Veterinary Dextrose And Sodium Chloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
2.5% Dextrose injections with low electrolyte concentrations should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.
The intravenous administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
Excessive administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP may result in significant hypokalemia.
In patients with diminished renal function, administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP may result in sodium retention.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP is indicated as a source of water, electrolytes, and calories.
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2.5% Dextrose and 0.45% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Discard unused portion. Composition, osmolarity, pH, concentration and caloric content are shown in Table 1.
The plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.