Bivalirudin ngoba umjovo

250mg / Amandla isitsha

Okubonisa: Bivalirudin kuboniswa ukusetshenziswa njengenhlangano anticoagulant ezigulini othola percutaneous kokungenela yenhliziyo (PCI).

isicelo Clinical: Kuyinto usedfor umjovo emthanjeni uconsisele emthanjeni.

Izinkomba KANYE USAGE

1.1 Percutaneous Transluminal coronary Angioplasty (PTCA)

Bivalirudin ngoba Injection kuboniswa ukusetshenziswa njengenhlangano anticoagulant in iziguli angina engazinzile othola percutaneous transluminal angioplasty yenhliziyo (PTCA).

1.2 Percutaneous Ukungenela coronary (PCI)

Bivalirudin ngoba Injection ngokusebezisa lwesikhashana glycoprotein IIb / IIIa inhibitor (GPI) njengoba ezisohlwini

REPLACE-2 Isivivinyo kuboniswa ukusetshenziswa njengenhlangano anticoagulant ezigulini othola percutaneous kokungenela yenhliziyo (PCI).

Bivalirudin ngoba Injection kuboniswa iziguli, noma ingozi, heparin thrombocytopenia eyenga (HIT) noma heparin eyenga thrombocytopenia futhi thrombosis syndrome (HITTS) PCI kungokoqobo.

1.3 Nathi e nge aspirin

Bivalirudin ngoba Injection kulezi izinkomba senzelwe ukusetshenziswa ungabuqeda nge aspirin futhi ibilokhu wafunda kuphela seziguli ezithola aspirin concomitant.

1.4 Umkhawulo yokusetshenziswa

Ukuphepha kanye nempumelelo bivalirudin ngoba umjovo ungazange sezisunguliwe in iziguli acute syndromes yenhliziyo abangabhalisile othola PTCA noma PCI.

2 NGOMTHAMO KANYE NOKUPHATHA

2.1 Umthamo Kunconywe

Bivalirudin for ukufakwa kuyinto kwezokuphatha emthanjeni kuphela.

Bivalirudin ngoba Injection senzelwe ukusetshenziswa ungabuqeda nge aspirin (mg 300 kuya 325 nsuku zonke) futhi ibilokhu wafunda kuphela seziguli ezithola aspirin concomitant.

Ezigulini abangafuni baye UKUSHAYA / HITTS

Umthamo watusa of bivalirudin ngoba lomjovo i emthanjeni (IV) bolus umthamo 0.75 mg / kg, balandela ngokushesha i ukumnika ka 1.75 mg / kg / h ngoba isikhathi PCI / inqubo PTCA. Five imiz emva komthamo bolus iye iqondiswa, isikhathi ekunqandeni yasebenza (UMTHETHO) kufanele kwenziwe kanye bolus ezingeziwe 0.3 mg / kg kufanele inikezwe uma kudingeka.

GPI abaphathi kufanele kubhekwe uma kwenzeka ukuthi noma yiziphi izimo ezisohlwini REPLACE-2 incazelo ocwaningweni lwezempilo likhona.

Ukuze ezigulini eziye UKUSHAYA / HITTS

Umthamo watusa of bivalirudin ngoba umjovo in iziguli HIT / HITTS othola PCI kuyinto bolus IV 0.75 mg / kg. Lokhu kumele kulandelwe ukumnika okuqhubekayo ngesilinganiso esingamaphesenti 1.75 mg / kg / h isikhathi inqubo.

Ukuze okuqhubekayo inqubo okuthunyelwe ukwelashwa

Bivalirudin ngoba umjovo ukumnika ingase baqhubeka elandelayo PCI / PTCA for amahora angu-4 ukuthumela inqubo ngokuzikhethela udokotela ekwelapheni.

In iziguli ST ingxenye kokuphakama isilethikusebenza (STEMI) phambili bivalirudin ngoba umjovo ukumnika ngesilinganiso esingamaphesenti 1.75 mg / kg / h elandelayo PCI / PTCA kufika emahoreni angu-4 post-inqubo kufanele kubhekwe ukukwehlisela ingozi stent thrombosis.

Ngemva kwamahora amane, i IV ukumnika ezingeziwe bivalirudin ngoba umjovo angase izoqaliswa ngesilinganiso esingamaphesenti 0.2 mg / kg / h (ephansi Izinga ukumnika), kuze kuphele amahora 20, uma kudingeka.

2.2 Umthamo e Ukuphazamiseka kwezinso

Ayikho nokuncipha umthamo bolus kuyadingeka nganoma yisiphi degree of ukungakhuli kwezinso. Umthamo ukumnika ka bivalirudin ngoba umjovo kungase kudingeke zingancishiswa, nesimo anticoagulant elibukhali in iziguli ukungakhuli kwezinso. Iziguli ngokulinganisela ukungakhuli kwezinso (30 kuya ku-59 ml / iminithi) Uzothola i ukumnika ka 1.75 mg / kg / h. Uma imvume creatinine lingaphansi kuka-30 ml / imiz, nokwehlisa izinga ukumnika ukuba 1 mg / kg / h kufanele kubhekwe. Uma isiguli hemodialysis, izinga ukumnika kufanele ibe ngu- 0.25 mg / kg / h.

2.3 Imiyalelo Administration

Bivalirudin ngoba Injection senzelwe emthanjeni bolus umjovo kanye ukumnika okuqhubekayo ngemva Reconstitution futhi dilution. Ukuze ngamunye 250 mg isitsha, engeza 5 ml Lamanzi Oyinyumba for ukufakwa, USP. Ngomusa ashwibeka kuze zonke izinto siphela. Ngokulandelayo, ukuhoxisa bese ulahla 5 ml kusuka 50 ml isikhwama ukumnika equkethe 5% Dextrose Emanzini noma 0.9% sodium chloride for ukufakwa. Bese wengeza okuqukethwe isitsha kabusha isikhwama ukumnika equkethe 5% Dextrose Emanzini noma 0.9% sodium chloride ngoba Injection ukuthela lokuhlushwa lokugcina 5 mg / ml (isib, 1 isitsha e 50 ml; 2 izitsha eziyisikhombisa e 100 ml; 5 vials e 250 ml). Umthamo esizosingathwa is ivunyelaniswe isisindo isiguli (bheka Ithebula 1).

Uma ephansi izinga ukumnika isetshenziswa ngemva ukumnika kokuqala, esikhwameni lokuhlushwa engezansi kufanele uzilungiselele. Ukuze ulungiselele lokhu lokuhlushwa ephansi, abumbe kabutjha isitsha 250 mg 5 ml Lamanzi Oyinyumba for ukufakwa, USP. Ngomusa ashwibeka kuze zonke izinto siphela. Ngokulandelayo, ukuhoxisa bese ulahla 5 ml kusukela esikhwameni 500 ml ukumnika equkethe 5% Dextrose Emanzini noma 0.9% sodium chloride for ukufakwa. Bese wengeza okuqukethwe isitsha kabusha isikhwama ukumnika equkethe 5% Dextrose Emanzini noma sodium 0.9% chloride ngoba Injection ukuthela lokuhlushwa sokugcina 0.5 mg / ml. Izinga ukumnika esizosingathwa Kufanele kukhethwe kusukela ikholomu ngakwesokudla kuThebula 1.