Label: STERILE WATER- water injection, solution

Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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 may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications.

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.

Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.

Hemolysis may occur following infusion of Sterile Water for Injection, USP.  Hemoglobin induced renal failure has been reported following hemolysis.

Do not administer unless solution is clear and seal is intact.

The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying additive drug.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Sterile Water Container Label

Sterile Water Container Label

LOT EXP

2B0304

NDC 0338-0013-04

STERILE WATER

STERILE WATER FOR INJECTION USP

FOR DRUG DILUENT USE ONLY

1000mL

NO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDED

pH 5.5 (5.0 TO 7.0) STERILE NONPYROGENIC SINGLE

DOSE CONTAINER ADMINISTER INTRAVENOUSLY ONLY AFTER

RENDERING APPROXIMATELY ISOTONIC WITH SUITABLE SOLUTE

ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST

IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC

TECHNIQUE MIX THOROUGHLY DO NO STORE DOSAGE

INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE

DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE

FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT

USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN

MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C)

UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX PLUS CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

BAXTER

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN THE USA