BACTERIOSTATIC SODIUM CHLORIDE- sodium chloride injection

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
APP Pharmaceuticals, LLC
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 9 mg in 1 mL
Administration route:
SUBCUTANEOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
These parenteral preparations are 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.  NOT FOR INHALATION. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.
Product summary:
Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with parabens is available as follows:   Product No. NDC No. Strength 205910 63323-259-10 0.9% 10 mL multiple dose vial, in packages of 25. 205930 63323-259-30 0.9% 30 mL multiple dose vial, in packages of 25. Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Authorization status:
unapproved drug other
Authorization number:
63323-259-30

BACTERIOSTATIC SODIUM CHLORIDE- sodium chloride injection

APP Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Bacteriostatic Sodium Chloride Injection USP

0.9%

NOT FOR USE IN NEWBORNS

DESCRIPTION

Bacteriostatic Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic, isotonic solution.

Each mL contains: Sodium chloride 9 mg; methylparaben 0.12%; propylparaben 0.012%; Water for

Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH

4.5-7.0).

Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste.

Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol.

The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

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 Sodium Chloride

Injection, USP, 0.9%, 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 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 to 1.5 liters each of

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.

INDICATIONS AND USAGE

These parenteral preparations are 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. NOT FOR INHALATION.

CONTRAINDICATIONS

Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride

replacement.

WARNINGS

Data is unavailable on the toxicity of parabens and other preservatives in newborns. Where a sodium

chloride solution is required for preparing or diluting medications for use in newborns, only

preservative free Sodium Chloride Injection, USP, 0.9% should be used. Preservative free Sodium

Chloride Injection, USP, 0.9% should be used for flushing intravascular catheters.

PRECAUTIONS

General

Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for those medicinals that

specify the use of only Sodium Chloride Injection, USP, 0.9% as a sterile solvent.

Sodium chloride must be used with caution in the presence of congestive heart failure, circulatory

insufficiency, kidney dysfunction or hypoproteinemia.

Excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis.

Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary

edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or

corticotropin or drugs that may give rise to sodium retention.

Pregnancy

Pregnancy Category C—

Animal reproduction studies have not been conducted with Bacteriostatic Sodium Chloride Injection,

USP, 0.9%. It is also not known whether Bacteriostatic Sodium Chloride Injection, USP, 0.9% can

cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Bacteriostatic Sodium Chloride Injection, USP, 0.9% should be given to a pregnant woman only if

clearly needed.

ADVERSE REACTIONS

Reactions which may occur because of Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 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.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate

countermeasures and if possible, retrieve and save the remainder of the unused vehicle for examination.

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 very small infants. In the event these should occur,

reevaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and

ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

NOT FOR INHALATION. Before Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used as a

vehicle for the administration of a drug, specific references should be checked for any possible

incompatibility with sodium chloride or the bacteriostatic agents.

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.

Isotonic solutions may be given subcutaneously, intravenously, and occasionally, intramuscularly.

Use Bacteriostatic Sodium Chloride Injection, USP, 0.9% with due regard for the compatibility of the

antimicrobial agents it contains with the particular medicinal substance that is to be dissolved or diluted.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with parabens is available as follows:

Product

No.

NDC

No.

Strength

205910 63323-259-

0.9%

10 mL multiple dose vial, in

packages of 25.

205930 63323-259-

0.9%

30 mL multiple dose vial, in

packages of 25.

Use only if solution is clear and seal intact.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

45787C

Revised: April 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Bacteriostatic Sodium Chloride 30 mL Multiple

Dose Vial Label

NDC 63323-259-30

205930

Bacteriostatic Sodium Chloride Injection, USP

0.9%

Not for Use in Newborns

30 mL

Rx only

Multiple Dose Vial

For Drug Diluent Use Only

Not for Inhalation

BACTERIOSTATIC SODIUM CHLORIDE

sodium chloride injection

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:6 3323-

Route of Administration

SUBCUTANEOUS, INTRAVENOUS,

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE ION -

UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

9 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 3323-259 -30

25 in 1 TRAY

1

30 mL in 1 VIAL, MULTI-DOSE

APP Pharmaceuticals, LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 9 /0 1/20 0 0

Labeler -

APP Pharmaceuticals, LLC (608775388)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

APP Pharmaceuticals, LLC

8 40 771732

MANUFACTURE(6 3323-259 )

Revised: 8/2012

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