FrancophonIA/ELRC3.0 huggingface dataset:
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
Croatian: Nakon početne doze, preporučena doza održavanja Cimzije za odrasle bolesnike s aksijalnim spondiloartritisom je 200 mg svaka 2 tjedna ili 400 mg svaka 4 tjedna.
English: • skin sloughing, blistering, hair texture disorder
Croatian: • ljuštenje i mjehurići kože, promjena strukture vlasi
English: Not known Merkel cell carcinoma* Common eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia)
Croatian: nepoznato karcinom Merkelovih stanica* često eozinofilni poremećaji, leukopenija (uključujući neutropeniju, limfopeniju) manje često anemija, limfadenopatija, trombocitopenija, trombocitoza
English: Uncommo visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder
Croatian: Poremećaji oka manje često poremećaji vida (uključujući slabljenje vida), upala oka i očnog kapka, poremećaji suzenja
English: (p<0.05) ** Cimzia vs Placebo p < 0.001.
Croatian: (p<0,05) ** Cimzia naspram placeba p < 0,001.
English: In the CIMPACT study, among PASI 75 responders at Week 16 who received Cimzia 400 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (98.0%, 80.0%, and 36.0%, respectively).
Croatian: U ispitivanju CIMPACT, od bolesnika s PASI 75 odgovorom u 16. tjednu koji su primali Cimziju od 400 mg svaka 2 tjedna i ponovno su randomizirani za Cimziju 400 mg svaka 2 tjedna, Cimziju 200 mg svaka 2 tjedna ili placebo, bio je veći postotak bolesnika s PASI 75 odgovorom u 48. tjednu u skupini Cimzije u usporedbi s placebom (98,0%, 80,0% odnosno 36,0%).
English: The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Croatian: Zaštitni poklopac na igli načinjen je od stirensko-butadienske gume koja sadrži epoksipren, derivat lateksa prirodne gume (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cimzia 200 mg injection certolizumab pegol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Cimzia 200 mg injekcija certolizumabpegol s.c.
English: ACR 50 Week 24 Week 52
Croatian: ACR 50 24. tjedan 52. tjedan
English: Cimzia is provided as a solution for injection in a ready to use pre-filled pen (AutoClicks).
Croatian: Cimzia dolazi u obliku otopine za injekciju u napunjenoj brizgalici (AutoClicks).
English: • Firmly push the flat end cap into the medication/injection port at the bottom of ava - push until you hear a click.
Croatian: • Čvrsto gurnite plosnati zatvarač vrha u utor za uložak/injekciju na uređaju „ava”.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least 1 occasion was 9.6% in RA placebo-controlled trials.
Croatian: U RA placebom kontroliranim istraživanjima ukupan postotak bolesnika s detektabilnim protutijelima na Cimziju u najmanje 1 navratu bio je 9,6%.
English: The improvement in BASMI linear score achieved at Week 24 was maintained through Week 204 for patients who remained in the study.
Croatian: U bolesnika koji su ostali u istraživanju, poboljšanja linearnog BASMI rezultata postignuta u 24. tjednu održala su se sve do 204. tjedna.
English: Cimzia 200 mg + MTX N=393 Mean (SD)
Croatian: Cimzia 200 mg + MTX N=393 Srednja vrijednost (SD)
English: § Cimzia 200 mg every 2 weeks versus etanercept 50 mg twice weekly demonstrated non-inferiority
Croatian: * Cimzia naspram placeba: p< 0,0001. § Cimzia 200 mg svaka 2 tjedna naspram etanercepta 50 mg dvaput tjedno pokazala je neinferiornost
English: In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of 0 or 1 (Cimzia 400 mg every 2 weeks, 45.5% and 50.6% respectively; Cimzia 200 mg every 2 weeks, 47.4% and 46.2% respectively, versus placebo, 5.9% and 8.2% respectively).
Croatian: Pored toga, u 16. tjednu, liječenje Cimzijom bilo je povezano s većim udjelom bolesnika koji su postizali rezultat DLQI od 0 ili 1 (Cimzija 400 mg svaka 2 tjedna, 45,5% odnosno 50,6%;
English: Non-radiographic axial spondyloarthritis (nr-axSpA) The efficacy and safety of Cimzia were assessed in a 52 weeks multicenter, randomized, double-blind, placebo-controlled study (AS0006) in 317 patients ≥18 years of age with adult-onset axial spondyloarthritis and back pain for at least 12 months.
Croatian: Djelotvornost i sigurnost Cimzije ocijenjene su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna (AS0006) u 317 bolesnika u dobi od ≥18 godina s pojavom aksijalnog spondiloartritisa u odrasloj dobi i bolovima u leđima tijekom najmanje 12 mjeseci.
English: How to store Cimzia
Croatian: Kako čuvati Cimziju
English: The 24-week double-blind placebo controlled treatment period of the study was followed by a 24-week dose-blind treatment period and an 168-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 168-tjedno razdoblje otvorenog liječenja.
English: • oral disorders including pain on swallowing
Croatian: • poremećaji usne šupljine, uključujući bolno gutanje
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije manje često ozljede na koži, usporeno zacjeljivanje
English: Cimzia 200 mg + MTX N = 528 Mean (SD)
Croatian: Cimzia 200 mg + MTX N = 528 Srednja vrijednost (SD)
English: Patients were treated with placebo or a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 followed by 200 mg of Cimzia every 2 weeks.
Croatian: Bolesnici su primali placebo ili udarnu dozu Cimzije od 400 mg u 0., 2. i 4. tjednu nakon čega je slijedila primjena 200 mg Cimzije svaka 2 tjedna.
English: Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Croatian: Višestruko pakiranje koje sadrži 10 (5 pakiranja po 2) napunjenih štrcaljki i 10 (5 pakiranja po 2) alkoholnih vatica.
English: Step 2.
Croatian: Zatvarač vrha 2.
English: - If the seal(s) is missing or broken - do not use and contact your pharmacist.
Croatian: - Ako zaštitna naljepnica nedostaje ili je oštećena, nemojte primijeniti lijek i obratite se svom ljekarniku.
English: You should not receive certain (live) vaccines while using Cimzia.
Croatian: Cimzijom ne smijete primati određena (živa) cjepiva.
English: Your doctor should test you for HBV before starting Cimzia.
Croatian: Prije početka liječenja Cimzijom liječnik će Vas testirati na infekciju HBV-om.
English: - One or two medication cartridge(s), depending on your prescribed dose - One or two alcohol wipe(s)
Croatian: - jedan ili dva uloška s lijekom, ovisno o propisanoj dozi - jednu ili dvije alkoholne vatice
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Croatian: U postmarketinškom razdoblju među bolesnicima koji su liječeni TNF-antagonistima zabilježeni su slučajevi leukemije.
English: How to use Cimzia
Croatian: Kako primjenjivati Cimziju
English: • Look at the expiry date on the pre-filled pen and pack.
Croatian: • Provjerite rok valjanosti na napunjenoj brizgalici i pakiranju.
English: • skin disorders such as new onset or worsening of psoriasis, inflammation of the skin (such as eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries
Croatian: (kao što je ekcem), poremećaji žlijezda znojnica, vrijedovi, fotoosjetljivost, akne, ispadanje kose, promjene boje kože, odvajanje noktiju, suha koža i ozljede
English: In both studies 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.
Croatian: Bolesnici su u oba ispitivanja 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.
English: After proper training in injection technique, patients may self-inject using the pre-filled syringe if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Bolesnici mogu sami injicirati lijek nakon odgovarajuće vježbe tehnike injiciranja primjenjujući napunjenu brizgalicu, ako njihov liječnik procijeni da je to prihvatljivo, i prema potrebi uz liječničko praćenje.
English: Cimzia 200 mg + MTX every 2 weeks N=393
Croatian: Cimzia 200 mg + MTX svaka 2 tjedna N=393
English: • nausea
Croatian: • utrnulost
English: Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Croatian: Višestruko pakiranje koje sadrži 6 (3 pakiranja po 2) napunjenih štrcaljki i 6 (3 pakiranja po 2) alkoholnih vatica.
English: Syringe
Croatian: Dojenje
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 1.03 per patient-year for all Cimzia-treated patients and 0.92 per patient-year for placebotreated patients.
Croatian: U placebom kontroliranim kliničkim istraživanjima reumatoidnog artritisa stopa incidencije novih slučajeva infekcija među bolesnicima liječenih Cimzijom bila je 1,03 bolesnik/godina, odnosno u skupini koja je primala placebo skupini 0,92 bolesnik/godina.
English: Among patients who were PGA clear or almost clear at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every 2 weeks, the maintenance response rate at Week 48 were 85.9% and 84.3% respectively.
Croatian: Kod bolesnika koji su u 16. tjednu prema PGA imali odgovor „čista“ ili „gotovo čista“ i primali su Cimziju od 400 mg svaka 2 tjedna ili Cimziju od 200 mg svaka 2 tjedna, stopa odgovora u fazi održavanja u 48. tjednu je bila 85,9%, odnosno 84,3%.
English: Non-radiographic AxSpA
Croatian: Neradiografski aksijalni spondiloartritis (nr-axSpA)
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Sandoz GmbH
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: Partial remission(c,d)
Croatian: BASDAI 50(c,d)
English: • white blood cell morphology abnormal
Croatian: • nepravilan oblik bijelih krvnih stanica
English: ◦ One or two AutoClicks pre-filled pen(s), depending on your prescribed dose ◦ One or two alcohol wipe(s)
Croatian: jednu ili dvije napunjene brizgalice (AutoClicks), ovisno o propisanoj dozi jednu ili dvije alkoholne vatice
English: Do not bend the needle.
Croatian: Ne savijajte iglu.
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).
Croatian: Nakon primjene Cimzije može se javiti omaglica (uključujući vrtoglavicu, poremećaj vida i umor) (vidjeti dio 4.8).
English: Patients received a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either Cimzia 200 mg every 2 weeks or 400 mg every 4 weeks or placebo every 2 weeks.
Croatian: Bolesnici su primili udarnu dozu od 400 mg Cimzije u 0., 2. i 4. tjednu (za obje liječene skupine) ili placebo nakon kojeg je slijedilo 200 mg Cimzije svaka 2 tjedna ili 400 mg Cimzije svaka 4 tjedna ili placebo svaka 2 tjedna.
English: • enlarged spleen
Croatian: • povećanje slezene
English: • Store ava in the storage case after use.
Croatian: • Nakon uporabe spremite uređaj „ava” u zaštitnu kutiju.
English: Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
Croatian: Opsežne upute za pripremu i primjenu Cimzije u napunjenoj brizgalici dane su u uputi o lijeku.
English: Cimzia(a)200 mg Q2W N=138
Croatian: Cimzia(a) 200 mg svaka 2 tjedna N=138
English: • If you feel unsure about the injection process, contact your doctor or pharmacist.
Croatian: • Ako niste sigurni kako injicirati lijek, obratite se svom liječniku ili ljekarniku.
English: Common hepatitis (including hepatic enzyme increased) Uncommo hepatopathy (including cirrhosis), cholestasis, blood bilirubin increased
Croatian: Poremećaji probavnog sustava rijetko odinofagija, povećani motilitet često hepatitis (uključujući povećane razine jetrenih enzima) manje često poremećaji jetre (uključujući cirozu), kolestaza, povećane razine bilirubina u krvi
English: Patients on Cimzia 200 mg every 2 weeks were re-randomized to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks or placebo.
Croatian: Bolesnici koji su primali Cimziju u dozi od 200 mg svaka 2 tjedna, ponovno su randomizirani za primanje Cimzije od 200 mg svaka 2 tjedna, Cimzije od 400 mg svaka 4 tjedna ili placeba.
English: a Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4
Croatian: 52. tjedan a Cimzia je primjenjivana svaka 2 tjedna, čemu je prethodila udarna doza od 400 mg u 0., 2. i 4. tjednu
English: Cimzia 200 mg + MTX every 2 weeks N=246
Croatian: Cimzia 200 mg + MTX svaka 2 tjedna N=246
English: If the seal(s) is missing or broken - do not use and contact your pharmacist.
Croatian: Ako zaštitna naljepnica nedostaje ili je oštećena, nemojte primijeniti lijek i obratite se svom ljekarniku
English: Cimzia 200 mg + MTX every 2 weeks N=70
Croatian: Cimzia 200 mg + MTX svaka 2 tjedna N=70
English: ACR 20 Week 24 Week 52
Croatian: ACR 20 24. tjedan 52. tjedan
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) 2 single-use AutoClicks pre-filled pens 2 alcohol wipes
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici (AutoClicks) 2 napunjene brizgalice za jednokratnu uporabu (AutoClicks) 2 alkoholne vatice
English: After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks.
Croatian: Nakon početne doze, doza održavanja Cimzije za odrasle bolesnike s plak psorijazom je 200 mg svaka 2 tjedna.
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is 200 mg every 2 weeks.
Croatian: Nakon početne doze, preporučena doza održavanja Cimzije za odrasle bolesnike s reumatoidnim artritisom je 200 mg svaka 2 tjedna.
English: • feeling weak or tired
Croatian: • slabost ili umor
English: Treatment regimen week 0 to 16 Cimzia 400 mg + MTX at week 0, 2 and 4, followed by
Croatian: Tablica 7 ACR odgovor u DoseFlex kliničkom istraživanju u 34. tjednu Režim liječenja 0. do 16. tjedan Cimzia 400 mg + MTX 0., 2. i 4. tjedan, nakon čega slijedi
English: For both the Cimzia and placebo arms, MTX was initiated as of Week 0 (10 mg/week), titrated up to maximum tolerated dose by Week 8 (min 15 mg/week, max 25 mg/week allowed), and maintained throughout the study (average dose of MTX after Week 8 for placebo and Cimzia was 22.3 mg/week and 21.1 mg/week respectively).
Croatian: 25 mg/tjedan) i održavan dalje tijekom ispitivanja (prosječna doza MTX-a nakon 8. tjedna je bila 22,3 mg/tjedan za placebo skupinu, odnosno 21,1 mg/tjedan za Cimzia skupinu).
English: • Look at the expiry date on the syringe and pack.
Croatian: • Provjerite rok valjanosti na štrcaljki i pakiranju.
English: ACR 70 Week 24 Week 52
Croatian: ACR 70 24. tjedan 52. tjedan
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 10 (5 x 2) single-use AutoClicks pre-filled pens and 10 (5 x 2) alcohol wipes
Croatian: Otopina za injekciju u napunjenoj brizgalici (AutoClicks) Višestruko pakiranje: 10 (5 x 2) napunjenih brizgalica za jednokratnu uporabu (AutoClicks) i 10 (5 x 2) alkoholnih vatica
English: Keep this Patient Reminder Card with you.
Croatian: Imajte Karticu s podsjetnicima sa sobom.
English: The 14-day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned.
Croatian: Kad se planira kirurški zahvat, treba uzeti u obzir da je poluvijek certolizumabpegola 14 dana.
English: Response Placebo + MTX N=199
Croatian: Placebo + MTX N=199
English: Tell your doctor IMMEDIATELY if you notice any of the following side effects: • severe rash, hives or other signs of allergic reaction (urticaria)
Croatian: Obavijestite liječnika prije liječenja Cimzijom ako se bilo koje od sljedećih upozorenja odnosi na Vas: Alergijske reakcije - ako iskusite ALERGIJSKE REAKCIJE kao što su stezanje u prsima, piskanje pri disanju,
English: Solution for injection in a pre-filled pen (AutoClicks) 2 AutoClicks pre-filled pens 2 alcohol wipes
Croatian: Otopina za injekciju u napunjenoj brizgalici (AutoClicks) 2 napunjene brizgalice (AutoClicks) 2 alkoholne vatice
English: Patients were treated with a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either 200 mg of Cimzia every 2 weeks or 400 mg of Cimzia every 4 weeks or placebo.
Croatian: Bolesnici su liječeni udarnom dozom Cimzije od 400 mg u 0., 2. i 4. tjednu (za obje liječene skupine) ili su primali placebo nakon kojeg je slijedilo 200 mg Cimzije svaka 2 tjedna ili 400 mg Cimzije svaka 4 tjedna ili placebo.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 2 single-use pre-filled syringes with needle guard 2 alcohol wipes
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki 2 napunjene štrcaljke za jednokratnu uporabu sa štitnikom za iglu 2 alkoholne vatice
English: Common bacterial infections (including abscess), viral infections
Croatian: Nuspojave često bakterijske infekcije (uključujući apsces), virusne infekcije (uključujući herpes zoster, papilomavirus, influencu)
English: Patient on Cimzia 400 mg every 2 weeks were re-randomized to Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo.
Croatian: Bolesnici koji su primali Cimziju u dozi od 400 mg svaka 2 tjedna, ponovno su randomizirani za primanje Cimzije od 400 mg svaka 2 tjedna, Cimzije od 200 mg svaka 2 tjedna ili placeba.
English: Major
Croatian: Učestalost
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) Multipack: 6 (3 x 2) single-use AutoClicks pre-filled pens and 6 (3 x 2) alcohol wipes
Croatian: Otopina za injekciju u napunjenoj brizgalici (AutoClicks) Višestruko pakiranje: 6 (3 x 2) napunjenih brizgalica za jednokratnu uporabu (AutoClicks) i 6 (3 x 2) alkoholnih vatica
English: Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.
Croatian: Prije, tijekom i poslije liječenja Cimzijom bolesnike se mora strogo pratiti zbog znakova i simptoma infekcije uključujući tuberkulozu.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
Croatian: U bolesnika u kojih nema terapijske koristi unutar prvih 12 tjedana odluku o nastavku terapije treba pažljivo razmotriti.
English: INSTRUCTIONS FOR USE FOR CIMZIA INJECTION BY MEANS OF A PRE-FILLED SYRINGE
Croatian: UPUTE ZA INJICIRANJE CIMZIJE U NAPUNJENOJ BRIZGALICI
English: Multipack containing 10 (5 packs of 2) dose-dispenser cartridge and 10 (5 packs of 2) alcohol wipes.
Croatian: Višestruko pakiranje koje sadrži 10 (5 pakiranja po 2) uložaka za dozator i 10 (5 pakiranja po 2) alkoholnih vatica.
English: Cimzia 200 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard certolizumab pegol
Croatian: Cimzia 200 mg otopina za injekciju u napunjenoj štrcaljki napunjena štrcaljka sa štitnikom za iglu certolizumabpegol
English: If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Croatian: Ako imate KOPB ili ste teški pušač, obavijestite o tome svog liječnika koji će procijeniti je li liječenje blokatorima TNFa za Vas odgovarajuće. - ako imate bolesti živčanog sustava kao što je multipla skleroza, liječnik će procijeniti trebate li primjenjivati Cimziju. - u nekih bolesnika organizam ne proizvodi dovoljno krvnih stanica koje pomažu organizmu u obrani od infekcija ili u zaustavljanju krvarenja.
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is 200 mg every 2 weeks.
Croatian: Nakon početne doze, preporučena doza održavanja Cimzije za odrasle bolesnike s psorijatičnim artritisom je 200 mg svaka 2 tjedna.
English: Uncommo blood alkaline phosphatase increased, coagulation time prolonged
Croatian: • povišeni neki krvni parametri (povišena alkalna fosfataza u krvi) • produženo vrijeme u testovima koagulacije (zgrušavanja krvi)
English: • The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4.
Croatian: • Početna doza za odrasle s reumatoidnim artritisom je 400 mg, a primjenjuje se u 0., 2., i 4. tjednu.
English: Tell your doctor IMMEDIATELY if you notice any of the following side effects:
Croatian: Ako primijetite neku od sljedećih nuspojava ODMAH o tome obavijestite liječnika:
English: The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex (see section 6.5).
Croatian: Zaštitni poklopac na igli unutar uklonjivog zatvarača napunjene brizgalice Cimzia sadrži derivat lateksa prirodne gume (vidjeti dio 6.5).
English: Solution for injection in pre-filled syringe 2 single-use pre-filled syringes 2 alcohol wipes
Croatian: Otopina za injekciju u napunjenoj štrcaljki 2 napunjene štrcaljke za jednokratnu uporabu 2 alkoholne vatice
English: • sensory abnormalities such as numbness, tingling, burning sensation
Croatian: • smetnje osjeta kao što su utrnulost, trnci i osjećaj peckanja
English: Handle with care!” and “Please replace needle cap” are shown until the needle cap is put back on.
Croatian: Budite oprezni” i „Vratite zatvarač na iglu”.
English: You will be instructed by your doctor or healthcare giver on the technique of self-injection.
Croatian: O tehnici samoinjiciranja podučit će Vas liječnik ili zdravstveni radnik.
English: The needle shield inside the removable cap of the CIMZIA dose-dispenser cartridge contains a derivative of natural rubber latex (see section 6.5).
Croatian: Zaštitni poklopac na igli unutar uklonjivog zatvarača napunjenog uloška za dozator Cimzia sadrži derivat lateksa prirodne gume (vidjeti dio 6.5).
English: Multipack containing 6 (3 packs of 2) dose-dispenser cartridge and 6 (3 packs of 2) alcohol wipes.
Croatian: Višestruko pakiranje koje sadrži 6 (3 pakiranja po 2) uložaka za dozator i 6 (3 pakiranja po 2) alkoholnih vatica.
English: • numbness
Croatian: • mučnina
English: INSTRUCTIONS FOR USE FOR THE CIMZIA INJECTION BY MEANS OF A DOSEDISPENSER CARTRIDGE
Croatian: UPUTE ZA INJICIRANJE CIMZIJE U ULOŠKU ZA DOZATOR
English: improve your physical function and performance of daily tasks.
Croatian: Odgovor fizikalne funkcije i zdravstveni ishodi
English: There is limited safety experience with surgical procedures in patients treated with Cimzia.
Croatian: Podaci o sigurnosti primjene Cimzije u bolesnika koji moraju na kirurški zahvat ograničeni su.
English: Improvements in physical function and HRQoL were maintained through 2 years in the open-label extension to RA-I. Cimzia-treated patients reported statistically significant improvements in the Work Productivity Survey compared to placebo.
Croatian: Bolesnici liječeni Cimzijom izvijestili su o statistički značajnim poboljšanjima u Anketi radne produktivnosti u usporedbi s placebom.
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Cimzia 200 mg otopina za injekciju u napunjenoj štrcaljki
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/010
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 200 mg certolizumab pegol in one ml.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena brizgalica sadrži 200 mg certolizumabpegola u jednom ml.