Dabigatran Etexilate Mesylate

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Kufotokozera US DMF EU DMF CEP
Dabigatran Etexilate Mesylate Anticoagulant M'nyumba      


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Kufotokozera

Dabigatran etexilate mesylate (BIBR 1048MS) ndi mankhwala opangidwa pakamwa a Dabigatran. Dabigatran etexilate mesylate ali anticoagulant zotsatira ndipo ntchito prophylaxis wa venousthromboembolism ndi sitiroko chifukwa cha matenda fibrillation.

Mbiri

Kufotokozera: IC50 Mtengo: 4.5nM (Ki); 10nM(Thrombin-induced platelet aggregation) [1] Dabigatran ndi chosinthika komanso chosankha, cholunjika cha thrombin inhibitor (DTI) chomwe chikupita patsogolo pachipatala monga mankhwala ake ogwiritsira ntchito pakamwa, dabigatran etexilate. mu vitro: Dabigatran amaletsa mwa kusankha komanso mosintha kusintha kwa thrombin ya anthu (Ki: 4.5 nM) komanso kuphatikiza kwa mapulateleti opangidwa ndi thrombin (IC(50): 10 nM), pomwe sikuwonetsa zotsatira zoletsa pazinthu zina zokongoletsa mapulateleti. -Poor plasma (PPP), yoyesedwa ngati mphamvu yamkati ya thrombin (ETP) inali yoletsedwa kudalira (IC (50): 0.56 microM). Dabigatran adawonetsa zotsatira zodalira anticoagulant m'mitundu yosiyanasiyana mu vitro, kuwirikiza kawiri nthawi ya thromboplastin (aPTT), nthawi ya prothrombin (PT) ndi nthawi ya ecarin clotting (ECT) mu PPP yaumunthu pamagulu a 0.23, 0.83 ndi 0.18 microM, motsatira [ 1]. mu vivo: Dabigatran adatalikitsa mlingo wa aPTT modalira pambuyo polowetsedwa m'mitsempha mu makoswe (0.3, 1 ndi 3 mg/kg) ndi anyani a rhesus (0.15, 0.3 ndi 0.6 mg/kg). Mlingo ndi nthawi yodalira anticoagulant zotsatira adawonedwa ndi dabigatran etexilate yoperekedwa pakamwa kwa makoswe ozindikira (10, 20 ndi 50 mg / kg) kapena anyani a rhesus (1, 2.5 kapena 5 mg / kg), ndi zotsatira zazikulu zomwe zimawonedwa pakati pa 30 ndi 120 min pambuyo poyang'anira, motsatana [1]. Odwala omwe amathandizidwa ndi dabigatran etexilate adakumana ndi zikwapu zochepa za ischemic (3.74 dabigatran etexilate vs 3.97 warfarin) ndi zochepa zophatikizira zotuluka m'magazi ndi zikwapu za haemorrhagic (0.43 dabigatran etexilate vs 0.99 warfarin) [odwala 10] pazaka 10. Kuyesa kwachipatala: Kuwunika kwa Pharmacokinetics ndi Pharmacodynamics ya Oral Dabigatran Etexilate mu Hemodialysis Odwala. Gawo 1

Kusungirako

Ufa

-20 ° C

3 zaka
 

4°C

zaka 2
Mu zosungunulira

-80 ° C

6 miyezi
 

-20 ° C

1 mwezi

Kuyesa Kwachipatala

Nambala ya NCT Wothandizira Mkhalidwe Tsiku loyambira

Gawo

NCT02170792 Boehringer Ingelheim Wathanzi February 2001

Gawo 1

NCT02170974 Boehringer Ingelheim Wathanzi July 2004

Gawo 1

NCT02170831 Boehringer Ingelheim Wathanzi Meyi 1999

Gawo 1

NCT02170805 Boehringer Ingelheim Wathanzi Epulo 2001

Gawo 1

NCT02170610 Boehringer Ingelheim Wathanzi March 2002

Gawo 1

NCT02170909 Boehringer Ingelheim Wathanzi December 2004

Gawo 1

NCT02171000 Boehringer Ingelheim Wathanzi Epulo 2005

Gawo 1

NCT02170844 Boehringer Ingelheim Wathanzi June 2004

Gawo 1

NCT02170584 Boehringer Ingelheim Wathanzi Januware 2001

Gawo 1

NCT02170935 Boehringer Ingelheim Thromboembolism ya venous Epulo 2002

Gawo 2

NCT02170636 Boehringer Ingelheim Wathanzi Januware 2002

Gawo 1

NCT02170766 Boehringer Ingelheim Wathanzi October 2000

Gawo 1

NCT02171442 Boehringer Ingelheim Wathanzi Epulo 2002

Gawo 1

NCT02170896 Boehringer Ingelheim Wathanzi October 2001

Gawo 1

NCT02173730 Boehringer Ingelheim Wathanzi Novembala 2002

Gawo 1

NCT02170623 Boehringer Ingelheim Wathanzi February 2002

Gawo 1

NCT02170116 Boehringer Ingelheim Wathanzi Novembala 1998

Gawo 1

NCT02170597 Boehringer Ingelheim Wathanzi Ogasiti 2003

Gawo 1

NCT01225822 Boehringer Ingelheim Thromboembolism ya venous Novembala 2002

Gawo 2

NCT02170701 Boehringer Ingelheim Thromboembolism ya venous October 2000

Gawo 2

NCT02170740 Boehringer Ingelheim Wathanzi Novembala 1999

Gawo 1

NCT02170922 Boehringer Ingelheim Wathanzi July 1999

Gawo 1

Kapangidwe ka mankhwala

Dabigatran Etexilate Mesylate

CERTIFICATE

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

KUSINTHA KWA KHALIDWE

Kasamalidwe kabwino 1

Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

Kasamalidwe kabwino2

Dongosolo lotsogola lapadziko lonse lapansi loyang'anira bwino layala maziko olimba pakugulitsa.

Kasamalidwe kabwino3

Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zikuyenda bwino komanso zochiritsira.

Kasamalidwe kabwino4

Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

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WOTHANDIZA

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