GMP Certified / Rocuronium Bromide Injection 5ml: 50mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 50mg/5ml
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Rocuronium Bromide Injection
Strength	5ml:50mg
Packing	5 amps/box
Origin	China

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Product name:
Rocuronium Bromide Injection 5ml:50mg

Character:
This product is colorless to slightly yellow clear liquid.

Indications:
Rocuronium is used as an adjunct to general anesthesia for routine induction of tracheal intubation during anesthesia and for maintenance of intraoperative skeletal muscle relaxation.

Adverse reactions:
The most commonly occurring adverse reactions (ADRs) included injection site pain/reactions, changes in vital signs, and prolonged neuromuscular blocking effects. The most commonly reported serious ADRs during post-marketing surveillance are allergic and anaphylactic reactions and related symptoms.

Pharmacology and toxicology:
Rocuronium is a fast-acting, moderate-aging non-depolarizing neuromuscular blocker that acts by competitive binding to N-type acetylcholine receptors at the motor endplate and is antagonized by acetylcholinesterase inhibitors such as neostigmine, ephenolammonium chloride, and pyristigmine.
The ED90 value during intravenous anesthesia (the dose required to stimulate the ulnar nerve to suppress the thumb twitch response by 90%) is approximately 0.3mg/kg rocuronium. Within 60 seconds of intravenous injection of rocuronium 0.6mg/kg (twice the ED90 amount during intravenous anesthesia), almost all patients could obtain suitable conditions for endotracheal intubation, and 80% of them had excellent conditions for endotracheal intubation. The whole-body muscle relaxation produced in 2 minutes is suitable for all types of surgery. The clinical duration of action of this dose (the time from the end of infusion to the natural recovery of 25% of myogenesis) is 30 to 40 minutes. The total action time (90% time for spontaneous recovery of myokymia) was 50 minutes. The mean time (recovery index) for spontaneous recovery from 25% to 75% after a single injection of rocuronium 0.6mg/kg was 14 minutes.
When using smaller dose of rocuronium 0.3 ~ 0.45mg/kg (1 ~ 1.5 times ED90), its effect is slowed down and the aging is shortened. Appropriate conditions for endotracheal intubation were achieved 90 seconds after 0.45mg/kg rocuronium was administered.
Satisfactory intubation conditions were achieved within 60 seconds of 1.0mg/kg rocuronium during rapid induction anesthesia with propofol or fentanyl/thiopental sodium in 93% and 96% of patients, respectively, with excellent intubation conditions in 70% of patients. The clinical muscle relaxation effect of this dose is maintained for about 1 hour, and the muscle relaxation can be safely reversed. After rapid induction anesthesia with propofol or fentanyl/thiopental sodium, respectively, the rate of satisfactory intubation conditions within 60 seconds after 0.6mg/kg rocuronium was 81% and 75%, respectively. When the dose of rocuronium exceeded 1.0mg/kg, the intubation conditions did not improve further, but its aging was prolonged. The clinical application of doses greater than 4 times ED90 remains to be studied.
The 0.15mg/kg maintenance dose of rocuronium was approximately 20 minutes in elderly patients under enflurane and isoflurane anesthesia and in patients with liver and/or kidney disease, and was approximately 13 minutes in patients without excretory organ function impairment under intravenous anesthesia, with some extension in the former. No accumulation (i.e., a gradual increase in aging) was observed in muscle relaxation maintenance at repeated supplemental recommended doses.
In patients undergoing elective cardiac surgery, when rocuronium was administered 0.6 to 0.9mg/kg to the maximum block period, the most common cardiovascular changes were mild and of no clinical significance, manifested as a 9% increase in heart rate and a 16% increase in mean arterial pressure compared with control.

Storage:
Store at 2-8°C away from light. Rocuronium bromide injection can be stored for 12 weeks at 8-30°C.