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| Product NDC Code | 76297-001 | ||||||||||||||||||||
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| Drug Name | Sodium chloride |
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| Type | Generic | ||||||||||||||||||||
| Active Ingredients |
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| Route | INTRAVENOUS | ||||||||||||||||||||
| Dosage Form | INJECTION, SOLUTION | ||||||||||||||||||||
| RxCUI drug identifier | 1807631, 1807632, 1807633, 1807634, 1807639 |
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| Application Number | ANDA207956 | ||||||||||||||||||||
| Labeler Name | LABORATORIOS GRIFOLS SA | ||||||||||||||||||||
| 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 Excessive administration of 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death. Excessive administration of Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See Warnings and Adverse Reactions . When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
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 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. Hypersensitvity 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
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 None known.
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 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.
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 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.
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 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.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride Sodium Chloride Chloride Ion Sodium Cation Water Carton Label Container Label Container Fleboflex Luer Carton Fleboflex Luer
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 NDC 76297-001-01 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. Lot Exp LABEL REFERENCE 20 x 500 mL GRIFOLS LABORATORIOS GRIFOLS, S.A. Murcia - SPAIN Num.: IN HOUSE CONTROL NUMBER NDC 76297-001-02 0.9% Sodium Chloride Injection, USP 500 mL For intravenous use Rx Only Single dose container 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. Laboratorios Grifols, S.A. Murcia - SPAIN DATA MATRIX Fleboflex Container (PVC-free and DEHP-free) The container closure is not made with natural rubber latex. GRIFOLS LOT XXXXXX EXP MM-YYYY INTERNAL REFERENCE NDC 76297-001-81 0.9% Sodium Chloride Injection, USP 500 mL Fleboflex Luer 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. Lot Exp 1001332 24 x 500 mL GRIFOLS LABORATORIOS GRIFOLS, S.A. - SPAIN Num.: IN HOUSE CONTROL NUMBER LOT XXXXXX EXP MM-YYYY INTERNAL REFERENCE NDC 76297-001-82 0.9% Sodium Chloride Injection, USP 500 mL For intravenous use Rx Only Single dose container 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. Laboratorios Grifols, S.A. SPAIN 4000598 DATA MATRIX Fleboflex Luer Container (PVC-free and DEHP-free) The container closure is not made with natural rubber latex. GRIFOLS
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.Laboratorios Grifols , S.A. Murcia - SPAIN Printed in SPAIN Rev. 08/2020 GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A. 3054391 GRIFOLS Laboratorios Grifols, S.A. Calle Marte nº4 – Polígono Industrial Los Llanos 30565 Las Torres de Cotillas- Murcia SPAIN
Instructions for use
Information about safe handling and use of the drug product.DIRECTIONS FOR USE OF FLEBOFLEX AND FLEBOFLEX LUER PLASTIC CONTAINERS For Information on Risk of Air Embolism – see Dosage and Administration . To Open Peel off the overwrap and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. Preparation for Administration 1. Suspend container from eyelet support. 2. Fleboflex bags: Remove plastic protector from outlet port at bottom of container. Fleboflex Luer bags: Break the twist-off administration port by means of torsion. 3. Attach administration set. Refer to complete directions accompanying set. To Add Medication Additives may be incompatible. To add medication before solution administration 1. Prepare medication site. 2. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject. 3. Mix solution and medication thoroughly. To add medication during solution administration 1. Close clamp on the set. 2. Prepare medication site. 3. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject. 4. Remove container from intravenous pole and/or turn to an upright position. 5. Mix solution and medication thoroughly. 6. Return container to in-use position and continue administration.
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 The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: Size (mL) NDC Fleboflex bags : 50 (115 units in one carton) 76297-001-11 100 (70 units in one carton) 76297-001-21 250 (28 units in one carton) 76297-001-31 500 (20 units in one carton) 76297-001-01 1000 (10 units in one carton) 76297-001-41 Fleboflex Luer bags : 50 (90 units in one carton) 76297-001-51 100 (50 units in one carton) 76297-001-61 250 (32 units in one carton) 76297-001-71 500 (24 units in one carton) 76297-001-81 1000 (10 units in one carton) 76297-001-91 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.
| 50 (115 units in one carton) | 76297-001-11 |
| 100 (70 units in one carton) | 76297-001-21 |
| 250 (28 units in one carton) | 76297-001-31 |
| 500 (20 units in one carton) | 76297-001-01 |
| 1000 (10 units in one carton) | 76297-001-41 |
| 50 (90 units in one carton) | 76297-001-51 |
| 100 (50 units in one carton) | 76297-001-61 |
| 250 (32 units in one carton) | 76297-001-71 |
| 500 (24 units in one carton) | 76297-001-81 |
| 1000 (10 units in one carton) | 76297-001-91 |
General precautions
Information about any special care to be exercised for safe and effective use of the drug.Patients with Severe Renal Impairment Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see Warnings ). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Patients with Severe Renal Impairment Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see Warnings ). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions. Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Lithium Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations. Pregnancy There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman. Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See Dosage and Administration ). Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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. Consider monitoring renal function in elderly patients.
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 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.
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