Bivalirudinmaka injection

250mg / vial ike

Ngosipụta:Bivalirudinegosiputara maka ojiji dị ka ọgwụ mgbochi ọbara n'ime ndị ọrịa na-anata ọgwụgwọ akwara obi (PCI).

Ngwa Clinical: A na-eji ya maka ịgba ntụtụ na ntapu nke eriri afọ.

Ngosipụta na ojiji

1.1 Percutaneous transluminal coronary angioplasty (PTCA)

A na-egosi Bivalirudin maka injection maka ojiji dị ka ọgwụ mgbochi ọbara na ndị ọrịa nwere angina na-akwụghị ụgwọ na-enweta percutaneous transluminal coronary angioplasty (PTCA).

1.2 Ntinye aka nke akwara akwara (PCI)

Bivalirudin maka ịgba ọgwụ mgbochi na iji oge nwa oge nke glycoprotein IIb/III inhibitor (GPI) dị ka edepụtara na

Egosiri nnwale REPLACE-2 maka ojiji dị ka ọgwụ mgbochi ọbara n'ime ndị ọrịa na-anata ọgwụgwọ akwara obi (PCI).

A na-egosi Bivalirudin maka injection maka ndị ọrịa nwere, ma ọ bụ nọ n'ihe ize ndụ, heparin na-ebute thrombocytopenia (HIT) ma ọ bụ heparin na-ebute thrombocytopenia na ọrịa thrombosis (HITTS) na-enweta PCI.

1.3 Anyị na Aspirin

A na-ezubere Bivalirudin maka ịgba ọgwụ mgbochi n'ime ihe ngosi ndị a maka iji aspirin wee mụọ ya naanị na ndị ọrịa na-anata aspirin concomitant.

1.4 Mmachi ojiji

Edebebeghị nchekwa na ịdị irè nke bivalirudin maka injection na ndị ọrịa nwere nnukwu ọrịa obi na-adịghị anabata PTCA ma ọ bụ PCI.

2 usoro onunu ogwu na nchịkwa

2.1 akwadoro dose

Bivalirudin maka injection bụ naanị maka nchịkwa eriri afọ.

Bivalirudin maka injection bụ maka iji aspirin (300 ruo 325 mg kwa ụbọchị) ma a mụọ ya naanị na ndị ọrịa na-anata aspirin concomitant.

Maka ndị ọrịa na-enweghị HIT/HITTS

Usoro a na-atụ aro nke bivalirudin maka ịgba ọgwụ bụ ọgwụ mgbochi intravenous (IV) nke 0.75 mg / kg, na-esochi ya ozugbo infusion nke 1.75 mg / kg / h maka ogologo oge nke usoro PCI / PTCA. Nkeji ise ka emechara ọgwụ bolus, a ga-eme oge ịgbachi nkịtị (ACT) ma nyekwuo bolus nke 0.3 mg/kg ma ọ bụrụ na achọrọ ya.

Ekwesịrị ịtụle nchịkwa GPI ma ọ bụrụ na ọnọdụ ọ bụla edepụtara na nkọwa nnwale ụlọ ọgwụ REPLACE-2 dị.

Maka ndị ọrịa nwere HIT/HITTS

Usoro akwadoro nke bivalirudin maka ntụtụ n'ime ndị ọrịa nwere HIT/HITTS na-enweta PCI bụ bolus IV nke 0.75 mg/kg. Ekwesịrị ịgbaso nke a site na infusion na-aga n'ihu na ọnụego 1.75 mg / kg / h maka oge usoro ahụ.

Maka usoro ọgwụgwọ na-aga n'ihu na-aga n'ihu

Bivalirudin maka infusion injection nwere ike ịga n'ihu na-eso PCI / PTCA ruo awa 4 ka ọ gafechara usoro site n'aka dọkịta na-agwọ ya.

N'ime ndị ọrịa nwere ST segment elevation myocardial infarction (STEMI) na-aga n'ihu na bivalirudin maka infusion injection na ọnụego 1.75 mg / kg / h na-eso PCI / PTCA ruo awa 4 mgbe usoro gasịrị, a ga-atụle iji belata ihe ize ndụ nke thrombosis stent.

Mgbe awa anọ gachara, enwere ike ịmalite infusion IV ọzọ nke bivalirudin maka injection na ọnụego 0.2 mg / kg / h (nkwụsị dị ala), ruo awa 20, ọ bụrụ na ọ dị mkpa.

2.2 Dossing na Renal impairment

Ọ dịghị mbelata nke bolus dose a chọrọ maka ogo ọ bụla nke nkwarụ gbasara akụrụ. Enwere ike ibelata dose infusion nke bivalirudin maka injection, yana nyochaa ọnọdụ anticoagulant na ndị ọrịa nwere nsogbu gbasara akụrụ. Ndị ọrịa nwere nnukwu ọrịa gbasara akụrụ (30 ruo 59 ml / min) kwesịrị ịnata infusion nke 1.75 mg / kg / h. Ọ bụrụ na mkpochapụ creatinine erughị 30 ml / min, ekwesịrị ịtụle mbelata ọnụego infusion na 1 mg / kg / h. Ọ bụrụ na onye ọrịa nọ na hemodialysis, a ga-ebelata ọnụego infusion ka ọ bụrụ 0.25 mg / kg / h.

2.3 Ntuziaka maka nchịkwa

A na-eche Bivalirudin maka injection maka ịgba ọgwụ bolus na infusion na-aga n'ihu mgbe emezigharị na dilution. Na vial 250 mg nke ọ bụla, tinye 5 mL nke Mmiri Sterile maka ịgba ọgwụ, USP. Jiri nwayọọ tụgharịa ruo mgbe ihe niile agbazere. Na-esote, wepụ ma tụfuo 5 ml n'ime akpa infusion 50 ml nke nwere 5% Dextrose na mmiri ma ọ bụ 0.9% sodium chloride maka injection. Mgbe ahụ gbakwunye ọdịnaya nke vial a na-emegharị na akpa infusion nke nwere 5% Dextrose na Mmiri ma ọ bụ 0.9% Sodium Chloride maka Injection iji nye njedebe ikpeazụ nke 5 mg / ml (dịka ọmụmaatụ, 1 vial na 50 ml; 2 vial na 100 ml; 5 vials na 250 ml). A na-edozi dose a ga-enye ya dabere na ibu onye ọrịa (lee Tebụl 1).

Ọ bụrụ na a na-eji infusion nke dị ala mee ihe mgbe ntinye nke mbụ gasịrị, a ga-edozi obere akpa ntinye uche. Iji kwadebe nlebara anya a dị ala, megharịa vial 250 mg na 5 mL nke Mmiri Sterile maka injection, USP. Jiri nwayọọ tụgharịa ruo mgbe ihe niile agbazere. Na-esote, wepụ ma tụfuo 5 ml na akpa infusion 500 ml nke nwere 5% Dextrose na mmiri ma ọ bụ 0.9% sodium chloride maka injection. Mgbe ahụ gbakwunye ọdịnaya nke vial a rụgharịrị na akpa infusion nke nwere 5% Dextrose na mmiri ma ọ bụ 0.9% sodium chloride maka ịgba ọgwụ iji nye mkpokọta ikpeazụ nke 0.5 mg/mL. Ekwesịrị ịhọrọ ọnụọgụ infusion nke a ga-enye site na kọlụm aka nri na Tebụl 1.