Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 63323-924 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bacteriostatic sodium chloride |
||||||
| Type | Brand | ||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
||||||
| Active Ingredients |
|
||||||
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | ||||||
| Dosage Form | INJECTION | ||||||
| RxCUI drug identifier | 313002 | ||||||
| Application Number | ANDA088911 | ||||||
| Labeler Name | Fresenius Kabi USA, LLC | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Bacteriostatic Sodium Chloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in very small infants. In the event these should occur, reevaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS .
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 To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions which may occur because of Bacteriostatic Sodium Chloride Injection, USP, 0.9%, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant is potentially capable of producing blood pressure changes.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl - ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na + ) and chloride (Cl - ) are largely under the control of the kidney which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided by Bacteriostatic Sodium Chloride Injection, USP, 0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each of insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.
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 Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride Injection, USP, 0.9% containing benzyl alcohol must not be used in this patient population. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.
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 Bacteriostatic Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic, isotonic solution. Each mL contains: Sodium chloride 9 mg; benzyl alcohol 0.9%; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.
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 NOT FOR INHALATION . Before Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride or benzyl alcohol. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Isotonic solutions may be given subcutaneously, intravenously, and occasionally, intramuscularly. Use Bacteriostatic Sodium Chloride Injection, USP, 0.9% with due regard for the compatibility of the benzyl alcohol it contains with the particular medicinal substance that is to be dissolved or diluted. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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 These parenteral preparations are indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. NOT FOR INHALATION .
Spl product data elements
Usually a list of ingredients in a drug product.Bacteriostatic Sodium Chloride SODIUM CHLORIDE BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION
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 - Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Label NDC 63323-924-03 924830 Bacteriostatic Sodium Chloride Injection, USP 0.9% NOT FOR USE IN NEWBORNS 30 mL Multiple Dose Vial For Drug Diluent Use Only Not for Inhalation 924830-vial
PACKAGE LABEL – PRINCIPAL DISPLAY - Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Tray Label NDC 63323-924-30 924830 Bacteriostatic Sodium Chloride Injection, USP 0.9 % NOT FOR USE IN NEWBORNS 30 mL Multiple Dose Vial For Drug Diluent Use Only Not for Inhalation 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY - Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Tray 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.0.9% NOT FOR USE IN NEWBORNS
www.fresenius-kabi.com/us 45765E Revised: September 2019 Logo
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 Pregnancy Category C — Animal reproduction studies have not been conducted with Bacteriostatic Sodium Chloride Injection, USP, 0.9%. It is also not known whether Bacteriostatic Sodium Chloride Injection, USP, 0.9% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic Sodium Chloride Injection, USP, 0.9% 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 Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with benzyl alcohol is available as follows: Product Code Unit of Sale Strength Each 924810 NDC 63323-924-10 Unit of 25 0.9% NDC 63323-924-01 10 mL Multiple Dose Plastic Vial 924830 NDC 63323-924-30 Unit of 25 0.9% NDC 63323-924-03 30 mL Multiple Dose Plastic Vial Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
| | | | |
| 924810 | NDC 63323-924-10 Unit of 25 | 0.9% | NDC 63323-924-01 10 mL Multiple Dose Plastic Vial |
| 924830 | NDC 63323-924-30 Unit of 25 | 0.9% | NDC 63323-924-03 30 mL Multiple Dose Plastic Vial |
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for those medicinals that specify the use of only Sodium Chloride Injection, USP, 0.9% as a sterile solvent. Sodium chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. Excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for those medicinals that specify the use of only Sodium Chloride Injection, USP, 0.9% as a sterile solvent. Sodium chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. Excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. Pregnancy Pregnancy Category C — Animal reproduction studies have not been conducted with Bacteriostatic Sodium Chloride Injection, USP, 0.9%. It is also not known whether Bacteriostatic Sodium Chloride Injection, USP, 0.9% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should be given to a pregnant woman only if clearly needed.
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 Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection, USP, 0.9% has been associated with toxicity in newborns. Data is unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection, USP, 0.9% should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.
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