VETERINARY STERILE WATER- sterile water injection

Veterinary Sterile Water by

Drug Labeling and Warnings

Veterinary Sterile Water by is a Animal medication manufactured, distributed, or labeled by Vedco, Inc., Laboratorios Biogalenic SA de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

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:

Plastic Container:
PVC Free, DEHP Free, Latex Free

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 (250C/770F), brief exposure up to (400C/1040F)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

Manufacture for:

Vedco, Inc.

5503 Corporate Dr.

St. Joseph, MO 64507 USA

Printed in El Salvador

For a copy of the Safety Data Sheet (MSDS) or to report adverse reaction call Vedco, Inc.

Customer service at 1(888)708-3326

© 2015 Vedco, Inc.

Principal Display Panel

NDC: 50989-891-17

BIOGALENIC VEDCO

Veterinary Sterile Water for Injection, USP

INGREDIENTS AND APPEARANCE

VETERINARY STERILE WATER  
sterile water injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-891
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	100 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-891-17	1000 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/09/2016

Labeler - Vedco, Inc. (021634266)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Biogalenic SA de CV		851259507	api manufacture, manufacture