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| Product NDC Code | 64253-202 | ||||
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| 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, SOLUTION | ||||
| RxCUI drug identifier | 727820 | ||||
| Application Number | NDA202832 | ||||
| Labeler Name | Medefil, Inc. | ||||
| 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.6 ADVERSE REACTIONS Adverse reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include, but are not limited to, air embolization, 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 therapeutic countermeasures, and if possible, retrieve and save the remainder of unused vehicle for examination if deemed necessary. • Reactions that may occur because of this solution, added drugs or the technique of reconstitution or administration include air embolization, 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 extravasations ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact MEDEFIL, INC. at tel:1-630-682-4600 and http://www.medefilinc.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.7 DRUG INTERACTIONS Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, the drug product manufacturer’s instructions or other specific references should be checked for any possible incompatibility with sodium chloride. Consult with a pharmacist, if unsure of compatibility. • Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. • Consult with a pharmacist, if unsure of compatibility ( 7 ).
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 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 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 or for flushing of indwelling access devices, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.
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.4 CONTRAINDICATIONS None • None
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.11 DESCRIPTION Sodium Chloride Injection, USP 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostatic antimicrobial agents or added buffer. The nominal pH is 5.5 (4.5 to 7.0). Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment. Sodium Chloride Injection, USP, 0.9% contains 9 g/L Sodium Chloride, USP (NaCl) with a calculated osmolarity of approximately 308 mOsmol/L. It contains 154 mEq/L sodium and 154 mEq/L chloride. The syringe component of Sodium Chloride Injection, USP, 0.9% is manufactured with polypropylene and luer lock. The syringe is not made with natural rubber latex. The syringe is not made with DEHP. This product contains no preservative. The syringes require no vapor barrier to maintain the proper drug concentration. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44 g/mol. Supplied as single use syringes.
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.2 DOSAGE & ADMINISTRATION • Volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration recommended by the drug manufacturer ( 2.1 ). 2.1 Recommended Dosage The volume of 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 drug manufacturer. 2.2 Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping. Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. (Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated. (Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use. Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion. Do not reuse disposable syringes. 2.3 Preparation and Handling Precautions Before use check for any possible incompatibility with sodium chloride. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Do not store reconstituted solution or drugs for injection unless otherwise directed by the manufacturer of the solute. Adding additives may be incompatible. Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. Do not freeze. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
2.2 Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping. Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. (Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated. (Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use. Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion. Do not reuse disposable syringes.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS & STRENGTHS 10 mL fill in 12 mL syringe, 0.9% Sodium Chloride, USP, single use. • Injection, 0.9%
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.1 INDICATIONS & USAGE Sodium Chloride Injection, USP, 0.9% is indicated for: • Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections ( 1.1 ). 1.1 Dilution or Dissolution of Drugs Sodium Chloride Injection, USP, 0.9% is indicated 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 WATER SODIUM CHLORIDE SODIUM CATION
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 Manufactured by: Medefil, Inc., 250 Windy Point Drive, Glendale Heights, IL 60139. NDA 202832 Rev. 003 box-label syringe-label
Package Insert_Page 1 and 2 Package Insert_Page 1 Package Insert_Page 2
SODIUM CHLORIDE: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION 17.1 When using to dilute drug products, consult the drug product manufacturer’s instruction to confirm compatibility, appropriate dilution or volume for dissolving drugs 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. Do not use Sodium Chloride Injection, USP 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe damaged [ see Warning and Precautions, section 5.1 ]. 17.2 Syringes are for single use only. Discard unused portions and dispose of the unit in an appropriate sharps container. [ see Warning and Precaustions, section 5.2 ]. Medefil, Inc., 250 Windy Point Drive, Glendale Heights, IL 60139. Prepared 10/2020 Rev. 003
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.16 HOW SUPPLIED/STORAGE AND HANDLING The drug product is packaged in a clear plastic hypodermic syringe, which consists of a hypodermic barrel with luer lock, plunger stopper, plunger rod, and tip cap. The syringe is intended for single use and subsequent disposal. The 10 mL fill volume syringes are packaged individually in plastic pouches and 60 syringes are packaged into each dispensing box. DOSAGE FORM Product Number NDC Fill Volume MSD-0230 64253-202-30 10 mL fill in 12 mL syringe The above product is available in boxes of 30, 60 or 120 count each. STORAGE AND HANDLING Store at 25°C (77°F); excursions permitted to 15°-30°C (59° - 86°F). Do not freeze.
| Product Number | NDC | Fill Volume |
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