Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case; the 500 mL and 250 mL containers are packaged 24 per case. NDC REF Size 0.9% Sodium Chloride Injection USP (Canada DIN 01924303) 0264-7800-00 L8000 1000 mL 0264-7800-10 L8001 500 mL 0264-7800-20 L8002 250 mL 0.45% Sodium Chloride Injection USP (Canada DIN 01927949) 0264-7802-00 L8020 1000 mL 0264-7802-10 L8021 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. 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 - 0.9 g/1000 mL Container Label 0.9% Sodium Chloride Injection USP REF L8000 NDC 0264-7800-00 DIN 01924303 HK 22617 1000 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-229 LD-195-3 EXP LOT Other 1000 mL Container Label L8000; PRINCIPAL DISPLAY PANEL - 0.9 g/500 mL Container Label 0.9% Sodium Chloride Injection USP REF L8001 NDC 0264-7800-10 DIN 01924303 HK 22617 500 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5–7.0); Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-228 LD-137-3 EXP LOT L8001 Other L8001; PRINCIPAL DISPLAY PANEL - 0.9 g/250 mL Container Label 0.9% Sodium Chloride Injection USP REF L8002 NDC 0264-7800-20 DIN 01924303 HK 22617 250 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5–7.0); Calc. Osmolarity:310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarboough, Ontario M1H 2W4 Y94-003-223 LD-136-4 EXP LOT L8002 Other L8002; PRINCIPAL DISPLAY PANEL - 0.45 g/1000 mL Container Label 0.45% Sodium Chloride Injection USP REF L8020 NDC 0264-7802-00 DIN 01927949 HK 22616 1000 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter, hypotonic Electrolytes (mEq/liter): Na + 77; Cl – 77 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-230 LD-135-3 EXP LOT Other 1000 mL Container Label L8020; PRINCIPAL DISPLAY PANEL - 0.45 g/500 mL Container Label 0.45% Sodium Chloride Injection USP REF L8021 NDC 0264-7802-10 DIN 01927949 HK 22616 500 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter, hypotonic Electrolytes (mEq/liter): Na + 77; Cl – 77 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA USA 18018-3524 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-227 LD-134-4 EXP LOT L8021 Other L8021
- HOW SUPPLIED Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case; the 500 mL and 250 mL containers are packaged 24 per case. NDC REF Size 0.9% Sodium Chloride Injection USP (Canada DIN 01924303) 0264-7800-00 L8000 1000 mL 0264-7800-10 L8001 500 mL 0264-7800-20 L8002 250 mL 0.45% Sodium Chloride Injection USP (Canada DIN 01927949) 0264-7802-00 L8020 1000 mL 0264-7802-10 L8021 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. 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 - 0.9 g/1000 mL Container Label 0.9% Sodium Chloride Injection USP REF L8000 NDC 0264-7800-00 DIN 01924303 HK 22617 1000 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-229 LD-195-3 EXP LOT Other 1000 mL Container Label L8000
- PRINCIPAL DISPLAY PANEL - 0.9 g/500 mL Container Label 0.9% Sodium Chloride Injection USP REF L8001 NDC 0264-7800-10 DIN 01924303 HK 22617 500 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5–7.0); Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-228 LD-137-3 EXP LOT L8001 Other L8001
- PRINCIPAL DISPLAY PANEL - 0.9 g/250 mL Container Label 0.9% Sodium Chloride Injection USP REF L8002 NDC 0264-7800-20 DIN 01924303 HK 22617 250 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5–7.0); Calc. Osmolarity:310 mOsmol/liter Electrolytes (mEq/liter): Na + 154; Cl – 154 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarboough, Ontario M1H 2W4 Y94-003-223 LD-136-4 EXP LOT L8002 Other L8002
- PRINCIPAL DISPLAY PANEL - 0.45 g/1000 mL Container Label 0.45% Sodium Chloride Injection USP REF L8020 NDC 0264-7802-00 DIN 01927949 HK 22616 1000 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter, hypotonic Electrolytes (mEq/liter): Na + 77; Cl – 77 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-230 LD-135-3 EXP LOT Other 1000 mL Container Label L8020
- PRINCIPAL DISPLAY PANEL - 0.45 g/500 mL Container Label 0.45% Sodium Chloride Injection USP REF L8021 NDC 0264-7802-10 DIN 01927949 HK 22616 500 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH adjusted with HCl NF pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter, hypotonic Electrolytes (mEq/liter): Na + 77; Cl – 77 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: 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. Protect from freezing. See Package Insert. Do not remove 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. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA USA 18018-3524 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-227 LD-134-4 EXP LOT L8021 Other L8021
Overview
Each 100 mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH: 5.6 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154 Each 100 mL of 0.45% Sodium Chloride Injection USP contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH: 5.6 (4.5–7.0) Calculated Osmolarity: 155 mOsmol/liter, hypotonic pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 77 Chloride 77 Sodium Chloride Injections USP are sterile, nonpyrogenic, isotonic and contain 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 made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. 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 is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.
Indications & Usage
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. 0.45% Sodium Chloride Injection USP is primarily a hydrating solution and may be used to assess the status of the kidneys, since more water is provided than is required for excretion of salt. It may also be used in the treatment of hyperosmolar diabetes where the use of dextrose is inadvisable and there is a need for large amounts of fluid without an excess of sodium ions. Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.
Dosage & Administration
These solutions are for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride). 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 .) Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures. When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs. 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 The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. 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. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.
Contraindications
These solutions are 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. 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 infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. 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.
Storage & Handling
Avoid excessive heat. Protect from freezing. 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.
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