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| Product NDC Code | 0990-7972 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | IRRIGATION | ||||||||
| Dosage Form | IRRIGANT | ||||||||
| RxCUI drug identifier | 486515 | ||||||||
| Application Number | NDA018314 | ||||||||
| Labeler Name | ICU Medical 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 In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , 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 Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, 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 Each of these irrigation solutions exert a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. Each also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline). 0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. 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. 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.
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 NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
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 These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na + 154; Cl − 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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 dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer's recommendations should be followed. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS .
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 Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
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 - 1000 mL Bottle Label 1000 mL NDC 0990-7138-09 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5 – 7.0). Sterile, nonpyrogenic. Indications: Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only icumedical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7284 LOT EXP PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6138-03 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5–7.0). Sterile, nonpyrogenic. Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7282 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 2000 mL NDC 0990-7972-07 0.9% SODIUM CHLORIDE Irrigation , USP EACH 100 mL CONTAINS SODIUM CHLORIDE, 900 mg. pH 5.6 (4.5 to 7.0) 308 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC. INDICATIONS: ISOTONIC SOLUTION FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F). STORE AT 20 TO 25°C (68 TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM FREEZING. SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. RX ONLY 3 V CONTAINS DEHP icumedical IM-4375 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label
PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap
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.For All General Irrigation, Washing, Rinsing and Dilution Purposes Not For Injection By Usual Parenteral Routes Flexible Irrigation Container Semi-rigid Irrigation Container R x only
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.Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. This drug is known to be substantially secreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers: Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman.
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: Safety and effectiveness of Sodium Chloride irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride irrigation solution in the pediatric population is referenced in the medical literature. The Warnings, Precautions, and Adverse Reactions identified in the label should be observed in the pediatric population.
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: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Irrigation, USP 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 0.9% Sodium Chloride Irrigation, USP: Container Size NDC Single-dose 500 mL semi-rigid irrigation container 0409-6138-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Single-dose 500 mL semi-rigid irrigation container 0990-6138-03 Single-dose 250 mL semi-rigid irrigation container 0409-6138-22 Single-dose 250 mL semi-rigid irrigation container 0990-6138-22 Single-dose 1000 mL semi-rigid irrigation container 0409-7138-09 Single-dose 1000 mL semi-rigid irrigation container 0990-7138-09 Single-dose 1500 mL semi-rigid irrigation container 0409-7138-36 Single-dose 1500 mL semi-rigid irrigation container 0990-7138-36 Single-dose 1000 mL flexible irrigation container 0409-7972-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Single-dose 1000 mL flexible irrigation container 0990-7972-05 Single-dose 2000 mL flexible irrigation container 0409-7972-07 Single-dose 2000 mL flexible irrigation container 0990-7972-07 ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 EN-4660 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
| Container Size | NDC |
|---|---|
| Single-dose 500 mL semi-rigid irrigation container | 0409-6138-03 |
| Single-dose 500 mL semi-rigid irrigation container | 0990-6138-03 |
| Single-dose 250 mL semi-rigid irrigation container | 0409-6138-22 |
| Single-dose 250 mL semi-rigid irrigation container | 0990-6138-22 |
| Single-dose 1000 mL semi-rigid irrigation container | 0409-7138-09 |
| Single-dose 1000 mL semi-rigid irrigation container | 0990-7138-09 |
| Single-dose 1500 mL semi-rigid irrigation container | 0409-7138-36 |
| Single-dose 1500 mL semi-rigid irrigation container | 0990-7138-36 |
| Single-dose 1000 mL flexible irrigation container | 0409-7972-05 |
| Single-dose 1000 mL flexible irrigation container | 0990-7972-05 |
| Single-dose 2000 mL flexible irrigation container | 0409-7972-07 |
| Single-dose 2000 mL flexible irrigation container | 0990-7972-07 |
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Do not use for irrigation that may result in absorption into the blood. Caution should be observed when a hypotonic solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload. Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues. When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Nursing Mothers: Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman. Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed. Pediatric Use: Safety and effectiveness of Sodium Chloride irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride irrigation solution in the pediatric population is referenced in the medical literature. The Warnings, Precautions, and Adverse Reactions identified in the label should be observed in the pediatric population. Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. This drug is known to be substantially secreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
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 FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not heat container over 66°C (150°F).
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