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Sevorane

Sevorane Description

sevoflurane

Manufacturer:

Abbvie

Distributor:

Zuellig
Full Prescribing Info
Description
Sevoflurane is a nonflammable liquid anesthetic agent administered by vaporization. It is a fluorinated derivative of methyl isopropyl ether. Sevoflurane is identified chemically as fluoromethyl 2, 2, 2-trifluoro-1-(trifluoromethyl) ethyl ether and has a molecular weight of 200.05.
Sevoflurane has the following physical and chemical properties: See Tables 1 and 2.

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Sevoflurane is nonflammable and non-explosive as defined by the requirements of International Electrotechnical Commission 601-2-13.
Sevoflurane is a clear, colorless, liquid. Sevoflurane is nonpungent. It is miscible with ethanol, ether, chloroform and petroleum benzene, and it is slightly soluble in water.
Sevoflurane Degradation: Sevoflurane is stable when stored under normal room lighting conditions. No discernible degradation of sevoflurane occurs in the presence of strong acids or heat. Sevoflurane is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass, or copper beryllium alloy. Chemical degradation can occur upon exposure of inhaled anesthetics to CO2 absorbent within the anesthesia machine. When used as directed with fresh absorbents, degradation of sevoflurane is minimal, and degradants are undetectable or non-toxic. Sevoflurane degradation and subsequent degradant formation are enhanced by increasing absorbent temperature, desiccated CO2 absorbent (especially potassium hydroxide-containing), increased sevoflurane concentration and decreased fresh gas flow. Sevoflurane can undergo alkaline degradation by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropanyl fluoromethyl ether (PIFE or more commonly known as Compound A). The second pathway for degradation of sevoflurane occurs only in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated, cleared, and has toxicity comparable to sevoflurane. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide, in the presence of high temperature. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. With highly desiccated absorbents, especially those containing potassium hydroxide, the formation of formaldehyde, methanol, carbon monoxide, Compound A and perhaps some of it's degradants, Compounds B, C, and D may occur.
Lewis Acid Degradation: At least 300 ppm of water is added as a Lewis acid inhibitor. No other additives or chemical stabilizers are utilized.
Formulation: Contains: Fluoromethyl 2, 2, 2-trifluoro-1 -(trifluoromethyl) ethyl ether (Sevoflurane) 250 mL Wet Formulation.
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