
Croatian: • ublažili znakovi i simptomi
English: Cimzia solution for injection in a dose-dispenser cartridge is intended for single-use in conjunction with the electromechanical injection device named ava.
Croatian: Cimzia otopina za injekciju u ulošku za dozator namijenjena je samo za jednokratnu uporabu pomoću „ava” elektromehaničkog uređaja za injekciju.
English: One ml dose-dispenser cartridge containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber).
Croatian: Uložak za dozator volumena 1 ml koji sadrži napunjenu štrcaljku (staklo tipa I) s klipom štrcaljke (brombutilna guma).
English: • breast disorders
Croatian: • poremećaji dojki
English: Cimzia 400 mg + MTX every 4 weeks N=69
Croatian: Cimzia 400 mg + MTX svaka 4 tjedna N=69
English: The most common adverse reactions reported through Week 16 belonged to the system organ classes Infections and infestations, reported in 6.1% of patients on Cimzia and 7% of patients on placebo, General disorders and administration site conditions, reported in 4.1% of patients on Cimzia and 2.3% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 3.5% of patients on Cimzia and 2.8% of patients on placebo.
Croatian: Prema klasifikaciji nuspojava prema organskim sustavima najčešće nuspojave prijavljene do 16. tjedna bile su infekcije i infestacije, prijavljene u 6,1% bolesnika koji su primali Cimziju odnosno 7% bolesnika na placebu, opći poremećaji i reakcije na mjestu primjene u 4,1% bolesnika koji su primali Cimziju te 2,3% bolesnika na placebu, te poremećaji kože i potkožnog tkiva u 3,5% bolesnika koji su primali Cimziju i 2,8% bolesnika na placebu.
English: See the package leaflet for further information.
Croatian: Za dodatne informacije pogledajte uputu o lijeku.
English: Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.
Croatian: U bolesnika liječenih Cimzijom zabilježeni su rijetki slučajevi neuroloških poremećaja, uključujući napadaje, neuritis i perifernu neuropatiju.
English: • The starting dose for adults with plaque psoriasis is 400 mg every 2 weeks given at weeks 0, 2 and 4.
Croatian: • Početna doza za odrasle s plak psorijazom je 400 mg svaka 2 tjedna koja se daje u 0., 2. i 4.
English: • psoriatic arthritis
Croatian: • psorijatičnog artritisa
English: The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Croatian: Prema klasifikaciji nuspojava prema organskim sustavima najčešće nuspojave bile su infekcije i infestacije; opisane u 14,4% bolesnika koji su primali Cimziju, odnosno 8,0% bolesnika na placebu, opći poremećaji i reakcije na mjestu primjene u 8,8% bolesnika koji su primali Cimziju te 7,4% bolesnika na placebu, te poremećaji kože i potkožnog tkiva u 7,0% bolesnika koji su primali Cimziju i 2,4% bolesnika na placebu.
English: The 24-week double-blind, placebo-controlled treatment period of the study was followed by a 24-week dose-blind treatment period, and a 156-week open-label treatment period.
Croatian: Nakon 24-tjednog dvostruko slijepog, placebom kontroliranog razdoblja liječenja u ovom istraživanju uslijedilo je 24-tjedno razdoblje primjene zaslijepljene doze i 156-tjedno razdoblje otvorenog liječenja.
English: Keep the dose-dispenser cartridge in the outer carton in order to protect from light.
Croatian: Uložak za dozator čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: Excluding non-melanoma of the skin, 121 malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4,049 patients were treated, representing 9,277 patient-years.
Croatian: Izostavljajući nemelanomske kožne tumore, tijekom kliničkih istraživanja s Cimzijom u bolesnika s RA-om, u kojima je liječeno ukupno 4049 bolesnika, što znači 9277 bolesnik-godina, zabilježen je 121 slučaj malignih bolesti, uključujući 5 slučaja limfoma.
English: Among PASI75 responders at Week 16 who received Cimzia 200 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 4 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (88.6%, 79.5%, and 45.5%, respectively).
Croatian: Od bolesnika s PASI 75 odgovorom u 16. tjednu koji su primali Cimziju od 200 mg svaka 2 tjedna i ponovno su randomizirani za Cimziju 400 mg svaka 4 tjedna, Cimziju 200 mg svaka 2 tjedna ili placebo, također je bio veći postotak bolesnika s PASI 75 odgovorom u 48. tjednu u skupini Cimzije u usporedbi s placebom (88,6%, 79,5% odnosno 45,5%).
English: Patients should be tested for HBV infection before initiating treatment with Cimzia.
Croatian: Prije početka liječenja Cimzijom bolesnike treba testirati na HBV infekciju.
English: Pack size of 2 dose-dispenser cartridges and 2 alcohol wipes.
Croatian: Pakiranje od 2 uloška za dozator i 2 alkoholne vatice.
English: Uncommo blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, nonmelanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma)
Croatian: Infekcije i infestacije manje često sepsa (uključujući multiorgansko zatajenje, septički šok), tuberkuloza (uključujući milijarni, diseminirani i ekstrapulmonarni oblik bolesti), gljivične infekcije (uključujući oportunističke) manje često maligne bolesti krvi i limfnog sustava (uključujući limfom i leukemiju), tumori solidnih organa, nemelanomski kožni tumori, prekancerozne lezije (uključujući oralnu leukoplakiju, melanocitni madež), dobroćudni tumori i ciste (uključujući kožni papilom)
English: Cimzia(b) 400 mg Q4W N=135
Croatian: Cimzia(b) 400 mg svaka 4 tjedna N=135