natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with Kengrexal in one or more subsets of the paediatric population in the prevention of non-site specific embolism and thrombosis, for the treatment of thrombosis in paediatric patients undergoing diagnostic and / or therapeutic percutaneous vascular procedures. 
Pedijatrijska populacija Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Kengrexal u jednoj ili više podskupina pedijatrijske populacije u prevenciji embolije i tromboze nespecifične lokalizacije, u liječenju tromboze u pedijatrijskih bolesnika podvrgnutih dijagnostičkim i/ili terapijskim perkutanim vaskularnim postupcima.
From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. 
S mikrobiološkog stajališta, osim ako metoda rekonstitucije/razrjeđivanja isključuje rizik od mikrobiološke kontaminacije, lijek se mora primijeniti odmah.
For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6. 
Za uputu o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
The primary clinical evidence for the efficacy of cangrelor is derived from CHAMPION PHOENIX, a randomised, double-blind study comparing cangrelor (n=5,472) to clopidogrel (n=5,470), both given in combination with aspirin and other standard therapy, including unfractionated heparin (78%), bivalirudin (23%), LMWH (14%) or fondaparinux (2.7%). 
Primarni klinički dokaz djelotvornosti kangrelora dobiven je u randomiziranom, dvostruko slijepom ispitivanju CHAMPION PHOENIX, u kojem su uspoređivani kangrelor (n= 5472) i klopidogrel (n= 5470), oba davani u kombinaciji s aspirinom i drugom standardnom terapijom, uključujući nefrakcionirani heparin (78%), bivalirudin (23%), heparin male molekulske mase (14%) ili fondaparinuks (2,7%).
Irrespective of dose, following cessation of the infusion, blood levels decrease rapidly and platelet function returns to normal within one hour. 
Neovisno o dozi, nakon prekida infuzije, razine u krvi brzo se smanjuju, a funkcija trombocita vraća se u normalu unutar jednog sata.
The mean steady state concentration of cangrelor during a constant intravenous infusion of 4 micrograms/kg/min is 488 ng/mL. 
Srednja vrijednost koncentracije u stanju dinamičke ravnoteže kangrelora tijekom neprekidne intravenske infuzije od 4 mikrograma/kg/min je 488 ng/ml.
Cangrelor did not produce malformations in either the rat or rabbit reproductive studies. 
Kangrelor nije izazvao malformacije ni u štakora ni u kunića u ispitivanjima reprodukcije.
In addition, a higher rate of GUSTO moderate bleeding was reported in the cangrelor group (6.7%) compared to clopidogrel (1.4%). 
Nadalje, prijavljena je viša stopa umjerenog krvarenja prema kriterijima GUSTO u skupini koja je dobivala kangrelor (6,7%) u usporedbi s klopidogrelom (1,4%).
Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection. 
Rekonstituirajte svaku 50 mg/bočicu dodavanjem 5 ml sterilne vode za injekcije.
Sodium hydroxide 
Natrijev hidroksid
The pharmacokinetics of cangrelor are not affected by gender, age, or renal or hepatic status. 
Na farmakokinetiku kangrelora ne utječu spol, dob niti stanje bubrega ili jetre.
If you have any further questions on the use of this medicine, ask your doctor. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku.
OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis. 
OR= omjer šansi; CI= interval pouzdanosti; IDR= revaskularizacija zbog ishemije; MI=infarkt miokarda; mITT= modificirana ITT populacija; ST= tromboza stenta.
Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration. 
Svaki neobjašnjivi pad krvnog tlaka ili hematokrita mora potaknuti ozbiljno razmatranje mogućnosti krvarenja i prekid primjene kangrelora.
The primary adverse effects of cangrelor in rats and dogs occurred in the upper urinary tract and consisted of injury to renal tubules, renal pelvis, and ureter. 
Primarni štetni učinci kangrelora u štakora i pasa zabilježeni su u gornjem dijelu urinarnog trakta i sastojali su se od ozljede bubrežnih kanalića, bubrežne nakapnice i uretera.
Severe/life-threatening 
Teško/opasno po život
Mild w/o ecchymosis, oozing and haematoma <5 cm 98 (1.8) Patients with any transfusion 
Blago bez ekhimoze, eksudata i hematoma <5 cm 98 (1,8) Bolesnici s bilo kakvom transfuzijom
The pharmacokinetic/pharmacodynamic (PK/PD) effect of cangrelor is maintained consistently for the duration of the infusion. 
Farmakokinetički/farmakodinamički (FK/FD) učinak kangrelora održava se konstantno za vrijeme trajanja infuzije.
Cangrelor is deactivated rapidly in the plasma by dephosphorylation to form its primary metabolite, a nucleoside. 
Kangrelor se brzo deaktivira u plazmi defosforilacijom, čime se stvara njegov primarni metabolit,
For transition, a loading dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately following discontinuation of cangrelor infusion. 
Za prijelaz, udarna doza peroralne P2Y12 terapije (klopidogrel, tikagrelor ili prasugrel) mora se primijeniti neposredno nakon prekida infuzije kangrelora.
• increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function, 
• povišene razine kreatinina u krvi (utvrđene krvnim pretragama), koje ukazuju na smanjenu funkciju bubrega, • promjene u krvnom tlaku,
No effect on female fertility parameters were observed in animal studies of Kengrexal. 
U ispitivanjima na životinjama nisu opaženi učinci lijeka Kengrexal na parametre plodnosti u ženki.
Patients with coronary atherosclerosis were included who required PCI for stable angina (58%), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) (26%), or ST-elevation myocardial infraction (STEMI) (16%). 
Uključeni su bolesnici s koronarnom aterosklerozom kojima je trebao PCI za stabilnu anginu (58%), akutni koronarni sindrom bez elevacije ST-segmenta (26%), ili infarkt miokarda sa ST-elevacijom (16%).
In rabbits, cangrelor was associated with increased incidences of abortion and intrauterine losses, as well as foetal growth retardation at higher doses which may have been secondary to maternal toxicity. 
U kunića, kangrelor je bio povezan s povećanim incidencijama pobačaja i intrauterinim gubicima, te sa zastojem u fetalnom rastu pri višim dozama što je možda bila posljedica toksičnosti za majke.
Cangrelor is rapidly distributed reaching Cmax within two minutes after administration of an intravenous bolus followed by infusion. 
Kangrelor se brzo raspodjeljuje i dostiže Cmax unutar dvije minute nakon primjene intravenskog bolusa, nakon kojeg slijedi infuzija.
Mild w/o ecchymosis, oozing and haematoma <5 cm 707 (5.6) Patients with any transfusion 
Blago bez ekhimoze, eksudata i hematoma <5 cm 707 (5,6) Bolesnici s bilo kakvom transfuzijom
Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection. 
Prije primjene, iz svake bočice mora se izvući 5 ml rekonstituirane otopine i dodatno razrijediti s 250 ml otopine natrijevog klorida od 9 mg/ml (0,9%) za injekciju ili otopine glukoze (5%) za injekciju.
Kengrexal is intended for intravenous use, only after reconstitution and dilution. 
Kengrexal je namijenjen za intravensku primjenu, samo nakon rekonstitucije i razrjeđivanja.
• reduced clotting of the blood, 
• smanjeno zgrušavanje krvi,
Cangrelor is contraindicated in patients with any history of stroke/TIA, (see sections 4.3 and 4.8). 
Kangrelor je kontraindiciran u bolesnika s bilo kakvom anamnezom moždanog udara/TIA (vidjeti dijelove 4.3 i 4.8).
Kengrexal diminishes the clumping of platelets and so reduces the chance of a blood clot forming. 
Kengrexal smanjuje nakupljanje trombocita i tako smanjuje mogućnost nastanka krvnog ugruška.
A pharmacodynamic interaction study has been conducted with cangrelor and prasugrel, which demonstrated that cangrelor and prasugrel can be administered concomitantly. 
Ispitivanje farmakodinamičkih interakcija provedeno je s kangrelorom i prasugrelom, što je dokazalo da se kangrelor i prasugrel mogu primjenjivati istodobno.
Patients should be transitioned to oral P2Y12 therapy for chronic treatment. 
Bolesnike se mora prebaciti na peroralnu terapiju inhibitorima P2Y12 receptora za kronično liječenje.
Anatomical changes correlated with increased plasma creatinine and urea, and increased albumin and blood cells in urine. 
Anatomske promjene bile su povezane s povišenim kreatininom i urejom u plazmi te povišenim albuminom i krvnim stanicama u mokraći.
Serious adverse reactions associated with cangrelor in patients with coronary artery disease include severe/life threatening bleeding and hypersensitivity. 
Ozbiljne nuspojave povezane s kangrelorom u bolesnika s koronarnom arterijskom bolesti uključuju teško/po život opasno krvarenje i preosjetljivost.
For storage conditions after reconstitution and dilution of the medicinal product see section 6.3. 
Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colourless to pale yellow solution. 
Utvrdite da je sadržaj bočice u potpunosti otopljen i da je rekonstituirani materijal prozirna, bezbojna do blijedožuta otopina.
What you need to know before you use Kengrexal Do not use Kengrexal 
Što morate znati prije nego počnete primjenjivati Kengrexal
The medicinal product should be inspected visually for particulate matter after reconstitution. 
Lijek se nakon rekonstitucije mora vizualno pregledati na prisutnost čestica.
When clopidogrel is administered during infusion of cangrelor, the expected inhibitory effect of clopidogrel on platelets is not achieved. 
Kada se klopidogrel primjenjuje tijekom infuzije kangrelora, ne postiže se očekivani inhibicijski učinak klopidogrela na trombocite.
Kengrexal is not recommended for use during pregnancy. 
Ne preporučuje se koristiti Kengrexal tijekom trudnoće.
Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 
Kengrexal, istodobno primijenjen s acetilsalicilatnom kiselinom (ASK), je indiciran za smanjenje trombotičkih kardiovaskularnih događaja u odraslih bolesnika s koronarnom arterijskom bolesti koji se podvrgavaju perkutanoj koronarnoj intervenciji (engl. percutaneous coronary intervention, PCI), a nisu dobili peroralni inhibitor receptora P2Y12 prije postupka PCI, i u kojih peroralna terapija inhibitorima P2Y12 nije izvediva ili poželjna.
During this procedure you may have a stent inserted in your blood vessel to help to keep it open. 
Za vrijeme tog postupka možda će Vam u krvnu žilu biti ugrađena potpornica (stent) za održavanje prohodnosti.
When administered in the PCI setting, cangrelor was associated with a greater incidence of GUSTO mild bleeding compared with clopidogrel. 
Kada je primijenjen u okruženju PCI, kangrelor je bio povezan s većom incidencijom blagog krvarenja prema GUSTO kriterijima u usporedbi s klopidogrelom.
A reversible effect on fertility was observed in male rats treated with Kengrexal (see section 5.3). 
U mužjaka štakora liječenih lijekom Kengrexal opažen je reverzibilan učinak na plodnost (vidjeti dio 5.3).
The active substance is cangrelor. 
Djelatna tvar je kangrelor.
Oral P2Y12 agents (clopidogrel, prasugrel, ticagrelor) 
Peroralni P2Y12 lijekovi (klopidogrel, prasugrel, tikagrelor)
Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety. 
Podaci objedinjene populacije iz ispitivanja CHAMPION od preko 25 000 bolesnika podvrgnutih PCI
Kengrexal is a white to off-white freeze-dried powder. 
Kengrexal je bijeli do gotovo bijeli prašak osušen zamrzavanjem.
In the pooled safety population from the CHAMPION trials, the incidence of fatal bleeding within 30 days of dosing was low and similar in patients who received cangrelor compared to clopidogrel (8 [0.1%] vs. 9 [0.1%]). 
U objedinjenim podacima populacije uključene u ispitivanjima sigurnosti CHAMPION, incidencija fatalnog krvarenja unutar 30 dana od primjene doze bila je niska i slična u bolesnika koji su dobivali kangrelor u usporedbi s klopidogrelom (8 [0,1%] naspram 9 [0,1%]).
In patients with severe renal impairment (creatinine clearance 15-30 mL/min) a higher rate of worsening in renal function (3.2%) was reported in the cangrelor group compared to clopidogrel (1.4%). 
U bolesnika s teškim oštećenjem bubrega (klirens kreatinina 15-30 ml/min) prijavljena je viša stopa pogoršanja bubrežne funkcije (3,2%) u skupini koja je dobivala kangrelor u usporedbi s klopidogrelom (1,4%).
Cangrelor should be used with caution in patients taking medicines that may increase the risk of bleeding. 
Kangrelor se mora primjenjivati uz oprez u bolesnika koji uzimaju lijekove koji mogu povećati rizik od krvarenja.
In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban) with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor. 
U kliničkim ispitivanjima kangrelor je istodobno primijenjen s bivalirudinom, heparinom male molekulske mase, fondaparinuksom i inhibitorima GP IIb/IIIa (abciksimab, eptifibatid, tirofiban) bez vidljivog učinka na farmakokinetiku ili farmakodinamiku kangrelora.
Irrespective of dose, following cessation of the infusion, cangrelor blood levels decrease rapidly and platelet function returns to normal within one hour. 
Neovisno o dozi, nakon prekida infuzije razine kangrelora u krvi brzo se smanjuju, a funkcija trombocita vraća se u normalu unutar jednog sata.
Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting. 
Kengrexal mora primjenjivati liječnik s iskustvom u akutnoj koronarnoj njezi ili u postupcima koronarne intervencije i namijenjen je specijaliziranoj primjeni u akutnom i bolničkom okruženju.
Most dyspnoea events were mild or moderate in severity and the median duration of dyspnoea was two hours in patients receiving cangrelor (see section 4.8). 
Većina događaja dispneje bila je blage ili umjerene težine, a medijan trajanja dispneje bio je dva sata u bolesnika koji su primali kangrelor, (vidjeti dio 4.8).
Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus followed by an intravenous infusion. 
Kengrexal se primjenjuje režimom temeljenim na tjelesnoj težini koji se sastoji od početnog intravenskog bolusa nakon kojeg slijedi intravenska infuzija.
Reconstituted solution: the powder should be reconstituted immediately prior to dilution and use. 
Rekonstituirana otopina: prašak se mora rekonstituirati neposredno prije razrjeđivanja i primjene.
The metabolism of cangrelor is independent of organ function and does not interfere with other drugs metabolised by hepatic enzymes. 
Metabolizam kangrelora ne ovisi o funkciji organa niti interferira s drugim lijekovima koji se metaboliziraju jetrenim enzimima.
Cangrelor should be used with caution in patients with disease states associated with an increased bleeding risk. 
Kangrelor se mora primjenjivati uz oprez u bolesnika s bolesnim stanjima koja su povezana s povećanim rizikom od krvarenja.
• Bleeding leading to low platelet count or anaemia, 
• Krvarenje koje dovodi do niskog broja trombocita ili anemije,
Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal. 
Prašak u staklenim bočicama (staklo tipa 1) od 10 ml, zatvorenih čepom od butilne gume obložene
Cangrelor produced dose-related foetal growth retardation characterised by increased incidences of incomplete ossification and unossified hind limb metatarsals in rats. 
Reproduktivna toksičnost Kangrelor je izazvao zastoj u fetalnom rastu povezan s dozom koji je bio karakteriziran povećanim incidencijama nepotpune osifikacije i neosificiranih metatarzalnih dijelova stražnjih nogu u štakora.
Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound. 
Kangrelor se veže za proteine plazme 97-98%.
An analysis of non-coronary artery bypass grafting (CABG)-related bleeding is presented in Table 2. 
Analiza krvarenja koje nije povezano s operacijom ugradnje aortokoronarne premosnice (engl. coronary artery bypass graft, CABG) prikazana je u tablici 2.
Adverse reactions are classified according to frequency and system organ class. 
Nuspojave su klasificirane prema učestalosti i prema klasifikaciji organskih sustava.
Kengrexal is an anti-platelet medicine that contains the active substance cangrelor. 
Kengrexal je antitrombocitni lijek koji sadrži djelatnu tvar kangrelor.
Hepatic impairment No dose adjustment is needed (see section 5.2). 
Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
Key Secondary Endpoint 
Ključni sekundarni ishod
• balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls, 
• proširenje u stijenci arterije ili srca koje izgleda poput balončića, a zahvaća samo nekoliko slojeva stijenke krvnih žila,
A pharmacodynamic interaction study has also been conducted with cangrelor and ticagrelor. 
Ispitivanje farmakodinamičkih interakcija također je provedeno s kangrelorom i tikagrelorom.
Patients with HFI cannot break down fructose, which may cause serious side effects. 
Bolesnici s nasljednim nepodnošenjem fruktoze ne mogu razgraditi fruktozu sadržanu u ovom lijeku, što može uzrokovati ozbiljne nuspojave.
Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site. 
Iako se većina krvarenja povezanih s primjenom kangrelora pojavljuje na mjestu punkcije arterije,
Clopidogrel N=5,469 OR (95% CI) 
klopidogrel N= 5469 OR (95%-tni CI)
How to store Kengrexal 
Kako primjenjivati Kengrexal
Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration. 
Početak inhibicije P2Y12 događa se ubrzo nakon primjene kangrelora.
Table 2: Non-CABG-related bleeding GUSTO bleeding, n (%) CHAMPION pooled 
Tablica 2: Krvarenje koje nije povezano sa CABG Krvarenje prema kriterijima GUSTO, n (%) Objedinjeni podaci iz ispitivanja CHAMPION Kangrelor
Ecchymosis (petechiae, purpura) 
Poremećaji kože i potkožnog tkiva ekhimoza (petehije, purpura)
- If you have ever had a stroke, or a ‘mini-stroke' (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain. 
- ako imate nekontrolirani vrlo visok krvni tlak; - ako ste ikada imali moždani udar, ili mali moždani udar (još poznat pod nazivom tranzitorna ishemijska ataka, TIA) prouzročen privremenim prekidom dotoka krvi u mozak.
Bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors 
Bivalirudin, heparin male molekulske mase, fondaparinuks i inhibitori glikoproteinskih (GP) receptora Iib/IIIa
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Kengrexal is for injection, followed by infusion (drip), into a vein. 
Kengrexal je namijenjen za injekciju nakon koje slijedi infuzija (kapanje) u venu.
Any GUSTO bleeding Severe/life-threatening Moderate 
Bilo kakvo krvarenje prema kriterijima GUSTO Teško/opasno po život
There are no or limited amount of data from the use of Kengrexal in pregnant women. 
Nema podataka ili su podaci o primjeni lijeka Kengrexal u trudnica ograničeni.
Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by therapeutic concentrations of cangrelor or its major metabolites. 
Metabolizam kangrelora ne ovisi o enzimima CYP, terapijske koncentracije kangrelora niti njegovih glavnih metabolita ne inhibiraju izoenzime CYP-a.
Cangrelor N=5,462 
kangrelor N= 5462
Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo. 
Kengrexal sadrži kangrelor, izravan antagonist receptora P2Y12 trombocita koji blokira aktivaciju i agregaciju trombocita izazvanu adenozin difosfatom (ADP) in vitro i ex vivo.
Clopidogrel N=5,457 OR (95% CI) 
klopidogrel N= 5457 OR (95%-tni CI)
The most common adverse reactions with cangrelor include mild and moderate bleeding and dyspnoea. 
Najčešće nuspojave s kangrelorom uključuju blago i umjereno krvarenje i dispneju.
• You suffer from impaired kidney function or require dialysis. 
• ako imate oštećenu funkciju bubrega ili Vam je potrebna dijaliza;
Rash, pruritus, urticaria f 
osip, svrbež, urtikarija f angioedem
• heavy menstrual bleeding, 
• teško menstruacijsko krvarenje,
In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of cangrelor in clinical trials (see section 4.8). 
U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, prijavljeni su događaji akutnog zatajenja bubrega (0,1%), zatajenja bubrega (0,1%) i porasta kreatinina u serumu (0,2%) nakon primjene kangrelora u kliničkim ispitivanjima (vidjeti dio 4.8).
CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary Arteries; w/o: without a In the CHAMPION pooled analysis, GUSTO Mild was defined as other bleed not requiring blood transfusion or causing haemodynamic compromise. 
Global Use of Strategies to Open Coronary Arteries, globalna primjena strategija za otvaranje okludiranih arterija a U analizi objedinjenih ispitivanja CHAMPION, blagi GUSTO bio je definiran kao druga krvarenja koja ne zahtijevaju transfuziju krvi niti uzrokuju narušavanje hemodinamike.
Cardiac tamponade 
Srčana tamponada
Haematuria, blood urine present, urethral haemorrhage. 
hematurija, prisutnost krvi u mokraći, uretralno krvarenje f.
Cangrelor N=5,470 
kangrelor N= 5470
In pivotal studies conducted in patients undergoing PCI, there were more intracranial bleeds at 30 days with cangrelor (0.07%) than with clopidogrel (0.02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal. 
U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, bilo je više intrakranijalnih krvarenja nakon 30 dana s kangrelorom (0,07%) nego s klopidogrelom (0,02%), od kojih su 4 krvarenja s kangrelorom i 1 krvarenje s klopidogrelom imala smrtni ishod.
In pivotal studies conducted in patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than with clopidogrel (0.02%), (see section 4.8). 
U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, bilo je više srčanih tamponada nakon 30 dana s kangrelorom (0,12%) nego s klopidogrelom (0,02%), (vidjeti dio 4.8).
The GUSTO bleeding scale was measured in the CHAMPION (PHOENIX, PLATFORM, and PCI) clinical trials. 
U kliničkim ispitivanjima CHAMPION (PHOENIX, PLATFORM i PCI) izmjerena su krvarenja prema kriterijima skale GUSTO.