Bivalirudinkuitira jekiseni

250mg/vial Simba

Chiratidzo:Bivalirudininoratidzwa kuti ishandiswe se anticoagulant muvarwere vanopinda percutaneous coronary intervention (PCI).

Clinical application: Inoshandiswa kune jekiseni remutsinga uye kudonha kwemutsinga.

ZVIRATIDZO UYE MASHANDISI

1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)

Bivalirudin yeJekiseni inoratidzwa kuti ishandiswe seanticoagulant muvarwere vane angina isina kugadzikana vari pasi pepercutaneous transluminal coronary angioplasty (PTCA).

1.2 Percutaneous Coronary Intervention (PCI)

Bivalirudin yeJekiseni nekushandiswa kwenguva pfupi kweglycoprotein IIb/IIIa inhibitor (GPI) sezvakanyorwa mu

REPLACE-2 muedzo unoratidzwa kuti ushandiswe se anticoagulant kune varwere vari pasi pepercutaneous coronary intervention (PCI).

Bivalirudin yeInjection inoratidzwa kune varwere vane, kana pangozi, heparin induced thrombocytopenia (HIT) kana heparin induced thrombocytopenia uye thrombosis syndrome (HITTS) inopinda PCI.

1.3 Isu neAspirin

Bivalirudin yeJekiseni mune izvi zviratidzo inotarisirwa kushandiswa neAspirin uye yakadzidzwa chete muvarwere vanogamuchira aspirin inosanganiswa.

1.4 Kuganhurirwa kweKushandisa

Kuchengeteka uye kushanda kwebivalirudin yejekiseni hakuna kusimbiswa kune varwere vane acute coronary syndromes vasiri kuita PTCA kana PCI.

2 KUPIWA UYE KUTUNGAMIRIRA

2.1 Inokurudzirwa Dose

Bivalirudin yeJekiseni ndeyekutonga kwemutsinga chete.

Bivalirudin yeJekiseni inotarisirwa kushandiswa ne aspirin (300 kusvika 325 mg zuva nezuva) uye yakadzidzwa chete muvarwere vanogamuchira aspirin inosanganiswa.

Kune varwere vasina HIT/HITTS

Nhamba yakakurudzirwa yebivalirudin yejekiseni inonzi intravenous (IV) bolus dose ye 0.75 mg / kg, inoteverwa pakarepo nekuiswa kwe1.75 mg / kg / h kwenguva yePCI / PTCA maitiro. Maminitsi mashanu mushure mekunge iyo bolus dose yaitwa, iyo activated clotting time (ACT) inofanira kuitwa uye imwe bolus ye0.3 mg / kg inofanira kupiwa kana ichidiwa.

GPI kutonga kunofanirwa kutariswa muchiitiko chekuti chero mamiriro akanyorwa muREPLACE-2 tsananguro yekiriniki yekuedzwa iripo.

Kune varwere vane HIT/HITTS

Nhamba yakakurudzirwa yebivalirudin yejekiseni kune varwere vane HIT / HITTS vari pasi pePCI ndeye IV bolus ye0.75 mg / kg. Izvi zvinofanira kuteverwa nekuputira kunoramba kuripo pachiyero che 1.75 mg / kg / h kwenguva yakareba.

Kuenderera mberi kurapwa post process

Bivalirudin yekupinza jekiseni inogona kuenderera mberi ichitevera PCI/PTCA kweanosvika 4 maawa mushure mekuita pakufunga kwechiremba anorapa.

Muvarwere vane ST segment elevation myocardial infarction (STEMI) kuenderera mberi kwebivalirudin yejekiseni infusion pachiyero che 1.75 mg / kg / h inotevera PCI / PTCA kwemaawa mana mushure mekuita kunofanira kuonekwa kuderedza dambudziko re stent thrombosis.

Mushure memaawa mana, imwe IV infusion yebivalirudin yejojo ​​inogona kutangwa pamwero we 0.2 mg / kg / h (yakaderera-chiyero infusion), kusvika maawa makumi maviri, kana zvichidiwa.

2.2 Dosing muRenal Impairment

Hapana kuderedzwa kweiyo bolus dose inodiwa kune chero dhigirii renal impairment. The infusion dose yebivalirudin yejekiseni ingada kuderedzwa, uye anticoagulant mamiriro anotariswa muvarwere vane renal impairment. Varwere vane mwero renal impairment (30 kusvika 59 mL / min) vanofanira kugamuchira infusion ye 1.75 mg/kg/h. Kana iyo creatinine clearance iri pasi pe30 mL/min, kuderedzwa kweiyo infusion rate kusvika 1 mg/kg/h kunofanira kutariswa. Kana murwere ari pahemodialysis, infusion rate inofanira kuderedzwa kusvika 0.25 mg/kg/h.

2.3 Mirayiridzo yeKutarisira

Bivalirudin yeJekiseni inoitirwa intravenous bolus jekiseni uye inoenderera mberi infusion mushure mekuumbwa patsva uye dilution. Kune yega yega 250 mg vial, wedzera 5 mL yeMvura Yakaora yeJekiseni, USP. Zvinyoro nyoro kusvikira zvinhu zvose zvanyunguduka. Zvadaro, bvisa uye kurasa 5 mL kubva mu50 mL infusion bag ine 5% Dextrose muMvura kana 0.9% Sodium Chloride yeJekiseni. Wobva wawedzera zviri mubhodhoro rakagadziridzwa kubhegi rekupinza rine 5% Dextrose muMvura kana 0.9% Sodium Chloride yeJekiseni kuti ibudise huwandu hwekupedzisira hwe5 mg/mL (semuenzaniso, 1 vial mu50 mL; 2 mabhodhoro mu100 mL; 5 mabhodhoro mu250 mL). Chiyero chinofanirwa kupihwa chinogadziriswa zvinoenderana nehuremu hwemurwere (ona Tafura 1).

Kana iyo yakaderera-yero infusion inoshandiswa mushure mekutanga kuvharwa, bhegi rezasi rinofanirwa kugadzirirwa. Kuti ugadzirire iyi yakaderera, gadzirazve 250 mg vial ne5 mL yeSterle Water for Injection, USP. Zvinyoro nyoro kusvikira zvinhu zvose zvanyunguduka. Zvadaro, bvisa uye kurasa 5 mL kubva mu500 mL infusion bag ine 5% Dextrose muMvura kana 0.9% Sodium Chloride yeJekiseni. Wobva wawedzera zviri mubhodhoro rakagadziridzwa mubhegi rekuisira mvura ine 5% Dextrose muMvura kana 0.9% Sodium chloride yeJekiseni kuti ibudise huwandu hwekupedzisira hwe0.5 mg/mL. Muyero wekupinza uchapihwa unofanirwa kusarudzwa kubva kurudyi kurudyi muTafura 1.