Animal NDC 72483-208-01 Sterile Water For Irrigation
Sterile Water For Irrigation, Solution
Animal Product Information
Sterile Water For Irrigation Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description
Disclaimer: This product is intended for veterinary use only. It is manufactured in accordance with current good manufacturing practices (cGMP) and meets recognized standards for sterility and quality. This product is marketed as an unapproved veterinary drug in accordance with applicable regulations.
Sterile Water for Irrigation | For Animal Use Only | Sterile-Non-pyrogenic
ROUTE OF ADMINISTRATION: For irrigation only. Not for injection.
DESCRIPTION:
Sterile Water for Irrigation, USP is a sterile, nonpyrogenic, hypotonic solution intended for irrigation use in animals. It contains no antimicrobial agents, bacteriostatic agents, or added buffers. The solution is prepared by distillation and is intended for irrigation only. It functions as an irrigating fluid for cleansing body cavities, tissues, wounds, and surgical sites during diagnostic and operative procedures. Composition and pH range are shown in Table 1.
Table 1: Veterinary Sterile Water 100% for Irrigation, USP
| Size (mL) | Composition (mg/100 mL) | |
| Sterile Water | pH | |
| 100 | 100% | 5.0-7.0 |
| 250 | ||
| 500 | ||
| 1000 | ||
The plastic container, a semi-rigid bottle is made of Clear Polypropylene (PP) bottle with printed product label, with white/red plastic cap, safety strap and liner. Packed in corrugated boxes, identified with a white label with the corresponding information.
Other Safety Information
CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
Clinical Pharmacology (Veterinary Use):
Sterile Water for Irrigation, USP, is a sterile, nonpyrogenic, hypotonic solution intended for irrigation of body cavities, tissues, wounds, and surgical sites in animals. Its primary action is mechanical cleansing, aiding in the removal of debris, blood, and contaminants during diagnostic or surgical procedures. It may also serve as a diluent or vehicle for compatible veterinary drugs intended for irrigation. Because the solution is hypotonic and solute-free, systemic absorption of large volumes can lead to electrolyte disturbances; therefore, care should be taken to minimize absorption during use.
Indications And Usage
• Sterile Water for Irrigation, USP, is indicated for use as an irrigating fluid for washing, rinsing, and dilution procedures in animals where the use of a sterile, nonpyrogenic, solute-free solution is appropriate. For irrigation only. Not for injection. For veterinary use only.
Contraindications
• Sterile Water for Irrigation, USP is not for injection.
Warnings:
• Sterile Water for Irrigation, USP is hypotonic and may cause hemolysis. It is not recommended for use during surgical procedures. Single-use container. Discard any unused portion promptly after opening to minimize the risk of contamination or pyrogen formation. Inspect solution before use. See Instructions for Use.The container label bears the statement:This solution is hemolytic and may cause hemolysis. See package insert for complete warnings. Keep out of the reach of children
Precautions
• Inspect solution before use. See Instructions for Use.
• To minimize the risk of incompatibilities when mixing with additives, inspect the final solution for cloudiness or precipitation immediately after mixing, before administration, and periodically during use.
• Do not use if the product is expired, the lot number is missing or illegible.
• Maintain aseptic conditions
USE IN PREGNANT OR LACTATING ANIMALS:
The safety of Sterile Water for Irrigation, USP has not been established in pregnant or lactating animals. Use only when the potential benefits justify the potential risks. Veterinarian discretion is advised. A documented risk-benefit assessment is recommended.
ADVERSE EVENT REPORTING
To report suspected adverse reactions, contact Vedco Inc. at (888) 708-3326 or report to the FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
Adverse Reactions
If an adverse reaction does occur, discontinue the irrigation, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Reported adverse reactions include: Hemolysis due to hypotonicity. Hyponatremia and associated neurological symptoms. Neurological signs such as tremors or seizures may occur secondary to hyponatremia. Fluid overload leading to pulmonary edema.
Overdosage
Excessive absorption of Sterile Water for Irrigation, USP, particularly when used under pressure or in large volumes, may result in water intoxication, hyponatremia, hypoosmolality, and fluid overload. Clinical signs may include lethargy, weakness, ataxia, altered mentation, tremors, seizures, or respiratory distress. In severe cases, coma or death may occur. If clinically significant absorption is suspected, discontinue irrigation immediately and initiate appropriate corrective measures such as electrolyte monitoring, fluid restriction, and supportive care. Monitor serum electrolytes, fluid balance, and provide supportive care. In severe cases, consider diuretics, dialysis or other interventions as directed by a veterinarian. [see Warnings and Precautions for additional information]
Dosage And Administration
- • This is a single-use container.See Instructions for Use for inspection guidelines.
• Use only as directed by a veterinarian. Typical irrigation volumes range from 50 mL to 1000 mL depending on the size of the cavity or wound and the nature of the procedure.
• Inspect the solution visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for drugs, the manufacturer’s recommendations should be followed
• Administer slowly and avoid excessive pressure to minimize the risk of fluid absorption
• Aseptic technique must be used throughout handling and administration
• If additives are introduced, use aseptic technique and mix thoroughly
• Do not store any solution containing additives. See Shelf Life for disposal instructions.
How Supplied
Sterile water for irrigation, USP solution is available in the following sizes:
BOTTLES NDC#
Sterile Water for irrigation,1000 mL NDC 72483-208-02
Sterile Water for irrigation, 500 mL NDC 72483-208-01
Instructions For Use:
PLASTIC BOTTLE:
NOTE: Before use, perform the following checks:
• Read the label. Verify the solution composition, lot number, and expiration date on the container.
• Do not use if the product is expired, the lot number is missing or illegible, or if the solution is cloudy or contains a precipitate.
• Invert the container and inspect in good light for leaks or particulate matter. If leaks are found or the seal is not intact, discard the solution.
• Use only if the solution is clear and the container and seals are intact.
PREPARATION FOR ADMINISTRATION:
1. Use aseptic technique when preparing and handling the container.
2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt.
3. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.
4. Remove screw cap and pour.
5. Once opened, use immediately and discard any unused portion.
INTRODUCTION OF ADDITIVES:
Warning: Some additives may be incompatible.
Known incompatible additives include:
· Strong oxidizing agents
· Alcohol-containing solutions
· Solutions with high electrolyte concentrations
Always verify compatibility before mixing. If incompatibility is suspected, do not use the mixture.
To Add Medication Before Solution Administration.
1. If additives are introduced, follow aseptic technique as described above.
2. Mix solution and medication thoroughly before use.
NOTE: See full directions accompanying the administration set.
Storage
- Store at a temperature not higher than 30°C (86°F). Avoid excessive heat. Protect from freezing.
CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian
Manufactured by:
LABORATORIOS ALFA S.R.L
Santo Domingo, Dominican Republic
www.laboratoriosalfa.com
+1-809-544-0222
Toll Free: +1-800-969-0581
Made in Dominican Republic
Package Insert
For Animal Use Only
0.9% Sodium Chloride For Irrigation (Bottles)
For Veterinary Use Only
Sterile Water for Irrigation, 500 mL NDC 72483-208-01
Sterile Water for Irrigation,1000 mL NDC 72483-208-02
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
