FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism, whether immune- and/or non-immune-mediated, by which eptifibatide may induce thrombocytopenia is not fully understood.
Croatian: Mehanizam kojim eptifibatid može inducirati trombocitopeniju, bez obzira je li ona imunološki i/ili ne-imunološki posredovana, nije u potpunosti razjašnjen.
English: These may affect up to 1 in 10,000 people
Croatian: Mogu se javiti u do 1 na 10000 osoba
English: Platelet inhibition was readily reversed, with a return of platelet function towards baseline (> 50 % platelet aggregation) 4 hours after stopping a continuous infusion of 2.0 microgram/kg/min.
Croatian: Inhibicija trombocita brzo se poništila, pri čemu se > 50 % funkcije trombocita vratila na početne vrijednosti 4 sata nakon prestanka kontinuirane infuzije od 2,0 mikrograma/kg/min.
English: Eptifibatide Accord should not be used if it is noticed that particulate matter or discoloration is present.
Croatian: Eptifibatid Accord se ne smije upotrijebiti ako primijetite čestice ili promjenu boje otopine.
English: These may affect up to 1 in 100 people
Croatian: Mogu se javiti u do 1 na 100 osoba
English: Eptifibatide did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole.
Croatian: Nema pokazatelja da eptifibatid povećava rizik od većih i manjih krvarenja povezanih s istodobnom primjenom varfarina i dipiridamola.
English: If you develop severe allergic reaction or hives, notify your doctor or hospital pharmacist or nurse immediately.
Croatian: Ako nastupi jaka alergijska reakcija ili koprivnjača, odmah o tome obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: The undesirable effects are listed by body system and frequency.
Croatian: Nuspojave su navedene prema organskim sustavima i učestalosti.
English: Eptifibatide Accord solution for infusion must be used in conjunction with Eptifibatide Accord solution for injection.
Croatian: Eptifibatid Accord otopina za infuziju mora se upotrebljavati zajedno s Eptifibatid Accord otopinom za injekciju.
English: This study was a 726-center, 27-country, double-blind, randomised, placebo-controlled study in 10,948 patients presenting with UA or NQMI.
Croatian: randomizirana, placebom kontrolirana studija, u koju je uključeno 10 948 bolesnika sa simptomima NA ili NQIM.
English: The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min.
Croatian: Farmakokinetika eptifibatida je linearna i proporcionalna dozi bolusa od 90 do 250 mikrograma/kg i brzini infuzije od 0,5 do 3,0 mikrogram/kg/min.
English: Protection of Eptifibatide Accord solution from light is not necessary during administration.
Croatian: Zaštita otopine Eptifibatid Accorda od svjetlosti nije potrebna tijekom primjene.
English: In patients with moderate renal impairment, (creatinine clearance 30 - 50 ml/min) 100 % inhibition was achieved at 24 hours following administration of 2 microgram/kg/min.
Croatian: U bolesnika s umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - 50 ml/min) postignuta je 100 % -tna inhibicija 24 sata nakon primjene 2 mikrograma/kg/min.
English: Very common Bleeding (major and minor bleeding including femoral artery access, CABGrelated, gastrointestinal, genitourinary, retroperitoneal, intracranial, haematemesis, haematuria, oral/oropharyngeal, haemoglobin/haematocrit decreased and other).
Croatian: Vrlo često krvarenje (velika i manja krvarenja uključujući i krvarenje na mjestu pristupa femoralnoj arteriji, vezana uz CABG, gastrointestinalno, urogenitalno, retroperitonealno, intrakranijalno krvarenje, hematemeza, hematurija, oralno/orofaringealno krvarenje, pad hemoglobina/hematokrita i drugo)
English: The primary endpoint event rate was 11.9 % in patients who received a reduced dose (1microgram/kg/min) vs 11.2 % in patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.81).
Croatian: Stopa događaja primarnog ishoda je iznosila 11,9 % u bolesnika koji su primili smanjenu dozu (1 mikrogram/kg/min) naspram 11,2 % u bolesnika koji su primili standardnu dozu (2 mikrograma/kg/min), kada je eptifibatid primijenjen kao rana rutinska terapija (p=0,81).
English: If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately.
Croatian: Ako primijetite bilo kakav znak krvarenja, odmah obavijestite svog liječnika ili bolničkog ljekarnika ili medicinsku sestru.
English: Eptifibatide Accord solution for injection must be used in conjunction with Eptifibatide Accord solution for infusion.
Croatian: Eptifibatid Accord otopina za injekciju mora se upotrebljavati zajedno s Eptifibatid Accord otopinom za infuziju.
English: With delayed provisional eptifibatide administration, the event rates were 10 % vs 11.5 % in patients who received reduced dose and standard dose respectively (p=0.61).
Croatian: Uz odgođenu privremenu primjenu eptifibatida, stope događaja su za bolesnike sa smanjenom dozom lijeka iznosile 10 % u odnosu na 11,5 % u bolesnika na standardnoj dozi (p=0,61).
English: Citric acid monohydrate Sodium hydroxide Water for injections
Croatian: Citratna kiselina hidrat Natrijev hidroksid Voda za injekcije
English: Eptifibatide Accord 2 mg/ml: Each ml of solution for injection contains 2 mg of eptifibatide.
Croatian: Eptifibatid Accord 2mg/ml: jedan ml otopine za injekciju sadrži 2 mg eptifibatida.
English: The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
Croatian: Drugi sastojci su citratna kiselina hidrat, natrijev hidroksid i voda za injekcije.
English: Eptifibatide Accord 2 mg/ml: The clear, colourless solution is contained in a 10 ml glass vial, which is closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.
Croatian: Eptifibatid Accord 2 mg/ml: bistra bezbojna otopina u staklenoj bočici od 10 ml, zatvorenoj s gumenim čepom (butil guma) i aluminijskim „flip-off“ zaštitnim poklopcem.
English: All potential bleeding sites, (e.g., catheter insertion sites; arterial, venous, or needle puncture sites; cutdown sites; gastrointestinal and genitourinary tracts) must be observed carefully.
Croatian: Potrebno je pažljivo nadzirati sva mjesta mogućeg krvarenja, kao što su npr. mjesto uvođenja katetera, mjesto uboda igle u venu ili arteriju, rezove, gastrointestinalni i urogenitalni sustav.
English: − severe reduction in the number of platelets (blood cells necessary for blood clotting).
Croatian: − ozbiljno smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).
English: Eptifibatide Accord 0.75 mg/ml: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Croatian: Eptifibatid Accord 0,75 mg/ml: jedan ml otopine za infuziju sadržava 0,75 mg eptifibatida.
English: Eptifibatide Accord 0.75 mg/ml: The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.
Croatian: Eptifibatid Accord 0,75 mg/ml: bistra bezbojna otopina u staklenoj bočici od 100 ml, zatvorenoj s gumenim čepom (butil guma) i aluminijskim „flip-off“ zaštitnim poklopcem.
English: MI could also be reported following CEC adjudication of an investigator report.
Croatian: Infarkt miokarda se mogao prijaviti i nakon što je Povjerenstvo za kliničke događaje provjerilo ispitivačevo izvješće.
English: Common side effects These may affect up to 1 in 10 people - inflammation of a vein.
Croatian: Mogu se javiti u do 1 na 10 osoba − upala vene.
English: For a 2.0 microgram/kg/min infusion, mean steady-state plasma eptifibatide concentrations range from 1.5 to 2.2 microgram/ml in patients with coronary artery disease.
Croatian: Kod infuzije od 2,0 mikrogram/kg/min u stanju dinamičke ravnoteže eptifibatida u plazmi iznose od 1,5 do 2,2 mikrogram/kg u bolesnika s koronarnom bolesti srca.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) administered 1microgram/kg/min , 80 % inhibition was achieved in more than 80 % of patients at 24 hours.
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) u kojih je primijenjen lijek u dozi od 1 mikrogram/kg/min, nakon 24 sata postignuta je 80 % -tna inhibicija u više od 80 % bolesnika.
English: 0.75 mg/ml : 1.72 mg/ml (0.075 mmol/ml) sodium For the full list of excipients, see section 6.1.
Croatian: 0,75 mg/ml : 1,72 mg/ml (0,075 mmol/ml) natrija
English: Eptifibatide Accord 0.75 mg/ml solution for infusion: 100 ml vial, pack of one vial.
Croatian: Eptifibatid Accord 0,75 mg/ml otopina za infuziju: bočica sa 100 ml, kutija s jednom bočicom.
English: - if you have or have had severe kidney or liver problems.
Croatian: − ako ste imali ili imate ozbiljnih problema s bubrezima ili jetrom
English: The primary endpoint analysis [quadruple composite of death, MI, urgent target vessel revascularisation (UTVR) and thrombolytic bail-out (TBO) at 48 hours] showed a 37 % relative and 3.9 % absolute reduction in the eptifibatide group (6.6 % events versus 10.5 %, p= 0.0015).
Croatian: Analiza primarne mjere ishoda[kompozitna mjera sastavljena od četiri komponente: smrti, infarkta miokarda, hitne revaskularizacije ciljne krvne žile i tzv. 'bail-out' trombolize tijekom 48 sati] pokazala je 37 % relativno, te 3,9 % apsolutno smanjenje u skupini koja je primala eptifibatid (6,6 % događaja vs 10,5 %, p = 0,0015).
English: Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: citratna kiselina hidrat, natrijev hidroksid, voda za injekcije.
English: The rate of infusion was 2.0 microgram/kg/min for patients with serum creatinine ≤ 175 micromols/l or 1.0 microgram/kg/min for serum creatinine > 175 up to 350 micromols/l.
Croatian: Bolesnici s razinom serumskog kreatinina ≤ 175 mikromola/l primili su infuziju od 2,0 mikrograma/kg/min, a bolesnici s razinom serumskog kreatinina > 175 do 350 mikromola/l infuziju od 1,0 mikrograma/kg/min.
English: At the highest infusion rates (1.3 microgram/kg/min and 2.0 microgram/kg/min) studied, eptifibatide was associated with an increased incidence of bleeding and transfusions compared to the incidence seen when streptokinase was given alone.
Croatian: 2,0 mikrograma/kg/min), eptifibatid je bio povezan s povećanim rizikom krvarenja i transfuzije u usporedbi s incidencijom prilikom primjene same streptokinaze.
English: - if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding)
Croatian: − ako ste nedavno imali krvarenje iz želuca, crijeva, mokraćnog mjehura ili drugih organa, na primjer ako ste uočili abnormalnu pojavu krvi u stolici ili mokraći (osim menstrualnog krvarenja) u proteklih 30 dana − ako ste u proteklih 30 dana doživjeli moždani udar ili bilo koju drugu vrstu izljeva krvi u mozak
English: Patients were randomised to either placebo, eptifibatide 180 microgram/kg bolus followed by a 2.0 microgram/kg/min infusion (180/2.0), or eptifibatide 180 microgram/kg bolus followed by a 1.3 microgram/kg/min infusion (180/1.3).
Croatian: Bolesnici su randomizirani ili u skupinu koja je primala placebo ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 2,0 mikrograma/kg/min (180/2,0), ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 1,3 mikrograma/kg/min (180/1,3).
English: If you have any questions, ask your doctor or hospital pharmacist or nurse.
Croatian: Ako imate nekih pitanja, pitajte svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: − reduction in the number of platelets (blood cells necessary for blood clotting).
Croatian: − smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).
English: Eptifibatide Accord 2 mg/ml solution for injection: 10 ml vial, pack of one vial.
Croatian: Eptifibatid Accord 2 mg/ml otopina za injekciju: bočica s 10 ml, kutija s jednom bočicom.
English: If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia.
Croatian: 100 000/mm3, treba ponoviti test broja trombocita kako bi se isključila pseudotrombocitopenija.
English: However, in a population pharmacokinetic study there was no evidence of a pharmacokinetic interaction between eptifibatide and the following concomitant medicinal products: amlodipine, atenolol, atropine, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
Croatian: cefazolin, diazepam, digoksin, diltiazem, difenhidramin, enalapril, fentanil, furosemid, heparin, lidokain, lizinopril, metoprolol, midazolam, morfin, nitrati, nifedipin i varfarin.
English: In patients with moderate renal impairment (creatinine clearance ≥ 30 - < 50 ml/min), an intravenous bolus of 180 microgram/kg should be administered followed by a continuous infusion dose of 1.0 microgram/kg/min for the duration of therapy.
Croatian: U bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 do < 50 ml/min), treba primijeniti intravenski bolus od 180 mikrograma/kg nakon kojeg se nastavlja kontinuirana infuzija doze od 1,0 mikrogram/kg/min tijekom cijelog trajanja terapije.
English: TIMI major bleeding occurred in 2.7 % of patients who received a reduced dose (1microgram/kg/min) vs 4.2 % of patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.36).
Croatian: TIMI veliko krvarenje je nastupilo u 2,7 % bolesnika koji su primali smanjenu dozu (1 mikrogram/kg/min) naspram 4,2 % bolesnika na standardnoj dozi (2 mikrogram/kg/min) uz ranu rutinsku primjenu eptifibatida (p=0,36).
English: Each ml of solution for injection contains 2 mg of eptifibatide.
Croatian: Jedan ml otopine za injekciju sadržava 2 mg eptifibatida.
English: Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti koji je naveden na kutiji i bočici iza oznake Rok valjanosti i EXP.
English: - if you have or have had difficulty with your blood clotting or a low blood platelet count.
Croatian: − ako ste imali ili imate problema s zgrušavanjem krvi ili nizak broj trombocita.
English: If PCI was performed, the eptifibatide infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.
Croatian: Ako se provodila perkutana koronarna intervencija (PCI), infuzija eptifibatida se nastavila 24 sata nakon zahvata, do ukupno najduže 96 sati.
English: Eptifibatide Accord 2 mg/ml solution for injection
Croatian: Eptifibatid Accord 2 mg/ml otopina za injekciju
English: Results on the primary endpoint were mainly attributed to the reduction of enzymatic MI occurrence, identified as the occurrence of early elevation of cardiac enzymes after PCI (80 out of 92 MIs in the placebo group vs. 47 out of 56 MIs in the eptifibatide group).
Croatian: Rezultati primarne mjere ishoda uglavnom se mogu pripisati smanjenju enzimskih IM, definiranih kao nastup ranog povišenja vrijednosti srčanih enzima nakon PCI (80 od
English: Package leaflet: Information for the patient Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide
Croatian: Uputa o lijeku: Informacije za bolesnika Eptifibatid Accord 0,75 mg/ml otopina za infuziju eptifibatid
English: Package leaflet: Information for the patient Eptifibatide Accord 2 mg/ml solution for injection eptifibatide
Croatian: Uputa o lijeku: Informacije za bolesnika Eptifibatid Accord 2 mg/m lotopina za injekciju eptifibatid
English: How to store Eptifibatide Accord
Croatian: Kako primjenjivati Eptifibatid Accord
English: Interruption of breast-feeding during the treatment period is recommended.
Croatian: Preporučuje se prekinuti dojenje za vrijeme liječenja eptifibatidom.
English: - If you have any further questions, ask your doctor or hospital pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: Eptifibatide Accord 2 mg/ml solution for injection eptifibatide
Croatian: Eptifibatid Accord 2 mg/ml otopina za injekciju eptifibatid
English: There is limited data with regards to platelet inhibition in patients with renal impairment.
Croatian: Podaci o inhibiciji trombocita u bolesnika s bubrežnim oštećenjem su ograničeni.
English: Eptifibatide Accord 0.75 mg/ml solution for infusion
Croatian: Eptifibatid Accord 0,75 mg/ml otopina za infuziju
English: Intravenous use Read the package leaflet before use.
Croatian: Za primjenu u venu Prije uporabe pročitajte uputu o lijeku.
English: Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI).
Croatian: Bolesnici su mogli biti nakon liječenja lijekovima proslijeđeni na ugradnju CABG ili podvrgnuti PCI.
English: In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
Croatian: ACS ispitivanja ne mogu se izvući zaključci o odnosu rizika i koristi primjene smanjene doze u bolesnika s umjerenim oštećenjem bubrežne funkcije.
English: One 100 ml vial contains 75 mg of eptifibatide.
Croatian: Jedna bočica od 100 ml sadržava 75 mg eptifibatida.
English: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Croatian: Jedan ml otopine za infuziju sadržava 0,75 mg eptifibatida.
English: PURSUIT trial The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT.
Croatian: PURSUIT je bila pivotalna klinička studija za liječenje nestabilne angine (NA)/ infarkta miokarda bez
English: One 10 ml vial contains 20 mg of eptifibatide.
Croatian: Jedna bočica od 10 ml sadržava 20 mg eptifibatida.
English: With delayed provisional eptifibatide administration, the TIMI major events were 1.4 % vs 2.0 % in patients who received reduced dose and standard dose respectively (p=0.54).There were no notable differences observed with GUSTO severe bleeding rates.
Croatian: Uz odgođenu privremenu primjenu eptifibatida, TIMI velika krvarenja su iznosila 1,4 % u bolesnika koji su primali smanjenu dozu naspram 2,0 % u bolesnika na standardnoj dozi (p=0,54).
English: Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors.
Croatian: Willebrandovog faktora i drugih adhezivnih liganada za receptore glikoproteina (GP) IIb/IIIa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL for 10 ml vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Skin and subcutaneous tissue disorders
Croatian: Vrlo rijetko anafilaktička reakcija Poremećaji kože i potkožnog tkiva
English: Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide
Croatian: Eptifibatid Accord 0,75 mg/ml otopina za infuziju eptifibatid
English: Patients were managed according to the usual standards of the investigational site; frequencies of angiography, PCI and CABG therefore differed widely from site to site and from country to country.
Croatian: PCI i CABG su se stoga dosta razlikovale od centra do centra i od zemlje do zemlje.
English: If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first).
Croatian: 2 mikrograma/kg/min u trajanju do najviše 72 sata, do početka operacije ugradnje premosnice koronarne arterije (CABG) ili do otpusta iz bolnice (ovisno o tome što se dogodi prije).
English: One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.
Croatian: Jedna bočica sa 100 ml otopine za infuziju sadržava 75 mg eptifibatida.
English: Distrobution
Croatian: Distribucija
English: − fatal bleeding.
Croatian: Krvožilni poremećaji
English: UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr.
Croatian: Nestabilna angina ili infarkt miokarda bez Q-zupca: Za bolesnika koji teži ≥ 70 kg preporučuje se primjena bolus doze od 5000 jedinica, nakon koje treba uslijediti intravenska infuzija od 1000 jedinica/h.
English: - prothrombin time > 1.2 times control, or International Normalized Ratio (INR) ≥ 2.0
Croatian: − s protrombinskim vremenom > 1,2 puta u odnosu na kontrolnu vrijednost ili INR ≥ 2,0 − s teškom hipertenzijom (sistolički krvni tlak > 200 mm Hg ili dijastolički krvni tlak
English: If PCI is to be performed in the setting of UA/NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds.
Croatian: Ako je potrebno u uvjetima nestabilne angine ili infarkta miokarda bez Q-zupca izvesti perkutanu koronarnu angioplastiku, potrebno je pratiti aktivirano vrijeme zgrušavanja (ACT) kako bi se održala vrijednost između 300 i 350 sekundi.
English: Common side effects These may affect up to 1 in 10 people
Croatian: Vrlo rijetke nuspojave Mogu se javiti u dood 1 na 10000 osoba
English: Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Croatian: kad je ACT premašio 350 sekundi (vidjeti dio 4.4., Primjena heparina).
English: Solution for injection 1 vial of 10 ml
Croatian: NALJEPNICA za bočicu od 10 ml
English: One vial of 10 ml of solution for injection contains 20 mg of eptifibatide.
Croatian: Jedna bočica s 10 ml otopine za injekciju sadržava 20 mg eptifibatida.
English: One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.
Croatian: Jedna staklena bočica (staklo tipa I) od 100 ml, zatvorena gumenim čepom (butil guma) i aluminijskim
English: Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group.
Croatian: Primjena eptifibatida je povezana s porastom broja velikih i manjih krvarenja klasificiranih prema
English: One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.
Croatian: Jedna staklena bočica (staklo tipa I) od 10 ml, zatvorena gumenim čepom (butil guma) i aluminijskim
English: > 110 mm Hg on antihypertensive therapy) - severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis - clinically significant hepatic impairment - concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
Croatian: − s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili oni koji ovise o dijalizi − s klinički značajnim oštećenjem jetre
English: Thrombocytopenia, including acute profound thrombocytopenia, has been observed with eptifibatide administration post-marketing (see section 4.8)
Croatian: Pri primjeni eptifibatida nakon stavljanja lijeka u promet, zabilježena je trombocitopenija, uključujući akutnu, izraženu trombocitopeniju (vidjeti dio 4.8).
English: In patients with previous immune-mediated thrombocytopenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of eptifibatide.
Croatian: Trombocitopenija i imunogeničnost vezana uz GP IIb/IIIa inhibitore Eptifibatid Accord inhibira agregaciju trombocita, ali čini se da ne utječe na sposobnost preživljavanja trombocita.
English: APPROPRIATE
Croatian: DODATAK