Bivalirudinyokutofa

250mg/vial Amandla

Isalathiso:Bivalirudiniboniswa ukuba isetyenziswe njenge-anticoagulant kwizigulane ezithatha i-percutaneous coronary intervention (PCI).

Ukusetyenziswa kweklinikhi:Isetyenziselwa inaliti ye-intravenous kunye nethonsi ye-intravenous.

IZIbonakaliso NOKUSETYENZISWA

1.1 I-Percutaneous Transluminal Coronary Angioplasty (PTCA)

I-Bivalirudin ye-Injection iboniswa ukuba isetyenziswe njenge-anticoagulant kwizigulane ezine-angina engazinzanga ezihamba nge-percutaneous transluminal coronary angioplasty (PTCA).

1.2 I-Percutaneous Coronary Intervention (PCI)

I-Bivalirudin yokutofa ngokusetyenziswa okwethutyana kwe-glycoprotein IIb/IIIa inhibitor (GPI) njengoko kudweliswe kwi

Uvavanyo lwe-REPLACE-2 luboniswa ukuba lusetyenziswe njenge-anticoagulant kwizigulane ezithatha i-percutaneous coronary intervention (PCI).

I-Bivalirudin ye-Injection iboniswa kwizigulane, okanye ezisengozini, i-heparin induced thrombocytopenia (HIT) okanye i-heparin i-thrombocytopenia kunye ne-thrombosis syndrome (HITTS) ehamba nge-PCI.

1.3 Sisebenzisa iAspirin

I-Bivalirudin ye-Injection kwezi zibonakaliso zenzelwe ukusetyenziswa kunye ne-aspirin kwaye ifundwe kuphela kwizigulana ezifumana i-aspirin ye-concomitant.

1.4 Unyino losetyenziso

Ukukhuseleka kunye nokusebenza kakuhle kwe-bivalirudin kwi-injection akukasungulwa kwizigulane ezine-syndromes ezibuhlungu ezingenayo i-PTCA okanye i-PCI.

2 UMGANGATHO NOKULAWULWA

2.1 Idosi ecetyiswayo

I-Bivalirudin ye-Injection yeyolawulo lwe-intravenous kuphela.

I-Bivalirudin ye-Injection yenzelwe ukusetyenziswa kunye ne-aspirin (i-300 ukuya kwi-325 mg yonke imihla) kwaye ifundwe kuphela kwizigulane ezifumana i-aspirin edibeneyo.

Kwizigulane ezingenayo iHIT/HITTS

I-dose ephakanyisiweyo ye-bivalirudin ye-injection yi-intravenous (IV) ye-bolus dose ye-0.75 mg / kg, ilandelwa ngokukhawuleza i-infusion ye-1.75 mg / kg / h ngexesha lenkqubo ye-PCI / PTCA. Imizuzu emihlanu emva kokuba i-bolus dose iqhutywe, ixesha lokuvala elisebenzayo (UMTHETHO) kufuneka lenziwe kwaye i-bolus eyongezelelweyo ye-0.3 mg / kg kufuneka inikwe xa ifunekayo.

Ulawulo lwe-GPI kufuneka luqwalaselwe kwimeko apho nayiphi na imiqathango edweliswe kwi-REPLACE-2 inkcazo yolingo lwekliniki ikhona.

Kwizigulane ezine-HIT/HITTS

I-dose ephakanyisiweyo ye-bivalirudin ye-injection kwizigulane ezine-HIT / HITTS eziphantsi kwe-PCI yi-IV bolus ye-0.75 mg / kg. Oku kufuneka kulandelwe ukunyuswa okuqhubekayo kwinqanaba le-1.75 mg / kg / h ngexesha lenkqubo.

Kwinkqubo yesithuba sonyango oluqhubekayo

I-Bivalirudin ye-injection infusion inokuqhubeka ilandela i-PCI/PTCA ukuya kuthi ga kwiiyure ze-4 inkqubo yokuthumela ngokubona kukagqirha onyanga.

Kwizigulane ezine-ST segment elevation myocardial infarction (STEMI) ukuqhubeka kwe-bivalirudin ye-injection infusion ngesantya se-1.75 mg / kg / h ilandela i-PCI / PTCA ukuya kwiiyure ze-4 emva kwenkqubo kufuneka ithathelwe ingqalelo ukunciphisa umngcipheko we-stent thrombosis.

Emva kweeyure ezine, i-IV eyongezelelweyo yokunyuswa kwe-bivalirudin ye-injection ingaqaliswa kwinqanaba le-0.2 mg / kg / h (i-infusion ephantsi), ukuya kwiiyure ze-20, ukuba kuyimfuneko.

2.2 Ukusetyenziswa kwethamo kumonakalo wezintso

Akukho kuncipha kwidosi ye-bolus efunekayo kuyo nayiphi na iqondo lokukhubazeka kwezintso. Idosi yokufakwa kwe-bivalirudin yenaliti inokufuna ukuncitshiswa, kwaye imeko ye-anticoagulant ibekwe iliso kwizigulane ezinokukhubazeka kwezintso. Izigulane ezinokukhubazeka okuphakathi kwezintso (30 ukuya kwi-59 mL / min) kufuneka zifumane i-infusion ye-1.75 mg / kg / h. Ukuba imvume ye-creatinine ingaphantsi kwe-30 mL / min, ukunciphisa izinga lokungena kwi-1 mg / kg / h kufuneka kuthathelwe ingqalelo. Ukuba isigulane sikwi-hemodialysis, izinga lokungena kufuneka lincitshiswe libe ngu-0.25 mg / kg / h.

2.3 Imiyalelo yoLawulo

I-Bivalirudin ye-Injection yenzelwe inaliti ye-bolus ye-intravenous kunye ne-infusion eqhubekayo emva kokuhlaziywa kunye nokuhlanjululwa. Kwi-vial nganye ye-250 mg, yongeza i-5 mL yamanzi aNtsholongwane eSitofu, i-USP. Jika ngobunono de yonke into ichithwa. Emva koko, rhoxisa kwaye ulahle i-5 mL kwi-bag ye-infusion ye-50 mL equkethe i-5% ye-Dextrose emanzini okanye i-0.9% ye-Sodium Chloride ye-Injection. Emva koko yongeza imixholo ye-vial ehlaziyiweyo kwi-infusion bag equkethe i-5% ye-Dextrose emanzini okanye i-0.9% ye-Sodium Chloride ye-Injection ukuvelisa i-concentration yokugqibela ye-5 mg / mL (umz., i-1 vial kwi-50 mL; i-2 vials kwi-100 mL; Iibhotile ezi-5 kwi-250 mL). Umthamo oza kulawulwa ulungelelaniswa ngokobunzima besigulane (jonga iThebhile 1).

Ukuba i-infusion yezinga eliphantsi lisetyenziswe emva kokunyuswa kokuqala, isikhwama soxinzelelo esisezantsi kufuneka silungiswe. Ukuze ulungiselele le ngqwalasela ephantsi, phinda uhlanganise i-250 mg ye-vial kunye ne-5 mL yamanzi aNcinciweyo Amanzi e-Injection, i-USP. Jika ngobunono de yonke into ichithwa. Emva koko, uhoxise kwaye ulahle i-5 mL kwi-bag ye-infusion ye-500 mL equkethe i-5% ye-Dextrose emanzini okanye i-0.9% ye-Sodium Chloride ye-Injection. Emva koko yongeza imixholo ye-vial ehlaziyiweyo kwi-infusion bag equkethe i-5% Dextrose kuManzi okanye i-0.9% ye-Sodium chloride ye-Injection ukuvelisa i-concentration yokugqibela ye-0.5 mg / mL. Izinga lokugalela eliza kulawulwa kufuneka likhethwe kwikholamu esekunene kwiThebhile 1.