Sodium Chloride Injection 3% 5%

Name: Sodium Chloride Injection 3% 5%

Indications and Usage for Sodium Chloride Injection 3% 5%

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.

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.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

Sodium Chloride Injection 3% 5% Dosage and 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.

How is Sodium Chloride Injection 3% 5% 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.

Rx only

Revised: September 2016
EXCEL is a registered trademark of B. Braun Medical Inc.

Directions for Use of EXCEL® Container

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

  •  Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
  •  Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
  •  Use only if solution is clear and container and seals are intact.

Preparation for Administration

  1. Remove plastic protector from sterile set port at bottom of container.
  2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

  1. Prepare medication site.
  2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
  3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

  1. Close clamp on the set.
  2. Prepare medication site.
  3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
  4. Remove container from IV pole and/or turn to an upright position.
  5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
  6. Mix solution and medication thoroughly.
  7. Return container to in use position and continue administration.

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

Y36-002-928   LD-237-3

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