Sugammadex Sodium

Tsanangudzo Pfupi

Zita reAPI Indication Tsanangudzo US DMF EU DMF CEP
Sugammadex Sodium Neuromuscular blockade Mumba      


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PRODUCT DETAIL

舒更葡糖钠 Sugammadex Sodium 343306-79-6 Mumba

Tsanangudzo

Sugammadex sodium inogadzirwa neγ-cyclodextrin inotorwa, uye inoshanda sechinhu chitsva chinodzosera cheneuromuscular block.

Generic Zita: sugammadex (soo GAM ma dex)
Zita reBrand: Bridion

Sugammadex inodzosera mhedzisiro yeimwe mishonga inopihwa panguva yekuvhiya kuzorodza tsandanyama dzako.

Sugammadex inoshandiswa pakupera kwekuvhiyiwa, kubatsira kudzorera mhasuru basa rakavharwa panguva yekuvhiyiwa nemimwe mishonga.

Sugammadex inogona zvakare kushandiswa kune zvinangwa zvisina kunyorwa mugwaro remishonga.

Inoshandiswa kudzoreredza mhedzisiro yeimwe mishonga.

MuVivo

Jekiseni ye sugammadex haina mhedzisiro yakakosha paBP kana kurova kwemoyo.Mushure mejekiseni repamusoro rocuronium dose, iyo 90% kupora kwechitima-yechina chiyero inotora 28 min (SD 7 min) mushure mesaline, 26 min (SD 9.5 min) mushure me1 mg / kg sugammadex, uye 8 min (SD 3.6 min) mushure me2.5 mg / kg sugammadex [1].Sugammadex inokonzera kukurumidza uye kwakazara kutendeuka kwe rocuronium-induced neuromuscular block.Iyo yekudzoreredza nguva yekudzidzisa yechina chiyero = 0.9 mushure mekudzoreredza kupora ndeye 14.4 min (SD = 3.4 min; n = 14).Izvi zvakaderedzwa zvakanyanya kusvika ku3.7 min (SD = 3.3 min; n = 4) ne sugammadex 0.5 mg/kg uye ku1.9 min (SD=1.0 min; n = 4) ine sugammadex 1.0 mg/kg[2].Iyo inofungidzirwa hafu yehupenyu hwe sugammadex muRhesus monkey ndeye 30 (SEM = 4.9) min[3].

Storage

Upfu

-20°C

3 years

4°C

2 years
In solvent

-80°C

6 mwedzi

-20°C

1 mwedzi

Chimiro chemakemikari

Sugammadex Sodium

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

HUNHU MANAGEMENT

Quality management1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Quality management2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Quality management3

Kutariswa kwemhando yepamusoro kunofamba kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando nekurapa.

Quality management4

Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.

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