Get your patient on 3% Sodium Chloride - 3% Sodium Chloride injection, Solution (3% Sodium Chloride)
3% Sodium Chloride - 3% Sodium Chloride injection, Solution prescribing information
INDICATIONS AND USAGE:
3% Sodium Chloride Injection is indicated as a source of water and electrolytes.
DOSAGE AND ADMINISTRATION:
As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient's age, weight, clinical condition, concomitant treatment, and on the patient's clinical and laboratory response to treatment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
Do not administer unless solution is clear and seal is intact.
All injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.
CONTRAINDICATIONS:
None known.
ADVERSE REACTIONS:
Post-Marketing Adverse Reactions
The following adverse reactions have not been reported with 3% Sodium Chloride Injection but may occur:
- hyperchloremia
- hyperchloremic metabolic acidosis,
- hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus,
- Infusion site reactions, such as thrombosis, phlebitis, irritation, infusion site erythema, injection site streaking, burning sensation, infusion site urticaria.
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
Caution must be exercised in the administration of 3% Sodium Chloride Injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during the administration of 3% Sodium Chloride Injection. Administration of 3% Sodium Chloride Injection may, therefore, result in decreased lithium levels.
DESCRIPTION:
3% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1 .
•Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. | ||||||
| Size (mL) | Composition (g/L) | Ionic Concentration (mEq/L) | •Osmolarity (mOsmol/L) (calc) | pH | ||
| Sodium Chloride, USP (NaCl) | Sodium | Chloride | ||||
| 3% Sodium Chloride Injection, USP | 500 | 30 | 513 | 513 | 1,027 | 5.0 (4.5 to 7.0) |
The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
CLINICAL PHARMACOLOGY:
3% Sodium Chloride Injection has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
HOW SUPPLIED:
3% Sodium Chloride Injection, USP in a single dose flexible plastic container, is available as follows:
| Product No. | 1727170306 | 1727170306 |
| Presentation | Single-Dose Container | Carton |
| NDC # | 17271-703-06 | 17271-703-06 |
| Description | 15 grams per 500 mL in a 500 mL bag (30 mg per mL) | 20 Single-Dose Containers in 1 Carton |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Store at 20° to 25 °C ( 68° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product.
The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
INSTRUCTIONS FOR USE:
Check flexible container solution composition, lot number, and expiry date.
Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.
To Open
- Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
- Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
To Add Medication
- Identify WHITE Additive Port with arrow pointing toward container.
- Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
- Hold base of WHITE Additive Port horizontally.
- Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.
- Mix container contents thoroughly.
Preparation for Administration
- Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
- Use a non-vented infusion set or close the air-inlet on a vented set.
- Close the roller clamp of the infusion set.
- Hold the base of BLUE Infusion Port.
- Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set.
WARNING: Do not use flexible container in series connections.
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 USA For product Inquiry: 1-800-523-0502 Distributed by BD.Manufactured by Fresenius Kabi. Made in Germany.
451642
Issued: November 2019
