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| Product NDC Code | 0338-0051 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium chloride |
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| Type | Generic | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | IRRIGATION | ||||
| Dosage Form | IRRIGANT | ||||
| RxCUI drug identifier | 486515 | ||||
| Application Number | NDA019319 | ||||
| Labeler Name | Baxter Healthcare Corporation | ||||
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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 No serious adverse reactions are known.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Slushed solution is used to induce regional hypothermia in conditions such as certain open heart and kidney surgical procedures by direct application of slushed solution. The objective of regional hypothermia is to reduce cellular metabolic activity so that body tissues can tolerate a period of total or relative ischemia thereby inhibiting the formation and buildup of destructive autolytic enzymes and anaerobic by-products usually produced and accumulated in ischemic tissues.
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 None known
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 0.9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is a sterile, nonpyrogenic, isotonic solution for the preparation of slushed solution. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1. Table 1 Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 0.9 % Sodium Chloride Irrigation, USP 1000 9 308 5.0 (4.5 to 7.0) 154 154 The Baxter Sterile Container System is designed to provide a slush container with a sterile exterior surface for use within the surgical field. Within the overwrap, the unit is packaged in a dispensing bag which maintains the sterility of this surface. The flexible plastic slush 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by culture toxicity studies.
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 The volume of slushed solution required will vary with patient’s age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physician’s instructions.
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 Slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. Temperature probes may be used to determine requirements for replacement or addition of slushed solution.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Studies performed with slushed 0.9% Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
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.PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 1000 mL 2B7231 NDC 0338-0051-44 Din 00786160 NOT FOR INJECTION 0.9% Sodium Chloride Irrigation, USP Baxter Sterile Container System EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER FOR USE ONLY IN SLUSH PREPARATION FOR REGIONAL HYPOTHERMIA SEE ACCOMPANYING DIRECTIONS FOR USE DOSAGE AS DIRECTED BY A PHYSICIAN CAUTION RX ONLY Baxter Logo Baxter Healthcare Corporation Deerfield IL 60015 USA Made in USA Distributed in Canada by Baxter Corporation Misissauga ON L5N 0C2 PL 146 Plastic Baxter and PL 146 are trademarks of Baxter International Inc Representative Container Label for 0.9% Sodium Chloride Irrigation USP
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DIRECTIONS FOR USE OF THE BAXTER STERILE CONTAINER SYSTEM Guidelines for Preparation of Slush The following instructions are intended only as guidelines for the preparation of slush using the Baxter Sterile Container System. The specific procedure necessary to achieve the desired slush consistency will depend on the type of freezer used, location of the product in the freezer, and the utilization of freezer capacity. 1. Remove product from shipping carton and place in freezer at a temperature between minus 4ºC and minus 15ºC for 2 to 6 hours. Note: A pre-cooled product will require less time to slush. 2. During the freezing process, remove product from freezer periodically and carefully massage to break up large frozen chunks of solution. 3. Return product to freezer and repeat procedure until desired slush consistency is obtained. To Open: Use Aseptic Technique A. To prepare unit outside the surgical field. 1. Tear overwrap down side at slit and remove dispensing bag which contains the slush container. 2. Allow unit to stand at room temperature for approximately 10 minutes to allow container material to regain flexibility. 3. Check that all the seals of the dispensing bag are intact including the tamper evident button. If any broken seals or holes are detected, discard unit as sterility may be impaired. 4. Grasp tab of dispensing bag and peel open (Figure 1). Remove wrapped inner slush container. 5. Grasp point of sterile transfer wrap (Figure 2), and pull forward then back to expose sterile slush container (Figure 3). Caution should be exercised to avoid touch contamination. B. To transfer sterile slush container to the surgical field. 1. Using sterile gloved hands, remove slush container from the sterile transfer wrap (Figure 4). Place on surgical field or use immediately. 2. Grasp tab at top of slush container and peel directly across the width of the container with a steady motion (Figure 5). 3. Slush is ready for dispensing. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5
Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Distributed in Canada by Baxter Corporation Mississauga, ON L5N OC2 07-19-00-0323 Rev. April 2018 Baxter is a registered trademark of Baxter International Inc.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when slushed 0.9% Sodium Chloride Irrigation, USP is administered to a nursing mother.
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 of slushed 0.9% Sodium Chloride Irrigation, USP in pediatric patients have not been established by adequate and well controlled trials; however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. Do not administer unless seals of outer dispensing bag are intact.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with slushed 0.9% Sodium Chloride Irrigation, USP. It is also not known whether slushed 0.9% Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Slushed 0.9% Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects Animal reproduction studies have not been conducted with slushed 0.9% Sodium Chloride Irrigation, USP. It is also not known whether slushed 0.9% Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Slushed 0.9% Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.
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/STORAGE AND HANDLING .9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is supplied as follows: Code Size (mL) NDC DIN 2B7231 1000 0338-0051-44 786160 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Avoid freezing except during controlled slushing procedure. It is recommended that this product be stored at room temperature (25ºC); brief exposure up to 40ºC does not adversely affect this product.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Precautions Avoid prolonged direct contact between ice crystals and body tissues. Experience in use of slushed solutions in pediatrics is limited.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Precautions Avoid prolonged direct contact between ice crystals and body tissues. Experience in use of slushed solutions in pediatrics is limited. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies performed with slushed 0.9% Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with slushed 0.9% Sodium Chloride Irrigation, USP. It is also not known whether slushed 0.9% Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Slushed 0.9% Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when slushed 0.9% Sodium Chloride Irrigation, USP is administered to a nursing mother. Pediatric Use Safety and effectiveness of slushed 0.9% Sodium Chloride Irrigation, USP in pediatric patients have not been established by adequate and well controlled trials; however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. Do not administer unless seals of outer dispensing bag are intact.
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 Not for injection. For use in slush preparation for regional hypothermia.
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