3% Sodium Chloride

Becton Dickinson And Company
Human Prescription Drug
NDC 17271-703

3% Sodium Chloride is a human prescription drug labeled by 'Becton Dickinson And Company'. National Drug Code (NDC) number for 3% Sodium Chloride is 17271-703. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in 3% Sodium Chloride drug includes Sodium Chloride - 3 g/100mL . The currest status of 3% Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	17271-703
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	3% Sodium Chloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	3% Sodium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Becton Dickinson And Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	SODIUM CHLORIDE - 3 g/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	28 Feb, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA209476
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Becton Dickinson and Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	730781
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	451W47IQ8X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
17271-703-06	20 BAG in 1 CASE (17271-703-06) / 500 mL in 1 BAG	28 Feb, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

3% Sodium Chloride

Injection, Solution
Becton Dickinson and Company
NDC: 17271-703

Product Elements:

3% sodium chloride 3% sodium chloride sodium chloride sodium cation chloride ion water hydrochloric acid

Drug Interactions:

Drug interactions caution must be exercised in the administration of 3% sodium chloride injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. caution is advised in patients treated with lithium. renal sodium and lithium clearance may be increased during the administration of 3% sodium chloride injection. administration of 3% sodium chloride injection may, therefore, result in decreased lithium levels.

Indications and Usage:

Indications and usage: 3% sodium chloride injection is indicated as a source of water and electrolytes.

Warnings:

Warnings: hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 3% sodium chloride injection. stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. appropriate therapeutic countermeasures must be instituted as clinically indicated. depending on the volume and rate of infusion, the intravenous administration of 3% sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. the risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. monitor changes in fluid balance Read more...

, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. administer 3% sodium chloride injection with particular caution to patients with or at risk for hypernatremia, hyperchloremia, hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism (for example, associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia). certain medications may increase risk of sodium and fluid retention ( see drug interactions ). administer 3% sodium chloride injection with particular caution to patients with severe renal impairment. in such patients administration of sodium chloride injection may result in sodium retention.

General Precautions:

General do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. use of a vented intravenous administration set with the vent in the open position could result in air embolism. vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. 3% sodium chloride injection is hypertonic with an osmolarity of 1,027 mosmol/l. administration of hypertonic solutions may cause venous damage and thus should be administered through a large vein, for rapid dilution. Read more...

do not mix or administer 3% sodium chloride injection solution through the same administration set with whole blood or cellular blood components. rapid correction of hypo- and hypernatremia is potentially dangerous (risk of serious neurologic complications). dosage, rate, and duration of administration should be determined by a physician experienced in intravenous fluid therapy.

Dosage and Administration:

Dosage and administration: as directed by a physician. dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient's age, weight, clinical condition, concomitant treatment, and on the patient's clinical and laboratory response to treatment. 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. do not administer unless solution is clear and seal is intact. all injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic 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 Read more...

to introduce additives, use aseptic technique. mix thoroughly when additives have been introduced. do not store solutions containing additives. after opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. do not reconnect any partially used containers. discard any unused portion.

Contraindications:

Contraindications: none known.

Adverse Reactions:

Adverse reactions: post-marketing adverse reactions the following adverse reactions have not been reported with 3% sodium chloride injection but may occur: hyperchloremia hyperchloremic metabolic acidosis, hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, infusion site reactions, such as thrombosis, phlebitis, irritation, infusion site erythema, injection site streaking, burning sensation, infusion site urticaria. 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.

Drug Interactions:

Use in Pregnancy:

Pregnancy there are no adequate and well controlled studies with 3% sodium chloride injection in pregnant women and animal reproduction studies have not been conducted with this drug. therefore, it is not known whether 3% sodium chloride injection can cause fetal harm when administered to a pregnant woman. 3% sodium chloride injection should be given during pregnancy only if the potential benefit justifies the potential risks to the fetus.

Pediatric Use:

Pediatric use the use of 3% sodium chloride injection in pediatric patients is based on clinical practice (see dosage and administration ). plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

Geriatric Use:

Geriatric use clinical studies of 3% sodium chloride injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Overdosage:

Overdosage: excessive administration of 3% sodium chloride injection may lead to hypernatremia (which can lead to cns manifestations, including seizures, coma, cerebral edema and death) and sodium overload (which can lead to central and/or peripheral edema). when assessing an overdose, any additives in the solution must also be considered. the effects of an overdose may require immediate medical attention and treatment.

Description:

Description: 3% sodium chloride injection, usp is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. the ph may have been adjusted with hydrochloric acid. it contains no antimicrobial agents. composition, ionic concentration, osmolarity, and ph are shown in table 1 . table 1. *normal physiological osmolarity range is approximately 280 to 310 mosmol/l. size (ml) composition (g/l) ionic concentration (meq/l) *osmolarity (mosmol/l) (calc) ph sodium chloride, usp (nacl) sodium chloride 3% sodium chloride injection, usp 500 30 513 513 1,027 5.0 (4.5 to 7.0) the flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex Â® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers.

Clinical Pharmacology:

Clinical pharmacology: 3% sodium chloride injection has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient.

How Supplied:

How supplied: 3% sodium chloride injection, usp in a single dose flexible plastic container, is available as follows: product no. 1727170306 1727170306 presentation single-dose container carton ndc # 17271-703-06 17271-703-06 description 15 grams per 500 ml in a 500 ml bag (30 mg per ml) 20 single-dose containers in 1 carton exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. store at 20Â° to 25 Â°c ( 68Â° to 77 Â°f) [see usp controlled room temperature]; brief exposure up to 40Â°c/104Â°f does not adversely affect the product. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.

Package Label Principal Display Panel:

Package label - principal display â 3% sodium chloride injection, usp bag label ndc 17271-703-06 free flexÂ® 3% sodium chloride injection, usp 15 grams per 500 ml (30 mg per ml) hypertonic saline for intravenous use. rx only package label - principal display â 3% sodium chloride injection, usp bag label

Package label - principal display â 3% sodium chloride injection, usp case label ndc 17271-703-06 3% sodium chloride injection, usp 15 grams per 500 ml 500 ml x 20 single-dose container hypertonic saline for intravenous use rx only package label - principal display â 3% sodium chloride injection, usp case label

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