Bivalirudin maka ọgwụ

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    Mkpado ngwaahịa

    Bivalirudin maka ọgwụ

    250mg / mkpọ Ike

    Ngosi: Bivalirudin gosiri maka iji dị ka ihe anticoagulant na ọrịa n'ịnwụ percutaneous akwara aka (PCI).

    Clinical ngwa: Ọ bụ usedfor igba ogwu n'akwara ọgwụ na igba ogwu n'akwara ntapu.

    Na-egosi na ojiji

    1.1 Percutaneous Transluminal akwara Angioplasty (PTCA)

    Bivalirudin maka Ọgwụ gosiri maka iji dị ka ihe anticoagulant na ọrịa na-ejighị n'aka rịaworo n'ịnwụ percutaneous transluminal akwara angioplasty (PTCA).

    1.2 Percutaneous akwara Intervention (PCI)

    Bivalirudin maka Ọgwụ na-elebara ojiji nke glycoprotein IIb / IIIa inhibitor (GPI) dị ka e depụtara na

    Dochie-2 ikpe gosiri maka iji dị ka ihe anticoagulant na ọrịa n'ịnwụ percutaneous akwara aka (PCI).

    Bivalirudin maka Ọgwụ gosiri maka ọrịa na, ma ọ bụ n'ihe ize ndụ nke, heparin rata thrombocytopenia (kụrụ) ma ọ bụ heparin rata thrombocytopenia na thrombosis syndrome (HITTS) n'ịnwụ PCI.

    1.3 Anyị e na Ịṅụ Ọgwụ Aspirin

    Bivalirudin maka Ọgwụ na ndị a na-egosi a na-zubere maka ojiji na-aspirin na a mụwo naanị na ọrịa na-anata concomitant aspirin.

    1.4 mmachi nke Iji

    The nchekwa na irè nke bivalirudin maka ọgwụ adịghị ike ọrịa na nnukwu akwara ọrịamkpokọta ndị na-adịghị enwe PTCA ma ọ bụ PCI.

    2 onunu ogwu ochichi

    2.1 aro Dose

    Bivalirudin maka Ọgwụ bụ maka igba ogwu n'akwara ochichi naanị.

    Bivalirudin maka Ọgwụ a na-zubere maka ojiji na-aspirin (300 325 mg kwa ụbọchị) na a mụwo naanị na ọrịa na-anata concomitant aspirin.

    Maka ọrịa ndị na-adịghị adabara / HITTS

    The na-atụ aro dose nke bivalirudin maka ọgwụ bụ ihe igba ogwu n'akwara (IV) bolus dose of 0,75 mg / n'arọ, soro ozugbo site ihe infusion nke 1,75 mg / n'arọ / h maka oge nke PCI / PTCA usoro. Ise min mgbe bolus dose e ndinọ, ihe ọrụ clotting oge (Act) ga-rụrụ na ihe ọzọ bolus nke 0.3 mg / n'arọ kwesịrị ma ọ dị mkpa.

    GPI ochichi ga-atụle ihe omume nke ọ bụla n'ime ọnọdụ depụtara na Dochie-2 na-adakarị ikpe bụ nkọwa a.

    Maka ọrịa ndị kụrụ / HITTS

    The na-atụ aro dose nke bivalirudin maka ọgwụ na ọrịa na kụrụ / HITTS n'ịnwụ PCI bụ IV bolus nke 0,75 mg / n'arọ. Nke a ga-agbaso site a na-aga n'ihu infusion na a ọnụego nke 1,75 mg / n'arọ / h maka oge nke usoro.

    N'ihi na-aga n'ihu omume post usoro

    Bivalirudin maka ọgwụ infusion nwere ike iso na-esonụ PCI / PTCA ruo 4 awa biputere usoro na uche nke n'imeso dibịa.

    Na ọrịa na ST nke elu myocardial infarction (STEMI) n'ihu nke bivalirudin maka ọgwụ infusion na a ọnụego nke 1,75 mg / n'arọ / h esonụ PCI / PTCA ruo 4 awa post-usoro a ga-atụle n'ibelata ihe ize ndụ nke stent thrombosis.

    Mgbe awa anọ, ihe ọzọ IV infusion nke bivalirudin maka ọgwụ nwere ike butere na a ọnụego nke 0,2 mg / n'arọ / h (ala-ọnụego infusion), ruo awa 20, ma ọ dị mkpa.

    2.2 dosing na gbasara akụrụ impairment

    Ọ dịghị Mbelata na bolus dose dị mkpa n'ihi na ọ bụla ogo gbasara akụrụ impairment. The infusion dose of bivalirudin maka ọgwụ pụrụ ịdị mkpa ka-ebelata, na anticoagulant ọnọdụ ekwu na ọrịa na gbasara akụrụ impairment. Ọrịa na-agafeghị oke gbasara akụrụ impairment (30 na 59 ml / min) ga-enweta ihe infusion nke 1,75 mg / kg / h. Ọ bụrụ na ndị creatinine nwechapụ bụ ihe na-erughị 30 ml / min, mbelata nke infusion ọnụego 1 mg / n'arọ / h a ga-atụle. Ọ bụrụ na onye ọrịa bụ na hemodialysis, ndị infusion ọnụego ga-ebelata ka 0,25 mg / kg / h.

    2.3 Ntuziaka maka Administration

    Bivalirudin maka Ọgwụ a na-zubere maka igba ogwu n'akwara bolus injection na-aga n'ihu infusion mgbe reconstitution na dilution. Iji ọ bụla 250 mg mkpọ, tinye 5 ml akpali mmasị Water maka ịgba ntụtụ, USP. Jiri nwayọọ swirl ruo mgbe niile ihe na-etisasịwo. Ọzọ, ịdọrọ na tụfuo 5 ml si a 50 ml infusion akpa nwere 5% Dextrose na Water ma ọ bụ 0,9% sodium chloride maka Ọgwụ. Mgbe ahụ tinye ọdịnaya nke reconstituted mkpọ na infusion akpa nwere 5% Dextrose na Water ma ọ bụ 0,9% sodium chloride maka Ọgwụ ikwenyere a ikpeazụ ịta nke 5 mg / ml (eg, 1 mkpọ 50 ml; 2 vials na 100 ml; 5 vials na 250 ml). The dose ka ga-ndinọ na-gbanwee dị ka ọrịa ibu (lee Isiokwu 1).

    Ọ bụrụ na ndị ala-na-ọnụego infusion na-eji mgbe mbụ infusion, a ala ịta akpa kwesịrị a ga-akwadebe. Iji kwadebe a ala ịta, reconstitute 250 mg mkpọ na 5 ml akpali mmasị Water maka ịgba ntụtụ, USP. Jiri nwayọọ swirl ruo mgbe niile ihe na-etisasịwo. Ọzọ, ịdọrọ na tụfuo 5 ml site a 500 ml infusion akpa nwere 5% Dextrose na Water ma ọ bụ 0,9% sodium chloride maka Ọgwụ. Mgbe ahụ tinye ọdịnaya nke reconstituted mkpọ na infusion akpa nwere 5% Dextrose na Water ma ọ bụ 0,9% sodium chloride maka Ọgwụ ikwenyere a ikpeazụ ịta nke 0,5 mg / ml. The infusion ọnụego ka ga-ndinọ ga-ahọrọ si n'aka nri n'igbe Isiokwu 1.


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