Bivalirudin jekeseni

250mg / mbale Mphamvu

Chosonyeza: Bivalirudin akusonyeza ntchito ngati anticoagulant odwala likufa percutaneous inatsekeratu alowererepo (PCI).

Chipatala ntchito: Ndi usedfor mtsempha jekeseni ndi mtsempha kukapanda kuleka.

Zikuonetsa NDI zakagwiritsidwe

1.1 Percutaneous Transluminal inatsekeratu Angioplasty (PTCA)

Bivalirudin jekeseni akusonyeza ntchito ngati anticoagulant odwala ndi wosakhazikika angina likufa percutaneous transluminal inatsekeratu angioplasty (PTCA).

1.2 Percutaneous inatsekeratu Adzachitapo Kanthu (PCI)

Bivalirudin jekeseni ndi ntchito provisional wa glycoprotein IIb / IIIa woletsa (GPI) monga zalembedwa mu

Sinthanitsani-2 mayesero akusonyeza ntchito ngati anticoagulant odwala likufa percutaneous inatsekeratu alowererepo (PCI).

Bivalirudin jekeseni akusonyeza kuti odwala, kapena pa chiopsezo, heparin anachititsa thrombocytopenia (KUMENYA) kapena heparin anachititsa thrombocytopenia ndi thrombosis syndrome (HITTS) likufa PCI.

1.3 Ife mauthenga ndi Aspirin

Bivalirudin jekeseni mu zizindikiro izi cholinga ntchito ndi aspirin ndi wakhala ankaphunzira yekha odwala kulandira concomitant aspirin.

1.4 malire a Ntchito

Chitetezo ndi mphamvu ya bivalirudin jekeseni sizinachitike unakhazikitsidwa odwala syndromes pachimake inatsekeratu amene si likufa PTCA kapena PCI.

2 Mlingo ndi yoyendetsa

2.1 Analimbikitsa Mlingowu

Bivalirudin jekeseni ndi makonzedwe mtsempha yekha.

Bivalirudin jekeseni cholinga ntchito ndi aspirin ndi (300 325 mg ndi tsiku) ndipo afufuza yekha odwala kulandira concomitant aspirin.

Kwa odwala amene alibe KUMENYA / HITTS

Mlingo bivalirudin jekeseni ndi mtsempha (IV) bolus mlingo wa 0,75 mg / kg pa anamutsatira pomwepo ndi kulowetsedwa wa 1,75 mg / kg pa / h kwa nthawi ya PCI / PTCA ndondomeko. Mph asanu pambuyo bolus mlingo wakhala kutumikiridwa, ndi adamulowetsa clotting nthawi (zinthu) ayenera kuchitidwa ndi bolus zina 0,3 mg / kg pa ayenera kuperekedwa ngati pakufunika kutero.

GPI makonzedwe tiyenera kuziganizira kukachitika kuti aliyense zinthu kutchulidwa m'malo-2 matenda kufotokoza mayesero alipo.

Kwa odwala amene KUMENYA / HITTS

Mlingo bivalirudin jekeseni odwala ndi kugunda / HITTS likufa PCI ndi IV bolus wa 0,75 mg / kg. Izi akutsatiridwa ndi kulowetsedwa yopitirira pa mlingo wa 1,75 mg / kg pa / h kwa nthaŵi ya ndondomeko.

Pakuti kupitirirabe chithandizo positi ndondomeko

Bivalirudin kwa kulowetsedwa jekeseni akhoza anapitiriza zotsatirazi PCI / PTCA kwa maola 4 nsanamira ndondomeko pa kuchenjera kwa dokotala amachitira.

Mu odwala cha ku Switzerland gawo okwera m'mnyewa wamtima infarction (STEMI) kupitiriza kwa bivalirudin kwa kulowetsedwa jekeseni pa mlingo wa 1,75 mg / kg pa / h zotsatirazi PCI / PTCA kwa maola 4 pambuyo ndondomeko ayenera kuonedwa pochepetsa chiopsezo thrombosis stent.

Patapita maola anayi, ndi zina IV kulowetsedwa wa bivalirudin jekeseni akhoza kuyamba pa mlingo wa 0.2 mg / kg pa / h (otsika mtengo kulowetsedwa), kwa maola 20, ngati pakufunika kutero.

2.2 n'zimene mu kuwonongeka aimpso

No kuchepetsa mu bolus mlingo zingamuthandize digiri iliyonse ya kuwonongeka aimpso. The kulowetsedwa mlingo wa bivalirudin jekeseni zingafunikire yafupika, ndi anticoagulant udindo kuunikira odwala ndi kuwonongeka aimpso. Odwala ndi kuwonongeka zolimbitsa aimpso (30 mpaka 59 ml / Mph) ayenera kulandira ndi kulowetsedwa wa 1,75 mg / kg pa / h. Ngati creatinine chilolezo ndi zosakwana 30 mL / Mph, kuchepetsa mlingo kulowetsedwa kwa 1 mg / kg / h tiyenera kuziganizira. Ngati wodwala ali hemodialysis, mlingo kulowetsedwa ayenera kuchepetsedwa kwa 0,25 mg / kg pa / h.

2.3 Malangizo Administration

Bivalirudin jekeseni cholinga cha mtsempha jekeseni bolus ndi kulowetsedwa mosalekeza pambuyo reconstitution ndi dilution. Aliyense 250 mg mbale, kuwonjezera 5 ml ya wosabala Madzi a jekeseni, USP. Pang'ono pang'ono swirl mpaka zinthu zonse uli kusungunuka. Kenako, kutapa kutaya ndi mL 5 50 mL kulowetsedwa thumba munali 5% Dextrose mu Water kapena 0,9% sodium kolorayidi jekeseni. Kenaka yikani nkhani za mbale reconstituted mu thumba kulowetsedwa munali 5% Dextrose mu Water kapena 0,9% sodium kolorayidi jekeseni kudzipereka ndende womaliza wa 5 mg / mL (mwachitsanzo, 1 vial 50 mL; 2 mbale mu 100 mL; 5 vayozi mu 250 ml). mlingo zimene tikubweretsazi kusintha malinga ndi kulemera kwa wodwalayo (onani Table 1).

Ngati kulowetsedwa otsika mtengo ntchito pambuyo kulowetsedwa koyamba, thumba m'munsi ndende muyenera kukhala okonzeka. Kuti akonze izi ndende m'munsi, reconstitute a 250 mg vial ndi 5 ml ya wosabala Madzi a jekeseni, USP. Pang'ono pang'ono swirl mpaka zinthu zonse uli kusungunuka. Kenako, kutapa kutaya ndi mL 5 thumba 500 ml kulowetsedwa munali 5% Dextrose mu Water kapena 0,9% sodium kolorayidi jekeseni. Kenaka yikani nkhani za mbale reconstituted mu thumba kulowetsedwa munali 5% Dextrose mu Water kapena 0,9% sodium mankhwala enaake a jekeseni kudzipereka ndende womaliza wa 0.5 mg / mL. Mlingo kulowetsedwa zimene tikubweretsazi ayenera anasankha ku kumanjawo mu Table 1.