Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 0.9% Sodium Chloride Injection USP 0264-1800-36 S8004-5410 25/100 0264-1800-31 S8004-5384 50/100 0264-1800-32 S8004-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.; PRINCIPAL DISPLAY PANEL - 25 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-36 REF S8004-5410 25 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/25 mL): Sodium 3.8 Chloride 3.8 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-353 LD-227-2 25 mL Container Label; PRINCIPAL DISPLAY PANEL - 50 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-31 REF S8004-5384 50 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/50 mL): Sodium 7.7 Chloride 7.7 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-339 LD-226-A-2 50 mL Container Label; PRINCIPAL DISPLAY PANEL - 100 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-32 REF S8004-5264 100 mL Partial Fill in 150 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/100 mL): Sodium 15.4; Chloride 15.4 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-337 LD-225-A-2 100 mL Container Label
- HOW SUPPLIED 0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 0.9% Sodium Chloride Injection USP 0264-1800-36 S8004-5410 25/100 0264-1800-31 S8004-5384 50/100 0264-1800-32 S8004-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
- PRINCIPAL DISPLAY PANEL - 25 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-36 REF S8004-5410 25 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/25 mL): Sodium 3.8 Chloride 3.8 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-353 LD-227-2 25 mL Container Label
- PRINCIPAL DISPLAY PANEL - 50 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-31 REF S8004-5384 50 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/50 mL): Sodium 7.7 Chloride 7.7 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-339 LD-226-A-2 50 mL Container Label
- PRINCIPAL DISPLAY PANEL - 100 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-32 REF S8004-5264 100 mL Partial Fill in 150 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/100 mL): Sodium 15.4; Chloride 15.4 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-337 LD-225-A-2 100 mL Container Label
Overview
Each mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4 This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary.
Indications & Usage
This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.
Dosage & Administration
This solution is for intravenous use only. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use . When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used. Addition of medication should be accomplished using aseptic technique in order to assure sterility. Physicochemical studies have shown that the container and solution can withstand freezing. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
Contraindications
This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.
Adverse Reactions
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. 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.
Drug Interactions
Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP.
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