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| Product NDC Code | 0641-0497 | ||||
|---|---|---|---|---|---|
| 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 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | ||||
| Dosage Form | INJECTION | ||||
| RxCUI drug identifier | 1807636, 1807637 |
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| Application Number | ANDA201833 | ||||
| Labeler Name | Hikma Pharmaceuticals USA Inc. | ||||
| Packages |
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Overdosage of 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 carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate 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 Reactions which may occur because of this solution, 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.
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 Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single dose containers, discard unused portion.
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 Sodium Chloride Injection USP, 0.9% when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and 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 (1.0 to 1.5 liters each for 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.
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 This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sodium Chloride Injection USP, 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Its chloride and sodium ion concentrations are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment, pH 5.3 (4.5 to 7.0). Sodium chloride, USP occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. 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 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. This parenteral 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 This parenteral preparation 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.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM HYDROXIDE HYDROCHLORIC ACID WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM HYDROXIDE HYDROCHLORIC ACID 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.PRINCIPAL DISPLAY PANEL NDC 0641- 0497 -17 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL Preservative Free For use as a sterile diluent 2 mL Single Dose Vial NDC 0641- 0497 -25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL Preservative Free For use as a sterile diluent 25 x 2 mL Single Dose Vials vial shelfpack
PRINCIPAL DISPLAY PANEL NDC 0641-6144-01 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 10 mL Single Dose Vial Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. NDC 0641-6144-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 10 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. NDC 0641-6144-01 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 10 mL Single Dose Vial Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. NDC 0641-6144-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 10 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
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
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised August 2020 462-679-0
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 safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
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 Sodium Chloride Injection USP, 0.9%. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives 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 Sodium Chloride Injection USP, 0.9% is supplied in the following: 2 mL vials packaged in carton of 25 vials (NDC 0641-0497-25) 10 mL vials packaged in carton of 25 vials (NDC 0641-6144-25) Storage Store at 20° - 25°C (68°-77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Avoid freezing.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection USP, 0.9%. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single dose containers, discard unused portion.
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