FrancophonIA/ELRC3.0 huggingface dataset:
English: Always take the Patient Reminder Card and the outer carton from the Cimzia package with you, even if it is empty.
Croatian: Uvijek uzmite Karticu s podsjetnicima za bolesnika i vanjsko pakiranje Cimzije sa sobom, čak i ako je prazno.
English: • improve your physical function and performance of daily tasks.
Croatian: • poboljšala Vaša fizička funkcionalnost i olakšalo obavljanje svakodnevnih poslova.
English: Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs.
Croatian: Bolesnici su također imali aktivne psorijatične lezije na koži ili dokumentiranu povijest psorijaze i neuspjeh s 1 ili više DMARD-om.
English: Skin sensor (the skin sensor detects when the injection port is fully in contact with your skin).
Croatian: Senzor za kožu (senzor za kožu prepoznaje kada je utor za injekciju potpuno u doticaju s kožom).
English: • Merkel cell carcinoma (a type of skin cancer)*
Croatian: • karcinom Merkelovih stanica (vrsta raka kože)*
English: In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained.
Croatian: In vitro funkcijska ispitivanja na ljudskim vakuoliziranim makrofagima pokazala su da su sve testirane funkcije očuvane.
English: Active tuberculosis or other severe infections such as sepsis or opportunistic infections (see section 4.4).
Croatian: Aktivna tuberkuloza ili druge teške infekcije kao što su sepsa ili oportunističke infekcije (vidjeti dio 4.4).
English: Data from more than 500 prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, does not indicate a malformative effect of Cimzia.
Croatian: Prospektivno prikupljeni podaci u više od 500 trudnica izloženih Cimziji s poznatim ishodima trudnoće, koji su uključivali više od 400 trudnoća izloženih tijekom prvog trimestra, ne ukazuju na malformacijski učinak Cimzije.
English: Infections - If you have had RECURRENT or OPPORTUNISTIC INFECTIONS or other conditions that increase the risk of infections (such as treatment with immunosuppressants, which are medicines that could reduce your ability to fight infections).
Croatian: Infekcije - ako ste imali PONAVLJAJUĆE ili OPORTUNISTIČKE INFEKCIJE ili druga stanja koja povećavaju rizik nastanka infekcija (kao što je liječenje imunosupresivima koji mogu smanjiti Vašu sposobnost obrane od infekcija).
English: The typical Cavg that produces half the maximum probability of ACR 20 response (EC50) was 17 µg/ml (95% CI: 10-23 µg/ml).
Croatian: Tipičan Cavg kojim se postiže polovica najveće vjerojatnosti ACR 20 odgovora (EC50) iznosio je 17 µg/ml (95% CI: 10-23 µg/ml).
English: The use of adequate contraception should be considered for women of childbearing potential.
Croatian: Potrebno je razmotriti primjenu odgovarajuće kontracepcije za žene reproduktivne dobi.
English: - Avoid removing ava from the skin during the injection to ensure that you receive the full dose.
Croatian: - Izbjegavajte podizanje uređaja „ava” s kože tijekom injekcije kako biste bili sigurni da ste primili cijelu dozu.
English: About 22% (54/248) of the patients who were anti-certolizumab pegol antibody positive at any time, had antibodies that were classified as neutralizing.
Croatian: Oko 22% (54/248) bolesnika koji su bili pozitivni na protutijela na certolizumabpegol u bilo kojem trenutku, imalo je protutijela koja su bila klasificirana kao neutralizirajuća.
English: • azoospermia (lack of sperm production).
Croatian: • azoospermija (smanjeno stvaranje spermija).
English: In women, ASAS20 responses were not statistically significantly different from placebo until after the Week 12 time point.
Croatian: U žena, ASAS20 odgovori nisu se statistički značajno razlikovali od placeba do nakon 12. tjedna.
English: - Once the needle cap has been removed, you must give the injection within 5 minutes.
Croatian: - Nakon što skinete zatvarač igle, injekciju morate primijeniti unutar 5 minuta.
English: • sepsis (serious infection which can result in organ failure, shock or death)
Croatian: • sepsa (teška infekcija koja uzrokuje zatajivanje organa, šok ili smrt)
English: This difference in exposure is primarily due to patients on placebo being more likely to withdraw early.
Croatian: Ova razlika u izloženosti primarno je posljedica veće vjerojatnosti da bolesnici u placebo skupini ranije prekinu liječenje.
English: A total of 264 subjects (64.5%) completed the study through Week 216.
Croatian: Ukupno su 264 ispitanika (64,5%) završila 216 tjedana istraživanja.
English: Your physician will also give you a Patient Reminder Card, which contains important safety information of which you need to be aware before you are given Cimzia and during treatment with Cimzia.
Croatian: Vaš će Vam liječnik također dati Karticu s podsjetnicima za bolesnika koja sadrži bitne sigurnosne informacije s kojima morate biti upoznati prije no što dobijete Cimziju i tijekom liječenja Cimzijom.
English: • Continue to hold the pre-filled pen in place firmly against the skin until a second “click” is heard and the viewing window turns orange.
Croatian: • Nastavite držati napunjenu brizgalicu čvrsto pritisnutu na istom mjestu na koži, dok ne čujete drugi “klik”, a prozorčić za gledanje postane narančast.
English: • You must also carefully read the full instructions in the ava User Manual.
Croatian: • Morate pažljivo pročitati i sve upute navedene u korisničkom priručniku za uređaj „ava”.
English: Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Croatian: Kod nekih bolesnika s početnim djelomičnim odgovorom može doći do naknadnog poboljšanja uz nastavak liječenja i nakon 16 tjedana.
English: Choosing and preparing an injection site
Croatian: Odabir i priprema mjesta injiciranja
English: The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %.
Croatian: Postotak doze certolizumabpegola kod majke koji dospijeva u dojenče tijekom razdoblja od 24 sata bio je procijenjen na 0,04% do 0,30%.
English: • The current injection speed (medication flow rate) is shown.
Croatian: • Prikazuje se trenutna brzina injiciranja (brzina protoka lijeka).
English: • With one quick, short motion, push the needle all the way into the skin.
Croatian: • Jednim brzim i kratkim pokretom ubodite cijelu iglu u kožu.
English: The most frequent serious infections included pneumonia, tuberculosis infections.
Croatian: Najčešće ozbiljne infekcije uključivale su upalu pluća i tuberkulozne infekcije.
English: This number decreases with increasing doses of concomitant MTX treatment.
Croatian: Taj broj se smanjuje s povećanjem doze istodobno primjenjivanog MTX-a.
English: • suicide attempt, mental impairment, delirium
Croatian: • pokušaj samoubojstva, duševni poremećaji, delirij
English: •two alcohol wipes (for cleansing the areas chosen for injection).
Croatian: • dvije alkoholne vatice (za čišćenje izabranog mjesta injiciranja).
English: Patients should be given the special reminder card.
Croatian: Bolesnicima treba dati posebnu karticu s podsjetnicima.
English: • Stevens-Johnson syndrome (a serious skin condition which early symptoms include malaise,
Croatian: • Stevens-Johnsonov sindrom (ozbiljno stanje kože čiji rani simptomi uključuju malaksalost,
English: Certolizumab pegol has a bioavailability (F) of approximately 80% (range 76% to 88%) following subcutaneous administration compared to intravenous administration.
Croatian: Bioraspoloživost certolizumabpegola (F) je oko 80% (raspon 76% do 88%) nakon supkutane primjene u odnosu na intravensku primjenu.
English: Patients who were ‘primary' non-responders on any prior biologic therapy (defined as no response within the first 12 weeks of treatment) were excluded from the phase III studies (CIMPASI-1, CIMPASI-2 and CIMPACT).
Croatian: Bolesnici koji „primarno“ nisu imali odgovor na bilo koju prethodnu terapiju biološkim lijekovima (definiranu kao izostanak odgovora u prvih 12 tjedana liječenja), bili su isključeni iz ispitivanja faze III (CIMPASI-1, CIMPASI-2 i CIMPACT).
English: • fungal infections (occur when the ability to fight off infection is lessened)
Croatian: • gljivične infekcije (pojavljuju se kada se smanji sposobnost organizma za obranu od infekcija)
English: Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for:
Croatian: Reumatoidni artritis Cimzia je, u kombinaciji s metotreksatom (MTX), indicirana za:
English: Patients must have been intolerant to or had an inadequate response to at least two NSAIDs.
Croatian: Bolesnici su morali biti netolerantni ili imati neadekvatan odgovor na najmanje dva nesteroidna protuupalna lijeka.
English: * p<0.001 All percents reflect the proportion of patients who responded in the full analysis set.
Croatian: * p<0.001 Svi postotci odražavaju udio bolesnika s odgovorom u setu potpune analize.
English: However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy.
Croatian: Međutim, dostupno kliničko iskustvo je previše ograničeno da bi se, uz razumnu pouzdanost, moglo zaključiti da nema povećanog rizika povezanog s primjenom Cimzije tijekom trudnoće.
English: There is no experience with Cimzia in combination with DMARDs other than MTX.
Croatian: Nema iskustva s Cimzijom u kombinaciji s nekim drugim DMARD-om, osim MTX-om.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Croatian: • pogoršanje stanja koje se zove dermatomiozitis (očituje se kao kožni osip praćen slabošću mišića)
English: You can inject yourself or the injection can be given by someone else (caregiver).
Croatian: Lijek možete injicirati sami ili Vam ga može dati netko drugi (njegovatelj).
English: (On/Off button) for 1 second, or until the screen lights up and you hear sound - “Hello” is displayed for 2 seconds - this means ava is switched on.
Croatian: (tipku za uključivanje/isključivanje) i držite je pritisnutom 1 sekundu ili dok se ne upali zaslon i dok ne čujete zvuk - Na zaslonu će se 2 sekunde prikazivati poruka „Zdravo“, što znači da je uređaj „ava” uključen.
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Croatian: Ostali slučajevi bile su različite maligne bolesti, a uključivale su rijetke maligne bolesti obično povezane s imunosupresijom.
English: 1: Orange band 2: Viewing window 3: Black handle 4: Clear cap
Croatian: 1: Narančasta vrpca 2: Prozorčić za gledanje 3: Crni držač 4. Prozirni zatvarač
English: No dose recommendations can be made (see section 5.2).
Croatian: Nije moguće dati preporuke o doziranju (vidjeti dio 5.2).
English: • spontaneous abortion.
Croatian: • spontani pobačaj.
English: Quality of life / Patient reported outcomes
Croatian: Kvaliteta života / Ishodi prema izvješću bolesnika
English: Medicines that bind to TNFα are also called TNF blockers.
Croatian: Lijekove koji se vežu na TNFα također zovemo i blokatorima TNF-a.
English: If the indicator is not at the bottom, contact your pharmacist.
Croatian: Ako indikator nije na dnu uloška, obratite se svom ljekarniku.
English: If you experience these symptoms, contact your doctor.
Croatian: Ako primijetite te simptome, javite se svom liječniku.
English: Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of infections.
Croatian: Pri liječenju starijih bolesnika potreban je oprez, a osobito pozornost treba obratiti na pojavu infekcija.
English: Table 2 Clinical trial description Study number
Croatian: Tablica 2 Opis kliničkog istraživanja Broj ispitivanja
English: For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate (see section 5.2), but the need for treatment of the woman should also be taken into account (see below).
Croatian: Za žene koje planiraju trudnoću, potrebno je razmotriti kontinuiranu kontracepciju tijekom 5 mjeseci nakon posljednje doze Cimzije zbog brzine njezine eliminacije (vidjeti dio 5.2), ali potrebno je također uzeti u obzir potrebu za liječenjem žene (vidjeti u nastavku).
English: Do not try to touch the needle as it could activate the pre-filled pen.
Croatian: Nemojte pokušati dodirnuti iglu jer bi mogla aktivirati napunjenu brizgalicu.
English: In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant.
Croatian: Povrh toga, budući da je certolizumabpegol protein koji se razgrađuje u probavnom sustavu nakon primjene kroz usta, očekuje se da će apsolutna bioraspoloživost biti vrlo niska u dojene djece.
English: • blood clots in the veins or lungs
Croatian: • krvni ugrušci u venama ili plućima
English: Specific clinical trials have not been performed in elderly patients subjects.
Croatian: Posebna klinička istraživanja u starijih bolesnika nisu provedena.
English: To complete your injection: o Repeat Step 2 (Choosing and preparing an injection site), using a different injection site o Press ava firmly against the skin to begin the injection again, then o Press the (Start/Pause button).
Croatian: Da biste dovršili injekciju: o Ponovite 2. korak („Odabir i priprema mjesta injiciranja”), ali odaberite drugo mjesto za injiciranje o Čvrsto pritisnite uređaj „ava” na kožu da biste ponovno započeli injekciju, a zatim o Pritisnite (tipku za pokretanje/pauziranje).
English: Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.
Croatian: Stoga je rano otkrivanje svake infekcije, a posebno ozbiljnih infekcija s atipičnom kliničkom slikom, iznimno važno kako bi se spriječilo kašnjenje u postavljanju dijagnoze i započinjanju liječenja.
English: Improvements in ASAS5/6, Partial Remission and BASDAI-50 were statistically signficant at Week 12 and Week 24 and were sustained up to Week 48 in the overall popualtion as well as in the subpopulations.
Croatian: Poboljšanja u ASAS5/6, djelomičnoj remisiji i BASDAI-50 bila su statistički značajna u 12. i 24. tjednu i bila su održavana do 48. tjedna u ukupnoj populaciji kao i u subpopulaciji.
English: B-1070 Bruxelles Belgium
Croatian: B-1070 Bruxelles
English: If this occurs, you should stop using Cimzia.
Croatian: Ako se to dogodi, trebate prestati primjenjivati Cimziju.
English: The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Cimzije u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia.
Croatian: Neki bolesnici koji su uspješno liječeni od aktivne tuberkuloze ponovno su razvili tuberkulozu tijekom liječenja Cimzijom.
English: If your doctor says you can inject yourself, you need to be fully trained first.
Croatian: Ako Vam liječnik kaže da ga možete injicirati sami, najprije morate proći cjelovitu obuku.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Za bolesnike koji su pozitivni na HBV infekciju preporučuje se konzultacija s liječnikom specijalistom koji ima iskustva u liječenju hepatitisa B.
English: - If ava is accidentally removed from your skin during the injection, the injection will automatically stop and the needle will go back into ava.
Croatian: Ako slučajno odmaknete uređaj „ava” s kože tijekom injiciranja, injekcija će se automatski zaustaviti, a igla uvući natrag u uređaj „ava”.
English: Hold the pre-filled pen straight (at a 90° degree angle) against the skin, that previously has been cleaned (the “injection site”).
Croatian: Postavite napunjenu brizgalicu okomito (pod kutem od 90°) na kožu, na mjestu koje je prethodno očišćeno ("mjesto injiciranja").
English: • headaches (including migraines)
Croatian: • glavobolje (uključujući migrenu)
English: • With the other hand, hold the syringe at a 45-degree angle to the skin.
Croatian: • Drugom rukom držite štrcaljku pod kutem od 45 stupnjeva u odnosu na kožu.
English: Table 4: C-EARLY trial: percent of patients in sustained remission and sustained low disease activity at Week 52
Croatian: Tablica 4: C-EARLY ispitivanje: postotak bolesnika u stanju održane remisije i održane niske aktivnosti bolesti u 52. tjednu
English: Children and adolescents Cimzia is not recommended for use in children and adolescents under the age of 18 years.
Croatian: Djeca i adolescenti Cimzia se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: Tell your doctor if you have had or have a serious heart condition.
Croatian: Obavijestite svog liječnika ako imate ili ste imali tešku bolest srca.
English: • slow down the damage to the cartilage and bone of the joints caused by the disease,
Croatian: • usporila oštećenja hrskavice i kostiju zglobova uzrokovana bolešću,
English: • Gently grasp the cleaned area of skin with one hand and hold firmly.
Croatian: • Jednom rukom nježno primite očišćeno područje kože i čvrsto držite.
English: Injection device: ava
Croatian: Uređaj za injekciju: „ava”
English: Spinal mobility
Croatian: Spinalna pokretljivost
English: Mean baseline BSA was 25% and ranged from 10% to 96%.
Croatian: Srednja vrijednost početnog BSA rezultata bila je 25% i u rasponu od 10% do 96%.
English: The results of clinical trials RA-I and RA-II are shown in Table 3.
Croatian: Rezultati kliničkih istraživanja RA-I i RA-II prikazani su u Tablici
English: • Remove the following items from the Cimzia pack and set them up on a clean flat surface:
Croatian: • Iz pakiranja Cimzije uzmite sljedeće proizvode i postavite ih na čistu i ravnu površinu:
English: Cimzia, which you will take in combination with methotrexate, is used to:
Croatian: Cimzia, koju ćete primjenjivati u kombinaciji s metotreksatom, se koristi kako bi se:
English: Both Cimzia regimens showed sustained clinical response and were statistically significant compared to placebo at week 34.
Croatian: Oba Cimzia režima pokazala su kontinuiran klinički odgovor i bili su statistički značajni u odnosu na placebo u 34. tjednu.
English: This injection should not be mixed in the same syringe with any other medicine.
Croatian: Ovu injekciju ne smijete u istoj štrcaljki miješati ni s jednim drugim lijekom.
English: Randomised, double-blind treatment regimen week 18 to 34
Croatian: Režim randomiziranog, dvostruko slijepog liječenja 18. do 34. tjedan
English: • Do not remove the needle cap until ava instructs you to do so.
Croatian: • Nemojte skinuti zatvarač igle dok Vas uređaj „ava” ne uputi da to učinite.
English: Check the medicine through the viewing window.
Croatian: Provjerite lijek kroz prozorčić za gledanje.
English: Table 3 ACR response in clinical trials RA-I and RA-II Study RA-I Methotrexate combination (24 and 52 weeks)
Croatian: Tablica 3 ACR odgovor u kliničkim istraživanjima RA-I i RA-II Ispitivanje RA-I Kombinacija s metotreksatom (24 i 52 tjedna)
English: Do not try to touch the needle.
Croatian: Nemojte pokušavati dodirivati iglu.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor immediately.
Croatian: Ako imate dugotrajnu vrućicu koja ne prolazi, modrice ili vrlo lako prokrvarite ili ste jako blijedi, odmah se javite svom liječniku.
English: It is recommended to wait a minimum of 5 months following the mother's last Cimzia administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or liveattenuated vaccines to the infants.
Croatian: Preporučuje se pričekati najmanje 5 mjeseci nakon posljednje primjene Cimzije kod majke tijekom trudnoće prije primjene živih ili živih atenuiranih cjepiva (npr. cjepivo BCG), osim ako korist cjepiva jasno ne premašuje teoretski rizik za primjenu živih ili živih atenuiranih cjepiva u dojenčadi.
English: The baseline PGA score ranged from moderate (70%) to severe (30%).
Croatian: Početna vrijednost PGA rezultata bila je u rasponu od umjerenog (70%) do teškog (30%).
English: C-EARLY (to 52 wee ks)
Croatian: C-EARLY (do 52 tjedn a)
English: When assessed using the previous ELISA method, the presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance.
Croatian: Kada se procjenjivala prethodnom metodom ELISA, prisutnost protutijela na certolizumabpegol uzrokovala je otprilike trostruko povećanje klirensa.
English: There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4).
Croatian: Nema dokaza o povećanom riziku od infekcija zbog produljene izloženosti liječenju (vidjeti dio 4.4).
English: Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of 148 weeks overall.
Croatian: Od njih je 427 završilo 2 godine otvorenog praćenja te su ukupno bili izloženi Cimziji 148 tjedana.
English: The ava injection device currently does not support administration of a maintenance dose of 400 mg every 2 weeks; for plaque psoriasis patients receiving this maintenance dose, the physician is adviced to use other presentations.
Croatian: Elektromehanički uređaj za injekciju „ava” trenutno ne podržava primjenu doze održavanja od 400 mg svaka 2 tjedna; za bolesnike s plak psorijazom koji primaju ovu dozu održavanja, liječniku se savjetuje primjena drugih oblika.
English: Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection.
Croatian: Nakon supkutane primjene vršne koncentracije certolizumabpegola u plazmi postižu se između 54 i 171 sat nakon injiciranja.
English: Cimzia has not been studied specifically in a lupus population (see section 4.8).
Croatian: Cimzia nije posebno ispitivana u populaciji s lupusom (vidjeti dio 4.8).
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated.
Croatian: Liječenje treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju stanja u kojima je Cimzia indicirana.
English: 47% had received prior phototherapy or chemophototherapy, and 30% had received prior biologic therapy for the treatment of psoriasis.
Croatian: 47% ih je prethodno primalo fototerapiju ili kemoterapiju, a 30% je za liječenje psorijaze prethodno primalo terapiju biološkim lijekovima.
English: • You will be instructed by your doctor or healthcare giver how to inject the medicine.
Croatian: • Vaš liječnik ili zdravstveni radnik reći će Vam kako injicirati lijek.
English: The frequency of creatine phosphokinase (CPK) elevations was generally higher in patients with axSpA as compared to the RA population.
Croatian: Učestalost povećanja razine kreatin fosfokinaze (CPK) općenito je bila veća u bolesnika s axSpA u usporedbi s populacijom s RA.
English: One Cimzia pack contains:
Croatian: Jedno pakiranje Cimzije sadrži:
English: This will include a thorough medical history, a chest X-ray and a tuberculin test.
Croatian: To će uključivati detaljnu anamnezu, rendgensko snimanje pluća i tuberkulinski kožni test.
English: DoseFlex clinical trial
Croatian: DoseFlex kliničko istraživanje
English: Studies in rats indicated that > 90% of the administered PEG was eliminated in 3 months following a single dose, with the urine being the main route of excretion.
Croatian: Ispitivanja u štakora pokazala su da se > 90% jednokratno primijenjenog PEG-a eliminira unutar 3 mjeseca mokraćom, koja je i glavni put izlučivanja.