Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: Size (mL) NDC Catalog No. Item No. Fleboflex bags : 50 (115 units in one carton) 81826-001-01 NS0050 26.9459 100 (70 units in one carton) 81826-001-11 NS0100 26.9460 250 (28 units in one carton) 81826-001-21 NS0250 26.9461 500 (20 units in one carton) 81826-001-31 NS0500 26.9462 1000 (10 units in one carton) 81826-001-41 NS1000 26.9463 Fleboflex Luer bags : Not distributed by CODAN US Corporation 50 (90 units in one carton) 100 (50 units in one carton) 250 (32 units in one carton) 500 (24 units in one carton) 1000 (10 units in one carton) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NS0500 Item No. 26.9462 NDC 81826-001-31 0.9% Sodium Chloride Injection, USP 500 mL Fleboflex Container Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP controlled Room Temperature.] Avoid excessive heat. CODAN Manufactured for Codan US Corporation Santa Ana, CA 92704 Product of Spain LOT XXXXXX EXP YYYY-MM 1002033 Num.: IN HOUSE CONTROL NUMBER 20 x 500 mL NDC 81826-001-32 0.9% Sodium Chloride Injection, USP 500 mL For Intravenous use Single dose container Rx Only Each 100 mL contains 900 mg Sodium Chloride USP; pH 4.5 to 7.0 Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc) Sterile Non pyrogenic. Dosage intravenously as directed by a physician. See directions. Cautions: Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. Must not be used in series connections. Do not use unless solution is clear. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique. Mix thoroughly. Do not store. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Read package insert for full information. Grifols and Fleboflex are trademarks of Grifols, S.A. Manufactured for Codan US Corporation Santa Ana, CA 92704 Product of Spain 4000798 DATA MATRIX Fleboflex Container (PVC-free and DEHP-free) The container closure is not made with natural rubber latex. CODAN NS0500 Item No. 26.9462 LOT XXXXXX EXP YYYY-MM INTERNAL REFERENCE
- HOW SUPPLIED The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: Size (mL) NDC Catalog No. Item No. Fleboflex bags : 50 (115 units in one carton) 81826-001-01 NS0050 26.9459 100 (70 units in one carton) 81826-001-11 NS0100 26.9460 250 (28 units in one carton) 81826-001-21 NS0250 26.9461 500 (20 units in one carton) 81826-001-31 NS0500 26.9462 1000 (10 units in one carton) 81826-001-41 NS1000 26.9463 Fleboflex Luer bags : Not distributed by CODAN US Corporation 50 (90 units in one carton) 100 (50 units in one carton) 250 (32 units in one carton) 500 (24 units in one carton) 1000 (10 units in one carton) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NS0500 Item No. 26.9462 NDC 81826-001-31 0.9% Sodium Chloride Injection, USP 500 mL Fleboflex Container Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP controlled Room Temperature.] Avoid excessive heat. CODAN Manufactured for Codan US Corporation Santa Ana, CA 92704 Product of Spain LOT XXXXXX EXP YYYY-MM 1002033 Num.: IN HOUSE CONTROL NUMBER 20 x 500 mL NDC 81826-001-32 0.9% Sodium Chloride Injection, USP 500 mL For Intravenous use Single dose container Rx Only Each 100 mL contains 900 mg Sodium Chloride USP; pH 4.5 to 7.0 Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc) Sterile Non pyrogenic. Dosage intravenously as directed by a physician. See directions. Cautions: Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. Must not be used in series connections. Do not use unless solution is clear. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique. Mix thoroughly. Do not store. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Read package insert for full information. Grifols and Fleboflex are trademarks of Grifols, S.A. Manufactured for Codan US Corporation Santa Ana, CA 92704 Product of Spain 4000798 DATA MATRIX Fleboflex Container (PVC-free and DEHP-free) The container closure is not made with natural rubber latex. CODAN NS0500 Item No. 26.9462 LOT XXXXXX EXP YYYY-MM INTERNAL REFERENCE
Overview
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.
Indications & Usage
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
Dosage & Administration
Important Administration Instructions Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. Use a dedicated line without any connections to avoid air embolism. Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.
Warnings & Precautions
WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. 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. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See Drug Interactions . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see Drug Interactions . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.
Contraindications
None known.
Adverse Reactions
Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following: General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders: Hypernatremia, hyponatremia, hyperchloremic metabolic acidosis. Nervous System Disorders: Hyponatremic encephalopathy. 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.
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