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| Product NDC Code | 0019-1188 | ||||||
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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 | INTRAVASCULAR | ||||||
| Dosage Form | INJECTION | ||||||
| Application Number | NDA021569 | ||||||
| Labeler Name | Liebel-Flarsheim Company LLC | ||||||
| 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.10 OVERDOSAGE Use of Sodium Chloride Injection USP 0.9% may pose a threat of overdose marked by electrolyte disturbance and/or fluid overload, particularly in pediatric patients and patients with compromised renal or cardiac function. In the event of overdosage, discontinue the infusion, reevaluate the patient and institute appropriate corrective action.
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 Reported adverse reactions include: air embolization with stroke, chest pain, and dyspnea arrhythmia hypotension myocardial infarction sepsis febrile response local tenderness infection at the site of injection venous thrombosis or phlebitis extending from injection site extravasation fluid overload hypervolemia Adverse reactions due to solution or administration technique may include: air embolism with stroke, chest pain, and dyspnea, arrhythmia, hypotension, myocardial infarction, sepsis, febrile response, local tenderness, infection at the site of injection, venous thrombosis or phlebitis extending from injection site, extravasation, fluid overload and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liebel-Flarsheim Company LLC at 1-855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY Sodium Chloride Injection USP 0.9% has an osmotic pressure similar to plasma.
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 ( 4 )
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 formulation of sodium chloride in Water for Intravascular Injection. No preservative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution. Molecular formula = NaCl MW = 58.44 Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.). Sodium Chloride Injection USP 0.9% is provided in a 125 mL syringe with a 125 mL fill. The syringes are for single patient use and are disposable and not meant for reuse.
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 AND ADMINISTRATION The 125 mL syringe are for single patient use only. Determine the volume of the saline flush for each patient individually based, in part, on the imaging procedure, the location of the vascular access device, the length of tubing between the Liebel-Flarsheim contrast agent power injector and the vascular access device and the recommendations made on the package insert for the contrast agent. Typical Sodium Chloride Injection USP 0.9% flush volumes following contrast agent administration in adults are 10 to 25 mL per injection at rates not to exceed 10 mL/sec. Use of some Liebel-Flarsheim contrast agent power injectors allows for additional infusion of Sodium Chloride Injection USP 0.9% to maintain the patency of vascular access. Typical infusion rates used for this purpose are in the range of 0.5 to 1 mL per minute. Individualize infusion rates and flush volumes for each patient based on their body weight, fluid status and concomitant medical conditions. Consult the Liebel-Flarsheim contrast agent power injector manual for proper use. For single patient use only. ( 2 ) Determine the volume of flush based on the imaging procedure, location of the vascular access device, length of tubing between power injector and vascular access device, and the contrast agent package insert. ( 2 ) Individualize the volume of flush based on body weight, fluid status and concomitant medical conditions. ( 2 ) Typical flush volumes for adults are 10 to 25 mL per injection at rates not to exceed 10 mL/sec. ( 2 ) May be used for additional infusion to maintain the patency of vascular access at a typical infusion rate of 0.5 to 1 mL per minute. ( 2 ) Do not use if packaging is damaged, wet, or not intact, if syringe or its tip cap shows signs of damage, leakage or displacement. Do not use if solution is hazy, cloudy, discolored, or contains particulate matter. ( 2 ) Use aseptic technique. ( 2 ) Expel residual air from the syringe and tubing prior to connection with the patient’s vascular access. ( 2 ) 2.1 Drug Handling Inspect the syringe for signs of break in sterility. Do not use if the syringe or its tip cap shows signs of damage, leakage or displacement. Do not use if the solution is hazy, cloudy, discolored or contains particulate matter. Use aseptic technique. Expel residual air in both the syringe and tubing prior to connection with the patient’s vascular access. Instructions for assembly and inspection of the Sodium Chloride Injection USP 0.9% syringes prior to use are printed on this sheet. 2.2 125 mL Syringe Assembly and Inspection NOTE: Exterior of syringe is not sterile. Contents of syringe and area under tip cap and piston ribs are sterile and should be treated accordingly. Remove syringe from carton and inspect the area around the tip cap and outside of piston for signs of leakage. Do not use if leakage is observed. Load syringe into power injector. To remove tip cap from syringe, push in and twist off, then discard. The area under the cap is sterile. Caution should now be used when handling. Next remove cap from luer locknut dust cover by twisting to break tamper evident seal. Discard cap. Attach luer locknut to syringe by holding dust cover and screwing to the stop. Remove and discard dust cover when ready to attach sterile connector tubing. Inspecting the 125 mL syringe Twisting off the 125 mL syringe cap Luer locknut detail Removing cap from luer locknut Attaching luer locknut to syringe
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 AND STRENGTHS Sodium Chloride Injection USP (0.9%) a clear, colorless, odorless solution supplied in 125 mL prefilled syringes contents are sterile Supplied as a clear, colorless, odorless, sterile solution of Sodium Chloride 0.9% for intravenous administration ( 3 ) Supplied in 125 mL prefilled syringes ( 3 )
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 AND USAGE 125 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat ® , Illumena ® , Illumena ® Néo, CT9000 ® , CT9000 ® ADV, Optistat ® , Optivantage ® and Optistar Elite. For use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION 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.PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 125 mL Syringe For Intravascular Use Sterile Solution NDC 0019-1188-81 125 mL Sodium Chloride Injection USP 0.9% MEDICATION AND FLUID PATHWAY ARE STERILE. OUTSIDE OF SYRINGE IS NOT STERILE. SINGLE DOSE UNIT, DISCARD UNUSED PORTION. EXPEL AIR BEFORE USE. PROTECT FROM FREEZING. Rx only Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Each mL contains 9 mg sodium chloride. Dosage: See package insert. Discard if syringe seal is broken or leakage is observed. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA Guerbet 12070916 Principal Display Panel Carton
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.8.5 Geriatric Use No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection 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.
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.8.4 Pediatric Use Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. When performing manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients, take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if use of Sodium Chloride Injection USP 0.9% is appropriate. The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients. To minimize the risk of fluid overload, use the smallest dose of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line.
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.)8.1 Pregnancy Risk Summary Administration of Sodium Chloride Injection USP 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Chloride Injection USP 0.9.% All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS Pregnancy: It is not known whether Sodium Chloride Injection USP 0.9% can cause fetal harm. ( 8.1 ) Pediatrics: Safety and effectiveness have not been established in pediatric patients. ( 8.4 ) Geriatrics: Dosing for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ( 8.5 ) 8.1 Pregnancy Risk Summary Administration of Sodium Chloride Injection USP 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Chloride Injection USP 0.9.% All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause harm to a breastfed infant. 8.4 Pediatric Use Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. When performing manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients, take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if use of Sodium Chloride Injection USP 0.9% is appropriate. The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients. To minimize the risk of fluid overload, use the smallest dose of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line. 8.5 Geriatric Use No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection 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.
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 Sodium Chloride Injection USP 0.9% is a clear, colorless, odorless solution containing 9 mg/mL of sodium chloride. Sodium Chloride Injection USP 0.9% is supplied in 125 mL prefilled syringes containing 125 mL of solution. Each syringe is sealed with rubber closures and the contents are sterile. The 125 mL syringe is supplied with a luer locknut adapter which is cleared for manufacture and distribution as a device under 510(K) number 862653. The syringes are contained in shipping cartons with the following configurations: Volume Packaging NDC 125 mL in plastic syringes 20 syringes per carton 0019-1188-81 125 mL in plastic RFID-Tagged Syringes* 20 syringes per carton 0019-1188-27 *Radio Frequency Identification (RFID) Technology RFID-Tagged Syringe Description This information is for Ultraject ® syringes containing Sodium Chloride Injection USP 0.9% that has been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFID-enabled Optivantage Injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being unused prior to use and used after product administration. Patient information is not utilized in any form with this RFID technology. Sodium Chloride Injection USP 0.9% product quality is not impacted with the use of this RFID tag. Sodium Chloride Injection USP 0.9% RFID syringes require no special handling and should be stored at the conditions listed for the drug product. RFID-Tagged Syringe Directions for Use For the RFID technology to function, the syringe must be used with an Optivantage Injector with RFID technology. Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector. Instructions for use of the injector are provided on the injector interface screens and operator’s manual. If the RFID tag is damaged or otherwise non-functional, the injector will notify the user. Should this occur, the Sodium Chloride Injection USP 0.9% syringe with the non-functional RFID tag may still be used but no data will be transferred to the injector. Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-1-2 requirements for emission and immunity standards for medical devices. Follow all manufacturers’ guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator. Storage Store Sodium Chloride Injection USP 0.9% syringes and RFID-tagged syringes at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 11880919 Issued: 9/19 Guerbet
| 125 mL in plastic syringes | 20 syringes per carton | 0019-1188-81 |
| 125 mL in plastic RFID-Tagged Syringes* | 20 syringes per carton | 0019-1188-27 |
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