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18 Years Factory Canagliflozin Dosage - Sugammadex Sodium – CPF

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18 Years Factory Canagliflozin Dosage - Sugammadex Sodium – CPF Detail:

舒更葡糖钠

Sugammadex Sodium

343306-79-6

In-House

Description

Sugammadex sodium is a synthetic γ-cyclodextrin derivative, and acts as a new reversal agent for neuromuscular block.

Generic Name: sugammadex (soo GAM ma dex)
Brand Name: Bridion

Sugammadex reverses the effects of certain medications that are given during surgical procedures to relax your muscles.

Sugammadex is used at the end of surgery, to help restore muscle function that has been blocked during surgery by the other medicines.

Sugammadex may also be used for purposes not listed in this medication guide.

It is used to reverse the effects of some drugs.

In Vivo

Injection of sugammadex has no significant effects on blood pressure or heart rate. After injection of the high rocuronium dose, the 90% recovery of the train-of-four ratio takes 28 min (SD 7 min) after saline, 26 min (SD 9.5 min) after 1 mg/kg sugammadex, and 8 min (SD 3.6 min) after 2.5 mg/kg sugammadex[1]. Sugammadex causes a rapid and complete reversal of rocuronium-induced neuromuscular block. The recovery time to train of four ratio=0.9 after spontaneous recovery is 14.4 min (SD=3.4 min; n=14). This is reduced significantly to 3.7 min (SD=3.3 min; n=4) with sugammadex 0.5 mg/kg and to 1.9 min (SD=1.0 min; n=4) with sugammadex 1.0 mg/kg[2]. The estimated half-life of sugammadex in Rhesus monkey is 30 (SEM=4.9) min[3].

Storage

Powder	-20°C	3 years
	4°C	2 years
In solvent	-80°C	6 months
	-20°C	1 month

Chemical structure

Sugammadex Sodium

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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Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

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Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect.

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

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