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| Product NDC Code | 63323-530 | ||||
|---|---|---|---|---|---|
| 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 | INTRAVENOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| RxCUI drug identifier | 730781 | ||||
| Application Number | ANDA209476 | ||||
| Labeler Name | Fresenius Kabi USA, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Sodium Chloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
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: 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.
Sodium Chloride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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.
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: 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 ® 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.
| 3% Sodium Chloride Injection, USP | 500 | 30 | 513 | 513 | 1,027 | 5.0 (4.5 to 7.0) |
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. 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 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.
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: 3% Sodium Chloride Injection is indicated as a source of water and electrolytes.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER HYDROCHLORIC ACID
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 – 3% Sodium Chloride Injection, USP 500 mL Bag Label NDC 63323-530-21 free flex ® 500 mL 3% Sodium Chloride Injection, USP 15 grams per 500 mL (30 mg per mL) Hypertonic Saline For intravenous use. Rx only Figure
PACKAGE LABEL - PRINCIPAL DISPLAY – 3% Sodium Chloride Injection, USP Case Label NDC 63323-530-75 530175 3% Sodium Chloride Injection, USP, 15 grams per 500 mL 500 mL x 20 Single-Dose Container Hypertonic Saline For Intravenous Use Rx only Figure
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.Rx only Free Flex Logo
Instructions for use
Information about safe handling and use of the drug product.INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. Do not use if the solution is cloudy or a precipitate is present. To Add Medication Identify WHITE Additive Port with arrow pointing toward container. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. Mix container contents thoroughly. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of BLUE Infusion Port. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections. Manufactured for: Lake Zurich, IL 60047 Made in Germany www.fresenius-kabi.com/us 451532A Revised: February 2020 Fresenius Kabi Logo
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.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.
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 present in human milk. Because many drugs are excreted present in human milk, caution should be exercised when 3% Sodium Chloride Injection is administered to a nursing woman.
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 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.
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 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.
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: 3% Sodium Chloride Injection, USP in a single dose flexible plastic container, is available as follows: Product No. 530175 530175 Presentation Single-Dose Container Carton NDC # 63323-530-21 63323-530-75 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 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
| 530175 | 530175 | |
| Single-Dose Container | Carton | |
| 63323-530-21 | 63323-530-75 | |
| 15 grams per 500 mL in a 500 mL bag (30 mg per mL) | 20 Single-Dose Containers in 1 Carton |
Storage and handling
Information about safe storage and handling of the drug product.Store at 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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. 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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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. 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. 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. 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. Nursing Mothers It is not known whether this drug is excreted present in human milk. Because many drugs are excreted present in human milk, caution should be exercised when 3% Sodium Chloride Injection is administered to a nursing woman. 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 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.
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: 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, 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.
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