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| Product NDC Code | 0338-0013 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | INTRAVENOUS | ||||||||||
| Dosage Form | INJECTION, SOLUTION | ||||||||||
| Application Number | NDA018632 | ||||||||||
| Labeler Name | Baxter Healthcare Company | ||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sterile Water for Injection, USP is used for fluid replacement only after suitable admixing to approximate isotonicity.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without admixing.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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. It 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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral admixtures.
Spl product data elements
Usually a list of ingredients in a drug product.Sterile Water Water WATER WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - PRINCIPLE DISPLAY PANEL Container Label Container Label LOT EXP 2B0306 2000 mL NDC 0338-0013-06 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 logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA DISTRIBUTED IN CANADA BY BAXTER CORPORATION MISSISSAUGA ON L5N 0C2 BAXTER PL 146 AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC 1800 1600 1400 1200 1000 800 600 400 200 07-25-69-275/ 07-25-34-056 Carton Label Carton Label 2B0306 6 - 2000 ML VIAFLEX CONTAINER STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380013062 Sterile Water for Injection Representative Container Label Sterile Water for Injection Representative Carton Label
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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 Deerfield, IL 60015 USA Printed in USA Baxter, Viaflex, and PL 146 are trademarks of Baxter International Inc. 07 19 73 676 Rev. September 2014 Distributed in Canada by Baxter Corporation Mississauga, ON L5N 0C2
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS This solution is for compounding only, not for direct infusion. Hemolysis may occur following infusion of Sterile Water for Injection, USP. Hemoglobin induced renal failure has been reported following hemolysis. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API