FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept or anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists.
Croatian: Zbog prirode neželjenih događaja koji su uočeni tijekom primjene kombinacije nekog TNF-antagonista i abatacepta ili anakinre, slične toksične učinke može uzrokovati i kombinacija anakinre ili abatacepta i drugih TNF-antagonista.
English: Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone.
Croatian: Bolesnici koji su istodobno primali Cimziju i metotreksat imali su smanjeni humoralni odgovor u usporedbi s bolesnicima koji su primali samo Cimziju.
English: • formation of stones in the gall bladder
Croatian: • stvaranje kamenca u žučnom mjehuru
English: Cimzia contains sodium acetate and sodium chloride This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ‘sodium-free'.
Croatian: Cimzia sadrži natrijev acetat i natrijev klorid Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) na 400 mg, tj. u osnovi ne sadrži natrij.
English: For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate.
Croatian: Kod reumatoidnog artritisa i psorijatičnog artritisa, MTX treba nastaviti uzimati tijekom liječenja Cimzijom, kada je to moguće.
English: Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis
Croatian: Reumatoidni artritis, psorijatični artritis, aksijalni spondiloartritis, plak psorijaza
English: The following information is intended for medical or healthcare professionals only: INSTRUCTIONS FOR USE FOR THE CIMZIA INJECTION BY MEANS OF A PRE-FILLED SYRINGE WITH NEEDLE GUARD
Croatian: Sljedeće su informacije namijenjene samo zdravstvenim radnicima: UPUTE ZA INJICIRANJE CIMZIJE U NAPUNJENOJ ŠTRCALJKI SA ŠTITNIKOM ZA IGLU
English: Cimzia was also studied in 317 patients with nonradiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006).
Croatian: Cimzia je također ispitivana u 317 bolesnika s neradiografskim aksijalnim spondiloartritisom u placebom kontroliranom ispitivanju tijekom 52 tjedna (AS0006).
English: Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus.
Croatian: Ispitivanja na životinjama u kojima su korišteni anti-TNFα štakora nisu pokazala dokaze smanjene plodnosti ili štetan utjecaj na plod.
English: Response rates and p-values for PASI and PGA were estimated based on a logistic regression model where missing data were imputed using multiple imputation based on the MCMC method.
Croatian: Stope odgovora i p-vrijednosti za PASI i PGA procijenjene su na osnovi modela logističke regresije, pri čemu su se nedostajući podaci uvrštavali višestrukim uvrštavanjem po metodi MCMC.
English: It is likely that this finding was caused by cellular uptake of the PEG moiety.
Croatian: Vjerojatno je taj nalaz posljedica staničnog unosa dijela PEG molekule.
English: Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Croatian: Osim toga na zabilježenu incidenciju protutijela u testu dodatno može utjecati više faktora uključujući rukovanje uzorkom, vrijeme uzorkovanja, istodobnu primjenu drugih lijekova i osnovnu bolest.
English: • You can now remove the used pen by pulling the pen straight up carefully from the skin.
Croatian: • Upotrebljenu brizgalicu možete sada pažljivo ukloniti s kože podižući ju ravno prema gore.
English: At both Week 12 and 52, ASAS 40 responses were significantly greater than placebo.
Croatian: U 12. tjednu i 52. tjednu odgovori ASAS 40 bili su značajno veći u usporedbi s placebom.
English: PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.
Croatian: PEGilacija, kovalentno vezanje PEG-polimera na peptide, različitim mehanizmima odgađa eliminaciju tih spojeva iz cirkulacije, uključujući smanjenje bubrežnog klirensa, smanjenje proteolize i smanjenu imunogenost.
English: On the basis of Phase II and Phase III clinical trial data in patients with rheumatoid arthritis, a population exposure-response relationship was established between average plasma concentration of certolizumab pegol during a dosing interval (Cavg) and efficacy (ACR 20 responder definition).
Croatian: Na osnovi podataka kliničkih ispitivanja faze II i III u bolesnika s reumatoidnim artritisom, populacijski odnos izloženosti i odgovora utvrđen je između prosječnih koncentracija u plazmi certolizumabpegola unutar intervala doziranja (Cavg) i djelotvornosti (prema definiciji bolesnika s ACR 20 odgovorom).
English: Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent with those seen in healthy subjects.
Croatian: Farmakokinetika zabilježena u bolesnika s reumatoidnim artritisom i psorijazom bila je dosljedna onoj koja je viđena kod zdravih ispitanika.
English: Cimzia may have a minor influence on the ability to drive and use machines.
Croatian: Cimzia može imati blagi utjecaj na sposobnost upravljanja vozilima i strojevima.
English: However, population pharmacokinetic analysis based on subjects with mild renal impairment showed no effect of creatinine clearance.
Croatian: Međutim, populacijska farmakokinetička analiza temeljena na ispitanicima s blagim oštećenjem funkcije bubrega nije pokazala utjecaj na klirens kreatinina.
English: At Week 52, the percentage of patients achieving ASDAS inactive disease (ASDAS < 1.3) was 36.4 % for the Cimzia group compared to 11.8 % for the placebo group.
Croatian: U 52. tjednu postotak bolesnika koji su postigli neaktivnu bolest prema ASDAS-u (ASDAS < 1,3) iznosio je 36,4% za skupinu koja je liječena Cimzijom u usporedbi s 11,8% za skupinu koja je primala placebo.
English: During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.5% for Cimzia and 3.7% for placebo.
Croatian: U kontroliranim kliničkim ispitivanjima do 16. tjedna, omjer bolesnika s ozbiljnim štetnim događajima bio je 3,5% za Cimziju, a 3,7% za placebo.
English: Operations or dental procedures - Talk to your doctor if you are going to have any operations or dental procedures.
Croatian: Kirurški zahvati ili zahvati na zubima - posavjetujte se sa svojim liječnikom ako planirate ići na operaciju ili zahvat na zubima.
English: In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Croatian: U kliničkom istraživanju s drugim TNF-antagonistom zabilježeno je pogoršanje kongestivnog zatajenja srca te povećana smrtnost zbog kongestivnog zatajenja srca.
English: Clinically meaningful and statistically significant differences in Cimzia-treated patients compared with placebo-treated patients were demonstrated at each post-baseline visit.
Croatian: Klinički značajne i statistčki značajne razlike u bolesnika liječenih Cimzijom u usporedbi s bolesnicima koji su primali placebo pokazane su pri svakoj sljedećoj posjeti nakon prve.
English: • inflammatory skin rash (erythema multiforme)
Croatian: • upalni kožni osip (multiformni eritem)
English: - Position ava as shown so that you can comfortably reach the (Start/Pause button) without moving ava.
Croatian: - Postavite uređaj „ava” kako je prikazano na slici, kako biste mogli lako doseći tipku (tipku za pokretanje/pauziranje) bez pomicanja uređaja „ava”.
English: The impact of long-term treatment with Cimzia on the development of autoimmune diseases is unknown.
Croatian: Utjecaj dugotrajnog liječenja Cimzijom na razvoj autoimune bolesti nije poznat.
English: Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Croatian: Cimzia je indicirana za liječenje umjerene do teške plak psorijaze u odraslih koji su kandidati za sistemsku terapiju.
English: At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo.
Croatian: U 12. i 24. tjednu, postotak ispitanika s ASAS40 odgovorom bio je veći u skupinama liječenih Cimzijom u usporedbi s placebom.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Croatian: Ne može se isključiti rizik razvoja maligne bolesti u djece i adolescenata liječenih TNF-antagonistima.
English: Cimzia is used in adults for the following inflammatory diseases:
Croatian: Cimzia se primjenjuje u odraslih bolesnika za liječenje sljedećih upalnih bolesti:
English: Primary endpoint: ACR 20 at Week 24.
Croatian: Primarna mjera ishoda: ACR 20 u 24. tjednu.
English: Among patients remaining in the study, improvements in all afore-mentioned key efficacy outcomes were maintained through Week 204 in the overall population as well as in the subpopulations.
Croatian: Među bolesnicima koji su ostali u ispitivanju, poboljšanja svih prethodno navedenih ključnih ishoda djelotvornosti održala su se sve do 204. tjedna i u ukupnoj populaciji i u subpopulacijama bolesnika.
English: In the placebo-controlled trial in patients with non-radiographic axial spondyloarthritis, using a more sensitive and drug tolerant assay than in previous trials, the overall incidence of patients who were antibody positive to certolizumab pegol was 97% (248/255 patients) after up to 52 weeks of treatment.
Croatian: U placebom kontroliranom ispitivanju u bolesnika s neradiografskim aksijalnim spondiloartritisom, u kojem je korišten osjetljiviji test tolerantniji na lijek nego u prethodnim ispitivanjima, ukupna incidencija bolesnika koji su bili pozitivni na protutijela na certolizumabpegol iznosila je 97% (248/255 bolesnika) nakon najviše 52 tjedna liječenja.
English: If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, mora se započeti s odgovarajućom antituberkuloznom terapijom prije nego se započne liječenje Cimzijom, u skladu s lokalnim preporukama.
English: Latex-sensitivity
Croatian: Osjetljivost na lateks
English: Cimzia will usually be given to you by a specialist doctor or healthcare professional.
Croatian: Cimziju će Vam u pravilu primijeniti liječnik specijalist ili drugi zdravstveni radnik.
English: The incidence of serious infections was 0.02 per patient-year in Cimzia treated patients.
Croatian: Incidencija ozbiljnih infekcija bila je 0,02 po bolesnik-godini u bolesnika liječenih Cimzijom.
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage.
Croatian: Ocijeniti uspjeh liječenja znakova i simptoma bolesti te inhibicije strukturalnih oštećenja.
English: Cimzia was administered subcutaneously in combination with oral MTX for a minimum of 6 months with stable doses of at least 10 mg weekly for 2 months in both trials.
Croatian: Cimzia je u oba istraživanja primjenjivana supkutano u kombinaciji s oralnim MTX najmanje 6 mjeseci u stabilnim dozama od najmanje 10 mg tjedno kroz 2 mjeseca.
English: • tuberculosis infection
Croatian: • tuberkuloza
English: • gastrointestinal stenosis (narrowing of part of the digestive system).
Croatian: • gastrointestinalna stenoza (suženje dijela probavnog sustava).
English: In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.
Croatian: U slučajevima predoziranja preporučuje se strogo nadzirati bolesnike zbog mogućnosti nuspojava ili neželjenog događaja, te odmah započeti odgovarajuće simptomatsko liječenje.
English: These results were maintained over 52 weeks of treatment in DMARD-naïve subjects.
Croatian: Ovi rezultati su održani tijekom 52 tjedna u bolesnika koji prethodno nisu bili liječeni DMARD-ovima.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane redoslijedom prema smanjenju ozbiljnosti.
English: • Press the (Start/Pause button).
Croatian: • Pritisnite (tipku za pokretanje/pauziranje).
English: Among patients remaining in the study, ACR 20, 50 and 70 response rates were maintained through Week 216.
Croatian: Među bolesnicima koji su ostali u ispitivanju, stope ACR 20, ACR 50 i ACR 70 odgovora održale su se do 216. tjedna.
English: Interference with thrombin time (TT) and prothrombin time (PT) assays have not been observed.
Croatian: Nije uočena interferencija s testovima za određivanje trombinskog vremena (TV) i protrombinskog vremena (PV).
English: These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Croatian: Mogu se pojaviti kao crvenkaste mrlje nalik na metu ili u obliku okruglih područja često sa mjehurićima u njihovoj sredini na trupu, ljuštenje kože, ranice u ustima, grlu, nosu, genitalijama i očima kojima mogu prethoditi vrućica i simptomi nalik gripi (StevensJohnsonov sindrom).
English: Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of 11.1 µg/ml.
Croatian: Slično tome, na osnovi podataka kliničkih ispitivanja faze III u bolesnika s psorijazom, populacijski odnos izloženosti i odgovora utvrđen je između koncentracija certolizumabpegola u plazmi i PASI-ja s EC90 od 11,1 µg/ml.
English: • Press the pre-filled pen firmly against the skin.
Croatian: • Pritisnite napunjenu brizgalicu čvrsto na kožu.
English: Creatine phosphokinase elevations
Croatian: Povećanje razine kreatin fosfokinaze
English: Improvements in all afore mentioned outcomes were maintained through Week 48.
Croatian: Poboljšanja svih prethodno navedenih ishoda održala su se do 48. tjedna.
English: • Do not use the syringe if it has been dropped without its packaging.
Croatian: • Nemojte koristiti štrcaljku ako Vam je pala dok je bila izvan svog pakiranja.
English: • The medication is to be used with the electromechanical injection device called “ava” which is provided separately.
Croatian: • Uložak je namijenjen za uporabu elektromehaničkim uređajem za injekciju koji se zove „ava”, a isporučuje se zasebno.
English: *These events have been related to the class of TNF-antagonists, but incidence with certolizumab pegol is not known.
Croatian: *Ti su događaji povezani sa skupinom TNF-antagonista, no njihova incidencija s certolizumabpegolom nije poznata.
English: The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections (see sections 4.3 and 4.4).
Croatian: Infekcije su se primarno sastojale od infekcija gornjih dijelova dišnog sustava, infekcija mokraćnih puteva, infekcija donjeg dijela dišnog sustava i infekcija herpes virusom (vidjeti dijelove 4.3 i 4.4).
English: Injecting the solution subcutaneously which contains air bubbles is harmless.
Croatian: Potkožno injiciranje otopine koja sadrži mjehuriće zraka je bezopasno.
English: • immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of the fat tissue, angioneurotic oedema (swelling of the lips, face, throat)
Croatian: • imuni poremećaji kao što su sarkoidoza (osip, bolni zglobovi, vrućica), serumska bolest, upala masnog tkiva, angioneurotski edem (otečenost usana, lica, grla)
English: Do not stop using Cimzia without talking to your doctor first.
Croatian: Nemojte prestati primjenjivati Cimziju bez da o tome obavijestite liječnika.
English: The ACR 20 endpoint was achieved for both Cimzia 200 mg every 2 weeks and 400 mg every 4 weeks.
Croatian: ACR 20 ishod postignut je i za Cimzia 200 mg svaka 2 tjedna i 400 mg svaka 4 tjedna.
English: Certolizumab pegol does not cross-react with rodent TNF.
Croatian: Certolizumabpegol ne reagira križno s TNF-om glodavaca.
English: Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate.
Croatian: Istodobna primjena Cimzije i metotreksata nije imala značajnog učinka na farmakokinetiku metotreksata.
English: Below is a diagram of the AutoClicks pre-filled pen.
Croatian: Dolje je dijagram napunjene brizgalice (AutoClicks).
English: PASI 75 (c) Week 12 Week 24 Week 48
Croatian: PASI 75 (c) 12. tjedan 24. tjedan 48 tjedan
English: The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52.
Croatian: Ankylosing Spondylitis Disease Activity Score major improvement, ASDAS-MI) u 52. tjednu.
English: Table 8 Key efficacy outcomes in AS001 clinical trial (percent of patients)
Croatian: Tablica 8 Ključni ishodi djelotvornosti u AS001 kliničkom istraživanju (postotak bolesnika)
English: Tell your surgeon or dentist performing the procedure that you are having treatment with Cimzia by showing them your Patient Reminder Card.
Croatian: Obavijestite kirurga ili zubara koji će izvršiti zahvat da primjenjujete Cimziju i pokažite mu svoju Karticu s podsjetnicima za bolesnika.
English: If you take Cimzia, your risk of getting lymphoma or other cancers may increase.
Croatian: Ako primjenjujete Cimziju, moguće je da se rizik za nastanak limfoma ili drugih oblika zloćudnih tumora poveća.
English: Patients had to fulfil ASAS criteria for nraxSpA (not including family history and good response to NSAIDs), and have had objective signs of inflammation indicated by C-reactive protein (CRP) levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI), indicative of inflammatory disease [positive CRP (> ULN) and/or positive MRI], but without definitive radiographic evidence of structural damage on sacroiliac joints.
Croatian: Bolesnici su morali ispunjavati kriterije ASAS-a za neradiografski aksijalni spondiloartritis (bez uključivanja obiteljske povijesti i dobrog odgovora na nesteroidne protuupalne lijekove) i imali su objektivne znakove upale utvrđene temeljem razina C-reaktivnog proteina (CRP) iznad gornje granice normale i/ili sakroileitis na snimci magnetske rezonancije (MR), koji ukazuje na upalno oboljenje [pozitivni CRP (> GGN) i/ili pozitivni MR], ali bez definitivnih radiografskih dokaza o strukturalnom oštećenju sakroilijačnih zglobova.
English: In both clinical trials, Cimzia-treated patients reported significantly greater improvements in the SF-36 Physical and Mental Component Summaries and all domain scores.
Croatian: U oba klinička istraživanja bolesnici liječeni Cimzijom izvijestili su o značajno većim poboljšanjima u SF-36 Sažetcima fizičke i mentalne komponente i u svim domenama ocjenjivanja.
English: - Keep the needle cap - you will need it to remove the used medication from ava later.
Croatian: - Sačuvajte zatvarač igle jer će Vam kasnije trebati da biste izvadili upotrijebljeni uložak iz uređaja „ava”.
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Croatian: Nositelj odobrenja prije puštanja lijeka u promet mora osigurati da svi liječnici za koje se očekuje da će propisati/primijeniti Cimziju dobiju informacijski paket za liječnika koji sadrži sljedeće:
English: • increase of red cell mass
Croatian: • povećanje količine crvenih krvnih stanica
English: Patients treated with concomitant immunosuppressants (MTX) had a lower rate of antibody development than patients not taking immunosuppressants at baseline.
Croatian: Bolesnici koji su istodobno liječeni imunosupresivima (MTX-om) imali su manju stopu stvaranja protutijela nego bolesnici koji nisu od početka uzimali imunosupresive.
English: An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate.
Croatian: ANCOVA je prilagođena rangiranim promjenama u odnosu na početnu vrijednost za svako mjerenje s regijom i liječenjem kao faktorima, te početnom vrijednosti kao kovarijancom.
English: When Cimzia has been used to treat other diseases the following uncommon side effects have occurred:
Croatian: Kad se Cimzia primjenjivala u liječenju drugih bolesti, zabilježene su sljedeće manje česte nuspojave:
English: Instructions for self-injecting Cimzia
Croatian: Upute za samostalno injiciranje Cimzije
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), have been reported in patients treated with TNF-antagonists.
Croatian: Prijavljeni su postmarketinški slučajevi hepatospleničkog limfoma T-stanica (HSTCL) u bolesnika liječenih s TNF-antagonistima.
English: Cimzia should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Cimziju treba s oprezom primjenjivati u bolesnika s blagim zatajenjem srca (NYHA stupanj I/II).
English: Therefore the use of certolizumab pegol in combination with anakinra or abatacept is not recommended (see section 4.5).
Croatian: Stoga se primjena certolizumabpegola u kombinaciji s anakinrom ili abataceptom ne preporučuje (vidjeti dio 4.5).
English: The apparent volume of distribution (V/F) was estimated at 8.01 l in a population pharmacokinetic analysis of patients with rheumatoid arthritis and at 4.71 l in a population pharmacokinetic analysis of patients with plaque psoriasis.
Croatian: Populacijskom farmakokinetičkom analizom prividan volumen distribucije (V/F) u bolesnika s reumatoidnim artritisom procijenjen je na 8,01 l i kod farmakokinetičke analize populacije bolesnika s plak psorijazom procijenjen je na 4,71 l.
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.
Croatian: U eksploratornom kliničkom istraživanju koje je vrednovalo primjenu drugog TNF-antagonista, infliksimaba, u bolesnika s umjerenom do teškom opstruktivnom plućnom bolešću (KOPB) zabilježeno je više malignih bolesti, većinom pluća ili glave i vrata, u bolesnika koji su liječeni infliksimabom u odnosu na kontrolnu skupinu bolesnika.
English: Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months.
Croatian: Cimzia se ispitivala na 1112 bolesnika s psorijazom, u kontroliranim i otvorenim ispitivanjima u trajanju do 18 mjeseci.
English: • menstrual cycle (monthly period) disorders including lack of bleeding, or heavy or irregular bleeding
Croatian: • poremećaji menstruacijskog ciklusa (mjesečnice) uključujući izostanak krvarenja ili pojačano krvarenje ili nepravilno krvarenje
English: Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.
Croatian: Slučajevi kongestivnog zatajenja srca također su zabilježeni i u bolesnika s reumatoidnim artritisom koji su primali Cimziju.
English: Please remove from skin" - you can then remove ava from you skin.
Croatian: Uklonite s kože.“ - sada možete maknuti uređaj „ava” s kože.
English: Erosion Score
Croatian: Skor erozija