natgillin/translations-raw huggingface dataset:
What benefit has INTEGRILIN shown during the studies?
Kakšne koristi je zdravilo INTEGRILIN izkazalo med raziskavami?
In the PURSUIT trial, INTEGRILIN was more effective than placebo in preventing death or further heart attacks during the 30 days after it was given.
V raziskavi PURSUIT je bil INTEGRILIN učinkovitejši od placeba pri preprečevanju smrti ali nadaljnjih srčnih napadov v obdobju 30 dni po dajanju.
In the ESPRIT trial, a similar benefit at 30 days was seen.
Raziskava ESPRIT je po 30 dneh pokazala podobne koristi.
What is the risk associated with INTEGRILIN?
Kakšna tveganja so povezana z zdravilom INTEGRILIN?
The main risk of INTEGRILIN is bleeding (in more than one in 10 patients), and this may sometimes be severe.
Najpomembnejše tveganje, povezano z uporabo zdravila INTEGRILIN, je krvavitev (pri več kot enem izmed 10 bolnikov), ki je lahko včasih zelo huda.
Other side effects are uncommon or rare.
Drugi neželeni učinki so občasni oziroma redki.
For the full list of all side effects reported with INTEGRILIN, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila INTEGRILIN, glejte Navodilo za uporabo.
INTEGRILIN should not be used in people who may be hypersensitive (allergic) to eptifibatide or any of the other ingredients, in patients who have bleeding problems or have a disease which may cause bleeding (such as stroke, severe high blood pressure), or in patients with severe liver or kidney problems.
Zdravila INTEGRILIN ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eptifibatid ali katero koli drugo sestavino zdravila, bolniki, ki imajo težave s krvavitvami ali imajo obolenje, ki bi lahko povzročilo krvavitev (kot na primer kap, močno povišan krvni tlak), ali bolniki s hudimi jetrnimi ali ledvičnimi težavami.
Why has INTEGRILIN been approved?
Zakaj je bilo zdravilo INTEGRILIN odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that INTEGRILIN’ s benefits are greater than its risks to prevent early myocardial infarction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila INTEGRILIN pri preprečevanju zgodnjega miokardnega infarkta večje od z njim povezanih tveganj.
They recommended that INTEGRILIN be given marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom INTEGRILIN.
Other information about INTEGRILIN:
Druge informacije o zdravilu INTEGRILIN:
The European Commission granted a marketing authorisation valid throughout the European Union for INTEGRILIN on 1 July 1999.
Evropska komisija je dovoljenje za promet z zdravilom INTEGRILIN, veljavno po vsej Evropski uniji, odobrila dne 1. julija 1999.
The marketing authorisation was renewed on 1 July 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano 1. julija 2004.
The full EPAR for INTEGRILIN can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo INTEGRILIN je na voljo tukaj.
Invented name Strengths
Zaščiteno ime
EU/ 1/ 99/ 109/ 001 Integrilin EU/ 1/ 99/ 109/ 002 Integrilin
EU/ 1/ 99/ 109/ 001 Integrilin EU/ 1/ 99/ 109/ 002 Integrilin
Solution for infusion Solution for injection
Raztopina za infundiranje Raztopina za injiciranje
Intravenous use Intravenous use
Intravenska uporaba Intravenska uporaba
Vial (glass) Vial (glass)
Viala (steklena) Viala (steklena)
1 vial 1 vial
1 viala 1 viala
INTEGRILIN 0.75 mg/ ml, solution for infusion
INTEGRILIN 0, 75 mg/ ml, raztopina za infundiranje
INTEGRILIN contains 0.75 mg/ ml of eptifibatide.
INTEGRILIN vsebuje 0, 75 mg/ ml eptifibatida.
Solution for infusion Clear, colourless solution
Raztopina za infundiranje Bistra, brezbarvna raztopina.
INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin.
INTEGRILIN je namenjen uporabi z acetilsalicilno kislino in nefrakcioniranim heparinom.
INTEGRILIN is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and/ or elevated cardiac enzymes.
INTEGRILIN je indiciran za preprečevanje zgodnjega miokardnega infarkta pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG, ki so imeli zadnji napad bolečine v prsih v preteklih 24 urah ter imajo EKG spremembe, zvišano koncentracijo srčnih encimov ali oboje.
Patients most likely to benefit from INTEGRILIN treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty) (see section 5.1).
Mednje sodijo na primer tudi vsi bolniki, pri katerih bo verjetno opravljena zgodnja PTCA (Perkutana Transluminalna Koronarna Angioplastika (glejte poglavje 5. 1).
This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes.
Zdravilo je namenjeno le bolnišnični uporabi, dajati pa ga morajo specialisti z izkušnjami na področju zdravljenja akutnih koronarnih sindromov.
Adults (≥ 18 years of age) presenting with unstable angina or non-Q-wave myocardial infarction The recommended dosage is an intravenous bolus of 180 microgram/ kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2.0 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).
Zdravljenje naj se nadaljuje s kontinuirano infuzijo 2, 0 mikrograma/ kg/ min do 72 ur, bodisi do začetka koronarnega premostitvenega posega (CABG) ali do odpusta iz bolnišnice (karkoli nastopi prej).
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.
Če je med zdravljenjem z eptifibatidom opravljen perkutani koronarni poseg (PCI), morate nato z infuzijo nadaljevati še 20 do 24 ur po perkutanem koronarnem posegu; povprečno najdaljše skupno trajanje zdravljenja je 96 ur.
Emergency or semi-elective surgery If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately.
Urgentno ali polurgentno kirurško zdravljenje Če bolnik med zdravljenjem z eptifibatidom potrebuje nujno ali urgentno operacijo na srcu, nemudoma prekinite infuzijo.
2 Hepatic impairment Experience in patients with hepatic impairment is very limited.
2 Jetrna okvara Izkušnje pri bolnikih z jetrno okvaro so zelo skope.
Administer with caution to patients with hepatic impairment in whom coagulation could be affected (see section 4.3, prothrombin time).
Če bi bila pri takšnem bolniku lahko prizadeta tudi koagulacija, morate zdravilo uporabljati previdno (glejte poglavje 4. 3, protrombinski čas).
Renal impairment 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.
Ledvična okvara 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 1, 0 mikrograma/ kg/ min ves čas trajanja zdravljenja.
Experience in patients with more severe renal impairment is limited (see section 4.3).
Izkušnje pri bolnikih s hujšo ledvično okvaro so skope (glejte poglavje 4. 3).
Paediatric use 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.
Uporaba v pediatriji Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
INTEGRILIN must not be used to treat patients with: − hypersensitivity to the active substance or to any of the excipients − evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment − history of stroke within 30 days or any history of haemorrhagic stroke − known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm) − major surgery or severe trauma within past 6 weeks − a history of bleeding diathesis − thrombocytopaenia (< 100,000 cells/mm3) − prothrombin time > 1.2 times control, or International Normalized Ratio (INR) ≥ 2.0 − 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 GP IIb/IIIa inhibitor
- znaki krvavitve v prebavilih, obilno krvavitvijo v sečilih ali spolnih organih ali kako drugo
4.4 Special warnings and precautions for use
aktivno nenormalno krvavitvijo, ki nastopi v zadnjih 30 dneh pred zdravljenjem.
Bleeding INTEGRILIN is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
- anamnezo možganske kapi v zadnjih 30 dneh ali anamnezo hemoragične kapi kadarkoli.
Women, the elderly and patients with low body weight may have an increased risk of bleeding.
- znano anamnezo intrakranialne bolezni (neoplazme, arteriovenske malformacije, anevrizme).
Monitor these patients closely with regard to bleeding.
- večjo operacijo ali hujšo poškodbo v zadnjih 6 tednih.
Bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures.
trombocitopenijo (< 100. 000 celic/ mm3).
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.
Bolnika morate torej med zdravljenjem skrbno spremljati, da odkrijete znake krvavitve (glejte poglavje 4. 8).
Other potential bleeding sites such as central and peripheral nervous system and retroperitoneal sites, must be carefully considered too.
Skrbno morate opazovati vsa možna mesta krvavitve, npr. mesto vstavitve katetra, arterijska, venska ali igelna vbodna mesta, mesta vrezov; prebavila, sečila in spolne organe.
Because INTEGRILIN inhibits platelet aggregation, caution must be employed when it is used with other medicinal products that affect haemostasis, including ticlopidine, clopidogrel, thrombolytics, oral anticoagulants, dextran solutions (see section 6.2), adenosine, sulfinpyrazone, prostacyclin, non-steroidal anti-inflammatory agents, or dypyridamole (see section 4.5).
Ker INTEGRILIN zavira agregacijo trombocitov, je potrebna previdnost pri sočasni uporabi z drugimi zdravili, ki vplivajo na hemostazo, vključno s tiklopidinom, klopidogrelom, trombolitiki, peroralnimi antikoagulanti, raztopinami dekstrana (glejte poglavje 6. 2), adenozinom, sulfinpirazonom, prostaciklinom, nesteroidnimi protivnetnimi zdravili ali dipiridamolom.
3 There is limited therapeutic experience with INTEGRILIN in patients for whom thrombolytic therapy is generally indicated (e. g., acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
3 novimi patološkimi zobci Q, zvišanjem veznice ST ali levokračnim blokom v EKG).
Consequently the use of INTEGRILIN is not recommended in these circumstances.
Uporaba zdravila INTEGRILIN pri takšnih bolnikih torej ni priporočljiva.
Stop the INTEGRILIN infusion immediately if circumstances arise that necessitate thrombolytic therapy or if the patient must undergo an emergency CABG surgery or requires an intraortic balloon pump.
Infuzijo zdravila INTEGRILIN morate nemudoma ustaviti, če nastopijo okoliščine, ki zahtevajo trombolitično zdravljenje, če mora bolnik na nujen koronarni premostitveni poseg ali če potrebuje intraaortno balonsko črpalko.
If serious bleeding occurs that is not controllable with pressure, immediately stop the INTEGRILIN infusion and any unfractionated heparin that is given concomitantly.
Če se pojavi hujša krvavitev, ki je ni mogoče obvladati s pritiskom, nemudoma ustavite infuzijo zdravila INTEGRILIN in morebitno sočasno uporabo nefrakcioniranega heparina.
Arterial procedures During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Posegi na arterijah Med zdravljenjem z eptifibatidom se znatno poveča pogostnost krvavitev, zlasti v predelu femoralne arterije, kjer se vstavi vodilo katetra.
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).
Vodilo katetra lahko vzamete iz arterije, ko se koagulacija normalizira (t. j. ko je aktivirani čas strjevanja [AČS] manjši od 180 sekund; ponavadi 2 do 6 ur po ukinitvi heparina).
Thrombocytopaenia INTEGRILIN inhibits platelet aggregation, but does not appear to affect the viability of platelets.
Trombocitopenija INTEGRILIN zavira agregacijo trombocitov, ni pa videti, da bi vplival na njihovo življenjsko dobo.
As demonstrated in clinical trials, the incidence of thrombocytopaenia was low, and similar in patients treated with eptifibatide or placebo.
V kliničnih raziskavah je bila pri bolnikih, zdravljenih z eptifibatidom, incidenca trombocitopenije majhna in podobna kot pri tistih, ki so prejemali placebo.
Thrombocytopaenia, including acute profound thrombocytopaenia, has been observed with eptifibatide administration (see section 4.8).
Pri uporabi eptifibatida so opažali trombocitopenijo, vključno z akutno hudo trombocitopenijo (glejte poglavje 4. 8).
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.
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.
If the patient experiences a confirmed platelet decrease to < 100,000/ mm3, discontinue INTEGRILIN and unfractionated heparin and monitor and treat the patient appropriately.
Če se število trombocitov pri bolniku potrjeno zmanjša na < 100. 000 celic/ mm3, morate ukiniti INTEGRILIN in nefrakcionirani heparin ter bolnika spremljati in ustrezno zdraviti.
In patients with previous thrombocytopaenia from other parenteral GP IIb/ IIIa inhibitors, there are no data with the use of INTEGRILIN, and thus these patients require close monitoring as noted above.
Ni podatkov o uporabi zdravila INTEGRILIN pri bolnikih, ki imajo že prisotno trombocitopenijo zaradi prejemanja drugih parenteralnih zaviralcev GP IIb/ IIIa, zato morate te bolnike skrbno spremljati, kot je navedeno zgoraj.
Heparin administration Heparin administration is recommended unless a contraindication (such as a history of thrombocytopaenia associated with use of heparin) is present.
Uporaba heparina Uporaba heparina je priporočljiva le, če zanj ni kontraindikacij (npr. trombocitopenija v anamnezi v povezavi z uporabo heparina).
UA/ NQMI:
Bolniki z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG:
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.
Za bolnike, s telesno maso ≥ 70 kg, je priporočen bolusni odmerek 5. 000 enot, ki naj mu sledi stalna intravenska infuzija 1. 000 enot/ h.
If the patient weighs < 70 kg, a bolus dose of 60 units/ kg is recommended, followed by an infusion of 12 units/ kg/ hr.
Če pa je bolnikova telesna masa < 70 kg, uporabite bolusni odmerek 60 enot/ kg, ki naj mu sledi infuzija 12 enot/ kg/ h.
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.
Pri vrednostih nad 70 sekund je lahko povečana nevarnost krvavitev.
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.
Če je predviden perkutani koronarni poseg pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG, spremljajte aktivirani čas strjevanja krvi (AČS) in ga ohranjajte med 300 in 350 sekundami.
Monitoring of laboratory values Before infusion of INTEGRILIN, the following laboratory tests are recommended before treatment to identify pre-existing haemostatic abnormalities: prothrombin time (PT) and aPTT, serum creatinine, platelet count, haemoglobin and haematocrit levels.
Spremljanje laboratorijskih vrednosti Za ugotavljanje obstoječih motenj hemostaze je pred začetkom zdravljenja z infuzijo zdravila INTEGRILIN priporočljivo opraviti naslednje laboratorijske preiskave: določanje protrombinskega časa (PČ) in aPTČ, kreatinina v serumu, števila trombocitov ter koncentracije hemoglobina in hematokrita.
If the platelet count falls below
Hemoglobin, hematokrit in število trombocitov morate spremljati tudi v prvih 6 urah po začetku zdravljenja, nato pa vsaj enkrat na dan ves čas zdravljenja ali pa še pogosteje, če pride do znakov občutnega zmanjšanja.
4 100,000/ mm3, further platelet counts are required to rule out pseudothrombocytopaenia.
Če se število trombocitov zmanjša pod 100. 000 celic/ mm3, bodo potrebne dodatne določitve števila trombocitov, da izključite psevdotrombocitopenijo.
Patients must be monitored for bleeding and treated if necessary (see section 4.9).
4 Bolnike morate spremljati, da ugotovite morebitne krvavitve in jih po potrebi zdravite (glejte poglavje 4. 9).
Immunogenicity Immunogenic response or antibodies against eptifibatide have been observed in isolated cases in naïve patients or in rare cases of patients re-exposed to eptifibatide.
Imunogenost V posameznih primerih pri še nezdravljenih bolnikih ali v redkih primerih pri bolnikih, ki so ponovno prejeli eptifibatid, so zasledili imunogeni odziv ali nastanek protiteles proti eptifibatidu.
Only limited experience exists for readministration of INTEGRILIN.
Izkušnje s ponovno uporabo zdravila INTEGRILIN so skope.
If treatment with INTEGRILIN is repeated, no diminished therapeutic response is expected.
Pri ponovitvi zdravljenja z zdravilom INTEGRILIN ni pričakovati zmanjšanega terapevtskega odziva.
INTEGRILIN did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole.
Pri sočasni uporabi z varfarinom in dipiridamolom ni bilo videti, da bi INTEGRILIN povečal tveganje za pojav večjih ali manjših krvavitev.
INTEGRILIN-treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
Tudi pri z zdravilom INTEGRILIN zdravljenih bolnikih, ki so imeli protrombinski čas (PČ) > 14, 5 sekund in so sočasno prejemali varfarin, ni kazalo, da bi bili bolj ogroženi zaradi krvavitev.
There was no consistent evidence that eptifibatide increased the risk of major or minor bleeding associated with tissue plasminogen activator in either a PCI or an acute myocardial infarction study; however, eptifibatide appeared to increase the risk of bleeding when administered with streptokinase in an acute myocardial infarction study.
Vendar pa je v raziskavi akutnega miokardnega infarkta kazalo, da eptifibatid poveča tveganje za krvavitve pri sočasni uporabi s streptokinazo.
In an acute myocardial infarction study involving 181 patients, eptifibatide (in regimens up to a bolus injection of 180 microgram/ kg, followed by an infusion up to 2 microgram/ kg/ min for up to 72 hours) was administered concomitantly with streptokinase (1.5 million units over 60 minutes).
V raziskavi akutnega miokardnega infarkta, ki je zajela 181 bolnikov, so eptifibatid (v shemah z uporabo bolusne injekcije do 180 mikrogramov/ kg, ki ji je sledila infuzija do 2 mikrograma/ kg/ min v trajanju do 72 ur) uporabili sočasno s streptokinazo (1, 5 milijona enot v 60 minutah).
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.
Pri največjih proučenih hitrostih infundiranja (1, 3 mikrograma/ kg/ min in 2, 0 mikrograma/ kg/ min) je bila incidenca krvavitev in transfuzij pri sočasni uporabi eptifibatida večja kot pri uporabi same streptokinaze.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Interruption of breast-feeding during the treatment period is recommended.
Ni znano, ali se pri človeku eptifibatid izloča v materino mleko, zato priporočamo prekinitev dojenja v času zdravljenja.
Not relevant, as INTEGRILIN is intended for use in hospitalised patients.
Ni pomemben, ker je zdravilo INTEGRILIN namenjeno zdravljenju hospitaliziranih bolnikov.
The majority of undesirable effects experienced by patients treated with eptifibatide were generally related to bleeding, or to cardiovascular events that occur frequently in this patient population.
Večina neželenih učinkov, ki so jih imeli bolniki, zdravljeni z eptifibatidom, je bila praviloma povezana s krvavitvami ali kardiovaskularnimi pojavi, ki so v tej populaciji bolnikov tudi sicer pogosti.
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.
Pri priporočenem terapevtskem odmerku, ki so ga uporabili tudi v raziskavi PURSUIT, ki je zajela skoraj 11. 000 bolnikov, so bile krvavitve najpogostejši zaplet v času zdravljenja z eptifibatidom.
Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction (TIMI) study group.
Uporaba eptifibatida je povezana s povečanjem pogostnosti večjih in manjših krvavitev v skladu s klasifikacijo po merilih skupine za raziskave trombolize pri miokardnem infarktu, TIMI (Thrombolysis in Myocardial Infarction).
5 Bleeding Minor bleeding was a very common (> 1/ 10) complication of eptifibatide administration (13.1% eptifibatide vs 7.6% placebo).
5 Krvavitve Manjše krvavitve so bile zelo pogosti (> 1/ 10) zaplet uporabe eptifibatida (13, 1% za eptifibatid, 7, 6% za placebo).
Minor bleeding was defined as spontaneous gross haematuria, spontaneous haematemesis, observed blood loss with a haemoglobin decrease of more than 3 g/ dl, or more than 4 g/ dl in the absence of an observed bleeding site.
Za manjše krvavitve so šteli spontano močno hematurijo, spontano hematemezo, opaženo izgubo krvi z zmanjšanjem koncentracije hemoglobina za več kot 3 g/ dl ali za več kot 4 g/ dl brez ugotovljenega mesta krvavitve.
Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Krvavitve so bile pogostejše pri bolnikih, ki so med perkutanim koronarnim posegom sočasno prejemali tudi heparin, če je AČS presegal 350 sekund (glejte poglavje 4. 4 Uporaba heparina).
Major bleeding was defined as either an intracranial haemorrhage or a decrease in haemoglobin concentrations of more than 5 g/ dl (see table 1).
Večje krvavitve so se tudi pojavljale zelo pogosto (> 1/ 10) – po poročanju pogosteje pri bolnikih, zdravljenih z eptifibatidom (10, 8%), pojavljale pogosteje kot pri tistih, ki so prejemali placebo (9, 3%), opredeljene pa so bile kot intrakranialna krvavitev ali zmanjšanje koncentracije hemoglobina za več kot 5 g/ dl (glejte Tabelo 1).