FrancophonIA/ELRC3.0 huggingface dataset:
English: Determine the dose and the number of ORENCIA vials needed (see section 4.2).
Croatian: Odredite dozu i potreban broj bočica lijeka ORENCIA (vidjeti dio 4.2).
English: No dose adjustment is required (see section 4.4).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 4.4).
English: You should be screened for viral hepatitis in accordance with published guidelines.
Croatian: Trebate se testirati na virusni hepatitis u skladu s objavljenim smjernicama.
English: Overall, there was no apparent correlation of antibody development to clinical response or adverse events.
Croatian: Sveukupno, nije postojala očita korelacija između stvaranja antitijela i kliničkog odgovora ili nuspojava.
English: As in study SC-I, there was no effect of immunogenicity on safety or efficacy.
Croatian: Kao i u ispitivanju SC-I, imunogenost nije utjecala ni na sigurnost ni na djelotvornost.
English: * p < 0.05 vs placebo, p values not assessed for ACR 50 and ACR 70. a 37% of patients were previously treated with TNF inhibitor.
Croatian: * p < 0,05 naspram placeba; p-vrijednosti nisu se ocjenjivale za ACR 50 i ACR 70. a 37% bolesnika prethodno je bilo liječeno TNF-inhibitorom.
English: Administration of ORENCIA should be discontinued if a patient develops a serious infection.
Croatian: Primjena lijeka ORENCIA mora se prekinuti ako bolesnik razvije ozbiljnu infekciju.
English: The solution is clear, colourless to pale yellow with a pH of 6.8 to 7.4.
Croatian: Otopina je bistra, bezbojna do svjetložuta, pH vrijednosti 6,8 do 7,4.
English: You can press a cotton ball or gauze over the injection site.
Croatian: Možete pritisnuti pamučnu vatu ili gazu na mjesto injekcije.
English: Abatacept may cross the placenta into the serum of infants born to women treated with abatacept during pregnancy.
Croatian: Abatacept može proći kroz placentu u serum novorođenčadi čije su majke liječene abataceptom tijekom trudnoće.
English: The potential role of abatacept in the development of malignancies, including lymphoma, in humans is unknown.
Croatian: Nije poznata moguća uloga abatacepta u razvoju zloćudnih bolesti, uključujući limfom, u ljudi.
English: Patients who develop a new infection while undergoing treatment with ORENCIA should be monitored closely.
Croatian: Bolesnike koji tijekom liječenja lijekom ORENCIA razviju novu infekciju treba pomno nadzirati.
English: Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening.
Croatian: Anafilaksija ili anafilaktoidne reakcije mogu se pojaviti nakon prve infuzije i mogu biti opasne po život.
English: Based on its mechanism of action, abatacept is expected to have no or negligible influence on the ability to drive and use machines.
Croatian: Sudeći prema njegovu mehanizmu djelovanja, očekuje se da abatacept ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.
Croatian: ORENCIA može umanjiti sposobnost Vašeg tijela da se bori protiv infekcije, a liječenje može povećati vjerojatnost da dobijete infekciju ili pogoršati neku postojeću infekciju.
English: Uncommon Depression, anxiety, sleep disorder (including insomnia)
Croatian: Psihijatrijski poremećaji manje često depresija, anksioznost, poremećaj spavanja (uključujući nesanicu)
English: The syringe should not be shaken.
Croatian: Brizgalica se ne smije tresti.
English: HAQc Disability Index
Croatian: HAQc indeks nesposobnosti
English: The potential clinical relevance of neutralizing antibody formation is not known.
Croatian: Nije poznat mogući klinički značaj stvaranja neutralizirajućih antitijela.
English: There is insufficient evidence to assess the safety and efficacy of abatacept in combination with anakinra or rituximab (see section 4.4).
Croatian: Nema dovoljno dokaza da bi se mogla procijeniti sigurnost i djelotvornost abatacepta u kombinaciji s anakinrom ili rituksimabom (vidjeti dio 4.4).
English: Having an infection could put you at risk of serious side effects from ORENCIA.
Croatian: Infekcija Vas može izložiti riziku od ozbiljnih nuspojava lijeka ORENCIA.
English: A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2).
Croatian: Glavni put kostimulacije uključuje vezivanje molekula CD80 i CD86 na površini stanica koje prezentiraju antigen na receptor CD28 na T-limfocitima (signal 2).
English: Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease affecting one or more joints in children and adolescents.
Croatian: Poliartikularni juvenilni idiopatski artritis je dugotrajna upalna bolest koja zahvaća jedan ili više zglobova u djece i adolescenata.
English: E. Wash your hands thoroughly with soap and warm water.
Croatian: Dobro operite ruke sapunom i toplom vodom.
English: Read these instructions before you use the ClickJect Pre-filled Pen.
Croatian: Pročitajte ove upute prije nego što upotrijebite napunjenu brizgalicu ClickJect.
English: If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy.
Croatian: Ako ste primali lijek ORENCIA tijekom trudnoće, Vaše dijete može imati povećan rizik od razvoja takve infekcije tijekom približno 14 tjedana nakon posljednje doze koju ste primili tijekom trudnoće.
English: Study VII: Safety of abatacept in patients with or without washout of previous TNF-inhibitor therapy
Croatian: Ispitivanje VII: Sigurnost abatacepta u bolesnika sa ili bez faze ispiranja nakon prethodne terapije TNF-inhibitorima
English: Inject: push the plunger with your thumb as far as it will go.
Croatian: Injicirajte: gurnite klip palcem sve do kraja.
English: if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor.
Croatian: ako imate bilo kakvu infekciju, uključujući dugotrajnu ili lokaliziranu infekciju, ako često dobivate infekcije ili ako imate simptome infekcije (npr. vrućicu, slabost, tegobe sa zubima), važno je da o tome obavijestite svog liječnika.
English: ≥ 60 kg to ≤ 100 kg
Croatian: ≥ 60 kg do ≤ 100 kg
English: However, in some, RA may progress rapidly and yet other people may have RA for a limited period of time and then enter a period of remission.
Croatian: Međutim, u nekih osoba reumatoidni artritis može vrlo brzo napredovati, dok u drugih bolest može biti prisutna ograničeno vrijeme, a zatim ući u razdoblje mirovanja.
English: Step 4: Choose and Prepare an Injection Site Choose your injection site in either the abdomen, front of the thighs, or outer area of upper arm (only if caregiver administered).
Croatian: KORAK 4: Odaberite i pripremite mjesto injiciranja Odaberite mjesto injekcije na trbuhu, prednjem dijelu bedara ili vanjskom dijelu nadlaktice (samo ako injekciju daje skrbnik).
English: Your doctor will advise you on the duration of treatment and what other medicines you may continue to take while on ORENCIA.
Croatian: Liječnik će Vas obavijestiti o trajanju liječenja i koje druge lijekove možete nastaviti uzimati dok se liječite lijekom ORENCIA.
English: Contact your doctor, nurse, or pharmacist for further instructions.
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku za daljnje upute.
English: Description of selected adverse reactions Infections
Croatian: Opis odabranih nuspojava Infekcije
English: Overall antibodies against abatacept were generally transient and of low titer.
Croatian: Ukupna antitijela protiv abatacepta bila su općenito prolazna i niskog titra.
English: e After 6 months, patients were given the opportunity to enter into an open-label study.
Croatian: e Nakon 6 mjeseci bolesnici su dobili priliku da se uključe u otvoreno ispitivanje.
English: The medicinal product is for single use only.
Croatian: Lijek je samo za jednokratnu primjenu.
English: Disease activity was also assessed using the Disease Activity Score 28.
Croatian: Aktivnost bolesti procijenjena je i pomoću indeksa aktivnosti bolesti 28 (engl.
English: o Patient alert card: o A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using ORENCIA o That ORENCIA treatment may increase the risk of infections and allergic reactions.
Croatian: o Kartica s upozorenjima za bolesnika: o Poruka upozorenja za zdravstvene radnike koji liječe bolesnika u bilo kojem trenutku, uključujući u hitnim situacijama, da bolesnik koristi lijek ORENCIA o Liječenje lijekom ORENCIA može povećati rizik od infekcija i alergijskih reakcija.
English: If you stop using ORENCIA The decision to stop using ORENCIA should be discussed with your doctor.
Croatian: Ako prestanete primati lijek ORENCIA Odluku o prestanku liječenja lijekom ORENCIA morate raspraviti sa svojim liječnikom.
English: The response at year 1 in the abatacept group was maintained through year 2.
Croatian: Odgovor nakon 1. godine u skupini liječenoj abataceptom održao se tijekom 2. godine liječenja.
English: In a one-year toxicity study in cynomolgus monkeys, abatacept was not associated with any significant toxicity.
Croatian: U jednogodišnjem istraživanju toksičnosti na makaki majmunima, abatacept nije bio povezan sa značajnom toksičnošću.
English: Do not freeze.
Croatian: NEMOJTE JE ZAMRZAVATI.
English: The most frequently reported adverse reactions (≥ 5%) among abatacept-treated patients were headache, nausea, and upper respiratory tract infections (including sinusitis).
Croatian: Najčešće prijavljene nuspojave (≥ 5%) u bolesnika liječenih abataceptom bile su glavobolja, mučnina i infekcije gornjeg dijela respiratornog trakta (uključujući sinusitis).
English: Don't throw away used syringes in your household rubbish or recycling bins.
Croatian: Nemojte bacati upotrijebljene štrcaljke u kućni otpad niti u posude za recikliranje.
English: End of Period A (day 113)
Croatian: Razdoblja A (113. dan)
English: Immunogenicity to abatacept following long-term subcutaneous administration was assessed by a new electrochemiluminescence (ECL) assay.
Croatian: Imunogenost na abatacept nakon dugotrajne supkutane primjene ispitana je pomoću novog elektrokemiluminiscentnog (ECL) testa.
English: Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies.
Croatian: U uzorcima u kojima je potvrđeno vezivanje za CTLA-4 ispitana je prisutnost neutralizirajućih antitijela.
English: Abatacept 10 mg/kg IV N=40
Croatian: Abatacept 10 mg/kg i.v. N=40
English: No evidence of lymphomas or preneoplastic morphological changes was observed, despite the presence of a virus, lymphocryptovirus, which is known to cause such lesions in immunosuppressed monkeys within the time frame of this study.
Croatian: Nisu opaženi znakovi limfoma ni preneoplastičnih morfoloških promjena, unatoč prisutnosti limfokriptovirusa, virusa za koji se zna da unutar vremenskog okvira ove studije uzrokuje takve lezije u imunosuprimiranih majmuna.
English: Safety information related to the pharmacological class
Croatian: Podaci o sigurnosti s obzirom na farmakološku skupinu
English: Insert the needle with a quick motion into the pinched skin at a 45° angle (Figure 5).
Croatian: Ubodite iglu brzim pokretom u nabor kože pod kutom od 45° (Slika 5).
English: B. Let the syringe warm up
Croatian: Pustite da se štrcaljka zagrije
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost otopine u primjeni je 24 sata na temperaturi od 2°C - 8°C.
English: The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:
Croatian: Opisani simptomi mogu biti znakovi niže navedenih nuspojava, koje su sve zabilježene kod primjene lijeka ORENCIA u kliničkim ispitivanjima u odraslih.
English: ORENCIA is used to: slow down the damage to joints improve physical function improve other signs and symptoms of polyarticular juvenile idiopathic arthritis
Croatian: ORENCIA se primjenjuje kako bi se: usporilo oštećenje zglobova poboljšala fizička funkcija poboljšali drugi znakovi i simptomi poliartikularnog juvenilnog idiopatskog artritisa
English: Tuberculosis (TB): You should be screened for TB prior to ORENCIA treatment.
Croatian: Tuberkuloza (TBC): Prije liječenja lijekom ORENCIA trebate se testirati na TBC.
English: Formal studies of the potential effect of abatacept on human fertility have not been conducted.
Croatian: Nisu provedena formalna ispitivanja mogućih učinaka abatacepta na plodnost kod ljudi.
English: Change injection site Each week you can use the same area of your body, but use a different injection site in that area.
Croatian: Mjenjajte mjesto injekcije Svaki tjedan možete injicirati u isti dio tijela, ali odaberite drugo mjesto unutar tog područja.
English: Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard.
Croatian: Otpustite štitnik za iglu: polako podignite palac s klipa da biste aktivirali štitnik za iglu.
English: No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ORENCIA with other medicines.
Croatian: Nisu provedena ispitivanja fizikalne ili biokemijske kompatibilnosti istodobne primjene lijeka ORENCIA s drugim lijekovima.
English: n= 190 n= 58 n= 59 n= 33
Croatian: n=59 n=33
English: Intravenous use after reconstitution and dilution.
Croatian: Intravenska primjena nakon pripreme i razrjeđivanja.
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Croatian: Rekonstituciju i razrjeđivanje treba provesti sukladno pravilima dobre prakse, osobito s obzirom na asepsu.
English: Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 days) were comparable between subcutaneous and intravenous administration.
Croatian: Procijenjene prosječne vrijednosti sustavnog klirensa (0,28 ml/h/kg), volumena distribucije (0,11 l/kg) i terminalnog poluvijeka (14,3 dana) bile su usporedive kod supkutane i intravenske primjene.
English: N/A Proportion of randomised patients in remission at 12 months and at 18 months (6 months of complete drug withdrawal)
Croatian: N/P Udio randomiziranih bolesnika u remisiji nakon 12 mjeseci i nakon 18 mjeseci (6 mjeseci nakon potpunog prekida terapije)
English: The pre-filled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection.
Croatian: Napunjena štrcaljka ima proširen rubnik, koji olakšava držanje i injiciranje, te štitnik za iglu, koji automatski prekriva iglu nakon završetka injekcije.
English: If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: Ako ste primali lijek ORENCIA tijekom trudnoće, Vaše dijete može imati povećan rizik od razvoja infekcije.
English: Keep refrigerated until ready to use.
Croatian: Brizgalicu čuvajte u hladnjaku dok je ne budete spremni upotrijebiti.
English: No increase of tuberculosis was observed in the pivotal placebo-controlled studies; however, all ORENCIA patients were screened for tuberculosis.
Croatian: U pivotalnim placebom kontroliranim ispitivanjima nije opažen povećan broj slučajeva tuberkuloze; međutim, u svih bolesnika liječenih lijekom ORENCIA proveden je test na tuberkulozu.
English: ORENCIA should not be infused concomitantly in the same intravenous line with other medicinal products.
Croatian: ORENCIA se ne smije davati istodobno u istoj intravenskoj infuziji s drugim lijekovima.
English: The systemic clearance was approximately 0.22 mL/h/kg.
Croatian: Sustavni klirens bio je približno 0,22 ml/h/kg.
English: Consistent with previous experience, titers and persistence of antibody responses were generally low and did not increase upon continued dosing (6.8% subjects were seropositive on 2 consecutive visits), and there was no apparent correlation of antibody development to clinical response, adverse events, or pharmacokinetics.
Croatian: U skladu s ranijim iskustvom, titrovi i postojanost odgovora antitijela su uglavnom bili niski i nisu se povećavali nakon kontinuirane primjene (6,8% ispitanika bilo je seropozitivno na 2 uzastopne posjete) te nije postojala očita korelacija između stvaranja antitijela i kliničkog odgovora, nuspojava ili farmakokinetike.
English: Read these instructions before you use the ORENCIA pre-filled syringe.
Croatian: Pročitajte ove upute prije nego što upotrijebite ORENCIA napunjenu štrcaljku.
English: Abatacept decreases antigen specific TNFα, interferon-γ, and interleukin-2 production by T lymphocytes.
Croatian: Abatacept umanjuje stvaranje antigenski specifičnog TNFα, interferona-γ i interleukina-2 od strane T-limfocita.
English: Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Croatian: Eksplorativna ispitivanja kojima se ocjenjivao učinak abatacepta na odgovor protutijela na cijepljenje u zdravih ispitanika te odgovor protutijela na cjepiva protiv gripe i pneumokoka u bolesnika s reumatoidnim artritisom, ukazuju na to da abatacept može umanjiti učinkovitost imunog odgovora, ali ne inhibira značajno sposobnost razvoja klinički značajnog ili pozitivnog imunog odgovora.
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Croatian: Budući da su analize imunogenosti specifične za pojedini lijek, nije primjereno uspoređivati stope stvaranja antitijela s onima kod primjene drugih lijekova.
English: o Signs or symptoms of the safety concern and when to seek attention from a healthcare professional o Contact details of the ORENCIA prescriber o A warning message for patients who have received ORENCIA while pregnant to inform healthcare personnel before any vaccination is given to the baby due to the potential risk of severe infection caused by immunization with live vaccines
Croatian: o Znakovi ili simptomi zabrinutosti za sigurnost te kada tražiti pomoć zdravstvenog radnika o Podaci za kontakt propisivača lijeka ORENCIA o Poruka upozorenja za bolesnike koji su primali lijek ORENCIA za vrijeme trudnoće kako bi obavijestili zdravstvenog radnika prije bilo kojeg cijepljenja djeteta zbog mogućeg rizika od teških infekcija uzrokovanih imunizacijom živim cjepivima.
English: ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis.
Croatian: ORENCIA umanjuje napad imunološkog sustava na normalna tkiva, ometajući imunološke stanice (koje se zovu T-limfociti) koje pridonose razvoju reumatoidnog artritisa.
English: Each week you can use the same area of your body, but use a different injection site in that area.
Croatian: Svaki tjedan možete injicirati u isti dio tijela, ali odaberite drugo mjesto injekcije unutar tog područja.
English: Your baby may be at risk of severe infection caused by “live vaccines” for 14 weeks since your last ORENCIA administration.
Croatian: Vaše dijete može biti pod rizikom od teške infekcije uzrokovane "živim cjepivima" tijekom 14 tjedana nakon što ste primili posljednju dozu lijeka ORENCIA.
English: Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes).
Croatian: Liječnik može započeti liječenje lijekom ORENCIA jednokratnom dozom praška za koncentrat za otopinu za infuziju (koju ćete primiti u venu, obično na ruci, tijekom razdoblja od 30 minuta) ili bez nje.
English: Greater improvements were seen with abatacept than with placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Croatian: Kod primjene abatacepta opažena su veća poboljšanja u odnosu na placebo u drugim mjerilima aktivnosti reumatoidnog artritisa koja nisu obuhvaćena kriterijima ACR odgovora, primjerice jutarnjoj ukočenosti.
English: ORENCIA contains maltose, which is a type of sugar that can give falsely high blood glucose readings with certain types of blood glucose monitors.
Croatian: ORENCIA sadrži maltozu, vrstu šećera koja može dati lažno visoke rezultate šećera u krvi kod primjene određenih vrsta mjerača glukoze.
English: Serious infections were reported in 0.8% (1/119), 3.4% (4/116) and 0% (0/116) patients.
Croatian: Ozbiljne infekcije prijavljene su u 0,8% (1/119), 3,4% (4/116) odnosno 0% (0/116) bolesnika.
English: Adverse reactions in patients with chronic obstructive pulmonary disease (COPD)
Croatian: Nuspojave u bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB)
English: Pharmacokinetics of abatacept for subcutaneous injection have been studied in patients 2 to 17 years of age.
Croatian: Farmakokinetika abatacepta za supkutanu injekciju ispitivala se u bolesnika u dobi od 2 do 17 godina.
English: Mean radiographic changes over 12 months in study II
Croatian: Prosječne vrijednosti radiografskih promjena tijekom 12 mjeseci u ispitivanju II
English: STEP 1: Get the syringe ready
Croatian: KORAK 1: Pripremite štrcaljku
English: In the 2 to 5 year age cohort, 39 (84.8%) patients completed 2 years.
Croatian: U kohorti ispitanika u dobi od 2 do 5 godina, 39 (84.8%) bolesnika dovršila su 2 godine liječenja.
English: if you are a woman who could become pregnant, you must use reliable contraception (birth control) while using ORENCIA and up to 14 weeks after the last dose.
Croatian: ako ste žena koja može zatrudnjeti, morate koristiti pouzdanu metodu kontracepcije (zaštite od trudnoće) dok se liječite lijekom ORENCIA i do 14 tjedana nakon zadnje doze.
English: No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Croatian: Nisu utvrđeni značajni problemi s obzirom na sigurnost primjene kada se abatacept primjenjivao u kombinaciji sa sulfasalazinom, hidroksiklorokinom ili leflunomidom.
English: Total Sharp score Erosion score JSN score a Based on non-parametric analysis.
Croatian: Ukupna ocjena na Sharpovoj skali Ocjena erozije Ocjena JSN-a a Na temelju neparametrijske analize.
English: The respective values for ACR 50 and ACR 70 at 12 months and 24 months were consistent and similar for abatacept and adalimumab.
Croatian: Odgovori ACR 50 i ACR 70 u 12. mjesecu i 24. mjesecu bili su konzistentni i slični u skupini koja je primala abatacept i onoj koja je primala adalimumab.
English: the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
Croatian: liječenje izrazito aktivne i progresivne bolesti u odraslih bolesnika s reumatoidnim artritisom koji prethodno nisu bili liječeni metotreksatom.
English: Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.
Croatian: Liječnik će Vas obavijestiti o trajanju liječenja i koje druge lijekove, uključujući druge lijekove koji mijenjaju tijek bolesti, možete nastaviti uzimati dok se liječite lijekom ORENCIA.
English: ORENCIA can be used by adults over 65 with no change in dose.
Croatian: Odrasli stariji od 65 godina mogu primjenjivati lijek ORENCIA bez prilagođavanja doze.