natgillin/translations-raw huggingface dataset:
Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction. 
Otprilike 23,3% bolesnika koji su primali bivalirudin imalo je najmanje jedan štetan događaj, dok je u 2,1% bolesnika došlo do nuspojava.
ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for patients that received acetylsalicylic acid and clopidogrel as per protocol* 
Table 4. Ispitivanje ACUITY: 30-dnevne i 1-godišnje razlike rizika za ishemijski kompozitni ishod i njegovih komponenata u bolesnika koji su dobivali acetilsalicilatnu kiselinu i klopidogrel prema planu ispitivanja*
Bleeding definitions and outcomes from the REPLACE-2 trial are shown in Table 6. 
Definicije krvarenja i ishodi ispitivanja REPLACE-2 prikazani su u tablici 6.
HOW TO STORE ANGIOX 
Kako čuvati Angiox
In STEMI patients undergoing primary PCI, standard pre-hospital adjunctive therapy should include clopidogrel and may include the early administration of UFH (See section 5.1). 
U bolesnika sa STEMI infarktom koji su podvrgnuti primarnoj PCI, standardna dodatna terapija prije hospitalizacije treba uključivati klopidogrel i može uključivati ranu terapiju nefrakcioniranim heparinom (vidjeti dio 5.1).
The clearance of bivalirudin is similar in patients with normal renal function and those with mild renal impairment. 
Klirens bivalirudina sličan je u bolesnika s normalnom funkcijom bubrega i bolesnika s blagim oštećenjem bubrega.
Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention. 
Angiox je također indiciran za liječenje bolesnika s nestabilnom anginom (UA)/infarktom miokarda bez ST-elevacije (NSTEMI) kod kojih se planira hitna ili rana intervencija.
Ferrer-Galenica A.E. Τηλ: +30 210 5281700 
Τηλ: +30 210 5281700
Five patients had a post-baseline nadir platelet count of <150,000 cells/mm 
Pet bolesnika imalo je najniži broj trombocita nakon početne vrijednosti od <150 000 stanica/mm
As a peptide, bivalirudin is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acid in the body pool. 
Bivalirudin je peptid te se očekuje njegov katabolizam do sastavnih aminokiselina, koje se sakupljaju u tijelu za ponovnu uporabu.
Approximately 30% of patients receiving bivalirudin experienced at least one adverse event and 3% experienced an adverse reaction. 
Otprilike 30% bolesnika koji su primali bivalirudin imalo je najmanje jedan štetan događaj, dok je u 3% bolesnika došlo do nuspojava.
The 30-day results based on quadruple and triple endpoints from a randomized, double-blind trial of over 6,000 patients undergoing PCI (REPLACE-2) are shown in Table 5. 
Tridesetodnevni rezultati (REPLACE-2) istraživanja, prikazani su u tablici 5. Radi se o randomiziranom, dvostruko slijepom ispitivanju s preko 6000 bolesnika podvrgnutih PCI, koje je temeljeno na četverostrukim i trostrukim ishodima.
If you need to have a coronary artery bypass graft operation, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given by injection followed by an infusion of 1.75 mg/kg body weight per hour for the duration of surgery. 
Ako trebate ići na operaciju premoštenja koronarnih arterija, liječenje bivalirudinom bit će prekinuto jedan sat prije operacije ili će Vam biti dana injekcija dodatne doze od 0,5 mg/kg tjelesne težine nakon čega će uslijediti infuzija brzinom od 1,75 mg/kg tjelesne težine na sat tijekom trajanja operacije.
• In patients with moderate renal impairment (GFR 30-59 ml/ min) the infusion rate should be reduced to 1.4 mg/kg/h. 
• U bolesnika s umjerenim oštećenjem bubrežne funkcije (GFR 30-59 ml/ min) brzina infuzije mora se smanjiti na 1,4 mg/kg/h.
The following medicinal products should not be administered in the same intravenous line as bivalirudin since they result in haze formation, micro-particulate formation or gross precipitation; alteplase, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin HCl. 
Sljedeći lijekovi ne smiju se davati u istoj intravenskoj liniji s bivalirudinom jer uzrokuju mutnoću, formiranje mikročestica ili grubo taloženje: alteplaza, amiodaronklorid, amfotericin B, klorpromazin klorid (HCl), diazepam, proklorperazinedisilat, reteplaza, streptokinaza i vankomicinklorid.
Coronary artery thrombosis and coronary stent thrombosis with myocardial infarction, and catheter thrombosis have each been reported rarely. 
Tromboza koronarne arterije i tromboza koronarnog stenta s infarktom miokarda te tromboza katetera rijetko su zabilježene.
Angiox should be initially reconstituted to give a solution of 50 mg/ml bivalirudin. 
Angiox treba prvo rekonstituirati da se dobije otopina od 50 mg/ml bivalirudina.
Serious adverse reactions were reported more frequently in the heparin plus GP IIb/IIIa group than the bivalirudin treated group. 
Ozbiljne nuspojave prijavljene su češće u grupi liječenoj heparinom s GP IIb/IIIa, nego u grupi ispitanika koja je dobivala bivalirudin.
The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl. 
Lijekovi koji su inkompatibilni s bivalirudinom kod viših koncentracija su: dobutaminklorid, famotidin, haloperidol laktat, labetalolklorid, lorazepam i prometazinklorid.
3, representing a ≥50% decrease in platelets from baseline. 
3, što predstavlja smanjenje broja trombocita od ≥50% u odnosu na početnu vrijednost.
Bleeding definitions and outcomes from the HORIZONS trial are shown in Table 6. 
Definicije krvarenja i ishoda ispitivanja HORIZONS prikazani su u tablici 6.
In Arm A of the ACUITY trial, UFH or enoxaparin was administered in accordance with the relevant guidelines for the management of ACS in patients with UA and NSTEMI. 
Grupi ispitanika A u ispitivanju ACUITY bio je dan nefrakcionirani heparin ili enoksaparin u skladu s relevantnim smjernicama liječenja ACS-a u bolesnika s nestabilnom anginom i NSTEMI.
For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous infusion of bivalirudin should be continued until the time of surgery. 
Kod bolesnika koji idu na operaciju ugradnje srčanih premosnica (coronary artery bypass graft, CABG) bez ekstrakorporalne cirkulacije («off pump»), treba nastaviti s intravenskom infuzijom bivalirudina do vremena operacije.
Common side effects (may affect up to 1 in 10 people): 
Česte nuspojave (mogu zahvatiti do 1 na 10 osoba):
Co-administration with platelet inhibitors or anti-coagulants 
Istovremena primjena inhibitora trombocita ili antikoagulansa
In patients with mild or moderate renal insufficiency, the ACS dose (0.1 mg/kg bolus/0.25 mg/kg/h infusion) should not be adjusted. 
U bolesnika s blagom ili umjerenom bubrežnom insuficijencijom ne treba prilagoditi dozu za ACS (bolus 0,1 mg/kg/infuzija 0,25 mg/kg/sat).
Bleeding has been observed in some reports of overdose. 
U nekim izvješćima o predoziranju, opaženo je krvarenje.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8C. 
Rekonstituirana otopina: Kemijska i fizikalna stabilnost u uporabi dokazana je za 24 sata pri 2-8
Angiox contains sodium 
Angiox sadrži natrij
• In patients receiving warfarin, INR is increased by administration of bivalirudin. 
• U bolesnika koji primaju varfarin primjenom bivalirudina povećava se INR.
Rare (≥1/10,000 to 
Rijetko (≥1/10 000 i
Reperfusion injury (no or slow reflow), Contusion a. ADRs identified in post-marketing experience b. Compartment syndrome has been reported as a complication of forearm haematoma following administration of bivalirudin via the radial access route in post-marketing experience c. Further detail regarding stent thrombosis is provided in section 4.8: The HORIZONS Trial (Patients with STEMI undergoing primary PCI). 
Kompartment sindrom bio je, prema postmarketinškom iskustvu, zabilježen kao komplikacija hematoma podlaktice nakon primjene bivalirudina radijalnim pristupom c. Više detalja u vezi s trombozom stenta prikazano je u dijelu 4.8: Ispitivanje HORIZONS (bolesnici sa STEMIjem na kojima se provodi primarni PCI).
Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”. 
Pomoćna tvar Angiox sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
Angiox is intended for intravenous use. 
Način primjene Angiox je namijenjen intravenskoj primjeni.
Angiox is contraindicated in patients with severe renal insufficiency (GFR<30 ml/min) and also in dialysis-dependent patients (see section 4.3). 
Angiox je kontraindiciran u bolesnika s teškom bubrežnom insuficijencijom (GFR <30 ml/min), kao i u bolesnika koji ovise o dijalizi (vidjeti dio 4.3).
In healthy volunteers and patients, bivalirudin exhibits dose- and concentration-dependent anticoagulant activity as evidenced as prolongation of the ACT, aPTT, PT, INR and TT. Intravenous administration of bivalirudin produces measurable anticoagulation within minutes. 
U zdravih dobrovoljaca i bolesnika, bivalirudin pokazuje antikoagulantnu aktivnost koja je ovisna o dozi i koncentraciji, što se očituje produljenjem ACT-a, APTV-a, PV-a, INR-a, ITV-a.
If you have any further questions on the use of this medicine, ask your doctor. 
Obratite se liječniku ako imate više pitanja o uporabi ovog lijeka.
The recommended starting dose of bivalirudin for medically managed patients with acute coronary syndrome (ACS) is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h. 
Preporučena početna doza bivalirudina za medikamentozno liječene bolesnike s akutnim koronarnim sindromom (ACS-om) je intravenski bolus od 0,1 mg/kg nakon čega slijedi infuzija od 0,25 mg/kg/sat.
The dose of bivalirudin used in HORIZONS was the same as that used in the REPLACE-2 study (0.75 mg/kg bolus followed by a 1.75 mg/kg body weight/hour infusion). 
Primijenjena doza bivalirudina u ispitivanju HORIZONS bila je ista kao i za ispitivanje REPLACE-2 (bolus od 0,75 mg/kg nakon čega je uslijedila infuzija od 1,75 mg/kg tjelesne težine/sat).
Lyophilised (freeze-dried) powder: Do not store above 25C. 
Liofilizirani (osušen smrzavanjem) prašak: Ne čuvati na temperaturi iznad 25 C.
Angiox 250 mg powder for concentrate for solution for injection or infusion. 
Angiox 250 mg prašak za koncentrat za otopinu za injekciju ili infuziju.
The bolus dose remains 0.75 mg/kg (or 0.5 mg/kg in patients who proceed to PCI after receiving bivalirudin pre-cath lab (UA/NSTEMI)). 
Bolus doza ostaje 0,75 mg/kg (ili 0,5 mg/kg u bolesnika koji idu na PCI nakon što su primili bivalirudin prije kateterizacije (UA/NSTEMI)).
The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 10 out of 20 patients also received a GP IIb/IIIa inhibitor. 
Većina ovih bolesnika istovremeno je primila acetilsalicilatnu kiselinu i klopidogrel, a 10 od 20 bolesnika su također dobivali i inhibitor GP IIb/IIIa.
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava trombocitopenija,
The bolus dose remains 0.75 mg/kg; or 0.5 mg/kg in patients who proceed to PCI after receiving bivalirudin pre-cath lab (UA/NSTEMI). 
Bolus doza ostaje 0,75 mg/kg; ili 0,5 mg/kg u bolesnika koji koji idu na PCI nakon što su primili bivalirudin prije kateterizacije (UA/NSTEMI).
Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI 
Bolesnici koji se podvrgavaju perkutanoj koronarnoj intervenciji (PCI), uključujući bolesnike s infarktom miokarda sa ST-elevacijom (STEMI) podvrgnute primarnom PCI-ju
The following data are based on a clinical study of bivalirudin in patients with STEMI undergoing primary PCI; 1,800 patients were randomised to bivalirudin alone, 1,802 were randomised to heparin plus GP IIb/IIIa inhibitor. 
Sljedeći su podaci temeljeni na kliničkom ispitivanju s bivalirudinom u bolesnika sa STEMI-jem u kojih se provodi primarni PCI; 1800 bolesnika je randomizirano samo za bivalirudin, 1802 bolesnika je randomizirano za heparin s inhibitorom GP IIb/IIIa.
Clinical trials in a small number of patients have provided limited information about the use of Angiox in patients with HIT/HITTS. 
Klinička ispitivanja s malim brojem bolesnika dala su ograničene informacije o uporabi Angioxa u bolesnika s trombocitopenijom uzrokovanom heparinom i sindromom trombocitopenije/tromboze uzrokovane heparinom.
Brachytherapy 
Brahiterapija
these medicines may increase the risk of side effects such as bleeding when given at the same time as Angiox. 
Ako se daju istovremeno kad i Angiox, ti lijekovi mogu povećati opasnost od nuspojava kao što je krvarenje.
The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 6 out of the 10 patients also received a GP IIb/IIIa inhibitor. 
Većina ovih bolesnika istovremeno je primila acetilsalicilatnu kiselinu i klopidogrel, a 6 od 10 bolesnika dobivali su i inhibitor GP IIb/IIIa.
• Approved dose in patients undergoing percutaneous coronary intervention (PCI): The licensed and approved dosing regimen of Angiox is an intravenous (IV) bolus injection of 0.75 mg/kg body weight followed immediately by an intravenous infusion at 1.75 mg/kg/hour for at least the duration of the PCI. 
• Odobrenu dozu u bolesnika kod kojih se provodi perkutana koronarna intervencija (PCI): Licenciran i odobren raspored doziranja Angioxa je intravenska (i.v.) bolus injekcija od 0,75 mg/kg tjelesne težine nakon čega odmah slijedi intravenska infuzija pri 1,75 mg/kg/sat, barem tijekom trajanja PCI-ja.
Major bleeding rates for the intent-to-treat trial population are shown in Table 6. 
Stope velikih krvarenja u ispitivanoj populaciji s namjerom liječenja (ITT) prikazane su u tablici 6.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE
Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia-thrombosis syndrome (HIT/HITTS) 
Trombocitopenija uzrokovana heparinom i sindrom trombocitopenije/tromboze uzrokovan heparinom
Major bleeding rates in clinical trials of bivalirudin 30 day endpoints for intent-to 
Tablica 6. Stope velikih krvarenja u 30-dnevnim ishodima kliničkih ispitivanjima s bivalirudinom u populaciji s namjerom liječenja.
Your treatment with Angiox will be supervised by a doctor. 
Liječnik će nadzirati Vaše liječenje Angioxom.
In ACUITY, bleeding data were collected separately from adverse reactions. 
U ACUITY ispitivanju podaci o krvarenju sakupljani su odvojeno od nuspojava.
After being treated with Angiox for a cardiac event, you should stay in the hospital for at least 24 hours and you should be monitored for any symptoms or signs similar to the ones that remind you of your cardiac event and resulted in your hospitalisation. 
Vas se nadzirati na bilo koje simptome ili znakove slične onima koji Vas podsjećaju na Vaš srčani događaj zbog čega ste i primljeni u bolnicu.
The solution should be a clear to slightly opalescent, colourless to slightly yellow solution. 
Otopina treba biti bistra do blago opalescentna, bezbojna do blago žuta.
In Arms B and C of the ACUITY trial, the recommended dose of bivalirudin was an initial postrandomisation intravenous bolus of 0.1 mg/kg followed by a continuous intravenous infusion of 0.25 mg/kg/h during angiography or as clinically warranted. 
U grupama B i C ispitivanja ACUITY preporučena doza bivalirudina bila je kako slijedi: početni postrandomizacijski intravenski bolus od 0,1 mg/kg, nakon čega je uslijedila kontinuirana intravenskainfuzija od 0,25 mg/kg/sat tijekom angiografije ili kako je to zahtijevala klinička slika.
All of these bivalirudintreated patients received concomitant acetylsalicylic acid, all but 1 received clopidogrel and 15 also received a GP IIb/IIIa inhibitor. 
Svi bolesnici liječeni bivalirudinom primali su istovremeno i acetilsalicilatnu kiselinu, svi osim jednog primali su klopidogrel, a njih je 15 također primalo inhibitor GP IIb/IIIa.
Angiox is a white to off-white powder in a glass vial. 
Angiox je prašak za koncentrat za otopinu za injekciju ili infuziju (prašak za koncentrat) Angiox je bijeli do gotovo bijeli prašak u staklenoj bočici.
The incidence of major and minor bleeding was significantly less in patients treated with bivalirudin versus patients treated with heparin plus a GP IIb/IIIa inhibitor. 
Incidencija velikih i malih krvarenja bila je značajno manja u bolesnika liječenih bivalirudinom naspram bolesnika liječenih heparinom i inhibitorom GP IIb/IIIa.
Angiox 250 mg powder for concentrate for solution for injection or infusion bivalirudin 
Angiox 250 mg prašak za koncentrat za otopinu za injekciju ili infuziju bivalirudin
In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10). 
Velika i mala krvarenja često su se pojavljivala u ispitivanju HORIZONS (1/100 i <1/10).
Intra-procedural thrombus formation has been observed during gamma brachytherapy procedures with Angiox. 
Tijekom postupaka gama brahiterapije i liječenja lijekom Angiox opaženo je intraproceduralno stvaranje tromba.
Arm C bival alone (N=2,911) 
Grupa C samo bival (N=2911)
Per-protocol bivalirudin (N=2,994) 
Prema planu ispitivanja bivalirudin (N=2994)
Gastrointestinal haemorrhage (including haematemesis, melaena, oesophageal haemorrhage, anal haemorrhage), Retroperitoneal haemorrhage, Gingival haemorrhage, Nausea 
Poremećaji probavnog sustava gastrointestinalno krvarenje (uključujući hematemezu, melenu, ezofagealno krvarenje, analno krvarenje), retroperitonealno krvarenje, gingivalno krvarenje, mučnina peritonealno krvarenje, retroperitonealni hematom, povraćanje
Rare side effects (may affect up to 1 in 1000 people) 
Rijetke nuspojave (mogu zahvatiti do 1 na 1000 osoba):
Do not use without dilution. 
Ne koristiti nerazrijeđeno.
For patients undergoing PCI, an additional intravenous bolus of 0.5 mg/kg bivalirudin was administered and the rate of intravenous infusion increased to 1.75 mg/kg/h. 
Za bolesnike kod kojih se vršio PCI primijenjen je dodatni intravenski bolus od 0,5 mg/kg bivalirudina, a brzina intravenske infuzije povišena je na 1,75 mg/kg/sat.
Adverse drug reactions for bivalirudin are listed by system organ class in Table 1.The incidence of stent thrombosis within the first 24 hours was 1.5% in patients receiving bivalirudin versus 0.3% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.0002). 
Incidencija tromboze stenta unutar prva 24 sata u bolesnika koji su dobivali bivalirudin bila je 1,5% naspram 0,3% bolesnika koji su dobivali UFH s inhibitorom GP IIb/IIIa (p=0,0002).
Increased awareness due to high bleeding risk should be exercised in the elderly because of age-related decrease in renal function. 
Kod starijih bolesnika je potreban pojačan oprez od velikog rizika od krvarenja budući se s godinama starosti smanjuje bubrežna funkcija.Prilagodbu doze za tu dobnu skupinu treba temeljiti na bubrežnoj funkciji.
Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary. 
Nakon PCI-ja, može se nastaviti smanjenom dozom infuzije od 0,25 mg/kg/sat tijekom 4-12 sati, prema kliničkim potrebama.
The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)) 
ACUITY ispitivanje (bolesnici s nestabilnom anginom/infarktom miokarda bez elevacije ST segmenta (UA/NSTEMI))
• Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min) and in dialysis-dependent patients. 
• Angiox je kontraindiciran u bolesnika s teškom bubrežnom insuficijencijom (brzina glomerularne filtracije, GFR < 30 ml/min) i u bolesnika ovisnih o dijalizi.
Major Adverse Cardiac/Ischaemic Events (MACE) was defined as the occurrence of any of the following; death, reinfarction, stroke or ischaemic target vessel revascularisation. 
Revaskularizacija ishemične ciljne žile Moždani udar definiran je kao pojava jednog od sljedećeg: smrt, ponovni infarkt, moždani udar ili revaskularizacija ishemične ciljne žile.
• severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients. 
• teškim oštećenjem bubrega (GFR<30 ml/min) i u bolesnika ovisnih o dijalizi.
The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of 0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure. 
Preporučena doza bivalirudina za bolesnike podvrgnute PCI-ju je intravenski bolus od 0,75 mg/kg tjelesne težine, nakon čega odmah slijedi intravenska infuzija brzinom od 1,75 mg/kg tjelesne težine/sat, barem tijekom trajanja postupka.
REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations 
Tablica 5. Rezultati ispitivanja REPLACE-2: 30-dnevni ishodi (populacija s namjerom liječenja (ITT) i populacija prema planu ispitivanja)
50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin. 
- Nakon razrjeđivanja (miješanje 5 ml pripremljene otopine u vrećicu s infuzijom [ukupnog volumena 50 ml] otopine glukoze ili natrijeva klorida) 1ml sadrži 5 mg bivalirudina.
If the medically managed patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure. 
Ako medikamentozno liječen bolesnik ide na PCI, prije postupka treba primijeniti dodatni bolus od 0,5 mg/kg bivalirudina, a infuziju treba povećati na 1,75 mg/kg/sat tijekom trajanja postupka.
INR increased d 
Pretrage povećan INR
Adverse reactions for bivalirudin are listed by system organ class in Table 1. 
Nuspojave na bivalirudin navedene su prema klasifikaciji organskih sustava u tablici 1.
Bival + GP IIb/IIIa inhibitor 
Bival + inhibitor GP IIb/IIIa
• When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight per hour 
• Po završetku ove terapije, brzinu infuzije se može vratiti na 0,25 mg/kg tjelesne težine na sat tijekom dodatnih 4 do 12 sati.
+ GP IIb/IIIa inhibitor (%) 
+ inhibitor GP IIb/IIIa (%)
Nervous system disorders 
Poremećaji živčanog sustava intrakranijalno krvarenje
Adverse events were more frequent in females and in patients more than 65 years of age in both the bivalirudin and the heparin-treated comparator groups compared to male or younger patients. 
U usporedbi s muškim ili mlađim bolesnicima, nuspojave su bile učestalije u žena i bolesnika starijih od 65 godina u obje uspoređivane grupe ispitanika (liječeni bivalirudinom ili heparinom).
Medicinal products with dose concentration incompatibilities 
Inkompatibilni lijekovi ovisno o koncentraciji doze
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
6%) of bivalirudin-treated patients and in 67 (3.9%) of patients treated with heparin plus a GP IIb/IIIa inhibitor. 
Trombocitopenija je u ispitivanju HORIZONS prijavljena u 26 (1,6%) bolesnika liječenih bivalirudinom i u 67 (3,9%) bolesnika liječenih heparinom i inhibitorom GP IIb/IIIa.
• 0.75 mg/kg body weight as an intravenous injection, followed immediately by an infusion (drip) into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI. 
• 0,75 mg/kg tjelesne težine kao injekcija u venu, nakon čega odmah slijedi infuzija (drip) u venu od 1,75 mg/kg tjelesne težine na sat barem tijekom trajanja PCI-ja.
The incidence of both ACUITY-scale and TIMI-scale bleeding events to day 30 for the per protocol population are presented in Table 7. 
Incidencija krvarenja, prema ljestvicama ACTUITY i TIMI, do 30 dana u populaciji s namjerom liječenja (ITT) prikazana je u tablici 6. Incidencija krvarenja, prema ljestvicama ACTUITY i TIMI za 30 dana za populaciju prema planu ispitivanja prikazana je u tablici 7.
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva osip, urtikarija