Dexsome™ 510 IV Fluid

Veterinary Intravenous Fluids

Commercial Availability
Dexsome 510 is scheduled to be available in 2016

Dexsome 510 is a cost-effective intravenous solution (veterinary intravenous fluids) for veterinary emergency and critical care, surgery, and other key segments which utilize blood products, blood substitutes, and veterinary intravenous fluids and intravenous colloids.

Dexsome 510: a new veterinary intravenous fluid
Veterinary Intravenous Fluids

Indications and Use: Dexsome 510 is veterinary intravenous fluid for use in companion animals  where the replacement of fluid, dextrose, inorganic salts, vitamins, amino acids, carbohydrates, and antioxidants may be of benefit. 

Description: Dexsome 510 (5% Dextran Solution) veterinary intravenous fluid is a clear, yellow, isotonic, sterile, non-pyrogenic, animal component free, colloid and crystalloid solution for plasma volume expansion.  Dexsome 510 is slightly alkaline (pH: 7.1 – 7.3) and its osmolality is 320 – 430 mOsm/kg.

 

 

Veterinary Intravenous Fluids RegulationsDexsome 510 Manufacturing & Compliance
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.

Common LVPs:
Sodium chloride, Ringer’s, sodium bicarbonate and other electrolyte solutions
Dextrose (glucose) and other sugar solutions
Amino acid, peptide and other protein-fraction solutions
Solutions containing a combination of the above, sometimes with vitamins added
Dextrans and other plasma expanders

Large volume parenterals must meet the following conditions under CPG Sec. 635.100:

  1. The LVP is sterile.
  2. The LVP is free of preservatives.
  3. The LVP is supplied in sizes appropriate to label claims facilitating use of the contents promptly following initial entry.
  4. 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.
  5. The LVP is labeled to clearly indicate concentration of individual ingredients and physiological parameters of the solution.
  6. The LVP complies with other applicable labeling requirements in the FD&C Act and its implementing regulations, including 21 CFR Part 201.
  7. The LVP is manufactured in accordance with current Good Manufacturing Practices.
  8. 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).
veterinary regulationsDexsome 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, which information may be treated as confidential business information (CBI)