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Name:Sterile Water
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


Sterile Water For Injection, USP Pharmacy Bulk Package Not for Direct Infusion Viaflex® Plastic Container

STERILE WATER - water injection, solution 
BAXTER HEALTHCARE CORPORATION

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Sterile Water For Injection, USP
Pharmacy Bulk Package
Not for Direct Infusion
Viaflex® Plastic Container

DESCRIPTION

Sterile Water for Injection, USP is sterile, nonpyrogenic, distilled water in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. No antimicrobial or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity O mOsmol/L (calc.).

The Viaflex® plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146® Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. lt is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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.

CLINICAL PHARMACOLOGY

Sterile Water for Injection, USP is used for fluid replacement only after suitable admixing to approximate isotonicity.

CONTRAINDICATIONS

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

WARNINGS

This solution is for compounding only, not for direct infusion.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

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

Drug product contains no more than 25 µg/L of aluminum

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

The administration of a suitable admixture of prescribed drugs 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.

DOSAGE AND ADMINISTRATION

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Sterile Water for Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection, USP.

Directions for use of Viaflex® Plastic Pharmacy Bulk Package 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.

For compounding only, not for direct infusion.

Preparation for Admixing

1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

2. Suspend container from eyelet support.

3. Remove plastic protector from outlet port at bottom of container.

4. Attach solution transfer set. Refer to complete directions accompanying set.

Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

5. Viaflex® containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry.

6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.

HOW SUPPLIED

Sterile Water for Injection, USP is supplied in a Viaflex® plastic Pharmacy Bulk Package container as follows:

2000 mL 2B0306 NDC 0338-0013-06
3000 mL 2B0307 NDC 0338-0013-08
5000 mL 2B0309 NDC 0338-0013-29

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

Baxter Healthcare Corporation

Clintec Nutrition Division

07-19-12-915 Rev. October 2000

Distributed in Canada by

Baxter Corporation

Toronto, Ontario, Canada Deerfield, IL 60015 USA

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

Sterile Water for Injection Container Label

Sterile Water for Injection Container Label

LOT EXP

2B0309 5000 mL

NDC 0338-0013-29 DIN 02014882

Sterile Water

For Injection USP

Pharmacy Bulk Package

Not For Direct Infusion

Rx Only

NO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDED

pH 5.5 (5.0 TO 7.0) OSMOLARITY 0 mOsmol/L (CALC)

STERILE NONPYROGENIC

CONTAINS NO MORE THAN 25 μg/L OF ALUMINUM

ADDITIVES MAY BE INCOMPATIBLE WITH THE FLUID

WITHDRAWN FROM THIS CONTAINER CONSULT WITH

PHARMACIST IF AVAILABLE WHEN COMPOUNDING

ADMIXTURES USE ASEPTIC TECHNIQUE

MIX THOROUGHLY DO NOT STORE

DOSAGE ADMIX FOR INTRAVENOUS ADMINISTRATION

AS DIRECTED BY A PHYSICIAN SEE ACCOMPANYING

DIRECTIONS FOR USE ONCE CONTAINER CLOSURE

HAS BEEN PENETRATED WITHDRAWAL OF

CONTENTS SHOULD BE COMPLETED WITHOUT

DELAY AFFIX ACCOMPANYING LABEL FOR DATE

AND TIME OF ENTRY DISPENSE CONTENTS WITHIN

4 HOURS AFTER INITIAL ENTRY

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH

MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS

ARE FOUND DO NOT USE UNLESS SOLUTION IS

CLEAR AND SEAL IS INTACT

STORE UNIT IN MOISTURE BARRIER OVERWRAP

AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY

TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER PL 146 PLASTIC

BAXTER

BAXTER HEALTHCARE CORPORATION

CLINTEC NUTRITION DIVISION

DEERFIELD IL 60015 USA

MADE IN USA

BAXTER PL 146 AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

DISTRIBUTED IN CANADA BY

BAXTER CORPORATION

TORONTO ONTARIO CANADA

Sterile Water for Injection Carton Label

Sterile Water for Injection Carton Label

STERILE WATER FOR INJ, USP FOR DRUG DILUENT USE ONLY

VIAFLEX CONT

2-5000ML

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50303380013291

LOT XXXXX

EXP XXXXX

2B0309


STERILE WATER 
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0013
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 100 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0013-06 2000 mL in 1 BAG None
2 NDC:0338-0013-08 3000 mL in 1 BAG None
3 NDC:0338-0013-29 5000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA018632 06/30/1982

Labeler - BAXTER HEALTHCARE CORPORATION (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE CORPORATION 059140764 MANUFACTURE

Revised: 12/2009 BAXTER HEALTHCARE CORPORATION



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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