Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case. NDC REF Size 3% Sodium Chloride Injection USP 0264-7805-10 L8051 500 mL 5% Sodium Chloride Injection USP (Canada DIN 01928007) 0264-7806-10 L8061 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. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.; PRINCIPAL DISPLAY PANEL - 500 mL 3% Sodium Chloride Injection USP REF L8051 NDC 0264-7805-10 500 mL EXCEL® CONTAINER Hypertonic Y94-003-261 LD-259-2 Each 100 mL contains: Sodium Chloride USP 3 g; Water for Injection USP qs pH may be adjusted with HCI NF pH: 5.8 (4.5-7.0); Calc. Osmolarity: 1030 mOsmol/liter Electrolytes (mEq/liter): Na + 513; CI – 513 Sterile, nonpyrogenic. Single dose container. CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with constant observation of patient to avoid pulmonary edema. 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 Y94-003-260 LD-133-3 EXP LOT L8051 Other symbol L8051; PRINCIPAL DISPLAY PANEL - 500 mL 5% Sodium Chloride Injection USP REF L8061 NDC 0264-7806-10 DIN 01928007 HK 22618 500 mL EXCEL® CONTAINER Hypertonic Y94-003-269 LD-501-1 Each 100 mL contains: Sodium Chloride USP 5 g; Water for Injection USP qs pH may be adjusted with HCI NF pH: 5.8 (4.5-7.0) ; Calc. Osmolarity: 1710 mOsmol/liter Electrolytes (mEq/liter): Na + 856; CI – 856 Sterile, nonpyrogenic. Single dose container. CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with constant observation of patient to avoid pulmonary edema. 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 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-262 LD-132-3 EXP LOT L8061 Other symbol L8061
- HOW SUPPLIED 3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case. NDC REF Size 3% Sodium Chloride Injection USP 0264-7805-10 L8051 500 mL 5% Sodium Chloride Injection USP (Canada DIN 01928007) 0264-7806-10 L8061 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. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
- PRINCIPAL DISPLAY PANEL - 500 mL 3% Sodium Chloride Injection USP REF L8051 NDC 0264-7805-10 500 mL EXCEL® CONTAINER Hypertonic Y94-003-261 LD-259-2 Each 100 mL contains: Sodium Chloride USP 3 g; Water for Injection USP qs pH may be adjusted with HCI NF pH: 5.8 (4.5-7.0); Calc. Osmolarity: 1030 mOsmol/liter Electrolytes (mEq/liter): Na + 513; CI – 513 Sterile, nonpyrogenic. Single dose container. CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with constant observation of patient to avoid pulmonary edema. 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 Y94-003-260 LD-133-3 EXP LOT L8051 Other symbol L8051
- PRINCIPAL DISPLAY PANEL - 500 mL 5% Sodium Chloride Injection USP REF L8061 NDC 0264-7806-10 DIN 01928007 HK 22618 500 mL EXCEL® CONTAINER Hypertonic Y94-003-269 LD-501-1 Each 100 mL contains: Sodium Chloride USP 5 g; Water for Injection USP qs pH may be adjusted with HCI NF pH: 5.8 (4.5-7.0) ; Calc. Osmolarity: 1710 mOsmol/liter Electrolytes (mEq/liter): Na + 856; CI – 856 Sterile, nonpyrogenic. Single dose container. CAUTION: This is a concentrated sodium chloride solution. Infuse slowly with constant observation of patient to avoid pulmonary edema. 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 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-262 LD-132-3 EXP LOT L8061 Other symbol L8061
Overview
Each 100 mL of 3% Sodium Chloride Injection USP contains: Sodium Chloride USP 3 g; Water for Injection USP qs pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1030 mOsmol/liter pH may be adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 513 Chloride 513 Each 100 mL of 5% Sodium Chloride Injection USP contains: Sodium Chloride USP 5 g; Water for Injection USP qs pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1710 mOsmol/liter pH may be adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 856 Chloride 856 3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic 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. 3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss. These hypertonic sodium chloride solutions are also indicated for the following clinical conditions. Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids. Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections. Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.
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. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be determined to evaluate the need for more sodium chloride. Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 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 Caution: These are concentrated hypertonic sodium chloride solutions. Infuse very slowly with constant observation of the patient to avoid pulmonary edema. 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.
Contraindications
3% and 5% Sodium Chloride Injections USP are contraindicated in the presence of elevated, normal, or only slightly decreased plasma electrolyte concentrations, or when additives of sodium and 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. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a well-placed small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) 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.
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