Document
DailyMed Label: BACTERIOSTATIC SODIUM CHLORIDE
Title
DailyMed Label: Bacteriostatic Sodium Chloride
Date
2024
Document type
DailyMed Prescription
Name
Bacteriostatic Sodium Chloride
Generic name
Sodium Chloride
Manufacturer
Henry Schein, Inc.
Product information
NDC: 0404-9953
Product information
NDC: 0404-9953
Description
This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.
Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0).
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
Indications
This parenteral preparation is indicated only for diluting or dissolving drugs
for intravenous, intramuscular or subcutaneous injection, according to
instructions of the manufacturer of the drug to be administered.
Dosage
The volume of the preparation to be used for diluting or
dissolving any drug for injection, is dependent on the vehicle concentration,
dose and route of administration as recommended by the manufacturer.
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit. See PRECAUTIONS.
Contraindications
Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.
Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement.
Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.
Precautions
Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Pregnancy: Animal reproduction studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.
Pediatric Use
The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.
Drug Interactions
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
Use aseptic technique for single or multiple entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly.
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
Do not use unless the solution is clear and seal intact.
Adverse reactions
Reactions which may occur because of this solution, added drugs
or the technique of reconstitution or administration include febrile response,
local tenderness, abscess, tissue necrosis or infection at the site of
injection, venous thrombosis or phlebitis extending from the site of injection
and extravasation.
How supplied
Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied as:
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
LifeShield® is the trademark of ICU Medical, Inc. and is used under license.
Distributed by Hospira, Inc., Lake Forest IL 60045 USA LAB-1096-3.0 Revised: 02/2019
Product repackaged by: Henry Schein, Inc., Bastian, VA 24314
From Original Manufacturer/Distributor's NDC and Unit of Sale
To Henry Schein Repackaged Product NDC and Unit of Sale
Total Strength/Total Volume (Concentration) per unit
NDC 0409-1966-12
Tray of 25 Multiple-Dose Lifeshield® Plastic Fliptop Vials
NDC 0404-9953-10
1 Multiple-Dose Lifeshield® Plastic Fliptop Vial in a bag (Vial bears NDC 0409-1966-06)
0.9% (10 mL)
NDC 0409-1966-07
Tray of 25 Multiple-Dose Plastic Fliptop Vials
NDC 0404-9953-30
1 Multiple-Dose Plastic Fliptop Vial in a bag (Vial bears NDC 0409-1966-02)
0.9% (30 mL)
Image1.jpg
Clinical pharmacology
Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. These ions
are normal constituents of the body fluids (principally extracellular) and are
essential for maintaining electrolyte balance.
The distribution and excretion of sodium (Na + ) and
chloride (Cl − ) are largely under the control of the
kidney which maintains a balance between intake and output.
The small volume of fluid and amount of sodium chloride provided by
Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only as a vehicle
for parenteral injection of drugs, is unlikely to exert a significant effect on
fluid and electrolyte balance except possibly in neonates and very small
infants.
Water is an essential constituent of all body tissues and accounts for
approximately 70% of total body weight. Average normal adult daily requirement
ranges from two to three liters (1.0 to 1.5 liters each for insensible water
loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water
distribution depends primarily on the concentration of electrolytes in the body
compartments and sodium (Na + ) plays a major role in
maintaining physiologic equilibrium.
Package label
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Label2.jpg
3 organizations
3 products
Organization
Henry Schein, Inc.Organization
Medical Purchasing Solutions, LLCOrganization
HF Acquisition Co LLC, DBA HealthFirstProduct
TPN Electrolytes