natgillin/translations-raw huggingface dataset:
The HORIZONS trial was a prospective, dual arm, single blind, randomised, multi-centre trial to establish the safety and efficacy of bivalirudin in patients with STEMI undergoing a primary PCI strategy with stent implantation with either a slow release paclitaxel-eluding stent (TAXUS™) or an otherwise identical uncoated bare metal stent (Express2™).
Ispitivanje HORIZONS bilo je prospektivno, jednostruko slijepo, randomizirano, multicentrično ispitivanje u dvije grupe ispitanika, u svrhu utvrđivanja sigurnosti i djelotvornosti bivalirudina u bolesnika sa STEMI-em u kojih se primjenjuje strategija primarnog PCI-ja ugrađivanjem stenta s polagano otpuštajućim paklitakselom (TAXUS™) ili identičnim metalnim stentom bez lijeka (Express2™).
A total of 356 (7.7%) of patients randomised to Arm C also received a GP IIb/IIIa inhibitor.
Ukupno 356 (7,7%) bolesnika randomizirano u grupu C također je dobivalo inhibitor GP IIb/IIIa.
30-day Composite ischaemia
30 dana Kompozitna ishemija
Thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.
Trombin također aktivira faktor V i VIII pospješujući daljnje stvaranje trombina te aktivira krvne pločice, stimulira agregaciju i otpuštanje granula.
Angiox contains a substance called bivalirudin which is an antithrombotic medicine.
Angiox sadrži tvar naziva bivalirudin koja je antitrombotski lijek.
Pharmacokinetic parameters for bivalirudin in patients with normal and impaired
Farmakokinetički parametri za bivalirudin u bolesnika s normalnom i oštećenom bubrežnom funkcijom
Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.
Angiox se isporučuje kao liofilizirani prašak u staklenim (tip 1) bočicama od 10 ml za jednokratnu uporabu, zatvorenima čepom od butilne gume koji je ovijen aluminijskim prstenom.
In clinical studies bivalirudin has been shown to provide adequate anticoagulation during PCI procedures.
Klinička su ispitivanja pokazala da bivalirudin omogućava adekvatnu antikoagulaciju tijekom PCI procedura.
The other ingredients are mannitol and sodium hydroxide 2% (for pH adjustment)
Drugi sastojci su manitol i natrijev hidroksid 2% (za podešavanje pH)
(For full information on posology see section 4.2 of SmPC)
(Za potpune informacije o doziranju vidjeti dio 4.2 Sažetka opisa svojstava lijeka)
Mannitol, sodium hydroxide 2%
manitol, 2% natrijev hidroksid
Unplanned revasc.
Neplanirana revaskularizacija
The primary metabolite resulting from the cleavage of Arg3-Pro4 bond of the Nterminal sequence by thrombin is not active because of the loss of affinity to the catalytic active site of thrombin.
Primarni metabolit, koji proizlazi iz cijepanja veze Arg3-Pro4 na N-terminalnom kraju sekvence trombinom, nije aktivan zbog gubitka afiniteta za katalitički aktivno mjesto na trombinu.
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.
Kad je ACT vrijednost veća od 225 sekundi, nije potreban daljnji nadzor, pod uvjetom da je infuzijska doza od 1,75 mg/kg/sat ispravno primijenjena.
Patients with renal impairment should be carefully monitored for clinical signs of bleeding during PCI, as clearance of bivalirudin is reduced in these patients (see section 5.2)
Bolesnike s oštećenjem bubrega treba pomno nadzirati na pojavu kliničkih znakova krvarenja tijekom PCI postupka jer je klirens bivalirudina u tih bolesnika smanjen (vidjeti dio 5.2).
Healthcare providers are recommended to refer to the Angiox Summary of Product Characteristics for full information on dosing.
Zdravstvenim djelatnicima preporučuje se pročitati sažetak opisa svojstava lijeka Angiox za potpune informacije o doziranju.
This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodiumfree”.
Lijek sadrži manje od 23 mg natrija po bočici što znači da u biti "ne sadrži natrij".
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 uključuje trombozu koronarnih arterija (krvni ugrušak u srčanim arterijama ili unutar stenta što se osjeća kao srčani udar koji također može biti smrtonosan) i/ili trombozu u kateteru, a obje se javljaju rijetko (mogu zahvatiti do 1 na 1000 osoba).
Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials.
U kliničkim ispitivanjima bilo je prijavljeno predoziranje u iznosu do 10 puta od preporučene doze.
Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience
Nuspojave bivalirudina iz ispitivanja HORIZONS, ACUITY, REPLACE-2 i postmarketinškog iskustva
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).
Stope većih krvarenja prikazane su u tablici 6 za ITT («intention to treat») populaciju i u tablici 7 za bolesnike prema planu ispitivanja (bolesnici koji su dobivali klopidogrel i acetilsalicilatnu kiselinu).
The following data is based on a clinical study of bivalirudin in 6,000 patients undergoing PCI, half of whom were treated with bivalirudin (REPLACE-2).
Sljedeći podaci temeljeni su na kliničkom ispitivanju bivalirudina u 6000 bolesnika u kojih se provodi PCI-ju, od kojih je polovica liječena bivalirudinom (REPLACE-2).
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.
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika i normalno ne smiju biti dulji od 24 sata pri 2-8
Single bolus doses of bivalirudin up to 7.5 mg/kg have also been reported.
Također je prijavljena pojedinačna doza bolusa bivalirudina do 7,5 mg/kg.
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 sati) opažena je u bolesnika sa STEMI-jem kod kojih je učinjena primarna PCI te je liječena je revaskularizacijom ciljne krvne žile (Target Vessel Revascularisation, TVR), (vidjeti dio 4.8 i 5.1).
Patients can be started on Angiox 30 minutes after discontinuation of unfractionated heparin given intravenously, or 8 hours after discontinuation of low molecular weight heparin given subcutaneously.
Angiox se može dati bolesniku 30 minuta nakon prekida terapije nefrakcioniranim heparinom primijenjenim intravenski, ili 8 sati nakon prekida terapije niskomolekularnog heparina primijenjenog supkutano.
Reconstituted and diluted product should be thoroughly mixed prior to administration.
Rekonstituirani i razrijeđeni lijek treba dobro promiješati prije primjene.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim nadopunama Plana.
If you are breast-feeding, the doctor will decide whether Angiox should be used.
Ako dojite, liječnik će odlučiti smijete li uzimati Angiox.
Patients must be observed carefully for symptoms and signs of bleeding during treatment particularly if bivalirudin is combined with another anticoagulant (see section 4.5).
Tijekom liječenja, mora se obratiti pozornost na znakove i simptome krvarenja u bolesnika, pogotovo ako se bivalirudin daje u kombinaciji s drugim antikoagulansom (vidjeti dio 4.5).
Gum bleeding (uncommon, may affect up to 1 in 100 people) is usually not serious.
Krvarenje iz desni (manje često, može zahvatiti do 1 na 100 osoba) obično nije ozbiljno.
Treatment-emergent positive bivalirudin antibodies are rare and have not been associated with clinical evidence of allergic or anaphylactic reactions.
Protutijela na bivalirudin koja su nastala kao posljedica liječenja, rijetka su i nisu bila povezana s kliničkom slikom alergijskih ili anafilaktičnih reakcija.
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).
Taj povećani rizik od akutne tromboze stenta opažen je tijekom prvih 4 sata nakon kraja postupka u bolesnika koji su prekinuli infuziju bivalirudina na kraju postupka ili nastavili dobivati infuziju smanjenom dozom od 0,25 mg/kg/h (vidjeti dio 4.2).
Similar reductions in bleeding were observed in patients who were switched to bivalirudin from heparin-based therapies (N = 2,078).
Slična smanjenja krvarenja opažena su u bolesnika koji su bili prebačeni s liječenja temeljenog na heparinu na bivalirudin (N = 2078).
Minor bleeding was defined as any observed bleeding event that did not meet the criteria as major.
Malo krvarenje definirano je kao pojava krvarenja koja nije zadovoljila kriterije za veliko krvarenje.
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
Acute stent thrombosis
Akutna tromboza stenta
Bival alone (N=2,911) %
Samo bival (N=2911) %
HORIZONS 30-day study results (intent-to-treat population)
Tablica 2. Rezultati 30-dnevnog ispitivanja HORIZONS (populacija s namjerom liječenja)
Major bleeding in the HORIZONS study was also defined using the ACUITY scale.
Veliko krvarenje za ispitivanje HORIZONS također je definirano uporabom ljestvice ispitivanja ACUITY.
Angiox is available in cartons containing 10 vials.
Angiox je dostupan u kutijama koje sadrže 10 bočica.
ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT)
Table 3. Ispitivanje ACUITY: 30-dnevne i 1-godišnje razlike rizika za ishemijski kompozitni ishod i njegovih komponenata za cjelokupnu populaciju (ITT)
Bivalirudin remains active and is not neutralised by products of the platelet release reaction.
Bivalirudin ostaje aktivan i nije neutraliziran tvarima oslobođenim iz trombocita.
Angiox contains bivalirudin, a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.
Angiox sadrži bivalirudin, izravan i specifičan inhibitor trombina koji se veže i na katalitičko mjesto i na vanjsko anionsko mjesto vezanja slobodnog trombina kao i trombina vezanog u ugrušku.
• with chest pain due to heart disease (acute coronary syndromes - ACS)
• koji imaju bolove u prsima zbog srčanih bolesti (akutni koronarni sindrom)
For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:
Za bolesnike koji počinju liječenje s perkutanom intervencijom (PCI) preporučena doza je:
Additional anti-platelet therapy utilised in the study included acetylsalicylic acid and clopidogrel.
Dodatna antitrombocitna terapija korištena u ispitivanju obuhvatila je acetilsalicilatnu kiselinu i klopidogrel.
A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction.
Ukupno 55,1% bolesnika koji su primali bivalirudin imalo je najmanje jedan štetan događaj, dok je u 8,7% bolesnika došlo do nuspojave na lijek.
The reconstituted/diluted solution should be inspected visually for particulate matter and discolouration.
Rekonstituiranu/razrijeđenu otopinu mora se vizualno pregledati na prisutnost čestica i promjenu boje.
There are no gender effects in the pharmacokinetics of bivalirudin.
Spol ne utječe na farmakokinetiku bivalirudina.
In REPLACE-2 thrombocytopenia occurred in 20 bivalirudin-treated patients (0.7%).
U ispitivanju REPLACE-2 trombocitopenija se pojavila u 20 bolesnika liječenih bivalirudinom (0,7%).
The following six medicinal products show dose-concentration incompatibilities with bivalirudin.
Sljedećih šest lijekova pokazuje inkompatibilnost ovisnu o koncentraciji doze s bivalirudinom.
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.
Vezanje bivalirudina na trombin je reverzibilno, a prema tome i utjecaj na njegovu aktivnost, jer trombin polagano cijepa bivalirudin, vezu Arg3-Pro4 što uzrokuje uspostavljanje funkcije aktivnog mjesta trombina.
Intravenous infusion lines should be primed with bivalirudin to ensure continuity of drug infusion after delivery of the bolus.
Liniju za intravensku infuziju treba prethodno napuniti bivaluridinom kako bi se osigurao kontinuitet infuzije lijeka nakon primjene bolusa.
Other medicines and Angiox tell your doctor
Drugi lijekovi i Angiox
Patients should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.
Nakon primarnog PCI-ja, bolesnike treba pažljivo motriti radi znakova i simptoma koji ukazuju na ishemiju miokarda.
Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience are listed by system organ class in Table 1.
Nuspojave bivalirudina identificirane u ispitivanjima HORIZONS, ACUITY, REPLACE-2 i tijekom postmarketinškog iskustva navedene su prema klasifikaciji organskih sustava u tablici 1.
Reconstituted material should then be further diluted in a total volume of 50 ml to give a solution of 5 mg/ml bivalirudin.
Rekonstituirani materijal treba nadalje dodatno razrijediti u ukupnom volumenu od 50 ml kako bi se dobila otopina od 5 mg/ml bivalirudina.
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 prema terapiji UFH/enoksaparin plus inhibitor GP IIb/IIIa obzirom na krvarenja opažena je samo u grupi monoterapije bivalirudinom.
The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS.
Procjena farmakokinetičkih svojstava bivalirudina utvrdila je linearnost u bolesnika podvrgnutih perkutanoj koronarnoj intervenciji i u bolesnika s ACS-om.
If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered and the ACT re-checked 5 minutes after the administration of the second bolus dose.
Ako je 5-ominutni ACT manji od 225 sekundi, potrebno je primijeniti drugu bolus dozu od 0,3 mg/kg a ACT ponovno provjeriti 5 minuta nakon primjene druge bolus doze.
Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10).
Mala krvarenja pojavljivala su se vrlo često (1/10), a velika krvarenja pojavljivala su se često (1/100 i <1/10).
It is, therefore, unlikely to affect your ability to drive or to use machines.
Prema tome, nije vjerojatno da bi ovaj lijek imao učinka na Vašu sposobnost upravljanja vozilima i strojevima.
Other less frequently observed bleeding sites with greater than 0.1% (uncommon) bleeding included “other” puncture site, retroperitoneal, gastrointestinal, ear, nose or throat.
Druga manje učestala uočena mjesta krvarenja s više od 0,1% (manje često) krvarenja uključila su “druga” ubodna mjesta, retroperitonealno, gastrointestinalno, uho, nos ili grlo.
Posology
E-post
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).
In vitro ispitivanja također su pokazala da bivalirudin, ovisno o koncentraciji, produljuje aktivirano parcijalno tromboplastinsko vrijeme (APTV), trombinsko vrijeme (TV) i protrombinsko vrijeme (PV) normalne ljudske plazme te da bivalirudin ne inducira agregaciju krvnih pločica kao odgovor na serum bolesnika koji imaju povijest sindroma heparinom prouzročene trombocitopenije/tromboze.
Normal renal function (≥ 90ml/min) Mild renal impairment (60-89 ml/min) Moderate renal impairment (30-59 ml/min) Severe renal impairment (10-29 ml/min) Dialysis dependent patients (off-dialysis)
Normalna bubrežna funkcija (≥ 90ml/min) Blago oštećena bubrežna funkcija (60-89 ml/min) Umjereno oštećena bubrežna funkcija (30-59 ml/min) Teško oštećena bubrežna funkcija (10-29 ml/min)
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.
Bolesnici s umjerenim oštećenjem bubrega (GFR 30-59 ml/min) podvrgnuti PCI-ju (bez obzira jesu li liječeni bivalirudinom za ACS ili ne) trebaju dobiti infuziju niže brzine i to od 1,4 mg/kg/sat.
In the elderly, if their kidney function is decreased, the dose may need to be reduced.
Kod starijih osoba možda će biti potrebno smanjiti dozu ako je njihova bubrežna funkcija oslabljena.
Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Angiox je indiciran kao antikoagulans u odraslih bolesnika koji se podvrgavaju perkutanoj koronarnoj intervenciji (PCI), uključujući i bolesnike s infarktom miokarda sa ST-elevacijom (STEMI) koji se podvrgavaju primarnoj perkutanoj koronarnoj intervenciji.
If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Ako je 5minutni ACT manji od 225 sekundi, treba primijeniti drugi bolus (dozu) od 0,3 mg/kg.
There is no known antidote to bivalirudin, however, bivalirudin is haemo-dialysable.
Nema poznatog antidota na bivalirudin, međutim, bivalirudin se može odstraniti hemodijalizom.
In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin.
In vitro ispitivanja pokazala su da bivalirudin inhibira, kako topiv (slobodan) tako i vezani trombin (u ugrušku).
Injection site reactions (Injection site discomfort, Injection site pain, Puncture site reaction)
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injekcije (nelagoda na mjestu ubrizgavanja, bol na mjestu ubrizgavanja, reakcija na mjestu uboda)
Thrombocytopenia was reported in 10 bivalirudin-treated patients participating in the ACUITY study (0.1%).
Trombocitopenija je registrirana u 10 bolesnika liječenih bivalirudinom koji su sudjelovali u ispitivanju ACUITY (0,1%).
: 00800 1103246 или +359(0) 24916041 e-mail: medical.information@themedco.com
The Medicines Company UK Ltd Teл.: 00800 1103246 или +359(0) 24916041 e-mail: medical.information@themedco.com
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.
S infuzijom doze treba započeti neposredno nakon primjene bolus doze, vodeći računa da se lijek isporuči bolesniku prije postupka te da isporuka lijeka bude neprekinuta tijekom trajanja postupka.
The steady-state volume of distribution is 0.1 l/kg.
Volumen distribucije u stanju dinamičke ravnoteže je 0,1 l/kg.
The REPLACE-2 Trial (Patients undergoing PCI)
Ispitivanje REPLACE-2 (bolesnici koji se podvrgavaju PCI)
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.
ACUITY je bilo prospektivno, randomizirano, otvoreno ispitivanje bivalirudina s inhibitorom ili bez inhibitora GP IIb/IIIa (grupa B, odnosno, grupa C) naspram nefrakcioniranog heparina ili enoksaparina s inhibitorom GP IIb/IIIa (grupa A) u 13.819 visokorizičnih AKS bolesnika.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of chest, wheezing, hypotension and anaphylaxis.
Bolesnike treba obavijestiti o ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje pri disanju, hipotenziju i anafilaksiju.
The reconstituted/diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution.
Rekonstituirana/razrijeđena otopina bit će bistra do blago opalescentna, bezbojna do blago žuta.
The approved adult weight-based intravenous bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hour was studied and pharmacokinetic/pharmacodynamic analysis found a response similar to that of adults, although weight-normalized clearance (ml/min/kg) of bivalirudin was higher in neonates than in older children and decreased with increasing age.
Ispitivana je doza odobrena za odrasle, intravenski bolus od 0,75 mg/kg tjelesne težine nakon kojeg slijedi infuzija od 1,75 mg/kg/sat, a farmakokinetička/farmakodinamička analiza pokazala je odgovor sličan onome u odraslih, iako je klirens bivalirudina normaliziran s obzirom na tjelesnu težinu (ml/min/kg) bio viši u novorođenčadi nego u starije djece i smanjivao se s povećanjem dobi.
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.
Sljedeći su podaci temeljeni na kliničkom ispitivanju s bivalirudinom u 13 819 bolesnika s ACS-om; 4612 bolesnika bilo je randomizirano na terapiju samo bivalirudinom, 4604 bilo je randomizirano za primanje bivalirudina i inhibitora GP IIb/IIIa, a 4603 bilo je randomizirano na ili nefrakcionirani heparin ili enoksaparin s inhibitorom GP IIb/IIIa.
Driving and using machines the effects of this medicine are known to be short-term.
Poznato je da je učinak ovog lijeka kratkotrajan.
Reconstituted solution: Store in a refrigerator (2 - 8
Rekonstituirana otopina: Čuvati u hladnjaku (2 - 8
• Angiox must be administered as a bolus dose followed immediately by an intravenous infusion, even if a short PCI procedure is planned.
• Angiox mora biti primijenjen kao bolus doza nakon čega odmah mora slijediti intravenska infuzija, čak i ako je planirana kratka PCI procedura.
Your warfarin blood test result (INR test) may be affected by Angiox.
Angiox bi mogao utjecati na rezultate Vašeg krvnog testa na varfarin (INR test).
Angiox 250 mg powder for concentrate bivalirudin
Angiox 250 mg prašak za koncentrat bivalirudin
The most common, (may affect up to 1 in 10 people) serious side effect of treatment with Angiox, is major bleeding which could occur anywhere inside the body (e.g. stomach, digestive system (including vomiting blood or passing blood with the stools), abdomen, lungs, groin, bladder, heart, eye, ear, nose or brain).
Najčešća, (može zahvatiti do 1 na 10 osoba) ozbiljna nuspojava u liječenju Angioxom je veliko krvarenje koje se može javiti na bilo kojem mjestu u tijelu (primjerice u želucu, probavnom sustavu (uključujući povraćanje krvi ili izlučivanje krvi sa stolicom),trbuhu, plućima, preponama,
TIMI scale major bleeding *clopidogrel pre-angiography or pre-PCI
Ljestvica velikog krvarenja TIMI *klopidogrel prije angiografije ili PCI-ja