Dexsome 510™ is subject to the FDA-Center for Veterinary Medicine's Compliance Policy Guide (CPG Sec. 635.100) for Large Volume Parenterals (LVPs) for animal use.
• Sodium Chloride, Ringer's, Sodium Bicarbonate, & Other Electrolyte Solutions
• Dextrose (Glucose), & Other Sugar Solutions
• Amino Acid, Peptide, & Other Protein-Fraction Solutions
• Solutions Containing a Combination of the above, Sometimes with Vitamins Added
• Dextrans & Other Plasma Expanders
Large Volume Parenterals Must Meet the Following Conditions under CPG Sec. 635.100:
• The LVP is sterile.
• The LVP is free of preservatives.
• The LVP is supplied in sizes appropriate to label claims facilitating use of the contents promptly following initial entry.
• The LVP is labeled to indicate that:(a) they contain no preservatives, (b) they are intended for use promptly following initial entry, and (c) any portions not used promptly should be discarded.
• The LVP is labeled to clearly indicate concentration of individual ingredients and physiological parameters of the solution.
• The LVP complies with other applicable labeling requirements in the FD&C Act and its implementing regulations, including 21 CFR Part 201.
• The LVP is manufactured in accordance with current Good Manufacturing Practices.
• The LVP is manufactured by an establishment that is registered with FDA and the LVP is drug listed with FDA in accordance with section 510 of the FD&C Act (21 U.S.C. 360).
• Dexsome 510™ veterinary large volume parenteral contains no antimicrobials, preservatives or animal components.
• Dexsome 510™ is manufactured under GMP conditions as a sterile isotonic solution. More information on manufacturing and compliance with CGP Sec. 635.100 may be obtained through LMI-Vet, LLC™, whose information may be treated as confidential business information (CBI).