ʻO Bivalirudinno ka injection

250mg / vial ikaika

Hōʻike:ʻO Bivalirudinua hōʻike ʻia no ka hoʻohana ʻana ma ke ʻano he anticoagulant i nā poʻe maʻi e hana ana i ka percutaneous coronary intervention (PCI).

Hoʻohana lapaʻau: Hoʻohana ʻia ia no ka injection intravenous a me ka drip intravenous.

NA HOIKE A ME KA HOohana

1.1 ʻO ka Angioplasty ʻAi ʻAi ʻAi ʻAi ʻAʻe (PTCA)

Hōʻike ʻia ʻo Bivalirudin no ka hoʻohana ʻana ma ke ʻano he anticoagulant i nā poʻe maʻi me ka angina paʻa ʻole e hana ana i ka percutaneous transluminal coronary angioplasty (PTCA).

2

ʻO ka Bivalirudin no ka Injection me ka hoʻohana manawaleʻa o ka glycoprotein IIb/IIIa inhibitor (GPI) e like me ka mea i helu ʻia ma ka

Hōʻike ʻia ka hoʻāʻo REPLACE-2 no ka hoʻohana ʻana ma ke ʻano he anticoagulant i nā poʻe maʻi e hana ana i ka percutaneous coronary intervention (PCI).

Hōʻike ʻia ʻo Bivalirudin no ka Injection no nā poʻe maʻi me ka thrombocytopenia (HIT) i hoʻokomo ʻia heparin a i ʻole ka thrombocytopenia a me ka thrombosis syndrome (HITTS) i hana ʻia ma PCI.

1.3 Mākou e me Aspirin

ʻO Bivalirudin no ka Injection i kēia mau hōʻailona i manaʻo ʻia no ka hoʻohana ʻana me ka aspirin a ua aʻo ʻia i nā maʻi wale nō e loaʻa ana i ka aspirin concomitant.

1.4 Ka palena o ka hoʻohana

ʻAʻole i hoʻokumu ʻia ka palekana a me ka maikaʻi o ka bivalirudin no ka injection i nā poʻe maʻi me nā maʻi maʻi coronary acute i loaʻa ʻole i ka PTCA a i ʻole PCI.

2 KA HANA A ME KA HOOPONOPONO

2.1 Manaʻo ʻia

ʻO ka Bivalirudin no ka injection no ka hoʻokele intravenous wale nō.

Hoʻohana ʻia ʻo Bivalirudin for Injection me ka aspirin (300 a 325 mg i kēlā me kēia lā) a ua aʻo ʻia i nā maʻi e loaʻa ana i ka aspirin concomitant.

No nā maʻi i loaʻa ʻole ka HIT/HITTS

ʻO ka nui o ka bivalirudin i manaʻo ʻia no ka inikini he intravenous (IV) bolus dose o 0.75 mg / kg, ukali koke ʻia e ka infusion o 1.75 mg / kg / h no ka lōʻihi o ke kaʻina hana PCI / PTCA. ʻElima mau minuke ma hope o ka hāʻawi ʻia ʻana o ka bolus dose, pono e hana ʻia kahi manawa clotting activated (ACT) a hāʻawi ʻia kahi bolus hou o 0.3 mg / kg inā pono.

Pono e noʻonoʻo ʻia ka hoʻokele GPI inā loaʻa kekahi o nā kūlana i helu ʻia ma ka wehewehe hoʻokolohua lapaʻau REPLACE-2.

No nā maʻi i loaʻa iā HIT/HITTS

ʻO ka maʻi i manaʻo ʻia o ka bivalirudin no ka hoʻokele ʻana i nā maʻi me HIT/HITTS e hana ana i ka PCI he IV bolus o 0.75 mg/kg. Pono e hahai ʻia kēia e ka infusion mau i ka 1.75 mg / kg / h no ka lōʻihi o ke kaʻina hana.

No ke kaʻina hana ma hope o ka mālama ʻana

Hiki ke hoʻomau ʻia ʻo Bivalirudin no ka hoʻopiʻi ʻana ma hope o PCI/PTCA a hiki i 4 mau hola ma hope o ke kaʻina hana ma ka manaʻo o ke kauka lapaʻau.

I nā poʻe maʻi me ST segment elevation myocardial infarction (STEMI) e hoʻomau i ka bivalirudin no ka infusion infusion ma ka helu o 1.75 mg / kg / h ma hope o PCI / PTCA a hiki i 4 mau hola ma hope o ke kaʻina hana e noʻonoʻo ʻia e hoʻēmi i ka pilikia o ka thrombosis stent.

Ma hope o ʻehā mau hola, hiki ke hoʻomaka ʻia kahi hoʻohui IV hou o ka bivalirudin no ka hoʻopaʻa ʻana ma ka wikiwiki o 0.2 mg / kg / h (infusion haʻahaʻa haʻahaʻa), a hiki i 20 mau hola, inā pono.

2.2 Hoʻopaʻa ʻia i ka hōʻino ʻana i ka Renal

ʻAʻole pono ka hōʻemi ʻana i ka nui o ka bolus no kekahi degere o ka hōʻino ʻana i ka renal. Pono e hoʻemi ʻia ka nui o ka infusion o ka bivalirudin no ka injection, a nānā ʻia ke kūlana anticoagulant i nā mea maʻi me ka maʻi renal. ʻO ka poʻe maʻi me ka hōʻino ʻana i ka renal haʻahaʻa (30 a 59 mL / min) pono e loaʻa i kahi infusion o 1.75 mg / kg / h. Inā ʻoi aku ka liʻiliʻi o ka hoʻomaʻemaʻe creatinine ma mua o 30 mL/min, pono e noʻonoʻo ʻia ka hoʻemi ʻana o ka infusion i 1 mg/kg/h. Inā aia ka mea maʻi i ka hemodialysis, pono e hoʻemi ʻia ka nui o ka infusion i 0.25 mg / kg / h.

2.3 Nā kuhikuhi no ka hoʻokele

Manaʻo ʻia ʻo Bivalirudin no ka injection no ka intravenous bolus injection a me ka infusion mau ma hope o ka hoʻoponopono hou ʻana a me ka dilution. I kēlā me kēia vial 250 mg, e hoʻohui i 5 mL o ka wai Sterile no ka Injection, USP. E wili mālie a hiki i ka pau ʻana o nā mea. A laila, hoʻihoʻi a hoʻolei i 5 mL mai kahi ʻeke infusion 50 mL i loaʻa ka 5% Dextrose i loko o ka wai a i ʻole 0.9% Sodium Chloride no ka Injection. A laila e hoʻohui i nā mea i loko o ka hue i hoʻohui ʻia i loko o ka ʻeke infusion i loaʻa i ka 5% Dextrose i ka wai a i ʻole 0.9% Sodium Chloride no ka Injection e loaʻa ai ka hopena hope o 5 mg/mL (e laʻa, 1 vial i 50 mL; 2 vial i 100 mL; 5 hue i loko o 250 mL). Hoʻoponopono ʻia ka nui o ka hoʻohana ʻana e like me ke kaumaha o ka mea maʻi (e nānā i ka Papa 1).

Inā hoʻohana ʻia ka infusion haʻahaʻa ma hope o ka infusion mua, pono e hoʻomākaukau i kahi ʻeke hoʻohaʻahaʻa haʻahaʻa. No ka hoʻomākaukau ʻana i kēia ʻano haʻahaʻa haʻahaʻa, e hoʻohui hou i ka vial 250 mg me 5 mL o ka wai Sterile for Injection, USP. E wili mālie a hiki i ka pau ʻana o nā mea. A laila, e hoʻihoʻi a hoʻolei i 5 mL mai kahi ʻeke infusion 500 mL i loaʻa ka 5% Dextrose i ka wai a i ʻole 0.9% Sodium Chloride no ka Injection. A laila e hoʻohui i nā mea o ka vial i hoʻohui ʻia i loko o ka ʻeke infusion i loaʻa ka 5% Dextrose i ka wai a i ʻole 0.9% Sodium chloride no ka Injection e hoʻohua i ka hopena hope o 0.5 mg/mL. Pono e koho ʻia ka helu infusion e lawelawe ʻia mai ke kolamu ʻākau ma ka Papa 1.