Dabigatran Etexilate Mesylate

Tlhaloso e Khutšoanyane:

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Dabigatran Etexilate Mesylate Anticoagulant Ka Ntlong      


Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

TLHAKISO SEHLAHISO

Tlhaloso

Dabigatran etexilate mesylate (BIBR 1048MS) ke sehlahisoa se sebetsang ka molomo sa Dabigatran.Dabigatran etexilate mesylate e na le litlamorao tsa anticoagulant mme e sebelisoa bakeng sa prophylaxis ea venousthromboembolism le stroke ka lebaka la fibrillation ea atrial.

Ka morao

Tlhaloso: IC50 Boleng: 4.5nM (Ki);10nM(Thrombin-induced platelet aggregation) [1] Dabigatran ke ntho e fetolehang hape e khetha, e tobileng thrombin inhibitor (DTI) e ntseng e tsoela pele ka tsoelo-pele ea bongaka e le prodrug ea eona ea molomo, dabigatran etexilate.in vitro: Dabigatran e thibela thrombin ea motho ka ho khetha le ka ho fetola (Ki: 4.5 nM) hammoho le ho kopana ha platelet e bakoang ke thrombin (IC(50): 10 nM), ha e sa bontše phello e thibelang lintho tse ling tse susumetsang platelet. -Poor plasma (PPP), e lekantsoeng e le endogenous thrombin potential (ETP) e ne e thibetsoe mahloriso-ho itšetlehile ka (IC (50): 0.56 microM).Dabigatran e bonts'itse litlamorao tsa anticoagulant tse itšetlehileng ka mahloriso mefuteng e fapaneng ea vitro, e imena habeli nako ea karolo ea thromboplastin (aPTT), nako ea prothrombin (PT) le nako ea ho koala ea ecarin (ECT) ho PPP ea motho maemong a 0.23, 0.83 le 0.18 microM, ka ho latellana [ 1].in vivo: Dabigatran e lelefatsa lethal dose ea aPTT ka mor'a ho tsamaisoa ka methapo ho likhoto (0.3, 1 le 3 mg/kg) le litšoene tsa rhesus (0.15, 0.3 le 0.6 mg/kg).Litlamorao tsa anticoagulant tse itšetlehileng ka nako le nako li ile tsa bonoa ka dabigatran etexilate e tsamaisoang ka molomo ho likhoto tse tsebang (10, 20 le 50 mg / kg) kapa litšoene tsa rhesus (1, 2.5 kapa 5 mg / kg), ka litlamorao tse kholo tse bonoang lipakeng tsa 30 le 120. metsotso ka mor'a tsamaiso, ka ho latellana [1].Bakuli ba tšoaroang ka dabigatran etexilate ba ile ba e-ba le lichapo tse fokolang tsa ischemic (3.74 dabigatran etexilate vs 3.97 warfarin) le ho fokotseha ho fokolang ho kopantsoeng ha mali a intracranial le liropo tsa haemorrhagic (0.43 dabigatran etexilate vs 0.99 warfarin) ka selemo sa 10.Teko ea meriana: Tlhahlobo ea Pharmacokinetics le Pharmacodynamics ea Oral Dabigatran Etexilate ho Bakuli ba Hemodialysis.Mokhahlelo oa 1

Polokelo

Phofo

-20°C

3 lilemo
 

4°C

lilemo tse 2
Ka solvent

-80°C

Likhoeli tse 6
 

-20°C

1 khoeli

Teko ea Tleliniki

Nomoro ea NCT Motšehetsi Boemo Letsatsi la qalo

Mokhahlelo

NCT02170792 Boehringer Ingelheim Bophelo bo botle Hlakola 2001

Mokhahlelo oa 1

NCT02170974 Boehringer Ingelheim Bophelo bo botle Phupu 2004

Mokhahlelo oa 1

NCT02170831 Boehringer Ingelheim Bophelo bo botle Ka May 1999

Mokhahlelo oa 1

NCT02170805 Boehringer Ingelheim Bophelo bo botle Mmesa 2001

Mokhahlelo oa 1

NCT02170610 Boehringer Ingelheim Bophelo bo botle Hlakubele 2002

Mokhahlelo oa 1

NCT02170909 Boehringer Ingelheim Bophelo bo botle December 2004

Mokhahlelo oa 1

NCT02171000 Boehringer Ingelheim Bophelo bo botle Mmesa 2005

Mokhahlelo oa 1

NCT02170844 Boehringer Ingelheim Bophelo bo botle Phuptjane 2004

Mokhahlelo oa 1

NCT02170584 Boehringer Ingelheim Bophelo bo botle Pherekhong 2001

Mokhahlelo oa 1

NCT02170935 Boehringer Ingelheim Thromboembolism ea Venus Mmesa 2002

Mokhahlelo oa 2

NCT02170636 Boehringer Ingelheim Bophelo bo botle Pherekhong 2002

Mokhahlelo oa 1

NCT02170766 Boehringer Ingelheim Bophelo bo botle October 2000

Mokhahlelo oa 1

NCT02171442 Boehringer Ingelheim Bophelo bo botle Mmesa 2002

Mokhahlelo oa 1

NCT02170896 Boehringer Ingelheim Bophelo bo botle Mphalane 2001

Mokhahlelo oa 1

NCT02173730 Boehringer Ingelheim Bophelo bo botle November 2002

Mokhahlelo oa 1

NCT02170623 Boehringer Ingelheim Bophelo bo botle Hlakola 2002

Mokhahlelo oa 1

NCT02170116 Boehringer Ingelheim Bophelo bo botle November 1998

Mokhahlelo oa 1

NCT02170597 Boehringer Ingelheim Bophelo bo botle Phato 2003

Mokhahlelo oa 1

NCT01225822 Boehringer Ingelheim Thromboembolism ea Venus November 2002

Mokhahlelo oa 2

NCT02170701 Boehringer Ingelheim Thromboembolism ea Venus October 2000

Mokhahlelo oa 2

NCT02170740 Boehringer Ingelheim Bophelo bo botle November 1999

Mokhahlelo oa 1

NCT02170922 Boehringer Ingelheim Bophelo bo botle July 1999

Mokhahlelo oa 1

Sebopeho sa lik'hemik'hale

Dabigatran Etexilate Mesylate

TSAMAISO KHABANE

Quality management1

Tlhahiso18Merero ea Tlhahlobo ea Boleng e amohetsoeng4, le6merero e tlas'a tumello.

Quality management2

Sistimi e tsoetseng pele ea boleng ba machaba e thehile motheo o tiileng oa thekiso.

Quality management3

Tlhokomelo ea boleng e tsamaisana le potoloho eohle ea bophelo ba sehlahisoa ho netefatsa boleng le phello ea kalafo.

Quality management4

Sehlopha sa Litaba tsa Taolo ea Setsebi se tšehetsa litlhoko tsa boleng nakong ea kopo le ngoliso.

TS'ELISO TS'OANELO

cpf5
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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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Mochini oa Sejeremane oa Fette Compacting

cpf12

Japan Viswill Tablet Detector

cpf14-1

Kamore ea ho laola ea DCS

MOTHOANA

Tšebelisano ea machaba
International cooperation
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