GMP Certified / Dexmedetomidine Hydrochloride Injection 2ml/0.2mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 2ml/0.2mg
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Dexmedetomidine Hydrochloride Injection
Strength	2ml/0.2mg
Packing	5 amps/box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Product name:
Dexmedetomidine Hydrochloride Injection 2ml/0.2mg

Character:
This product is colorless or almost colorless clear liquid.

Indications:
For sedation during endotracheal intubation and mechanical ventilation in patients undergoing surgery under general anesthesia.

Drug interaction:
Simultaneous administration of this product with narcotics, sedatives, hypnotics, and opioids may result in an enhancement of the drug's effects. Foreign research reports have identified the effects of dexmedetomidine hydrochloride on sevoflurane, isoflurane, propofol, afentanil and midazolam. There was no pharmacokinetic interaction between dexmedetomidine and isoflurane, propofol, afentanil and midazolam. However, due to possible pharmacodynamic interactions, it may be necessary to lower the dose of this product or accompanying narcotics, sedatives, hypnotics, and opioids when administered simultaneously.
Neuromuscular blockade
In a foreign study of 10 healthy volunteers, 45 min administration of dexmedetomidine hydrochloride at a plasma concentration of 1ng/ml did not result in a clinically significant increase in the degree of neuromuscular blockade associated with rocuronium administration.

Pharmacology and toxicology:
Pharmacological action
Dexmedetomidine is a relatively selective α2-adrenergic receptor agonist with sedative effects. Selective effects on α2-adrenoceptors were seen in animals with slow intravenous infusion of dexmedetomidine at 10 to 300μg/kg, but effects on both α1 and α2-receptors were observed with slow intravenous infusion or rapid intravenous administration at higher doses (≥1000μg/kg).
Toxicological study
genotoxicity
Dexmedetomidine Ames test and mammalian cell positive gene mutation test were negative. Chromosomal aberration test of human lymphocytes in vitro under S9 metabolic activation in rats and in vivo micronucleus test in NMRI mice were positive, but chromosomal aberration test of human lymphocytes in vitro with or without human S9 metabolic activation and in vivo micronucleus test in CD-1 mice were negative.
Reproductive toxicity
In male or female rats, daily subcutaneous injection of dexmedetomidine up to 54μg/kg(calculated as μg/m2, below the maximum recommended human intravenous dose) from 10 and 3 weeks before and until mating, respectively, showed no effect on fertility.
The dose of dexmedetomidine was as high as 200μg/kg on the 5th to 16th day of gestation in rats and 96μg/kg on the 6th to 18th day of gestation in rabbits. No teratogenic effect was observed. According to the calculation of μg/m2, the rat dose is equivalent to twice the maximum recommended human intravenous dose. Based on plasma drug AUC values, exposure in rabbits was similar to exposure at the maximum recommended human intravenous dose. Fetal toxicity was observed in rats at a dose of 200μg/kg, with increased loss and decreased number of surviving pups after implantation. The no-effect dose is 20μg/kg(based on μg/m2), which is lower than the maximum recommended dose for intravenous administration in humans.
Subcutaneous injection of dexmedetomidine in rats from the 16th day of pregnancy to lactation resulted in weight loss in the pups at doses of 8 and 32μg/kg(calculated according to μg/m2, lower than the maximum recommended human intravenous dose), and retardation of motor function was observed in the pups in the 32μg/kg dose group. In the 32μg/kg dose group, fetal and fetal toxicity was also observed in F2 generation. No such toxicity was observed at 2μg/kg.
Placental transport was observed in pregnant rats after subcutaneous injection of radiolabelled dexmedetomidine.

Storage:
Dark, sealed, room temperature (10 ~ 30ºC) store.