Rivaroxaban

Faʻamatalaga puʻupuʻu:

Igoa ole API Faailoga Faʻamatalaga US DMF  EU DMF  CEP
Rivaroxaban Anticoagulant Totonu o le Fale TDP    

Oloa Faʻamatalaga

Pine o oloa

FAʻAMATALAGA FAʻAMATALAGA

Talaʻaga

Rivaroxaban, 5-chloro-N - [[(5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] thiophene-2 -carboxamide, o se tamaʻi mole mole mole faʻamalosi o le mea Xa ose mea e maua ai le faʻamafanafanaina i se faʻalavelave ogaoga i le toto auala o le faʻataʻitaʻiga e mafua ai le gaosiga o le thrombin ma le faʻavaeina o le poloka. O le Rivaroxaban e fusifusia i le Tyr288 i le S1 taga o le mea Xa e ala i le fegalegaleai a le Tyr288 ma le vailaʻau o le chlorine o le lagona o le chlorothiophene. O le taofiofi e mafai ona toe suia (koff = 5x10-3s-1), vave (kon = 1.7x107 mol / L-1 s-1), ma i se faʻalagolago-faʻalagolago faiga (Ki = 0.4 nmol / L). Rivaroxaban o loʻo suʻesuʻeina nei mo le togafitia o le VTE, puipuia o mea e tutupu i le fatu i tagata mamaʻi ua maua i le maʻi o le coronary syndrome, puipuia le papala i tagata mamaʻi ua iai le fibrillation i tua.

Tusitusiga

Elisabeth Perzborn, Susanne Roehrig, Alexander Straub, Dagmar Kubitza, Wolfgang Mueck, ma Volker Laux. Rivaroxaban: o se mea fou e tautala ai Xa taofiofi. Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Faʻamatalaga

Rivaroxaban (BAY 59-7939) e malosi tele,filifili ma tuusaʻo Factor Xa (FXa) taofi, mauaina se malosi maua i anti-FXa gafatia (IC50 0.7 nM; Ki 0.4 nM).

 

I Vitro

Rivaroxaban (BAY 59-7939) o se tautala, tuusaʻo Factor Xa (FXa) taofiofia i atinaʻe mo le puipuia ma togafitiga o arterial ma venous thrombosis. Rivaroxaban faʻatauvaga taofia le tagata FXa (Ki 0.4 nM) ma le> 10 000-lafu sili atu filifili nai lo mo isi serine proteases; e taofia ai foʻi le gaioiga o le prothrombinase (IC50 2.1 nM). Rivaroxaban taofiofia endogenous FXa sili atu le malosi i le tagata ma lapiti plasma (IC50 21 nM) nai lo rat plasma (IC50 290 nM). O loʻo faʻaalia ai aafiaga o le anticoagulant i le plasma o le tagata, faʻaluaina le taimi o le prothrombin (PT) ma faʻagaoioia le vaega o le thromboplastin i le 0.23 ma le 0.69μM, faʻatulagaina.

 

Rivaroxaban (BAY 59-7939) o se malosi ma filifilia, tuusaʻo FXa tagata faʻatamaina ma sili ona lelei i gaioiga vivo ma lelei gutu bioavailability. Rivaroxaban (BAY 59-7939), faʻatautaia e iv bolus aʻo leʻi faʻatinoina le thrombus, faʻaititia le thrombus faʻatulagaina (ED50 0.1 mg / kg), taofia le FXa, ma faʻalauteleina faʻalauteleina PT fualaʻau. PT ma FXa e afaina laʻititi ile ED50 (1.8-faʻateleina faʻaopoopoga ma 32% taofi, faʻasologa) I le 0.3 mg / kg (fualaʻau e oʻo atu i le toeititi maeʻaeʻaina o le thrombus faʻavaeina), Rivaroxaban feololo e faʻalauteleina PT (3.2±0.5-lafu) ma taofia le gaioiga a le FXa (65±3%).

 

Teuina o Meaai

Efuefu

-20 ° C

3 tausaga
 

4 ° C

2 tausaga
I le mafai ona totogi aitalafu

-80 ° C

6 masina
 

-20 ° C

1 masina

Fausaga o vailaʻau

Rivaroxaban

FAUTUAINA

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

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Quality management4

E lagolagoina e le 'aufaʻatonutonu o mataupu tau tulafono le tulaga lelei o manaʻoga i le taimi o le tusi talosaga ma le lesitalaina.

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