Bivalirudinrau txhaj tshuaj

250mg / vial Lub zog

Kev taw qhia:Bivalirudinyog qhia rau siv raws li ib tug anticoagulant nyob rau hauv cov neeg mob nyob rau hauv lub percutaneous coronary intervention (PCI).

Daim ntawv thov kev kho mob: Nws yog siv rau kev txhaj tshuaj hauv cov hlab ntsha thiab cov hlab ntsha.

Kev qhia thiab kev siv

1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)

Bivalirudin rau Kev Txhaj Tshuaj yog qhia rau kev siv los ua cov tshuaj tiv thaiv kab mob hauv cov neeg mob uas tsis ruaj tsis khov angina tab tom ua rau percutaneous transluminal coronary angioplasty (PTCA).

1.2 Percutaneous Coronary Intervention (PCI)

Bivalirudin rau Kev Txhaj Tshuaj nrog kev siv ib ntus ntawm glycoprotein IIb / IIIa inhibitor (GPI) raws li tau teev tseg hauv

REPLACE-2 mus sib hais yog qhia rau kev siv raws li ib tug anticoagulant nyob rau hauv cov neeg mob uas muaj percutaneous coronary intervention (PCI).

Bivalirudin rau Kev Txhaj Tshuaj yog qhia rau cov neeg mob, lossis muaj kev pheej hmoo ntawm, heparin induced thrombocytopenia (HIT) lossis heparin induced thrombocytopenia thiab thrombosis syndrome (HITTS) nyob rau hauv PCI.

1.3 Peb e nrog Aspirin

Bivalirudin rau Kev Txhaj Tshuaj hauv cov lus qhia no yog npaj rau kev siv tshuaj aspirin thiab tau kawm tsuas yog hauv cov neeg mob tau txais cov tshuaj aspirin concomitant.

1.4 Kev txwv kev siv

Kev nyab xeeb thiab kev ua tau zoo ntawm bivalirudin rau kev txhaj tshuaj tsis tau tsim nyob rau hauv cov neeg mob uas muaj tus mob coronary syndromes uas tsis tau txais PTCA lossis PCI.

2 QHOV TSEEB THIAB TXOJ CAI

2.1 Pom zoo koob tshuaj

Bivalirudin rau Kev Txhaj Tshuaj yog rau kev tswj hwm txoj hlab ntshav nkaus xwb.

Bivalirudin rau Kev Txhaj Tshuaj yog npaj rau kev siv nrog tshuaj aspirin (300 mus rau 325 mg txhua hnub) thiab tau kawm tsuas yog hauv cov neeg mob tau txais cov tshuaj aspirin concomitant.

Rau cov neeg mob uas tsis muaj HIT/HITTS

Qhov pom zoo koob tshuaj bivalirudin rau kev txhaj tshuaj yog txhaj tshuaj intravenous (IV) bolus ntawm 0.75 mg / kg, tom qab ntawd tam sim ntawd los ntawm kev txhaj tshuaj ntawm 1.75 mg / kg / h rau lub sijhawm ntawm PCI / PTCA txheej txheem. Tsib feeb tom qab txhaj koob tshuaj bolus, yuav tsum tau ua kom lub sijhawm ua kom ntshav khov (ACT) thiab ntxiv bolus ntawm 0.3 mg / kg yog tias xav tau.

GPI kev tswj hwm yuav tsum raug txiav txim siab yog tias ib qho ntawm cov xwm txheej tau teev tseg hauv REPLACE-2 cov lus piav qhia kho mob tam sim no.

Rau cov neeg mob uas muaj HIT/HITTS

Qhov pom zoo koob tshuaj bivalirudin rau kev txhaj tshuaj rau cov neeg mob uas muaj HIT / HITTS nyob rau hauv PCI yog IV bolus ntawm 0.75 mg / kg. Qhov no yuav tsum tau ua raws li kev txhaj tshuaj tas li ntawm tus nqi ntawm 1.75 mg / kg / h rau lub sijhawm ua haujlwm.

Rau kev kho mob tsis tu ncua tom qab txheej txheem

Bivalirudin rau kev txhaj tshuaj tuaj yeem txuas ntxiv tom qab PCI / PTCA txog li 4 teev tom qab tus txheej txheem ntawm kev txiav txim siab ntawm tus kws kho mob.

Hauv cov neeg mob uas muaj ST ntu nce myocardial infarction (STEMI) txuas ntxiv ntawm bivalirudin rau kev txhaj tshuaj ntawm tus nqi ntawm 1.75 mg / kg / h tom qab PCI / PTCA txog li 4 teev tom qab txheej txheem yuav tsum tau txiav txim siab kom txo qis kev pheej hmoo ntawm stent thrombosis.

Tom qab plaub teev, ib qho ntxiv IV infusion ntawm bivalirudin rau kev txhaj tshuaj tuaj yeem pib ntawm tus nqi ntawm 0.2 mg / kg / h (qhov qis qis), txog li 20 teev, yog tias xav tau.

2.2 Dosing nyob rau hauv lub raum tsis ua hauj lwm

Tsis tas yuav txo qhov koob tshuaj bolus rau txhua qib ntawm lub raum tsis zoo. Kev txhaj tshuaj ntawm bivalirudin rau kev txhaj tshuaj yuav tsum raug txo kom tsawg, thiab cov tshuaj tiv thaiv coagulant tau saib xyuas hauv cov neeg mob lub raum tsis zoo. Cov neeg mob uas muaj lub raum tsis zoo (30 mus rau 59 mL / min) yuav tsum tau txais kev txhaj tshuaj ntawm 1.75 mg / kg / h. Yog tias qhov kev tshem tawm creatinine tsawg dua 30 mL / min, qhov txo qis ntawm qhov infusion mus rau 1 mg / kg / h yuav tsum xav txog. Yog hais tias tus neeg mob nyob rau hauv hemodialysis, tus nqi ntawm infusion yuav tsum tau txo mus rau 0.25 mg / kg / h.

2.3 Cov lus qhia rau kev tswj hwm

Bivalirudin rau Kev Txhaj Tshuaj yog npaj rau kev txhaj tshuaj bolus thiab kev txhaj tshuaj tas li tom qab rov tsim kho thiab dilution. Rau txhua 250 mg vial, ntxiv 5 mL ntawm Sterile Water for Injection, USP. Maj mam swirl kom txog thaum tag nrho cov khoom yog yaj. Tom ntej no, tshem tawm thiab muab pov tseg 5 mL los ntawm 50 mL infusion hnab uas muaj 5% Dextrose hauv dej los yog 0.9% Sodium Chloride rau Txhaj. Tom qab ntawd ntxiv cov ntsiab lus ntawm reconstituted vial rau lub hnab infusion uas muaj 5% Dextrose hauv dej los yog 0.9% Sodium Chloride rau Kev Txhaum kom tau txais txiaj ntsig kawg ntawm 5 mg / mL (xws li 1 vial hauv 50 mL; 2 vials hauv 100 mL; 5 vials hauv 250 mL). Cov koob tshuaj yuav tsum tau muab kho raws li tus neeg mob qhov hnyav (saib Table 1).

Yog hais tias tus nqi qis yog siv tom qab thawj zaug infusion, lub hnab ntim qis dua yuav tsum tau npaj. Txhawm rau npaj qhov qis qis dua, rov ua dua 250 mg vial nrog 5 mL ntawm Sterile Dej rau Txhaj Tshuaj, USP. Maj mam swirl kom txog thaum tag nrho cov khoom yog yaj. Tom ntej no, tshem tawm thiab muab pov tseg 5 mL los ntawm 500 mL infusion hnab uas muaj 5% Dextrose hauv dej los yog 0.9% Sodium Chloride rau Txhaj. Tom qab ntawd ntxiv cov ntsiab lus ntawm reconstituted vial mus rau lub hnab infusion uas muaj 5% Dextrose hauv dej los yog 0.9% Sodium chloride rau Txhaj kom tawm los qhov kawg ntawm 0.5 mg / mL. Tus nqi infusion yuav tsum tau xaiv los ntawm sab xis sab xis hauv Table 1.