Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
SEVOFLURANE (UNII: 38LVP0K73A) (SEVOFLURANE - UNII:38LVP0K73A)
Baxter Healthcare Corporation
SEVOFLURANE
SEVOFLURANE 250 mL in 250 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane, USP should be used.
Sevoflurane, USP, Volatile Liquid for Inhalation, is available as: NDC 10019-651-64 - Aluminum bottle with plastic screw-on cap containing 250 mL sevoflurane, USP. NDC 10019-655-06 - Aluminum bottle with an integrated crimped-on valve closure containing 250 mL sevoflurane, USP. There is no specific work exposure limit established for sevoflurane, USP. However, the National Institute for Occupational Safety and Health has recommended an 8 hour time-weighted average limit of 2 ppm for halogenated anesthetic agents in general (0.5 ppm when coupled with exposure to N2 O) (see ADVERSE REACTIONS). Store at controlled room temperature 15°- 30°C (59°- 86°F). See USP. The bottle cap should be replaced securely after each use of sevoflurane, USP.
Abbreviated New Drug Application
SEVOFLURANE- SEVOFLURANE LIQUID BAXTER HEALTHCARE CORPORATION ---------- SEVOFLURANE, USP VOLATILE LIQUID FOR INHALATION DESCRIPTION Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is: SEVOFLURANE, USP, PHYSICAL CONSTANTS ARE: Molecular weight 200.05 Boiling point at 760 mm Hg 58.6°C Specific gravity at 20°C 1.520 - 1.525 Vapor pressure in mm Hg 157 mm Hg at 20°C 197 mm Hg at 25°C 317 mm Hg at 36°C DISTRIBUTION PARTITION COEFFICIENTS AT 37°C: Blood/Gas 0.63 - 0.69 Water/Gas 0.36 Olive Oil/Gas 47 - 54 Brain/Gas 1.15 MEAN COMPONENT/GAS PARTITION COEFFICIENTS AT 25°C FOR POLYMERS USED COMMONLY IN MEDICAL APPLICATIONS: Conductive rubber 14.0 Butyl rubber 7.7 Polyvinylchloride 17.4 Polyethylene 1.3 Sevoflurane, USP is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane, USP is a clear, colorless, liquid containing no additives. Sevoflurane, USP is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane, USP is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane, USP is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane, USP occurs in the presence of strong acids or heat. When in contact with alkaline CO absorbents (e.g., Baralyme and to a lesser extent soda lime) within the anesthesia machine, Sevoflurane, USP can undergo degradation under certain conditions. Degradation of sevoflurane, USP is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane, USP degradation and subsequent degradant formation are enhanced by inc Preberite celoten dokument