I-Bivalirudinngomjovo

250mg/vial Amandla

Inkomba:I-Bivalirudiniboniswa ukuze isetshenziswe njenge-anticoagulant ezigulini ezibhekene ne-percutaneous coronary intervention (PCI).

Isicelo somtholampilo: Isetshenziselwa umjovo we-intravenous kanye ne-drip emthanjeni.

IZIKHOMBISO NOKUSETSHENZISWA

1.1 I-Percutaneous Transluminal Coronary Angioplasty (PTCA)

I-Bivalirudin Yomjovo iboniswa ukuthi isetshenziswe njenge-anticoagulant ezigulini ezine-angina engazinzile ezibhekana ne-percutaneous transluminal coronary angioplasty (PTCA).

1.2 I-Percutaneous Coronary Intervention (PCI)

I-Bivalirudin Yomjovo ngokusetshenziswa kwesikhashana kwe-glycoprotein IIb/IIIa inhibitor (GPI) njengoba ibalwe ku-

Isivivinyo se-REPLACE-2 siboniswa ukuthi sisetshenziswe njenge-anticoagulant ezigulini ezibhekene ne-percutaneous coronary intervention (PCI).

I-Bivalirudin Yomjovo iboniswa ezigulini ezine-heparin induced thrombocytopenia (HIT) noma i-thrombocytopenia ne-thrombosis syndrome (HITTS) eyenziwa yi-heparin kanye ne-thrombosis syndrome (HITTS) engaphansi kwe-PCI.

1.3 Sisebenzisa i-Aspirin

I-Bivalirudin Yomjovo kulezi zinkomba ihloselwe ukusetshenziswa ne-aspirin futhi ihlolisiswe kuphela ezigulini ezithola i-aspirin ehambisanayo.

1.4 Umkhawulo Wokusebenzisa

Ukuphepha nokusebenza kahle kwe-bivalirudin yomjovo akukasungulwa ezigulini ezine-acute coronary syndromes ezingayitholi i-PTCA noma i-PCI.

2 ISIKAMO KANYE NOLAWULO

2.1 Umthamo onconyiwe

I-Bivalirudin Yomjovo ingeyokulawulwa ngomjovo kuphela.

I-Bivalirudin Yomjovo ihloselwe ukusetshenziswa ne-aspirin (300 kuya ku-325 mg nsuku zonke) futhi ihlolisiswe kuphela ezigulini ezithola i-aspirin kanyekanye.

Okweziguli ezingenayo i-HIT/HITTS

Umthamo onconyiwe we-bivalirudin womjovo umthamo we-bolus we-intravenous (IV) we-0.75 mg/kg, olandelwa ngokushesha ukumnika okungu-1.75 mg/kg/h ngesikhathi senqubo ye-PCI/PTCA. Amaminithi amahlanu ngemva kokulawulwa komthamo we-bolus, isikhathi sokujiya esimisiwe (ACT) kufanele senziwe futhi i-bolus eyengeziwe ye-0.3 mg/kg kufanele inikezwe uma kudingeka.

Ukuphathwa kwe-GPI kufanele kucatshangelwe uma kwenzeka noma yiziphi izimo ezibalwe ku-REPLACE-2 incazelo yesilingo somtholampilo zikhona.

Okweziguli ezine-HIT/HITTS

Umthamo onconyiwe we-bivalirudin womjovo ezigulini ezine-HIT/HITTS ezithola i-PCI yi-IV bolus engu-0.75 mg/kg. Lokhu kufanele kulandelwe ukumnika okuqhubekayo ngesilinganiso se-1.75 mg/kg/h ngesikhathi senqubo.

Ukuze uthole inqubo yokwelashwa okuqhubekayo

I-Bivalirudin yokujova umjovo ingase iqhutshwe ngokulandela i-PCI/PTCA kuze kufike kumahora angu-4 inqubo yokuthumela ngokubona kukadokotela owelaphayo.

Ezigulini ezine-ST segment elevation myocardial infarction (STEMI) ukuqhubeka kwe-bivalirudin yokujova ngomjovo ngenani elingu-1.75 mg/kg/h kulandela i-PCI/PTCA kuze kufike emahoreni angu-4 emva kwenqubo kufanele kucatshangelwe ukunciphisa ingozi ye-stent thrombosis.

Ngemva kwamahora amane, ukumnika okwengeziwe kwe-IV kwe-bivalirudin ngomjovo kungase kuqalwe ngenani lika-0.2 mg/kg/h (ukumnika okunesilinganiso esiphansi), kuze kufike emahoreni angu-20, uma kudingeka.

2.2 Umthamo Ekulimaleni Kwezinso

Akukho ukuncipha kumthamo we-bolus odingekayo kunoma yiliphi izinga lokukhubazeka kwezinso. Umthamo wokumnika we-bivalirudin womjovo ungadinga wehliswe, futhi isimo se-anticoagulant siqashwe ezigulini ezinokukhubazeka kwezinso. Iziguli ezinokukhubazeka okuphakathi kwezinso (30 kuya ku-59 mL/min) kufanele zithole ukumnika okungu-1.75 mg/kg/h. Uma imvume ye-creatinine ingaphansi kwama-30 mL/min, kufanele kuncishiswe izinga lokumnika libe ngu-1 mg/kg/h. Uma isiguli siku-hemodialysis, izinga lokumnika kufanele lehliswe libe ngu-0.25 mg/kg/h.

2.3 Imiyalo Yokuphatha

I-Bivalirudin Yomjovo ihloselwe umjovo we-bolus emithanjeni kanye nokuthela okuqhubekayo ngemva kokuhlanganiswa kabusha nokuhlanjululwa. Ebhodleleni ngalinye elingu-250 mg, engeza u-5 mL Wamanzi Ayinyumba Womjovo, USP. Phenduka ngobumnene kuze kuncibilike yonke into. Okulandelayo, khipha futhi ulahle u-5 mL esikhwameni sokumnika esingu-50 mL esiqukethe u-5% we-Dextrose Emanzini noma u-0.9% we-Sodium Chloride Womjovo. Bese wengeza okuqukethwe kwe-vial ehlanganiswe kabusha esikhwameni sokumnika esiqukethe u-5% we-Dextrose Emanzini noma u-0.9% we-Sodium Chloride Yomjovo ukuze ukhiphe ukugcwala kokugcina okungu-5 mg/mL (isb., ibhodlela elingu-1 ku-50 mL; 5 izitsha ku-250 ml). Umthamo okufanele unikezwe ulungiswa ngokuya ngesisindo sesiguli (bheka Ithebula 1).

Uma i-infusion yezinga eliphansi isetshenziswa ngemuva kokufakwa kokuqala, isikhwama sokuhlushwa esiphansi kufanele silungiswe. Ukuze ulungise lokhu kuhlanganiswa okuphansi, hlanganisa kabusha ibhodlela elingu-250 mg no-5 mL Wamanzi Amagciwane Omjovo, USP. Phequlula ngobumnene kuze kuncibilike yonke into. Okulandelayo, khipha futhi ulahle u-5 mL esikhwameni sokumnika esingu-500 mL esiqukethe u-5% we-Dextrose Emanzini noma u-0.9% we-Sodium Chloride Womjovo. Bese wengeza okuqukethwe kwebhodlela elihlanganiswe kabusha esikhwameni sokumnika esiqukethe u-5% we-Dextrose Emanzini noma u-0.9% we-Sodium chloride YoMjovo ukuze ukhiphe ukugcwala kokugcina okungu-0.5 mg/mL. Izinga lokumnika elizosetshenziswa kufanele likhethwe kukholamu engakwesokudla kuThebula 1.