FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF.
Croatian: Stoga su ispitivanja reprodukcijske toksičnosti provedena s homolognim reagensom koji prepoznaje TNF štakora.
English: Allée de la Recherche 60 1070 Brussels Belgium
Croatian: Allée de la Recherche 60 1070 Bruxelles Belgija
English: Percentage response based upon number of subjects contributing data (n) to that endpoint and time point which may differ from N
Croatian: Odgovor u postotcima prema broju ispitanika od kojih su prikupljeni podatci (n) na kraju, odnosno u određenom vremenu koje može biti drugačije od N
English: A total of 199 subjects (61.2% of randomized subjects) completed the study through Week 204.
Croatian: Ukupno je199 ispitanika (61,2% randomiziranih ispitanika) završilo 204 tjedna istraživanja.
English: • Push plunger head all the way down until the entire dose has been given and the plunger head is between the needle guard activation clips.
Croatian: • Pritišćite glavu klipa do kraja dok ne date cijelu dozu i glava klipa ne bude između aktivacijskih spojnica za štitnik igle.
English: (difference between etanercept and Cimzia 200 mg every 2 weeks was 8.0%, 95% CI -2.9, 18.9, based on a pre-specified non-inferiority margin of 10%).
Croatian: (razlika između etanercepta i Cimzije 200 mg svaka 2 tjedna bila je 8,0%, 95% CI -2,9, 18.9, ) na osnovi prethodno specificirane margine neinferiornosti od 10%).
English: • allergic conditions including allergic rhinitis and allergic reactions to the medicine (including anaphylactic shock)
Croatian: • alergijska stanja uključujući alergijski rinitis i alergijske reakcije na lijek (uključujući anafilaktički šok)
English: These diseases are inflammatory diseases of the spine.
Croatian: Ove bolesti su upalne bolesti kralježnice.
English: - You can change this speed using the “scroll wheel” on the side of your ava.
Croatian: - Brzinu možete promijeniti kotačićem koji se nalazi s bočne strane uređaja „ava”.
English: Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.
Croatian: Unatoč prethodnom ili konkomitantnom profilaktičkom liječenju tuberkuloze, pojavili su se slučajevi aktivne tuberkuloze u bolesnika liječenih TNF-antagonistima, uključujući Cimziju.
English: ASAS 40 Week 12
Croatian: ASAS 40 12. tjedan
English: The empty syringe and needle will automatically move back into the barrel and lock in place.
Croatian: Ispražnjena štrcaljka i igla će se automatski vratiti natrag u trup i zaključati na mjestu.
English: The mTSS Score was modified for psoriatic arthritis by addition of hand distal interphalangeal joints.
Croatian: mTSS zbroj modificiran je za psorijatični artritis dodavanjem distalnih interfalangealnih zglobova ruku.
English: Approximately one-third of antibody-positive patients had antibodies with neutralising activity in vitro.
Croatian: U prosjeku oko jedna trećina bolesnika pozitivnih na protutijela imala je protutijela s neutralizirajućom aktivnosti in vitro.
English: - Press the
Croatian: - Pritisnite
English: The conduct of these tests should be recorded on your Patient Reminder Card.
Croatian: Rezultate tih testova treba zabilježiti u Vašoj kartici s podsjetnicima za bolesnika.
English: If you respond to the medicine, your doctor may prescribe an alternative maintenance dosing of 400 mg every 4 weeks.
Croatian: Ako odgovorite na lijek, Vaš liječnik može propisati alternativnu dozu održavanja od 400 mg svaka 4 tjedna.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath or swelling of your feet), you must contact your doctor immediately.
Croatian: Ako Vam se razviju novi ili pogoršaju postojeći simptomi zatajenja srca (npr. osjećaj nedostatka zraka ili oticanje stopala), morate se odmah javiti svom liječniku.
English: Only the highest titers were associated with reduced certolizumab pegol plasma levels, however, no impact on efficacy was observed.
Croatian: Samo najviši titri bili su povezani sa smanjenim razinama certolizumabpegola u plazmi, no nije zabilježen utjecaj na djelotvornost.
English: The Fab' fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Croatian: Fab fragment uključuje proteinske dijelove te se može očekivati da će se proteolizom razgraditi u peptide i aminokiseline.
English: However, no effect of age was observed in a population pharmacokinetic analysis in patients with rheumatoid arthritis in which 78 subjects (13.2% of the population) were aged 65 or greater and the oldest subject was aged 83 years.
Croatian: Međutim, nije uočen učinak dobi tijekom populacijske farmakokinetičke analize u bolesnika s reumatoidnim artritisom među kojima je 78 ispitanika (13,2% populacije) bilo u dobi od 65 godina ili više, a najstariji ispitanik bio je u dobi od 83 godine.
English: Certolizumab pegol does not bind to the human neonatal Fc receptor (FcRn).
Croatian: Certolizumabpegol se ne veže za humani neonatalni Fc receptor (FcRn).
English: Micro-USB Port
Croatian: Utor za mikro USB
English: The majority of reported TNF-antagonist cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis.
Croatian: Većina prijavljenih slučajeva javila se u adolescenata i mađih odraslih ljudi s Crohnovom bolešću ili ulceroznim kolitisom.
English: If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued (see section 4.3).
Croatian: Ako se aktivna tuberkuloza dijagnosticira prije ili tijekom liječenja, terapija Cimzijom se ne smije započeti i mora se odmah prekinuti (vidjeti dio 4.3).
English: These 3 groups were well balanced with regards to clinical response following the active run-in period (ACR 20: 83-84% at week 18).
Croatian: Te 3 skupine bile su dobro uravnotežene s obzirom na klinički odgovor nakon razdoblja prije početka istraživanja tijekom kojeg se nije primala terapija (ACR 20: 83-84% u 18. tjednu).
English: • feeling weak and generally unwell
Croatian: • osjećaj slabosti i opće loše osjećanje
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment.
Croatian: Treba dobro razmotriti nastavak terapije kod bolesnika koji ne pokazuju dokaz terapijske koristi u prvih 16 tjedana liječenja.
English: • Guillain-Barré syndrome*
Croatian: • Guillain-Barréov sindrom*
English: Check the red medication level indicator is at the bottom of the cartridge - this shows you have had all of your injection.
Croatian: Provjerite nalazi li se crveni indikator razine lijeka na dnu uloška - to pokazuje da ste primili cijelu dozu.
English: Figure 2 Figure 3
Croatian: Slika 2 Slika 3
English: Then, talk to your doctor and inject the following doses as instructed.
Croatian: Nakon toga, razgovarajte sa svojim liječnikom i nastavite primjenjivati sljedeće doze prema uputama.
English: Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
Croatian: Istodobno liječenje s metotreksatom, kortikosteroidima, nesteroidnim protuupalnim lijekovima (NSAIL) i analgeticima nije pokazalo nikakav utjecaj na farmakokinetiku certolizumabpegola na temelju populacijskih farmakokinetičkih analiza.
English: Assessments on remission (DAS28(ESR) <2.6), Low Disease Activity (DAS28(ESR) ≤3.2) status, ACR50 and ACR 70 by visit demonstrated that Cimzia+MTX treatment led to faster and greater responses than PBO+MTX treatment.
Croatian: Ocjena remisije (DAS28(ESR) <2,6), statusa niske aktivnosti bolesti (DAS28(ESR) ≤3,2), odgovora ACR50 i ACR70 po posjetu je pokazala da je liječenje režimom Cimzia+MTX dovelo do bržeg i većeg odgovora nego liječenje režimom placebo+MTX.
English: with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy.
Croatian: uz razumnu pouzdanost, moglo zaključiti da nema povećanog rizika povezanog s primjenom Cimzije tijekom trudnoće.
English: There is limited experience with Cimzia in pregnant women.
Croatian: Postoji ograničeno iskustvo s primjenom Cimzije u trudnica.
English: There is no evidence of an increased risk of infections with continued exposure over time.
Croatian: Nema dokaza o povećanom riziku od infekcija zbog produljene izloženosti liječenju.
English: - After a short pause, ava will automatically pull the cartridge in further.
Croatian: - Nakon kratke pauze uređaj „ava” automatski će uvući uložak u sebe.
English: Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered.
Croatian: Jednom kada je klinički odgovor potvrđen, može se razmotriti alternativna doza održavanja od 400 mg svaka 4 tjedna.
English: • some blood parameters increased (blood alkaline phosphatase increased)
Croatian: • povišeni neki krvni parametri (povišena alkalna fosfataza u krvi)
English: • trouble breathing, swallowing (multiple causes for these symptoms)
Croatian: • otežano disanje, gutanje (za te simptome uzroci su različiti)
English: See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.
Croatian: Vidjeti i dio 6.4 za rok valjanosti vezan uz čuvanje na sobnoj temperaturi do najviše 25°C.
English: Check the medicine in the body of the syringe.
Croatian: Provjerite lijek u tijelu štrcaljke.
English: Heart failure - If you have mild HEART FAILURE and you are being treated with Cimzia, your heart failure status must be closely monitored by your doctor.
Croatian: Zatajenje srca - ako imate blago ZATAJENJE SRCA i liječite se Cimzijom, liječnik će strogo nadzirati stanje Vašeg zatajenja srca.
English: In CIMPASI-1 and CIMPASI-2, sixty patients were antibody positive, 27 of these patients were evaluable for neutralizing antibodies and tested positive.
Croatian: U ispitivanjima CIMPASI-1 i CIMPASI-2, šezdesetoro bolesnika bilo je pozitivno na antitijela, od tih bolesnika 27 se moglo procijeniti za neutralizirajuća antitijela i bili su pozitivni.
English: Allergic reactions - If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness,
Croatian: Alergijske reakcije - ako iskusite ALERGIJSKE REAKCIJE kao što su stezanje u prsima, piskanje pri disanju,
English: Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.
Croatian: Zbog inhibicije TNFα Cimzia primijenjena tijekom trudnoće može utjecati na imunološki odgovor novorođenčeta.
English: • Each new injection should be given on a site separate from the last injection site.
Croatian: • Svaku novu injekciju treba dati na različito mjesto od zadnjeg mjesta injiciranja.
English: Cimzia is used to reduce skin inflammation and other signs and symptoms of your disease.
Croatian: Cimzia se koristi za ublažavanje upale kože i drugih znakova i simptoma
English: If inactive (‘latent') tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Croatian: Ako se sumnja na inaktivnu (latentnu) tuberkulozu, treba se konzultirati s liječnikom koji ima iskustva u liječenju tuberkuloze.
English: • changes in cholesterol and fat levels in the blood
Croatian: • promijenjene vrijednosti kolesterola i masnoća u krvi
English: Patients who miss a dose should be advised to inject the next dose of Cimzia as soon as they remember and then continue injecting subsequent doses as instructed.
Croatian: Bolesnicima koji su zaboravili dozu preporučuje se da sljedeću dozu Cimzije injiciraju čim se sjete i da nastave injicirati sljedeće doze kako su upućeni.
English: It is important that you tell your baby's doctors and other health care professionals about your Cimza use so they can decide when your baby should receive any vaccine.
Croatian: Važno je da obavijestite liječnika svog djeteta i druge zdravstvene radnike o tome da primjenjujete Cimziju kako bi oni mogli odlučiti kada će Vaše dijete moći primiti bilo koje cjepivo.
English: However, if any of the following steps go wrong and/or if you feel unsure about the injection process, contact your doctor or pharmacist.
Croatian: Međutim, ako pogriješite u nekom od sljedećih koraka i/ili ako se osjećate nesigurno oko postupka injiciranja, obratite se svome liječniku ili ljekarniku.
English: Other aPTT assays may be affected as well.
Croatian: Drugi APTV testovi također mogu biti promijenjeni.
English: Study RA-II Methotrexate combination (24 weeks)
Croatian: Ispitivanje RA-II Kombinacija s metotreksatom (24 tjedna)
English: Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Croatian: Liječenje Cimzijom mora se odmah prekinuti u bolesnika koji razviju nove simptome ili im se pogoršaju simptomi kongestivnog zatajenja srca.
English: - If you have an infection or if you develop symptoms such as fever, wounds, tiredness or dental problems.
Croatian: - ako imate infekciju ili Vam se pojave simptomi kao što su vrućica, rane, umor ili problemi sa zubima.
English: The difference from placebo tended to be greater in nr-axSpA than in the AS subpopulation which may be due to less chronic structural damage in nr-axSpA patients.
Croatian: Razlike u odnosu na placebo veće su u subpopulaciji s nr-axSpA nego u subpopolaciji s AS a razlog tome može biti manje kronično oštećenje u strukturi u bolesnika s nr-axSpA.
English: In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to receive a single subcutaneous dose of 400 mg of certolizumab pegol or placebo.
Croatian: U kliničkom istraživanju koje je ocjenjivalo učinak certolizumabpegola na parametre kakvoće sjemena, 20 zdravih muških ispitanika je randomizirano za primanje jednokratne supkutane doze 400 mg certolizumabpegola ili placeba.
English: Use of TNF-antagonists has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, including multiple sclerosis.
Croatian: Primjena TNF-antagonista povezana je s rijetkim slučajevima pojave novih ili egzacerbacije postojećih kliničkih simptoma i/ili radiografskih dokaza demijelinizirajuće bolesti, uključujući multiplu sklerozu.
English: Week 52 p-values were < 0.001 for both mTSS and erosion score and ≤ 0.01 for JSN score.
Croatian: 52. tjedan p-vrijednosti bile su < 0,001 za oba, mTSS zbroj i zbroj erozija te ≤ 0,01 za JSN zbroj.
English: In addition, experiments of FcRn-mediated transcytosis in cells transfected with human FcRn showed negligible transfer (see section 4.6).
Croatian: Povrh toga, pokusi transcitoze posredovane FcRn-om u stanicama transficiranim humanim FcRn-om pokazali su zanemariv prijenos (vidjeti dio 4.6).
English: The clinical significance of low levels certolizumab pegol for infants is unknown.
Croatian: Klinička značajnost niskih razina certolizumabpegola za dojenčad nije poznata.
English: Missing data were imputed using multiple imputation based on the MCMC method.
Croatian: Nedostajući podaci uvršteni su višestrukim uvrštavanjem na osnovi MCMC metode.
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Croatian: U populacijskim farmakokinetičkim analizama nije uočen utjecaj dobi (vidjeti dio 5.2).
English: Patient numbers
Croatian: Broj bolesnika
English: There is no evidence that Cimzia therapy has an effect on coagulation in vivo.
Croatian: Nema dokaza da terapija Cimzijom ima utjecaja na koagulaciju in vivo.
English: For women planning pregnancy, contraception may be considered for 5 months after the last Cimzia dose.
Croatian: Za žene koje planiraju trudnoću, potrebno je razmotriti kontracepciju tijekom 5 mjeseci nakon posljednje doze Cimzije.
English: The CPK elevations in the axSpA study were mostly mild to moderate, transient in nature and of unknown clinical significance with no cases leading to withdrawal.
Croatian: Povećanja razine CPK u ispitivanju axSpA su bila uglavnom blaga do umjerena, prolazne prirode i nepoznate kliničke značajnosti bez slučajeva koji bi doveli do prekida primjene.
English: Previous treatment with one TNF-antagonist was allowed and 20% of patients had prior TNF-antagonist exposure.
Croatian: Prethodno liječenje s jednim TNF-antagonistom bilo je dopušteno i 20% bolesnika bili su ranije izloženi TNF-antagonistima.
English: • Place the orange skin sensor against the injection site where you are going to inject.
Croatian: • Postavite narančasti senzor za kožu na mjesto za injiciranje na kojem ćete primijeniti lijek.
English: Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Croatian: Prije započinjanja terapije Cimzijom svi bolesnici moraju se testirati na aktivnu i inaktivnu (latentnu) tuberkuloznu infekciju.
English: The primary efficacy endpoint was the ASAS20 response rate at Week 12.
Croatian: Ishod primarne djelotvornosti bio je udio ASAS20 odgovora u 12. tjednu.
English: The pre-filled syringe with needle guard should only be used by healthcare professionals.
Croatian: Napunjenu štrcaljku sa štitnikom za iglu smiju primjenjivati samo zdravstveni radnici.
English: In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
Croatian: U ispitivanjima RA-I i RA-II dodatno je bilo zadano da se bolesnicima koji ne reagiraju na liječenje ono prekine u 16. tjednu, a većina tih bolesnika bila je u placebo skupini.
English: Since tumour necrosis factor (TNF) mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies.
Croatian: Budući da faktor nekroze tumora (TNF) posreduje u upali i modulira stanične imunološke odgovore, postoji mogućnost da TNF-antagonisti, uključujući i Cimziju, uzrokuju imunosupresiju, djelujući na obranu domaćina protiv infekcija i malignih bolesti.
English: Inject within 5 minutes of removing the needle cap.
Croatian: Injicirajte unutar 5 minuta od uklanjanja zatvarača igle.
English: Biochemiestraße 10
Croatian: Biochemiestraße 10 Lonzastraβe
English: Key results are presented in Table 9.
Croatian: Ključni rezultati navedeni su u tablici 9.
English: If you are given too much Cimzia
Croatian: Ako Vam je dano previše Cimzije
English: Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the foetal compartment.
Croatian: Podaci iz ex vivo modela zatvorenog - kružnog prijenosa kroz placentu u ljudi pokazuje nizak ili zanemariv prijenos u fetalni odjeljak.
English: You might get an infection more easily while you are being treated with Cimzia, including serious, or in rare cases, life-threatening infections.
Croatian: Tijekom liječenja Cimzijom infekcije se mogu lakše razviti, uključujući teške ili u rijetkim slučajevima životno ugrožavajuće infekcije.
English: There have been rare reports of other immunemediated conditions; the causal relationship to Cimzia is not known.
Croatian: Bilo je rijetkih izvješća o drugim stanjima koja su posredovana imunim mehanizmima; uzročna povezanost s Cimzijom nije nađena.
English: • after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis, or
Croatian: • nakon 12 tjedana ako imate reumatoidni artritis, aksijalni spondiloartritis ili psorijatični artritis, ili
English: Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.
Croatian: Obje doze Cimzije pokazale su djelotvornost u usporedbi s placebom neovisno o dobi, spolu, tjelesnoj težini, indeksu tjelesne mase, trajanju oboljenja od psorijaze, prethodnom liječenju sistemskim terapijama i prethodnom liječenju biološkim lijekovima.
English: • Do not use the medication if it has been dropped after taking it out of the pack.
Croatian: • Nemojte upotrijebiti uložak ako je pao nakon što ste ga izvadili iz pakiranja.
English: The solution is clear to opalescent, colourless to yellow.
Croatian: Otopina je bistra do opalescentna, bezbojna do žuta.
English: • changes in blood levels of different salts
Croatian: • promijenjene vrijednosti različitih soli u krvi
English: Plaque psoriasis is an inflammatory disease of the skin, and can also affect your scalp and nails.
Croatian: Plak psorijaza je upalna bolest kože, a može zahvatiti i vlasište i nokte.
English: • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Croatian: • liječenje teškog, aktivnog i progresivnog RA u odraslih bolesnika koji prethodno nisu bili liječeni MTX-om ili drugim DMARD-ovima.
English: Of the 850 patients randomized to receive placebo or Cimzia in these placebo-controlled studies, 29% of patients were naïve to prior systemic therapy for the treatment of psoriasis.
Croatian: Od 850 bolesnika koji su randomizirani za primanje placeba ili Cimzije u tim ispitivanjima uz kontrolu placebom, 29% ih prethodno nije primalo sistemsku terapiju za liječenje psorijaze.
English: Patients who develop a new infection while undergoing treatment with Cimzia should be monitored closely.
Croatian: Bolesnike koji razviju novu infekciju tijekom liječenja Cimzijom treba strogo nadzirati.
English: It is usually injected into the thigh or tummy.
Croatian: Obično se primjenjuje u područje bedra ili trbuha.
English: • Use a piece of gauze, apply pressure over the injection site for a few seconds: - Do not rub the injection site.
Croatian: • Komadom gaze pritišćite mjesto injiciranja nekoliko sekundi: - Nemojte trljati mjesto injiciranja.
English: Do not try to repeat the injection process without speaking to your doctor or your pharmacist.
Croatian: Nemojte pokušavati ponoviti postupak injiciranja bez razgovora sa svojim liječnikom ili ljekarnikom.
English: In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4.
Croatian: U sva 3 ispitivanja, stopa odgovora PASI 75 bila je značajno viša za Cimziju u usporedbi s placebom, počevši od 4. tjedna.
English: Cimzia treated patients also had significant improvements in ACR 50 and 70 response rates.
Croatian: Bolesnici liječeni Cimzijom imali su i značajna poboljšanja stopa ACR 50 i ACR 70 odgovora.
English: These response rates were based on a logistic regression model where missing data were imputed using multiple imputation (MCMC method).
Croatian: Te stope odgovora procijenjene su na osnovi modela logističke regresije, pri čemu su se nedostajući podaci uvrštavali primjenom višestrukog uvrštavanja (MCMC metoda).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 2009
Croatian: Datum prvog odobrenja: 1. listopada 2009.
English: • lung inflammation (interstitial lung disease, pneumonitis)
Croatian: • upala pluća (intersticijska bolest pluća, pneumonitis)
English: This is so that the doctor can determine if Cimzia is working for you or if another treatment needs to be considered.
Croatian: To je potrebno kako bi procijenio djeluje li Cimzia ili Vam je potrebno drugo liječenje.
English: • benign (non-cancerous) tumours and cysts (including those of the skin)
Croatian: • dobroćudni (nekancerogeni) tumori i ciste (uključujući i kožne)
English: Patients were predominantly men (64%) and Caucasian (94%), with a mean age of 45.7 years (18 to 80 years); of these, 7.2% were ≥ 65 years of age.
Croatian: Bolesnici su pretežno bili muškarci (64%) i bijelci (94%), sa srednjom vrijednošću dobi od 45,7 godina (18 do 80 godina); od toga, 7,2% su bili u dobi od ≥ 65 godina.