Sterile WaterFor Injection, USP

Sterile Water for Injection, USP

INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
SteriIe water for injection must be made approximately isotonic prior to use.

WARNINGS
Intravenous administration of sterile water for injection without a solute may result in hemolysis.

PRECAUTIONS
Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate
isotonic admixture.

Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile water for injection with additives should be given to a pregnant woman only if clearly needed.

Pediatric Use
Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

ADVERSE REACTIONS
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate counter measures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

OVERDOSAGE
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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