FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Levetiracetam Teva be given marketing authorisation.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Levetiracetam Teva u promet.
English: The active substance in Levetiracetam Teva, levetiracetam, is an epilepsy medicine.
Croatian: Djelatna tvar u lijeku Levetiracetam Teva, levetiracetam, lijek je za epilepsiju.
English: When Levetiracetam Teva is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Croatian: Ako se primjenjuje kao monoterapija, početna doza lijeka Levetiracetam Teva iznosi 250 mg dvaput na dan, a nakon dva tjedna potrebno ju je povećati na 500 mg dvaput na dan.
English: Why has Levetiracetam Teva been approved?
Croatian: Zašto je lijek Levetiracetam Teva odobren?
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđeni rizik, kao i za lijek Keppra.
English: How has Levetiracetam Teva been studied?
Croatian: Kako je Levetiracetam Teva ispitivan?
English: What is Levetiracetam Teva used for?
Croatian: Za što se Levetiracetam Teva koristi?
English: How is Levetiracetam Teva used?
Croatian: Kako se Levetiracetam Teva koristi?
English: How does Levetiracetam Teva work?
Croatian: Kako djeluje Levetiracetam Teva?
English: 200 mg Capsule, hard
Croatian: 200 mg Kapsula, tvrda
English: Bottle (glass)
Croatian: Bočica (stakla)
English: 100 capsules
Croatian: 100 kapsula
English: Oral use
Croatian: Put primjene
English: 90 (3 x 30) tablets
Croatian: 90 (3x30) tableta
English: Ask your hospital pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog bolničkog ljekarnika kako baciti lijekove koje više ne koristite.
English: A target aPTT of 50-70 seconds was recommended.
Croatian: Preporučen je ciljni aPTT od 50-70 sekundi.
English: Date of first authorisation:11th January 2016
Croatian: Datum prvog odobrenja: 11th siječanj 2016
English: There was no increased benefit thereafter, up to 1 year.
Croatian: Nakon toga, tijekom jedne godine, nije bilo dodatne koristi.
English: • or increased CK-MB.
Croatian: • ili povišeni CK-MB.
English: Take care to ensure that only the anterior wall of the femoral artery is punctured.
Croatian: Treba paziti da se probije samo prednji zid femoralne arterije.
English: It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
Croatian: Ne preporučuje se primjena u djece i adolescenata mlađih od 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: Thus, changes in laboratory parameters associated with bleeding (e.g. bleeding time) are common and expected.
Croatian: Stoga su promjene u laboratorijskim parametrima povezane s krvarenjem (npr. vrijeme krvarenja) uobičajene i očekivane.
English: Please tell your doctor if you have had any of these conditions.
Croatian: Recite svom liječniku ako ste imali ili imate bilo koje od ovih stanja.
English: EARLY-ACS trial
Croatian: Ispitivanje EARLY-ACS
English: Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.
Croatian: Mjere sigurnosti koje se poduzimaju kako bi se ovo sprječilo uključuju pretrage krvi i pažljiv nadzor zdravstvenih radnika koji brinu o Vama.
English: This recommendation is based on pharmacodynamic and pharmacokinetic data.
Croatian: Ova se preporuka temelji na farmakodinamičkim i farmakokinetičkim podacima.
English: Wessling Hungary Kft Fòti ùt 56, Budapest 1047, Hungary
Croatian: Wessling Hungary Kft Fòti ùt 56, Budapest 1047,
English: 30 days
Croatian: 30 dana
English: Warfarin and dipyridamole
Croatian: Varfarin i dipiridamol
English: Discontinue unfractionated heparin.
Croatian: Treba ukinuti nefrakcionirani heparin.
English: You must also be given doses of aspirin and heparin (if not contraindicated in your case).
Croatian: Također morate uzimati aspirin i heparin (ako nisu kontraindicirani u Vašem slučaju).
English: Monitoring of laboratory values
Croatian: Praćenje laboratorijskih vrijednosti
English: Arterial procedures
Croatian: Arterijski postupci
English: Emergency or semi-elective surgery
Croatian: Hitna ili poluelektivna kirurška intervencija
English: - sudden, severe allergic reaction.
Croatian: − iznenadna, teška alergijska reakcija.
English: In the absence of compatibility studies, Eptifibatide Accord must not be mixed with other medicinal products except those mentioned in 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, Eptifibatid Accord se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: These trials are briefly described below.
Croatian: Ova su ispitivanja ukratko opisana u nastavku teksta.
English: The carcinogenic potential of eptifibatide has not been evaluated in long-term studies.
Croatian: Karcinogeni potencijal eptifibatida nije evaluiran u dugotrajnim ispitivanjima.
English: The extent of eptifibatide binding to human plasma protein is about 25 %.
Croatian: Količina eptifibatida vezanog na proteine plazme u ljudi je oko 25 %.
English: Very rarely, bleeding has become severe and even fatal.
Croatian: Vrlo rijetko, krvarenje može postati jako ili završiti smrću.
English: The first bolus and the infusion were started simultaneously, immediately before the PCI procedure and were followed by a second bolus 10 minutes after the first.
Croatian: Prvi bolus i infuzija započeti su simultano, neposredno prije početka PCI postupka, a zatim je uslijedio drugi bolus 10 minuta nakon prvog.
English: Consequently these studies are not suitable to evaluate the toxicity of eptifibatide on reproductive function (see section 4.6).
Croatian: Stoga ova ispitivanja nisu prikladna za ocjenu toksičnosti eptifibatida na reproduktivnu funkciju (vidjeti dio 4.6).
English: Heparin administration
Croatian: Primjena heparina
English: The available clinical evidence cannot however confirm that this dose modification results in a preserved benefit (see section 5.1).
Croatian: Međutim, dostupni klinički podaci ne mogu potvrditi da ovakva prilagodba doze rezultira održanom koristi (vidjeti dio 5.1).
English: Stop heparin administration if the ACT exceeds 300 seconds; do not administer until the ACT falls below 300 seconds.
Croatian: Primjenu heparina valja prekinuti ako ACT premaši 300 sekundi i ne smije se primjenjivati dok ACT ne padne ispod 300 sekundi.
English: The dose given is based on your weight.
Croatian: Doza lijeka se određuje prema Vašoj tjelesnoj težini.
English: Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.
Croatian: Drugi događaji koji mogu nastupiti u bolesnika koji zahtijevaju ovu vrstu terapije uključuju one koji su povezani sa stanjima koja se liječe, kao što su brz ili nepravilan rad srca, niski krvni tlak, šok ili zastoj rada srca.
English: When administered alone, eptifibatide has no measurable effect on prothrombin time (PT) or activated partial thromboplastin time (aPTT).
Croatian: Kad se daje sam, eptifibatid nema mjerljiv učinak na protrombinsko vrijeme (PV) ili na aktivirano parcijalno tromboplastinsko vrijeme (aPTT).
English: Specifically, no patients experienced an intracranial bleed.
Croatian: Specifično, niti jedan bolesnik nije razvio intrakranijalno krvarenje.
English: Eptifibatide p-Value
Croatian: Eptifibatid p-vrijednost
English: No formal pharmacokinetic interaction studies have been conducted.
Croatian: Formalna istraživanja farmakokinetičkih interakcija nisu provođena.
English: 0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
Croatian: 0,034a a: Paersonov hi-kvadrat razlike između placeba i eptifibatida.
English: - reduced blood flow to the brain.
Croatian: − smanjeni dotok krvi u mozak.
English: - Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.
Croatian: − Eptifibatid Accord nije namijenjen za primjenu u djece ili adolescenata mlađih od 18 godina.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Monitor these patients closely with regard to bleeding.
Croatian: Takve bolesnike treba pažljivo nadzirati radi krvarenja.
English: It is usually given with aspirin and unfractionated heparin.
Croatian: Obično se primjenjuje zajedno s aspirinom i nefrakcioniranim heparinom.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna za konačan zaključak u pogledu trudnoće, embriofetalnog razvoja, poroda i postnatalnog razvoja (vidjeti dio 5.3).
English: This product is for hospital use only.
Croatian: Ovaj lijek se primjenjuje samo u bolnicama.
English: This means that it helps to prevent blood clots from forming.
Croatian: To znači da pomaže u sprječavanju nastanka krvnih ugrušaka.
English: For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Croatian: Za ovu dijagnozu u 24 sata od PCI postupka najmanje dvije CK-MB vrijednosti morale su biti ≥ 3 x iznad gornje granice normale; stoga validacija od strane Povjerenstva za kliničke događaje nije bila potrebna.
English: It should be administered by specialist physicians experienced in the management of acute coronary syndromes.
Croatian: Trebaju ga primjenjivati liječnici specijalisti s iskustvom u liječenju akutnog koronarnog sindroma.
English: The decision to use platelet transfusions should be based upon clinical judgment on an individual basis.
Croatian: Odluku o transfuziji trombocita treba temeljiti na kliničkoj prosudbi u svakom pojedinom slučaju.
English: Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥ 10 minutes) within the previous 24 hours and had:
Croatian: Bolesnici su mogli biti uključeni samo ako su u prethodna 24 sata imali srčanu ishemiju u mirovanju (≥ 10 minuta) i jedno od sljedećeg:
English: Arterial sheaths may be removed when coagulation has returned to normal (e.g. when activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after discontinuation of heparin).
Croatian: Arterijske uvodnice mogu se odstraniti kad se koagulacija vrati u normalu (npr. kad je aktivirano vrijeme zgrušavanja (ACT) manje od 180 sekundi (obično 2-6 sati nakon prestanka davanja heparina).
English: Potentially, an overdose of eptifibatide could result in bleeding.
Croatian: Prevelika doza eptifibatida potencijalno može izazvati krvarenje.
English: The vast majority of patients received acetylsalicylic acid (75-325 mg once daily).
Croatian: Velika većina bolesnika primala je acetilsalicilatnu kiselinu (75-325 mg jednom na dan).
English: Prolongation of bleeding time
Croatian: Produljenje vremena krvarenja
English: − if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section
Croatian: − ako ste alergični na eptifibatid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The clinical relevance of such enzymatic MIs is still controversial.
Croatian: Klinički značaj tih enzimskih infarkta miokarda još uvijek je kontroverzan.
English: PURSUIT was conducted at a time when the standard of care of managing acute coronary syndromes was different from that of present times in terms of thienopyridine use and the routine use of intracoronary stents.
Croatian: PURSUIT ispitivanje je provođeno u vrijeme kada je standard liječenja akutnih koronarnih sindroma bio različit od današnjeg u pogledu upotrebe tienopiridina i rutinske ugradnje intrakoronarnih stentova.
English: If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.
Croatian: Ako bolujete od neke bolesti bubrega, infuzijska doza može se smanjiti na 1 mikrogram/kg/minuti.
English: Eptifibatide Accord should not be used during pregnancy unless clearly necessary.
Croatian: Eptifibatid Accord ne treba primjenjivati tijekom trudnoće osim u slučaju jasne potrebe.
English: There was no indication of severe adverse reactions associated with administration of accidental large bolus doses, rapid infusion reported as overdose or large cumulative doses.
Croatian: Ne postoje naznake teških nuspojava povezanih sa slučajnim davanjem velikih bolus doza, brzim infuzijama prijavljenim kao predoziranje ili visokim kumulativnim dozama.
English: Reproduction studies in animal species where eptifibatide shows a similar pharmacologic activity as in humans are not available.
Croatian: Nisu provedene reproduktivne studije na životinjama gdje bi eptifibatid pokazao sličnu farmakološku aktivnost kao u ljudi.
English: Thus, although eptifibatide can be dialysed, the need for dialysis is unlikely.
Croatian: Stoga, iako se eptifibatid može dijalizirati, nije vjerojatno da će biti potrebna dijaliza.
English: • either ST-segment changes: ST depression > 0.5 mm of less than 30 minutes or persistent ST elevation > 0.5 mm not requiring reperfusion therapy or thrombolytic agents, T-wave inversion (> 1 mm),
Croatian: • promjene ST-segmenta: depresiju ST segmenta > 0,5 mm u trajanju manjem od 30 minuta ili trajnu ST elevaciju > 0,5 mm koja ne zahtijeva reperfuzijsku terapiju ili trombolitike, inverziju T-vala (> 1 mm)
English: The component MI could be defined as asymptomatic with enzymatic elevation of CK-MB or new Q wave.
Croatian: Komponenta IM može se definirati kao asimptomatska s povišenjem enzima CK-MB ili novonastalim Q-zupcem.
English: ESPRIT trial
Croatian: Ispitivanje ESPRIT
English: Consequently the use of Eptifibatide Accord is not recommended in these circumstances (see section 4.5).
Croatian: Stoga se u takvim okolnostima ne preporuča primjena Eptifibatid Accorda (vidjeti dio 4.5).
English: Warnings and precautions
Croatian: Upozorenja i mjere opreza:
English: Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: - if you have been treated with another medicine of the same type as Eptifibatide Accord.
Croatian: − ako ste bili liječeni nekim drugim lijekom istog djelovanja kao Eptifibatid Accord.
English: Eptifibatide Accord is not compatible with furosemide.
Croatian: Eptifibatid Accord nije kompatibilan s furosemidom.
English: < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Croatian: 1/1000), vrlo rijetko (< 1/10000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: The primary endpoint of the study was the occurrence of death from any cause or new myocardial infarction (MI) (evaluated by a blinded Clinical Events Committee) within 30 days of randomisation.
Croatian: Primarna mjera ishoda studije bila je pojava smrti zbog bilo kojeg uzroka ili novog infarkta miokarda (IM) (prema evaluaciji zaslijepljenog Povjerenstva za kliničke događaje) unutar 30 dana od randomizacije.
English: No unexpected toxic effects for an agent with this pharmacologic profile were observed and findings were predictive of clinical experience, with bleeding effects being the principal adverse event.
Croatian: Nisu zamijećeni neočekivani toksični učinci za tvar s takvim farmakološkim profilom i na osnovu rezultata moglo se predvidjeti kliničko iskustvo, s krvarenjem kao glavnom nuspojavom.
English: Shock, hypotension, phlebitis.
Croatian: Često šok, hipotenzija, flebitis
English: The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment (within the first 72-96 hours) and this reduction was maintained through 6 months, without any significant effect on mortality.
Croatian: Smanjenje incidencije događaja mjere ishoda u bolesnika koji su primali eptifibatid dogodilo se u ranoj fazi liječenja (u prvih 72-96 sati) i to se smanjenje održalo tijekom 6 mjeseci, bez značajnog utjecaja na mortalitet.
English: Women, the elderly, patients with low body weight or with moderate renal impairment (creatinine clearance > 30 - < 50 ml/min) may have an increased risk of bleeding.
Croatian: Žene, stariji, osobe male tjelesne težine ili s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 do ≤ 50 ml/min) mogu imati povećani rizik od krvarenja.
English: An increased risk of bleeding may also be observed in patients who receive early administration of eptifibatide (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
Croatian: Povećani rizik od krvarenja se može vidjeti i u bolesnika koji rano prime eptifibatid (npr. odmah po postavljenoj dijagnozi), u odnosu na primjenu neposredno prije PCI, kao što je zamijećeno u ‘Early ACS' ispitivanju.
English: There is no experience with eptifibatide and low molecular weight heparins.
Croatian: Nema iskustava s primjenom eptifibatida i heparina niske molekulske težine.
English: During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Croatian: Tijekom liječenja eptifibatidom dolazi do značajnog povećanja stope krvarenja, osobito u području femoralne arterije, gdje se postavlja uvodnica katetera.
English: Note that causality has not been determined for all adverse reactions.
Croatian: Treba napomenuti da uzročno-posljedična veza nije utvrđena za sve nuspojave.
English: As demonstrated in clinical trials, the incidence of thrombocytopenia was low, and similar in patients treated with eptifibatide or placebo.
Croatian: Kao što je pokazano u kliničkim ispitivanjima, incidencija trombocitopenije bila je niska i slična u bolesnika koji su bili liječeni eptifibatidom ili placebom.
English: These are absolute reporting frequencies without taking into account placebo rates.
Croatian: To su apsolutne frekvencije učestalosti bez uzimanja u obzir stope pri primjeni placeba.
English: Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.
Croatian: Vaš će liječnik procijeniti korist primjene Eptifibatid Accorda za Vas i rizik za Vaš plod tijekom trudnoće.
English: Changes during eptifibatide treatment result from its known pharmacological action, i.e., inhibition of platelet aggregation.
Croatian: Promjene do kojih dolazi za vrijeme liječenja eptifibatidom posljedica su njegovog poznatog farmakološkog djelovanja, tj. inhibicije agregacije trombocita.
English: Other potential bleeding sites such as central and peripheral nervous system and retroperitoneal sites, must be carefully considered too.
Croatian: Treba voditi računa i o ostalim potencijalnim mjestima krvarenja poput središnjeg i perifernog živčanog sustava i retroperitoneuma.
English: Patients were to undergo an invasive strategy for further management after receiving study drug for 12 to 96 hours.
Croatian: Bolesnici su trebali biti podvrgnuti invazivnom liječenju nakon primanja ispitivanog lijeka tijekom 12 do 96 sati.
English: A total of 1,250 patients underwent PCI within 72 hours after randomisation, in which case they received intravenous unfractionated heparin to maintain an activated clotting time (ACT) of 300-350 seconds.
Croatian: Ukupno je 1250 bolesnika podvrgnuto PCI unutar 72 sata nakon randomizacije, i tada su primili nefrakcionirani heparin intravenski kako bi se održalo aktivno vrijeme zgrušavanja (ACT) od 300-350 sekundi.
English: In the same population, plasma elimination half-life is approximately 2.5 hours, plasma clearance 55 to 80 ml/kg/hr and volume of distribution of approximately 185 to 260 ml/kg.
Croatian: U istoj populaciji, poluvrijeme eliminacije iz plazme je približno 2,5 sata, klirens plazme je 55 do 80 ml/kg/h i volumen distribucije je približno 185 do 260 ml/kg.
English: What Eptifibatide Accord is and what it is used for What you need to know before you are given Eptifibatide Accord How to use Eptifibatide Accord
Croatian: Što je Eptifibatid Accord i za što se koristi Što morate znati prije nego počnete primati Eptifibatid Accord Kako primjenjivati Eptifibatid Accord
English: In healthy subjects, renal excretion accounted for approximately 50 % of total body clearance; approximately 50 % of the amount cleared is excreted unchanged.
Croatian: U zdravih ispitanika, izlučivanje putem bubrega je odgovorno za oko 50 % ukupnog tjelesnog klirensa; približno 50 % od te količine se izlučuje nepromijenjeno.
English: It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Croatian: Koristi se u bolesnika s teškom koronarnom insuficijencijom, koja se definira kao spontana i nedavna bol u prsima s elektrokardiografskim abnormalnostima ili biološkim promjenama.
English: How to store Eptifibatide Accord Contents of the pack and other information
Croatian: Kako čuvati Eptifibatid Accord Sadržaj pakiranja i druge informacije
English: Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Croatian: Rezultati primarne mjere ishoda prvenstveno su bili pripisani nastupu infarkta miokarda.
English: There are no adequate data from the use of eptifibatide in pregnant women.
Croatian: Nema dovoljno podataka o primjeni eptifibatida u trudnica.
English: At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
Croatian: U preporučenim terapijskim dozama primijenjenim u PURSUIT ispitivanju koje je uključivalo gotovo 11 000 bolesnika, krvarenje je bila najčešća komplikacija tijekom terapije eptifibatidom.
English: In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
Croatian: U PURSUIT ispitivanju prikupljani su podaci za krvarenja i događaje nevezane uz krvarenja nakon otpusta iz bolnice do kontrolne posjete 30. dana.
English: Cardiac arrest, congestive heart failure, atrial fibrillation, hypotension, and shock, which are commonly reported events from the PURSUIT trial, were events related to the underlying disease.
Croatian: Kardijalni arest, kongestivno zatajenje srca, fibrilacija atrija, hipotenzija i šok koji se ubrajaju u česte nuspojave iz PURSUIT ispitivanja, bile su događaji vezani uz osnovnu bolest.
English: Unlike the approved posology in the EU, all patients in this trial were administered a double bolus before the infusion (see section 5.1).
Croatian: Za razliku od odobrenog načina doziranja lijeka u EU, svi su bolesnici u tom ispitivanju primali dvostruku bolus dozu prije infuzije (vidjeti dio 5.1).
English: Please refer to the Normosol R Summary of Product Characteristics for details on its composition.
Croatian: Molimo pogledati Sažetak opisa svojstava lijeka Normosol R otopine za detaljni sastav iste.
English: GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8 %).
Croatian: Prema GUSTO kriterijima, jako/životno ugrožavajuće krvarenje je bilo manje često i usporedivo u pojavnosti za obje ispitivane skupine (0,8 %).