GMP Certified / Propofol Injectable Emulsion 100mg/10ml

• Customization: Available
• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Model NO.: injection
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 100mg/10ml
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Propofol Injectable Emulsion
Strength	100mg/10ml
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
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Product name:
Propofol Injectable Emulsion 100mg/10ml

Character:
This product is a white milky liquid.

Indications:
It is suitable for the induction and maintenance of general anaesthesia, as well as for enhancing sedation of supervised patients undergoing mechanical ventilation, and for performing painless abortion under anaesthesia.

Adverse reactions:
Systemic adverse reactions:
1. Induction of anesthesia is usually smooth, with little excitement. However, dose-dependent inhibition of respiratory and circulatory function was found, which was positively correlated with injection speed, and the decrease of arterial pressure and peripheral resistance was more obvious than that of sodium thiopental. During induction of anesthesia, hypotension and transient apnea may occur due to the dose, preoperative medication used, and other medications. To correct hypotension, intravenous fluids are sometimes required and the rate of propofol injection is reduced during maintenance anesthesia.
2. The incidence of muscular twin was about 1% during induction.
3. Epileptoid movement with convulsion and anisocytosis has been reported occasionally, and pulmonary edema has also been reported.
4. Anaphylaxis is rare and can be characterized by bronchospasm, erythema, and hypotension.
5. During anesthesia resuscitation, a small number of patients experienced nausea, vomiting, and headache.
6. Postoperative fever after propofol administration has been reported.
Seven. Occasional changes in urine color were reported after prolonged propofol administration.
Local adverse reactions:
Local pain may occur during propofol induction, but can be alleviated by combining lidocaine (see usage and dosage) or by using thicker veins in the forearm. Thrombosis and phlebitis are rare.

Pharmacology and toxicology:
Pharmacological action: Propofol is an intravenous general anesthetic used for the induction and maintenance of anesthesia and sedation. Usually the therapeutic dose can produce hypnotic effect about 40 seconds after intravenous injection, and the excitatory effect is small. The mechanism of action of this drug may be the activation of aminobutyric acid (GABA) receptor-chloride complex, which increases chloride ion conduction at conventional doses and desensitizes GABA receptors at large doses, thereby inhibiting the central nervous system.
Toxicological study
Genotoxicity: Propofol Ames test, Saccharomyces cerevisiae gene mutation/gene transformation test, in vitro Chinese hamster cytogenetics studies, and mouse micronucleus test results were negative.
Reproductive toxicity: Continuous intravenous administration of 15mg/kg/ day of propofol (equivalent to the clinically recommended induction dose based on body surface area) in female rats during the first two weeks of pregnancy until day 7 of gestation did not show an adverse effect on fertility. In the dominant lethal test of intravenous propofol 15mg/kg/ day for 5 consecutive days, the fertility of male rats was not affected. Propofol 15mg/kg/ day was given intravenously to rats and rabbits, and there was no harm to the fetus. However, studies have shown that propofol 15mg/kg/ day given to lactating mothers or rabbits can cause maternal death and reduce the survival rate of the young. The adverse reactions observed in the offspring may be due to the pharmacological activity of propofol on the mother (anesthetic effect).

Storage:
Store between 2-25ºC, do not freeze.