Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows: 1000 mL 2B0304 NDC 0338-0013-04 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.; PACKAGE LABEL.PRINCIPLE DISPLAY PANEL 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 Sterile Water Container Label NDC 0338-0013-04
- HOW SUPPLIED Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows: 1000 mL 2B0304 NDC 0338-0013-04 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.
- PACKAGE LABEL.PRINCIPLE DISPLAY PANEL 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 Sterile Water Container Label NDC 0338-0013-04
Overview
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.
Indications & Usage
Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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.
Contraindications
Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.
Adverse Reactions
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.
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