Sodium Chloride Injection, USP, in VIAFLEX Plastic Container

/Sodium Chloride Injection, USP, in VIAFLEX Plastic Container
Sodium Chloride Injection, USP, in VIAFLEX Plastic Container2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sodium Chloride Injection, USP, in VIAFLEX Plastic Container

ID:

c65c642a-6b0e-4811-b565-aa30eda34074

Code:

34391-3

DESCRIPTION


id: 0dcb79b1-8b88-4c23-8e27-318b6d18bff4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). Hydrochloric Acid, NF or Sodium Hydroxide, NF may be added for pH adjustment. It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinylchloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY


id: f427fed6-86b5-40db-8adb-0d88403dd8ca
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

INDICATIONS AND USAGE


id: e94b3401-4cb1-4a60-b10b-2cf0f2f1b4b6
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

CONTRAINDICATIONS


id: 7c5ad1ec-0473-486a-af81-1e09e48b4321
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

None known.

WARNINGS


id: ff3decb2-5b15-40ec-b554-d1be905f355e
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Administer 0.9% Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypernatremia, hyperchloremia, or metabolic acidosis. Administer Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism [e.g., associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia]. Certain medications may increase risk of sodium and fluid retention, see Drug Interactions. Administer Sodium Chloride Injection, USP with particular caution, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection, USP may result in sodium retention.

OVERDOSAGE


id: 76c94890-d4d7-4568-b85e-872d16e1aa98
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Excessive administration of 0.9% Sodium Chloride Injection, USP may lead to hypernatremia. Hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death. Excessive administration of Sodium Chloride Injection, USP may lead to sodium overload (which can lead to central and/or peripheral edema). When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.

DOSAGE AND ADMINISTRATION


id: 43cf9c83-7ffc-4352-b601-0e6f0f1ab93f
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment. 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. When other electrolytes or medicines are added to this solution, the dosage and the infusion rate will also be dictated by the dose regimen of the additions. 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 the solution is clear and seal is intact. Additives may be incompatible with Sodium Chloride Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sodium Chloride Injection, USP is appropriate. After addition, check for unexpected color changes and/or the appearance of precipitates, insoluble complexes or crystals. The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible must not be used. When introducing additives to Sodium Chloride Injection, USP, aseptic technique must be used. Mix the solution 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.

HOW SUPPLIED


id: 19f51c78-db3f-4485-9b7e-8634132b511b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

The available sizes of each injection in VIAFLEX plastic containers are shown below:

Code Size (mL) NDC Product Name
EZPB1306 50(single pack) 0338-9529-70 0.9% Sodium Chloride Injection, USP
EZPB1307 100(single pack) 0338-9537-50
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER


id: ceab191f-104b-48eb-ab85-5a1a70be0679
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

For Information on Risk of Air Embolism – see PRECAUTIONS.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL


id: d0a8e0ca-df67-423c-a666-ac69905bde61
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

EZPB1306
NDC 0338-9529-70
0.9%
Sodium Chloride
Injection USP
50 mL Single Dose
Container Each 50 mL
contains 450 mg
Sodium Chloride USP
mEq/50 mL Sodium 8
Chloride 8 Sterile
See prescribing
information Additive
compatibility consult
Pharmacist For
intravenous use
Rx Only
Baxter Logo

Baxter Healthcare
Corporation
Deerfield IL 60015 USA
Made in Ireland
CB-35-04-456 Lot
Exp
2D bar code
1D bar code area
Code EZPB1306
QTY 70 x 50 mL
0.9% SODIUM CHLORIDE, INJ USP
NDC 0338-9529-70
Baxter Healthcare Corporation

Deerfield IL 60015 USA
Made in Ireland STORE AT ROOM TEMPERATURE (25°C/77°F)
[SEE USP CONTROLLED ROOM TEMPERATURE]
LOT: 88G88G88B8 EXP: 12/2020 Bar Code
(01)50085412578458(17)201200(10)88G88G88B8
Code EZPB1306 QTY 70 x 50 mL 0.9% SODIUM CHLORIDE,
INJ USP
88-46-12-960 LOT:
88G88G88B8
EXP:
12/2020
EZPB1307
NDC 0338-9537-50
0.9%
Sodium Chloride
Injection USP
100 mL Single Dose
Container Each 100 mL
contains 900 mg Sodium
Chloride USP mEq/100 mL
Sodium 15 Chloride 15
Sterile See prescribing
information Additive
compatibility consult
Pharmacist For intravenous
use Rx Only
Baxter Logo
Baxter Healthcare Corporation

Deerfield IL 60015 USA
Made in Ireland
CB-35-04-500 Lot
Exp
bar code
(01) 00303389537502
bar code
Code EZPB1307
QTY 50 x 100 mL
0.9% SODIUM CHLORIDE, INJ USP
NDC 0338-9537-50
Baxter Healthcare Corporation

Deerfield IL 60015 USA
Made in Ireland STORE AT ROOM TEMPERATURE (25°C/77°F)
[SEE USP CONTROLLED ROOM TEMPERATURE]
LOT: 88G88G88B8 EXP: 12/2020 Bar Code
(01)50085412578458(17)201200(10)88G88G88B8
Code EZPB1307 QTY 50 x 100 mL 0.9% SODIUM CHLORIDE,
INJ USP
88-46-12-961 LOT:
88G88G88B8
EXP:
12/2020