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| Product NDC Code | 0338-0050 | ||||
|---|---|---|---|---|---|
| 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 | EXTRACORPOREAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 486515 | ||||
| Application Number | NDA017867 | ||||
| Labeler Name | Baxter Healthcare Corporation | ||||
| 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 None known
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid.
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 Sodium Chloride Processing Solution is a sterile, nonpyrogenic solution in single dose container for use in blood cell processing devices. It contains no antimicrobial agents. Composition, osmolarity, pH, and ionic concentration are shown in Table 1. Table 1 0.9% Sodium Chloride Processing Solution Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 3000 9 308 5.5 (4.5 to 7.0) 154 154 The 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (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 tissue 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 As directed by a physician. See directions accompanying blood cell processing device. Processing Solutions should be inspected visually for particulate matter and discoloration prior to use.
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 0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION 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 PRINCIPAL DISPLAY PANEL 3000 mL 2B7207 NDC 0338-0050-47 NOT FOR INJECTION 0.9% SODIUM CHLORIDE Processing Solution EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 TO 7.0) mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DOSAGE AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS ACCOMPANYING BLOOD CELL PROCESSING DEVICE FOR USE THIS CONTAINER SHOULD NOT BE CONNECTED FOR DIRECT INTRAVENOUS ADMINISTRATION CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 0.9% Sodium Chloride NaCl Processing Solution VIAFLEX CONTAINER PL146 PLASTIC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA Baxter VIAFLEX and PL 146 are trademarks of Baxter International Inc Sodium Chloride Representative Container Label
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.Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA ©Copyright 1983, 1990, 1995, Baxter Healthcare Corporation. All rights reserved. 07-19-73-065 Rev. May 2014 BAXTER, AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC.
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 in pediatric patients have not been established. Do not administer unless solution is clear and seal is 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 Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution 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 Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution 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 0.9% Sodium Chloride Processing Solution in Flexible Plastic Container is available as follows: Code Size (mL) NDC 2B7207 3000 0338-0050-47 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product. 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. Preparation for Use 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach to blood cell processing device. Refer to complete directions accompanying blood cell processing device.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Do not administer unless solution is clear and seal is 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 This container should not be connected for direct intravenous administration. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of processing solution.
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