natgillin/translations-raw huggingface dataset:
In vitro studies have also shown that bivalirudin prolongs the activated partial thromboplastin time (aPTT) thrombin time (TT) and pro-thrombin time (PT) of normal human plasma in a concentrationdependent manner and that bivalirudin does not induce a platelet aggregation response against sera from patients with a history of Heparin-Induced Thrombocytopenia/Thrombosis Syndrome (HIT/HITTS). 
Študije in vitro kažejo tudi, da bivalirudin od koncentacije odvisno podaljša aktivirani parcialni tromboplastinski čas (aTPČ), trombinski čas (TČ) in protrombinski čas (PČ) normalne človeške plazme in da bivalirudin ne povzroča agregacije krvnih ploščic kot odziv na serum pri bolnikih s heparinsko povzročenim sindromom trombocitopenije/tromboze (HIT/HITTS - »Heparin-Induced Thrombocytopenia/Thrombosis Syndrom«) v anamnezi.
Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia-thrombosis syndrome (HIT/HITTS) 
Heparinsko povzročena trombocitopenija (HIT - »»Heparin-Induced Thrombocytopenia«) in heparinsko povzročeni sindrom trombocitopenije/tromboze (HIT/HITTS - »Heparin-Induced Thrombocytopenia/Thrombosis Syndrom«)
Prolonged post PCI infusions of bivalirudin at recommended doses have not been associated with an increased rate of bleeding (see section 4.2). 
Podaljšane infuzije bivalirudina po PCI v priporočenih odmerkih niso bile povezane s povečano pogostostjo krvavitev (glejte poglavje 4.2).
The pharmacodynamic effects of bivalirudin may be assessed using measures of anticoagulation including the ACT. 
Farmakodinamične učinke bivalirudina lahko ocenimo s pomočjo merjenja antikoagulacije z ACT.
Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see sections 4.8 and 5.1). 
Akutna tromboza stenta (< 24 ur) se pojavlja pri bolnikih s STEMI, pri katerih se izvaja primarna PCI in je bila izvedena revaskularizacija prizadete žile (TVR) (glejte poglavji 4.8 in 5.1).
Your warfarin blood test result (INR test) may be affected by Angiox. 
Zdravilo Angiox lahko vpliva na vaš krvni izvid varfarina (INR test).
Hypersensitivity, including anaphylactic reaction and shock, including reports with fatal outcome 
Bolezni imunskega sistema preobčutljivost, vključno z anafilaktično reakcijo in šokom, vključno s poročili o smrtnem
The systemic clearance of bivalirudin decreases with glomerular filtration rate (GFR). 
Telesni očistek bivalirudina se zmanjšuje s stopnjo glomerularne filtracije (GFR - »glomerular filtration rate«).
This increased risk of acute stent thrombosis was observed during the first 4 hours following the end of the procedure among patients who either discontinued the infusion of bivalirudin at the end of the procedure or received a continued infusion at the reduced dose of 0.25 mg/kg/h (see section 4.2). 
To povečano tveganje za akutno trombozo stenta so opazili v prvih 4 urah po koncu postopka pri bolnikih, ki so prekinili infuzijo bivalirudina na koncu postopka ali nadaljevali infuzijo z zmanjšanim odmerkom 0,25 mg/kg/h (glejte poglavje 4.2).
The clearance of bivalirudin is similar in patients with normal renal function and those with mild renal impairment. 
Očistek bivalirudina je podoben pri bolnikih z normalno ledvično funkcijo in blago ledvično okvaro.
It is, therefore, unlikely to affect your ability to drive or to use machines. 
Zaradi tega je verjetnost vpliva na vaše sposobnosti upravljanja vozil in strojev majhna.
The reconstituted/diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution. 
Rekonstituirana/razredčena raztopina bo bistra do rahlo opalescentna, brezbarvna do rahlo rumene barve.
The steady-state volume of distribution is 0.1 l/kg. 
Volumen porazdelitve v stanju dinamičnega ravnovesja je 0,1 l/kg.
The binding of bivalirudin to thrombin, and therefore its activity, is reversible as thrombin slowly cleaves the bivalirudin, Arg3-Pro4, bond, resulting in recovery of thrombin active site function. 
Vezava bivalirudina na trombin in njegova aktivnost je reverzibilna, saj trombin počasi cepi bivalirudinijevo vez Arg3-Pro4, kar povzroči povrnitev funkcije aktivnega mesta trombina.
The other ingredients are mannitol and sodium hydroxide 2% (for pH adjustment) 
Drugi sestavini zdravila sta manitol in 2 % raztopina natrijevega hidroksida (za uravnavanje pH)
Thrombocytopenia was reported in 10 bivalirudin-treated patients participating in the ACUITY study (0.1%). 
O trombocitopeniji so poročali pri 10 bolnikih, ki so jih zdravili z bivalirudinom, ki so sodelovali v študiji ACUITY (0,1 %).
Angiox has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Angiox nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The REPLACE-2 Trial (Patients undergoing PCI) 
Preskušanje REPLACE-2 (Bolniki med PCI)
The safety and efficacy of a bolus without subsequent infusion dose of ANGIOX has not been evaluated and is not recommended even if a short PCI procedure is planned. 
Varnost in učinkovitost bolusa brez naknadne infuzije odmerka zdravila ANGIOX ni bila ocenjena in ni priporočena, tudi če se načrtuje krajši poseg PCI.
The infusion dose should be initiated immediately after the bolus dose is administered, ensuring delivery to the patient prior to the procedure, and continued uninterrupted for the duration of the procedure. 
Odmerek infuzije je treba sprožiti takoj po bolusnem odmerku, zagotoviti, da infundirani odmerek doseže bolnika pred postopkom, ter zagotoviti neprekinjeno dajanje med trajanjem postopka.
What Angiox looks like and contents of the pack 
Izgled zdravila Angiox in vsebina pakiranja
• Angiox must be administered as a bolus dose followed immediately by an intravenous infusion, even if a short PCI procedure is planned. 
• Zdravilo Angiox je treba dati kot bolusni odmerek, ki mu takoj sledi intravenska infuzija, tudi če se načrtuje krajši poseg PCI.
All patients received acetylsalicylic acid and clopidogrel with twice as many patients (approximately 64%) receiving a 600mg loading dose of clopidogrel than a 300mg loading dose of clopidogrel. 
Vsi bolniki so prejeli acetilsalicilno kislino in klopidogrel, pri čemer je 600 mg začetni odmerek klopidogrela prejelo dvakrat toliko bolnikov (približno 64 %) kot 300 mg začetni odmerek klopidogrela.
Dose adjustments for this age group should be on the basis of renal function, see section 4.2. 
Prilagoditev odmerkov za to starostno skupino mora biti odvisna od ledvične funkcije; glejte poglavje
Patients should remain for at least 24 hours in a facility capable of managing ischaemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia. 
Bolniki morajo vsaj 24 ur ostati v oskrbi, kjer jih lahko oskrbijo, če pride do ishemičnih zapletov in kjer jih po primarni PCI pozorno spremljajo glede znakov in simptomov, ki kažejo na miokardno ishemijo.
Intra-procedural thrombus formation has been observed during gamma brachytherapy procedures with Angiox. 
Med gama brahiterapevtskimi postopki z zdravilom Angiox je bila med postopkom opažena tvorba trombusa.
Pharmacokinetic parameters for bivalirudin in patients with normal and impaired 
Farmakokinetični parametri za bivalirudin pri bolnikih z normalno in okvarjeno ledvično funkcijo.
Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials. 
V kliničnih preskušanjih so poročali o primerih prevelikih odmerkov, ki so bili do 10-krat višji od priporočenega odmerka.
- After dilution (mixing of 5 ml of the reconstituted solution into an infusion bag [total volume of 
- Po nadalnjem redčenju (5 ml rekonstituirane raztopine se v infuzijski vrečki [skupni volumen 50
Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg/h infusion dose is properly administered. 
Ko vrednost ACT preseže 225 sekund, nadaljnji nadzor ni potreben, če je infuzijski odmerek 1,75 mg/kg/h dan pravilno.
Very common side effects (may affect more than 1 in 10 people): • Minor bleeding 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): • manjša krvavitev
This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodiumfree”. 
Zdravilo Angiox vsebuje manj kot 23 mg natrija na vialo, to dejansko pomeni, da je »brez natrija«.
• In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice. 
• V klinični praksi EU so poročali dajanju bolusa (brez naknadne infuzije).
Thrombosis includes coronary artery thrombosis (blood clot in the heart arteries or within a stent being felt as a heart attack which can also be fatal) and/or thrombosis in the catheter, both of which are rare (may affect up 
Tromboza vključuje trombozo koronarne arterije (krvni strdek v srčni arteriji ali znotraj stenta, kar se čuti kot srčni napad, ki je prav tako lahko smrten) in/ali trombozo v katetru, oba pojava sta redka (pojavita se lahko pri največ 1 od 1.000 bolnikov).
There are no gender effects in the pharmacokinetics of bivalirudin. 
Spol ne vpliva na farmakokinetiko bivalirudina.
The mean steadystate concentration of bivalirudin following a constant intravenous infusion of 2.5 mg/kg/h is 12.4 µg/ml. 
Povprečna koncentracija bivalirudina v stanju dinamičnega ravnovesja po konstantni intravenski infuziji 2,5 mg/kg/h je 12,4 µg/ml.
The HORIZONS Trial (Patients with STEMI undergoing primary PCI) 
Preskušanje HORIZONS (Bolniki s STEMI pri katerih se izvede primarna PCI)
• In patients with moderate renal impairment (GFR 30-59 ml/ min) the infusion rate should be reduced to 1.4 mg/kg/h. 
• Pri bolnikih z zmerno ledvično insuficienco (GFR 30-59 ml/min) je treba hitrost infuzije zmanjšati na 1,4 mg/kg/h.
Compatible concentrations Incompatible concentrations 
Združljive koncentracije
Patients with moderate renal impairment (GFR 30-59 ml/min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h. 
Bolniki z zmerno okvaro ledvic (GFR 30-59 ml/min), ki prestajajo PCI (ne glede na to, ali se zaradi AKS zdravijo z bivalirudinom ali ne), bi morali prejemati nižji infuzijski odmerek, ki je 1,4 mg/kg/h.
The following data are based on a clinical study of bivalirudin in 13,819 patients with ACS; 4,612 were randomised to bivalirudin alone, 4,604 were randomised to bivalirudin plus GP IIb/IIIa inhibitor and 4,603 were randomised to either unfractionated heparin or enoxaparin plus GP IIb/IIIa inhibitor. 
Naslednji podatki temeljijo na klinični študiji z bivalirudinom pri 13.819 bolnikih z AKS, od katerih so jih 4.612 randomizirali v skupino, ki je prejemala le bivalirudin, 4.604 jih je bilo randomiziranih v skupino, ki je prejemala bivalirudin skupaj z inhibitorjem GP IIb/IIIa, 4.603 pa jih je bilo randomiziranih v skupino z nefrakcioniranim heparinom ali enoksaparinom in inhibitorjem GP IIb/IIIa.
• For patients undergoing PCI, bivalirudin MUST be administered initially as an intravenous bolus followed immediately by an infusion. 
• Bolnikom med PCI je treba bivalirudin najprej dati kot intravenski bolus, ki mu takoj sledi infuzija.
This is administered and supervised by a doctor experienced in caring for patients with heart disease. 
Zdravilo vam bo dal in zdravljenje nadzoroval zdravnik z izkušnjami z zdravljenem srčnih bolnikov.
Major bleeding rates are shown in Table 6 for the IIT population and Table 7 for the per protocol population (patients receiving clopidogrel and acetylsalicylic acid). 
Deleži večjih krvavitev so prikazani v preglednici 6 za populacijo, ki predhodno še ni bila zdravljena (ITT) in v preglednici 7 za bolnike po protokolu (bolniki, ki prejemajo klopidogrel in acetilsalicilno kislino).
Bivalirudin is metabolized by proteases, including thrombin. 
Bivalirudin presnavljajo proteaze, vključno s trombinom.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. 
Ne shranjujte dlje kot 24 ur pri temperaturi med oC in 8 °C, razen če rekonstitucija in redčenje nista bila opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
For patients with acute coronary syndromes (ACS) who are treated medically the recommended starting dose is: 
Za bolnike z akutnim koronarnim sindromom (AKS), ki se zdravijo je priporočen začetni odmerek:
3, representing a ≥50% decrease in platelets from baseline. 
3, kar predstavlja ≥ 50 % zmanjšanje števila trombocitov glede na izhodišče.
In REPLACE-2 thrombocytopenia occurred in 20 bivalirudin-treated patients (0.7%). 
Pri študiji REPLACE-2 se je trombocitopenija pojavila pri 20 bolnikih, ki so bili zdravljeni z bivalirudinom (0,7%).
For patients who proceed to CABG surgery on pump, the intravenous infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin (UFH). 
Pri bolnikih, ki bodo deležni kirurškega postopka CABG ob uporabi črpalke, morate z intravensko infuzijo bivalirudina nadaljevati do 1 ure pred operacijo, po postopku pa infuzijo prekiniti in bolnika zdraviti z nefrakcioniranim heparinom (UFH).
Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours. 
Pri bolnikih, ki bodo v nadaljnji zdravstveni obdelavi, lahko nadaljujete z infuzijo 0,25 mg/kg/h, do 72 ur.
The ACUITY trial was a prospective, randomised open-label, trial of bivalirudin with or without GP IIb/IIIa inhibitor (Arms B and C respectively) versus unfractionated heparin or enoxaparin with GP IIb/IIIa inhibitor (Arm A) in 13,819 high risk ACS patients. 
Študija ACUITY je bila prospektivna, odprta, randomizirana študija bivalirudina z ali brez inhibitorja GP IIb/IIIa (krak B in krak C v istem vrstnem redu) v primerjavi z nefrakcioniranim heparinom ali enoksaparinom z inhibitorjem GP IIb/IIIa (krak A) pri 13.819 bolnikih z visokim tveganjem za AKS.
Five patients had a post-baseline nadir platelet count of <150,000 cells/mm 
Pet bolnikov je imelo po izhodišču najnižje število trombocitov < 150.000 celic/mm
The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS. 
Farmakokinetične lastnosti bivalirudina so bile ovrednotene in so linearne pri bolnikih med perkutano koronarno intervencijo in pri bolnikih z akutnim koronarnim sindromom (AKS).
If you are breast-feeding, the doctor will decide whether Angiox should be used. 
Če dojite, bo zdravnik odločil, ali lahko uporabljate zdravilo Angiox.
Medicinal products with dose concentration incompatibilities 
Nezdružljiva zdravila glede na odmerek/koncentracijo incompatibilities
In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10). 
V študiji HORIZONS so se večje in manjše krvavitve pojavile pogosto (≥ 1/100 do < 1/10).
2Major bleeding was defined using the ACUITY bleeding scale. 
Večja krvavitev je opredeljena na osnovi ACUITY lestvice krvavitev.
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. 
Naslednjih zdravil ne dajajte po isti intravenski poti kot bivalirudin, ker ima to lahko za posledico tvorbo razpršenih kapljic, mikrodelcev ali močno precipitacijo; alteplas, amiodaronijev klorid, amfotericin B, klorpromazinijev klorid, diazepam, proklorperazin edisilat, reteplas, streptokinaza in vankomicinijev klorid.
In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin. 
Študije in vitro kažejo, da bivalirudin inhibira tako topni (prosti) kot tudi na strdek vezani trombin.
A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction. 
55,1 % bolnikov, ki so prejemali bivalirudin, je izkusilo vsaj en neželen dogodek, 8,7 % bolnikov pa je izkusilo neželen učinek zdravila.
REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations 
Rezultati študije REPLACE-2: opazovani dogodki (vključena populacija ("intent-to-treat") in populacija po protokolu) po 30 dneh
Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban. 
Interakcijske študije so bile izvedene z inhibitorji krvnih ploščic, vključno z acetilsalicilno kislino, tiklopidinom, klopidogrelom, abciksimabom, eptifibatidom ali tirofibanom.
Such a reaction is uncommon (may affect up to 1 in 100 people). 
Takšne reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov)
A total of 3,602 patients were randomised to receive either bivalirudin (1,800 patients) or unfractionated heparin plus a GP IIb/IIIa inhibitor (1,802 patients). 
3.602 randomiziranih bolnikov je prejelo ali bivalirudin (1.800 bolnikov) ali nefrakcioniran heparin in zaviralec GP IIb/IIIa (1.802 bolnikov).
Per-protocol bivalirudin (N=2,994) 
Po protokolu bivalirudin (N=2.994)
Medicinal products with dose concentration incompatibilities to bivalirudin. 
Zdravila glede na odmerek/koncentracijo, ki niso združljiva z bivalirudinom.
Use with other anticoagulant therapy 
Uporaba z drugimi antikoagulanti:
Do not use Angiox 
Ne uporabljajte zdravila Angiox:
A total of 17 deaths occurred after subacute stent thrombosis, 3 in the bivalirudin arm and 14 in the UFH plus GP IIb/IIIa arm. 
Po subakutni trombozi stenta je bilo skupaj 17 smrtnih žrtev, 3 iz kraka z bivalirudinom in 14 pri UFH in GP IIb/IIIa.
Reconstituted solution: Store in a refrigerator (2 - 8 
Rekonstituirana raztopina: Shranjujte v hladilniku (2
Two deaths occurred after acute stent thrombosis, 1 in each arm of the study. 
Po akutni trombozi sta se pojavili dva smrtna primera, vsak iz enega kraka študije.
• Angiox must be administered as a bolus dose followed immediately by an intravenous infusion, 
• Zdravilo Angiox je treba dati kot bolusni odmerek, ki mu takoj sledi intravenska infuzija, tudi
Healthcare providers are recommended to refer to the Angiox Summary of Product Characteristics for full information on dosing. 
Zdravstvenim delavcem se priporoča, naj si za vse informacije o odmerjanju ogledajo povzetek glavnih značilnosti zdravila Angiox.
Angiox is contraindicated in patients with: 
Angiox je kontraindiciran pri bolnikih z:
Swelling or pain in the groin or the arm, back pain, bruising, headache, coughing blood, pink or red urine, sweating, feeling faint or sick or dizzy due to low blood pressure may be signs of internal bleeding. 
Znaki notranje krvavitve so lahko otekanje ali bolečina v dimljah ali roki, bolečina v križu, modrice, glavobol, izkašljevanje krvi, roza ali rdeč urin, potenje, občutek omedlevice, slabosti ali omotičnosti zaradi nizkega krvnega tlaka.
Uncommon side effects (may affect up to 1 in 100 people): • nausea (feeling sick) and/or vomiting (being sick) 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • navzea (slabost) in/ali bruhanje
Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI 
Bolniki, ki bodo imeli PCI, vključno z bolniki z miokardnim infarktom z zvišanjem intervala ST (STEMI), pri katerih se bo izvedla primarna PCI
*clopidogrel pre-angiography or pre-PCI 
*klopidogrel pred angiografijo ali pred PCI
Arm C bival alone (N=4,612) 
Krak C samo bival (N=4.612)
Dose adjustments for this age group should be on the basis of renal function. 
Prilagajanje odmerkov za to starostno skupino se naredi glede na stanje delovanja ledvic.
Rare (≥1/10,000 to 
Občasni (≥ 1/1.000 do
ACUITY trial; bleeding events up to day 30 for the population of patients who received acetylsalicylic acid and clopidogrel as per protocol* 
Študija ACUITY; krvavitve do dne 30 za vključeno populacijo in populacijo bolnikov, ki so prejemali acetililsalicilno kislino klopidogrel v skladu s protokolom*
Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10). 
Manjša krvavitev je bila zelo pogosta (≥ 1/10), večja krvavitev pa pogosta (≥ 1/100 in < 1/10).
ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT) 
Študija ACUITY: razlike v tveganju za kompozito ishemije in njene komponente pri celotni populaciji (ITT) pri 30 dneh in 1 letu
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6. 
Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
HORIZONS 30-day study results (intent-to-treat population) 
Rezultati študije HORIZONS (Celotna populacija) po 30 dneh
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 kot peptid podvržen katabolizmu na aminokisline, ki ga sestavljajo, s posledično ponovno uporabo aminokislin v telesu.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
The advantage of bivalirudin over UFH/enoxaparin plus GP IIb/IIIa inhibitor in terms of bleeding events was only observed in the bivalirudin monotherapy arm. 
Prednost bivalirudina pred UFH/ enoksaparinom in zaviralcem GP IIb/IIIa, kar zadeva krvavitve, je bila opažena samo pri skupini, ki je prejemala monoterapijo z bivalirudinom.
Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”. 
Pomožna snov Zdravilo Angiox vsebuje manj kot 1 mmol natrija (23 mg) na vialo, to dejansko pomeni »brez natrija«.
Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction. 
Približno 23,3 % bolnikov, ki so prejeli bivalirudin, je izkusilo vsaj en neželen dogodek, 2,1 % bolnikov pa je izkusilo neželen učinek, povezan z zdravilom.
For further information regarding the use of bivalirudin with or without a GP IIb/IIIa inhibitor, please see section 5.1. 
Za podrobne podatke glede uporabe bivalirudina z ali brez zaviralca GP IIb/IIIa glejte poglavje 5.1.
Angiox is a white to off-white powder in a glass vial. 
Zdravilo Angiox je bel do belkast prašek v stekleni viali.
In patients taking warfarin who are treated with bivalirudin, International Normalised Ratio (INR) monitoring should be considered to ensure that it returns to pre-treatment levels following discontinuation of bivalirudin treatment. 
Pri bolnikih, ki jemljejo varfarin in jih zdravite z bivalirudinom, morate po koncu zdravljenja za zagotovitev povratka bivalirudina na ravni pred zdravljenjem razmisliti o opazovanju po mednarodno umerjenemu razmerju (INR).
However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects. 
Bivalirudin se pri standardnih analizah za takšne učinke ni izkazal kot mutagen ali klastogen.
Powder for concentrate for solution for injection or infusion 10 vials 
Prašek za koncentrat za raztopino za injiciranje ali infundiranje 10 vial
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. 
Bolniki v kraku A študije ACUITY so prejemali nefrakcionirani heparin ali enoksaparin, ki so ga dajali v skladu z veljavnimi smernicami za vodenje AKS pri bolnikih z UA in NSTEMI.
50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin. 
ml] zmeša z raztopino glukoze ali natrijevega klorida)1 ml vsebuje 5 mg bivalirudina.