FrancophonIA/ELRC3.0 huggingface dataset:
English: These may affect more than 1 in 10 people - minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).
Slovenian: Pojavijo se pri več kot 1 od 10 bolnikov - manjše ali večje krvavitve (npr. kri v seču, kri v blatu, kri v izbruhani vsebini ali krvavitve med kirurškimi posegi);
English: Eptifibatide Accord should not be used if it is noticed that particulate matter or discoloration is present.
Slovenian: Ne uporabljajte zdravila Eptifibatide Accord, če ste opazili delce ali obarvanje vsebine.
English: How to use Eptifibatide Accord
Slovenian: Kako uporabljati zdravilo Eptifibatide Accord
English: Physical and chemical compatibility testing indicate that Eptifibatide Accord may be administered through an intravenous line with atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, tissue plasminogen activator, or verapamil.
Slovenian: Accord dajete po intravenski liniji skupaj z atropinijevim sulfatom, dobutaminom, heparinom, lidokainom, meperidinom, metoprololom, midazolamom, morfinom, nitroglicerinom, tkivnim aktivatorjem plazminogena in verapamilom.
English: Administer with caution to patients with hepatic impairment in whom coagulation could be affected (see section 4.3, prothrombin time).
Slovenian: Če bi bila pri takšnem bolniku lahko prizadeta tudi koagulacija, morate zdravilo uporabljati previdno (glejte poglavje 4.3, protrombinski čas).
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.
Slovenian: Če je bil opravljen perkutani koronarni poseg, so infuzijo eptifibatida nadaljevali še 24 ur po posegu, tako da je infundiranje trajalo do 96 ur.
English: In patients undergoing CABG, the incidence of bleeding was not increased by eptifibatide compared to the patients treated with placebo.
Slovenian: Pri bolnikih z obvodom koronarne arterije incidenca krvavitev med uporabo eptifibatida ni bila večja kot med uporabo placeba.
English: The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/minute for up to 72 hours.
Slovenian: Priporočeni odmerek je 180 mikrogramov/kg v bolusu (hitri intravenski injekciji), čemur sledi (kapalna) infuzija 2 mikrograma/kg/minuto, ki traja do 72 ur.
English: Eptifibatide Accord 2 mg/ml solution for injection: 10 ml vial, pack of one vial.
Slovenian: Eptifibatide Accord 2 mg/ml raztopina za injiciranje: 10 ml viala, pakiranje po ena viala.
English: Eptifibatide Accord 0.75 mg/ml solution for infusion: 100 ml vial, pack of one vial.
Slovenian: Eptifibatide Accord 0,75 mg/ml raztopina za infundiranje: 100 ml viala, pakiranje po ena viala.
English: Post-marketing experience
Slovenian: Izkušnje po pridobitvi dovoljenja za promet
English: Eptifibatide Accord 2 mg/ml: Each ml of solution for injection contains 2 mg of eptifibatide.
Slovenian: Eptifibatide Accord 2 mg/ml: Vsak ml raztopine za injiciranje vsebuje 2 mg eptifibatida.
English: These plasma concentrations are achieved rapidly when the infusion is preceded by a 180microgram/kg bolus.
Slovenian: Plazemsko koncentracijo v tem območju lahko dosežete hitro, če pred infuzijo uporabite bolus 180 mikrogramov/kg.
English: Anaphylactic reactions.
Slovenian: Zelo redki anafilaktične reakcije.
English: If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately.
Slovenian: Če opazite kakršnekoli znake krvavitve, to nemudoma povejte zdravniku, bolnišničnemu farmacevtu ali medicinski sestri.
English: No apparent differences were observed between patients treated with eptifibatide or with placebo in values for liver function (SGOT/AST, SGPT/ALT, bilirubin, alkaline phosphatase) or renal function (serum creatinine, blood urea nitrogen).
Slovenian: Sicer pa med bolniki, zdravljenimi z eptifibatidom, in tistimi, ki so dobivali placebo, ni bilo očitnih razlik v testih delovanja jeter (SGOT/AST, SGPT/ALT, bilirubin, alkalna fosfataza) ali ledvic (kreatinin v serumu, sečnina).
English: Therefore, it is not recommended to administer eptifibatide in patients who have previously experienced immune mediated thrombocytopenia with GP IIb/IIIa inhibitors, including eptifibatide.
Slovenian: Zato eptifibatida ni priporočljivo uporabiti pri bolnikih, ki so predhodno imeli imunsko trombocitopenijo med uporabo zaviralcev GP IIb/IIIa,
English: EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) was a study of early routine eptifibatide versus placebo (with delayed provisional use of eptifibatide in the catheterization laboratory) used in combination with antithrombotic therapies (ASA, UFH, bivalirudin, fondaparinux or low molecular weight heparin), in subjects with high-risk NSTE ACS.
Slovenian: EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) je bila študija zgodnje rutinske uporabe eptifibatida v primerjavi s placebom (z odloženo pomožno uporabo eptifibatida v kateterizacijskem laboratoriju) v kombinaciji z antitrombotičnimi zdravili (acetilsalicilna kislina, nefrakcioniran heparin, bivalirudinom, fondaparinuksom ali nizkomolekularnim heparinom) pri preiskovancih z velikim tveganjem akutnega koronarnega sindroma brez elevacije ST. Bolniki so imeli po 12- do 96-urnem prejemanju raziskovanega zdravila predvideno invazivno nadaljnje vodenje.
English: What Eptifibatide Accord looks like and contents of the pack
Slovenian: Izgled zdravila Eptifibatide Accord in vsebina pakiranja
English: GUSTO moderate or severe/life threatening bleeding occurred significantly more often with early routine eptifibatide (7.4 % vs. 5.0 % in delayed provisional eptifibatide group; p <0.001).
Slovenian: Hude/smrtno nevarne krvavitve po GUSTO so se pojavile značilno pogosteje med zgodnjo rutinsko uporabo eptifibatida (7,4 % v prim.
English: These may affect more than 1 in 10 people
Slovenian: Zelo pogosti neželeni učinki Pojavijo se pri več kot 1 od 10 bolnikov
English: The activated partial thromboplastin time (aPTT) must be monitored in order to maintain a value between 50 and 70 seconds, above 70 seconds there may be an increased risk of bleeding.
Slovenian: Spremljajte aktivirani parcialni tromboplastinski čas (aPTČ) in ga ohranjajte med 50 in 70 sekundami.
English: Eptifibatide Accord 0.75 mg/ml: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Slovenian: Eptifibatide Accord 0,75 mg/ml: Vsak ml raztopine za injiciranje vsebuje 0,75 mg eptifibatida.
English: In patients undergoing PCI, measure the ACT also.
Slovenian: Pri bolnikih, ki so imeli perkutani koronarni poseg, merite tudi AČS.
English: The component MI could be defined as asymptomatic with enzymatic elevation of CK-MB or new Q wave.
Slovenian: Miokardni infarkt so opredelili kot asimptomatski pri zvišanju encima CK-MB ali pri pojavu novega zobca Q.
English: Since either repeat exposure with any GP IIb/IIIa ligand-mimetic agent (like abciximab or eptifibatide) or first-time exposure to a GP IIb/IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, monitoring is required, i.e. platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Slovenian: abciksimabu ali eptifibatidu) kot prva izpostavljenost zaviralcu GP IIb/IIIa povezana z imunskimi trombocitopeničnimi odzivi, so potrebne kontrole: število trombocitov morate spremljati pred zdravljenjem in v roku 6 ur po dajanju zdravila, potem pa najmanj enkrat na dan v času zdravljenja in tudi takoj ob pojavu kliničnih znakov nepričakovane nagnjenosti h krvavitvam.
English: As demonstrated in clinical trials, the incidence of thrombocytopenia was low, and similar in patients treated with eptifibatide or placebo.
Slovenian: V kliničnih raziskavah je bila pri bolnikih, zdravljenih z eptifibatidom, incidenca trombocitopenije majhna in podobna kot pri tistih, ki so prejemali placebo.
English: If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.
Slovenian: Če pa potrebuje polurgentno operacijo, morate infuzijo eptifibatida ustaviti dovolj zgodaj, da še omogočite normalizacijo delovanja trombocitov.
English: These may affect up to 1 in 10,000 people
Slovenian: Pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov
English: Similar differences were noted for TIMI major haemorrhage (118 [2.5 %] in early routine use vs. 83 [1.8 %] in delayed provisional use; p=0.016).
Slovenian: s 83 [1,8 %] med odloženo pomožno uporabo, p = 0,016).
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).
Slovenian: V primeru odložene pomožne uporabe eptifibatida pa je bil delež dogodkov med prejemniki nižjega odmerka 10 % in med prejemniki standardnega odmerka 11,5 % (p = 0,61).
English: Solution for infusion 100 ml
Slovenian: raztopina za infundiranje 100 ml
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.
Slovenian: Eptifibatide Accord 0,75 mg/ml: Bistra brezbarvna raztopina v 100-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom (tipa »flip-off«).
English: − if you have or have had bleeding problems.
Slovenian: − če imate ali ste kdaj v preteklosti imeli težave s krvavitvami;
English: Fatal bleeding (the majority involved central and peripheral nervous system disorders: cerebral or intracranial haemorrhages); pulmonary haemorrhage, acute profound thrombocytopenia, haematoma.
Slovenian: Zelo redki smrtne krvavitve (večinoma je šlo za motnje osrednjega in perifernega živčevja: možganske ali intrakranialne krvavitve), pljučne krvavitve, akutna huda trombocitopenija, hematomi.
English: − if you have or have had difficulty with your blood clotting or a low blood platelet count.
Slovenian: − če imate ali ste imeli težave s strjevanjem krvi ali premajhno število trombocitov v krvi;
English: Discard any unused medicinal product after opening.
Slovenian: Po odprtju zavrzite morebitni neporabljeni ostanek zdravila.
English: Before infusion of Eptifibatide Accord, the following laboratory tests are recommended to identify preexisting haemostatic abnormalities: prothrombin time (PT) and aPTT, serum creatinine, platelet count, haemoglobin and haematocrit levels.
Slovenian: Za ugotavljanje obstoječih motenj hemostaze je pred začetkom infuzije zdravila Eptifibatide Accord priporočljivo opraviti naslednje laboratorijske preiskave: določanje protrombinskega časa (PČ) in aPTČ, kreatinina v serumu , števila trombocitov ter koncentracije hemoglobina in hematokrita.
English: Solution for injection 1 vial of 10 ml
Slovenian: raztopina za injiciranje 1 viala 10 ml
English: Of the patients in PURSUIT, 13 % were managed with PCI during eptifibatide infusion, of whom approximately 50 % received intracoronary stents; 87 % were managed medically (without PCI during eptifibatide infusion).
Slovenian: Pri 13 % bolnikov vključenih v študijo PURSUIT so med infuzijo eptifibatida opravili perkutani koronarni poseg in od teh jih je približno 50 % dobilo intrakoronarne opornice (stente).
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.
Slovenian: Miokardni infarkt so ugotavljali na podlagi osrednjih laboratorijskih meril za CK-MB. Za to diagnozo sta morali biti v obdobju 24 ur po zadevnem perkutanem koronarnem posegu najmanj dve vrednosti CK-MB ≥ 3 x zgornji meji normalnih vrednosti.
English: If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours.
Slovenian: Če je med zdravljenjem z eptifibatidom opravljen perkutani koronarni poseg (PCIPercutaneous Coronary Intervention), morate nato z infuzijo nadaljevati še 20 do 24 ur po perkutanem koronarnem posegu; povprečno najdaljše skupno trajanje zdravljenja je 96 ur.
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.
Slovenian: Pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min), ki so prejeli 1 mikrogram/kg/min, je bila 80 % inhibicija po 24 urah dosežena pri več kot 80 % bolnikov.
English: - skin rash (such as hives).
Slovenian: - kožni izpuščaj (kot je koprivnica);
English: − severe reduction in the number of platelets (blood cells necessary for blood clotting).
Slovenian: - usodne krvavitve; - hudo zmanjšanje števila trombocitov (krvnih celic, ki so potrebne za strjevanje krvi);
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).
Slovenian: Večje krvavitve po TIMI so se pojavile pri 2,7 % prejemnikov nižjega odmerka (1 mikrogram/kg/min) in pri 4,2 % prejemnikov standardnega odmerka (2 mikrograma/kg/min), če je bil eptifibatid uporabljen v zgodnjem rutinskem načinu (p = 0,36).
English: Adults (≥ 18 years of age) presenting with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI)
Slovenian: Odmerjanje Odrasli (starost ≥ 18 let) z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG
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.
Slovenian: Eptifibatide Accord 2 mg/ml: Bistra brezbarvna raztopina v 10-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom (tipa »flip-off«).
English: If the patient weighs < 70 kg, a bolus dose of 60 units/kg is recommended, followed by an infusion of 12 units/kg/hr.
Slovenian: Če pa je bolnikova telesna masa < 70 kg, uporabite bolusni odmerek 60 enot/kg,
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.
Slovenian: Izsledki pa so bili tudi napovedni za klinične pojave, s krvavitvami kot glavnim neželenim dogodkom.
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.
Slovenian: Pri pomotoma uporabljenih velikih bolusnih odmerkih, hitrih infuzijah, prijavljenih kot preveliko odmerjanje ali pri velikih kumulativnih odmerkih ni bilo znakov hudih neželenih učinkov.
English: It is usually given with aspirin and unfractionated heparin.
Slovenian: Običajno se ga da skupaj z acetilsalicilno kislino in nefrakcioniranim heparinom.
English: Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi: citronska kislina monohidrat, natrijev hidroksid in voda za injekcije.
English: One 100 ml vial contains 75 mg of eptifibatide.
Slovenian: Ena 100 ml viala vsebuje 75 mg eptifibatida.
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.
Slovenian: Pogostnost angiografij, perkutanih koronarnih posegov in koronarnih premostitvenih operacij se je zato zelo razlikovala med posameznimi mesti in državami.
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.
Slovenian: Pri bolnikih z zmerno okvaro ledvic (kreatininski očistek ≥ 30 - < 50 ml/min) morate uporabiti intravenski bolus v odmerku 180 mikrogramov/kg, ki mu nato sledi kontinuirana infuzija v odmerku
English: If you have any questions, ask your doctor or hospital pharmacist or nurse.
Slovenian: Če imate kakršnakoli vprašanja, vprašajte svojega zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
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).
Slovenian: Zelo pogosti krvavitve (večje ali manjše krvavitve, vključujoč femoralni arterijski dostop, v povezavi s CABG, v prebavilih, v sečilih in spolnih organih, retroperitonealno,
English: Data are limited on the use of eptifibatide in patients receiving thrombolytic agents.
Slovenian: Eptifibatid in trombolitična zdravila Podatki o uporabi eptifibatida pri bolnikih, zdravljenih s trombolitičnimi zdravili, so omejeni.
English: Eptifibatide Accord solution for infusion must be used in conjunction with Eptifibatide Accord solution for injection.
Slovenian: Raztopino za infundiranje Eptifibatide Accord morate uporabljati skupaj z raztopino za injiciranje Eptifibatide Accord.
English: Eptifibatide Accord solution for injection must be used in conjunction with Eptifibatide Accord solution for infusion.
Slovenian: Raztopino za injiciranje Eptifibatide Accord morate uporabljati skupaj z raztopino za infundiranje Eptifibatide Accord.
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).
Slovenian: Rezultate za primarni končni cilj so večinoma pripisali zmanjšanju pojavljanja encimskega miokardnega infarkta, opredeljenega kot zgodnje zvišanje vrednosti srčnih encimov po perkutanem koronarnem posegu (PCI) (80 od
English: The combination of reduced dose tenecteplase and eptifibatide compared to placebo and eptifibatide significantly increased the risk of both major and minor bleeding when administered concomitantly in an acute ST-elevation myocardial infarction study.
Slovenian: V raziskavi akutnega miokardnega infarkta z dvigom spojnice ST je prišlo pri sočasni aplikaciji znižanega odmerka tenekteplaze in eptifibatida, v primerjavi s sočasno aplikacijo placeba in eptifibatida, do signifikantnega povečanja tveganja za večje in manjše krvavitve.
English: - severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 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
Slovenian: - protrombinskim časom > 1,2-krat večjim od kontrolne vrednosti ali mednarodnim normaliziranim količnikom (INR) ≥ 2,0; - hudo hipertenzijo (sistolični krvni tlak > 200 mm Hg ali diastolični krvni tlak > 110 mmHg ob antihipertenzivnem zdravljenju); - hudo okvaro ledvic (kreatininski očistek < 30 ml/min) ali odvisnost od dialize;
English: Protection of Eptifibatide Accord solution from light is not necessary during administration.
Slovenian: Med infundiranjem raztopine Eptifibatide Accord ni treba zaščititi pred svetlobo.
English: There is limited data with regards to platelet inhibition in patients with renal impairment.
Slovenian: Podatki o inhibiciji trombocitov pri bolnikih z okvaro ledvic so omejeni.
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).
Slovenian: 11,9 % pri prejemnikih nižjega odmerka (1 mikrogram/kg/min) in 11,2 % pri prejemnikih standardnega odmerka (2 mikrograma/kg/min), če je bil eptifibatid uporabljen v zgodnjem rutinskem načinu (p = 0,81).
English: MARKETING AUTHORISATION NUMBER
Slovenian: ŠTEVILKA DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Breast-feeding
Slovenian: Eptifibatid
English: This product is for hospital use only.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravilo je namenjeno le bolnišnični uporabi.
English: One 10 ml vial contains 20 mg of eptifibatide.
Slovenian: Ena 10 ml viala vsebuje 20 mg eptifibatida.
English: − The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
Slovenian: − Pomožne snovi so: citronska kislina monohidrat, natrijev hidroksid in voda za injekcije.
English: On the day of PCI, prior to catheterization, 53.2 % received a thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - mostly as a loading dose (300 mg or more).
Slovenian: (klopidogrel 52,7 % in tiklopidin 0,5 %), večinoma v obliki udarnega odmerka (300 mg ali več).
English: Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥ 10 minutes) within the previous 24 hours and had:
Slovenian: 24 urah ishemijo miokarda v mirovanju (≥ 10 minut) in:
English: If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
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.
Slovenian: Willebrandovega faktorja in drugih adhezivnih ligandov na receptorje glikoproteina (GP) IIb/IIIa.
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).
Slovenian: Zdravljenje naj se nadaljuje s kontinuirano infuzijo 2 mikrograma/kg/min do 72 ur, bodisi do začetka koronarnega premostitvenega posega (CABG - Coronary Artery Bypass Graft) ali do odpusta iz bolnišnice (karkoli nastopi prej).
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).
Slovenian: (TBO) v prvih 48 urah) je pokazala 37 % relativno in 3,9 % absolutno zmanjšanje v skupini za eptifibatid (6,6 % pojavov v primerjavi z 10,5 %, p = 0,0015).
English: One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.
Slovenian: Ena 100 ml viala iz stekla tipa I, zaprta z zamaškom iz butilne gume in zapečatena z aluminijasto zaporko (tipa »flip-off«).
English: Each ml of solution for injection contains 2 mg of eptifibatide.
Slovenian: En ml raztopine za injiciranje vsebuje 2 mg eptifibatida.
English: Common side effects These may affect up to 1 in 10 people - inflammation of a vein.
Slovenian: Pojavijo se pri 1 do 10 bolnikih od 100 bolnikov - vnetje ven.
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.
Slovenian: Skrbno morate opazovati vsa možna mesta krvavitve (npr. mesto vstavitve katetra, arterijska, venska ali igelna vbodna mesta, mesta vrezov; prebavila, sečila in spolne organe).