Bivalirudin ukuba isitofu

250mg / Amandla igutyana

Olubonisa: Bivalirudin iboniswe ukusetyenziswa njengento anticoagulant kwi iziguli ungenelelo percutaneous coronary (PCI).

isicelo Clinical: Le naliti usedfor efakwa kunye ngedriphu efakwa.

Zikhombisa AND SOKUSETYENZISWA

1.1 Percutaneous Transluminal Uqhaqho Angioplasty (PTCA)

Bivalirudin ngokuba Inaliti iboniswe ukusetyenziswa njengento anticoagulant kwizigulane kunye angina ezingazinzanga kokwenziswa percutaneous angioplasty transluminal coronary (PTCA).

1.2 Ungenelelo Percutaneous Uqhaqho (PCI)

Bivalirudin for Inaliti kunye nokusetyenziswa lwethutyana glycoprotein IIb / IIIa inhibitor (GPI) njengoko zidweliswe kule

REPLACE-2 cala eboniswe ukusetyenziswa njengento anticoagulant kwi iziguli ungenelelo percutaneous coronary (PCI).

Bivalirudin for Inaliti kuboniswe ukuba izigulane, okanye abasemngciphekweni wokuba, lweeHedfowuni thrombocytopenia eyabangelwa (HIT) okanye lweeHedfowuni eyabangelwa thrombocytopenia kunye thrombosis syndrome (HITTS) PCI novavanyo.

1.3 Us e ne aspirin

Bivalirudin for Inaliti kula okukhomba ilungiselelwe ukusetyenziswa kunye aspirin yaye kufundwe kuphela izigulane abafumana aspirin ezihamba.

1.4 Imida yokusebenzisa

Ukhuseleko kunye nokusebenza bivalirudin ukuba isitofu akukasekwa kwizigulane kunye syndromes zosulele coronary abangazenziyo bajamelene PTCA okanye PCI.

2 idosi NOLAWULO

2.1 Umthamo ezicetyiswayo

Bivalirudin ngokuba Inaliti yenzelwe kulawulo efakwa kuphela.

Bivalirudin for Inaliti ilungiselelwe ukusetyenziswa kunye aspirin (mg 300 ukuya-325 yonke imihla) kwaye sele kufundwe kuphela izigulane abafumana aspirin ezihamba.

Kuba kwizigulane Awuvumelekanga UKUBETHA / HITTS

Ithamo obacetyiswayo bivalirudin ukuba isitofu yi emthanjeni (IV) bolus ithamo 0.75 mg / kg, zamlandela yi ukumnika 1,75 mg / kg / h ngenxa ngexesha PCI / inkqubo PTCA. min emihlanu emva kwedosi bolus sele elali-, ngexesha iclotting yasebenza (ACT) kufuneka lwenziwe yaye bolus eyongezelelweyo 0.3 mg / kg kufuneka anikwe xa kuyimfuneko.

ulawulo GPI kufuneka ithathelwe ingqalelo xa kunokwenzeka ukuba naziphi na iimeko ezidweliswe kwi REPLACE-2 inkcazo yocwaningo ekhoyo.

Izigulane abaye UKUBETHA / HITTS

Ithamo obacetyiswayo bivalirudin ukuba isitofu kwizigulane kunye HIT / HITTS PCI usisisulu yi bolus IV we 0.75 mg / kg. Oku kufuneka kulandelwe ukumnika rhoqo ngesantya 1,75 mg / kg / h kuba ngexesha le nkqubo.

Kuba eziqhubekayo inkqubo post unyango

Bivalirudin for Inaliti ukumnika uya kuqhubeka emva PCI / PTCA iiyure ukuya ku-4 ukuthumela nenkqubo ngokwengqiqo gqirha okunyangayo.

Xa izigulane ST ingxenye umphakamo iposi engabalulekanga (STEMI) Ukuqhubekeka kwe-bivalirudin ukuba isitofu ukumnika ngeqondo ka-1,75 mg / kg / h ilandelayo PCI / PTCA iiyure ukuya ku-4 post-nkqubo kufuneka ukuba ziqwalaselwe ukuze ukunciphisa ingozi stent thrombosis.

Emva kweeyure ezine, enye IV nokubandakanywa eyongezelelweyo bivalirudin ukuba isitofu inokuba uzakwenziwa ngesantya 0.2 mg / kg / h (-izinga eliphantsi iimela), iiyure ukuya ku-20, xa kuyimfuneko.

2.2 nomthamo in Ubungozi kwezintso

Akukho unciphiso idosi bolus iyafuneka na iqondo lomonakalo kwezintso. Nokuhlanganiswa ithamo bivalirudin ukuba isitofu kusenokufuneka ukuba lifinyele, kunye nobume anticoagulant esweni kwizigulane kunye ongaboniyo kwezintso. Izigulane nokulolonga ongaboniyo kwezintso (30 to 59 ml / min) kufuneka afumane ukumnika 1,75 mg / kg / h. Ukuba kugqitywe creatinine kuba ngaphantsi kwe-30 ml / min, ukuncitshiswa izinga ukumnika 1 mg / kg / h kufuneka ingqalelo. Ukuba isigulane phezu wehemodialysis, izinga ukumnika kufuneka incitshiswe ku 0.25 mg / kg / h.

2.3 Imiyalelo Administration

Bivalirudin for Inaliti ilungiselelwe isitofu bolus efakwa kunye nokubandakanywa rhoqo emva iphelele kunye ukuxutywa. Ukuze ngamnye igutyana 250 mg, yongeza ml 5 abulawe Water ngenxa Inaliti, USP. Ngobunono singqonga de zonke izinto iyapheliswa. Okulandelayo, ukurhoxisa kwaye ulahle ml-5 ukusuka 50 ml bag ukumnika equlathe 5% Dextrose e Water okanye 0.9% Sodium chloride for Inaliti. Emva koko ukongeza imixholo igutyana kwakhona kwisingxobo ukumnika equlathe 5% Dextrose e Water okanye 0.9% Sodium chloride ukuba Inaliti ukuyekelela enamandla lokugqibela 5 mg / ml (umzekelo, 1 gutyana 50 ml; 2 ezineengqayi ngo-100 ml; 5 ezineengqayi ngo-250 ml). Ithamo ukuba iphathwe yoxhaso ukuya ubunzima yomguli (jonga Itheyibhile 1).

Ukuba ukumnika-izinga eliphantsi isetyenziswa emva nokuhlanganiswa sokuqala, ingxowa yoxinaniso asezantsi kufuneka ilungiswe. Ukwenzela ukulungiselela le yoxinaniso asezantsi, ubumbe igutyana 250 mg 5 ml abulawe Water ngenxa Inaliti, USP. Ngobunono singqonga de zonke izinto iyapheliswa. Okulandelayo, ukurhoxisa kwaye ulahle ml-5 ukusuka ingxowa 500 ml ukumnika equlathe 5% Dextrose e Water okanye 0.9% Sodium chloride for Inaliti. Emva koko ukongeza imixholo igutyana kwakhona kwisingxobo ukumnika equlathe 5% Dextrose e Water okanye 0.9% Sodium chloride ukuba Inaliti ukuyekelela enamandla lokugqibela 0.5 mg / ml. Izinga ukumnika ukuba iphathwe kufuneka akhethwe kwikholam lasekunene-lesandla kwiThebhile 1.