Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)
APP Pharmaceuticals, LLC
PROPOFOL
PROPOFOL 10 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
PROPOFOL- PROPOFOL INJECTION, EMULSION APP PHARMACEUTICALS, LLC ---------- PROPOFOL INJECTABLE EMULSION, USP FOR IV ADMINISTRATION Rx only STRICT ASEPTIC TECHNIQUE MUST ALWAYS BE MAINTAINED DURING HANDLING. PROPOFOL INJECTABLE EMULSION IS A SINGLE-USE PARENTERAL PRODUCT WHICH CONTAINS 0.005% DISODIUM EDETATE TO INHIBIT THE RATE OF GROWTH OF MICROORGANISMS, FOR UP TO 12 HOURS, IN THE EVENT OF ACCIDENTAL EXTRINSIC CONTAMINATION. HOWEVER, PROPOFOL INJECTABLE EMULSION CAN STILL SUPPORT THE GROWTH OF MICROORGANISMS, AS IT IS NOT AN ANTIMICROBIALLY PRESERVED PRODUCT UNDER USP STANDARDS. ACCORDINGLY, STRICT ASEPTIC TECHNIQUE MUST STILL BE ADHERED TO. DO NOT USE IF CONTAMINATION IS SUSPECTED. DISCARD UNUSED PORTIONS AS DIRECTED WITHIN THE REQUIRED TIME LIMITS (SEE DOSAGE AND ADMINISTRATION, _HANDLING PROCEDURES_). THERE HAVE BEEN REPORTS IN WHICH FAILURE TO USE ASEPTIC TECHNIQUE WHEN HANDLING PROPOFOL INJECTABLE EMULSION WAS ASSOCIATED WITH MICROBIAL CONTAMINATION OF THE PRODUCT AND WITH FEVER, INFECTION/SEPSIS, OTHER LIFE-THREATENING ILLNESS, AND/OR DEATH. DESCRIPTION Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6- diisopropylphenol. The structural formula is: C H O M.W. 178.27 Propofol is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to adjust pH. The Propofol Injectable Emulsion, USP is isotonic and has a pH of 7 to 8.5. CLINICAL PHARMACOLOGY GENERAL Propofol Injectable Emulsion is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol induces Прочитайте повний документ