Sodium Chloride 0.9%, Bacteriostatic Vial How Supplied/Storage and Handling | Pfizer Medical Information - US

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HOW SUPPLIED

Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied as:

Unit of Sale	Concentration
NDC 0409-1966-05	0.9% (20 mL)
Tray of 25 Multiple-dose Plastic Fliptop Vials
NDC 0409-1966-07	0.9% (30 mL)
Tray of 25 Multiple-dose Plastic Fliptop Vials
NDC 0409-1966-12	0.9% (10 mL)
Tray of 25 Multiple-dose LifeShield® Plastic Fliptop Vials

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 Hospira Logo

LAB-1096-3.0

Revised: 02/2019

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Sodium Chloride 0.9%, Bacteriostatic Vial Quick Finder

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WARNING: NOT FOR USE IN NEONATES.

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INDICATIONS AND USAGE

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...

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DOSAGE AND ADMINISTRATION

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...

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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...

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WARNINGS

Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group....

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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...

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OVERDOSAGE

Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in neonates and very small infants. In the event these should occur,...

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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...

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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...

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HOW SUPPLIED

Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied as:

...

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Multiple-dose Plastic Vial

Multiple-dose LifeShield®...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.