Veterinary Sterile Water: Product Information
VETERINARY STERILE WATER — water injection
Ivali LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
For Animal Use Only
Indications
Veterinary Sterile Water for Injection is suitable for use as a diluent for the preparation of pharmaceutical solutions
Description
Prepared by distillation. Contains no antimicrobial agents or other substance has been added. Discard unused portion. Sterile, nonpyrogenic. Osmolarity and pH are shown in Table 1:
TABLE 1
Veterinary Sterile Water for Injection, USP | |
Size (mL) | 1000 |
Osmolarity (mOsmol/L) (calc) | 0 |
pH | 5.5 (5.0 to 7.0) |
Contraindications:
None known
Warnings
This solution is not isotonic and is hemolytic.
Dosage and administration:
As directed by a veterinarian.
Cautions
Sterile water for Injection is not suitable for intravascular injection without first having been made isotonic by addition of suitable solutes. Do not use unless solution is clear and seal is intact. Discard unused portion.
How Supplied:
Veterinary Sterile Water for Injection, USP in plastic container is available as follows:
NDC Code | Size (mL) | Product Name |
86094-891-01 | 1000 | Sterile Water For Injection, USP |
Plastic Container: PVC Free, DEHP Free, Latex Free. The volumetric scales on the single dose plastic container should only be used as a reference. For precise dosage of volumes it is recommeded the use of IV Infusion pump or IV Burrette.
Storage
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored in the moisture overwrap at room temperature (250 C/770 F), brief exposure up to (400 C/1040 F)does not adversely affect the product.
Directions for use of plastic container
To Open
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
Not for injection, for irrigation only.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian
Manufactured for:
IVALI LLC
18205 Biscayne Blvd., Suite 2202
Aventura Florida
Printed in Argentina
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call IVALI LLC. Customer service at 1-305-692-7665
IVALI is a trademark of IVALI LLC., all rights reserved.
© 2018 IVALI LLC.
Principal Display Panel
NDC 86094-891-01
IVALI
Veterinary Sterile Water for Injection, USP
1000 mL
VETERINARY STERILE WATER sterile water injection | |||||||||||||
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Labeler — Ivali LLC (081136076) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LABORATORIOS JAYOR S.R.L. | 979312485 | api manufacture, manufacture |
Revised: 05/2018 Ivali LLC
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