Sodium Chloride description, usages, side effects, indications, overdosage, supplying and lots more!

Sodium Chloride

Baxter Healthcare Corporation

Sodium Chloride Injection, USPin VIAFLEX Plastic Container

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

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 pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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

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

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

None known.

WARNINGS

Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

PRECAUTIONS

GENERAL

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother.

Pediatric Use

The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency

.

Geriatric Use

Clinical studies of Sodium Chloride Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Do not administer unless solution is clear and seal is intact.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

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.

In addition to the above listed adverse reactions the following has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section):

- Hyponatremia

DOSAGE AND ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile 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.

HOW SUPPLIED

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

Code Size (mL) NDC Product Name
2B1313 500 0338-0043-03 0.45% Sodium Chloride Injection, USP
2B1314 1000 0338-0043-04
2B1355 100 0338-1452-48
2B1356 250 0338-1452-02
2B1300 25 Quad Pack 0338-0049-10 0.9% Sodium Chloride Injection, USP
50
2B1306 Single pack 0338-0049-41
2B1301 Quad pack 0338-0049-11
2B1308 Multi pack 0338-0049-31
100
2B1307 Single pack 0338-0049-48
2B1302 Quad pack 0338-0049-18
2B1309 Multi pack 0338-0049-38
2B1321 150 0338-0049-01
2B1322 250 0338-0049-02
2B1323 500 0338-0049-03
2B1324 1000 0338-0049-04

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

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

  • Suspend container from eyelet support.
  • Remove protector from outlet port at bottom of container.
  • Attach administration set. Refer to complete directions accompanying set.

To Add Medication

WARNING

Additives may be incompatible.

To add medication before solution administration

  • Prepare medication site.
  • Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

  • Close clamp on the set.
  • Prepare medication site.
  • Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • Remove container from IV pole and/or turn to an upright position.
  • Evacuate both ports by squeezing them while container is in the upright position.
  • Mix solution and medication thoroughly.
  • Return container to in-use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

*BAR CODE POSITION ONLY
071969741

07-19-69-741 Rev. September 2013

BAXTER, VIAFLEX and PL 146 are trademarks of
Baxter International Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL
Container Label LOTEXP2B1302NDC 0338-0049-18 0.9% Sodium Chloride Injection USP 100 mL Single dose container Each 100mL contains 900 mg SodiumChloride USP pH 5.0 (4.5 to 7.0)mEq/100 mL Sodium 15 Chloride 15Osmolarity 308 mOsmol/L (calc)Sterile Nonpyrogenic Readpackage insert for full informationAdditives may be incompatibleDosage Intravenously as directedby a physician Cautions Must notbe used in series connectionsDonot use unless solution is clear Rx Only VIAFLEX containerPL 146Baxter VIALFEX and PL 146 are trademarks ofBaxter International Inc Baxter    Baxter Healthcare Corporation Deerfiled IL 60015 USAMade in USA Carton Label Lot: PXX QTY: 96-100 mL Exp: XX XX Code: 2B1302 NDC: 0338-0049-18 0.9% SODIUM CHLORIDE INJ USP (17) XXXX00 (10) PXX(01) 50303380049184 Container Label LOT EXP 2813131 NDC  0338-0043-03 0.45°/o Sodium Chloride Injection USP 500ml EACH 100 mL CONTAINS 450 rng SODIUM CHLORIDE USPpH 5.0 (4. 5 TO 7.0) mEq/L SODIUM 77 CHLORIDE 77HYPOTONIC OSMOLARITY 154 mQsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLEWHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS Do NOT USE UNLESS SOLUTION IS CLEAR Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER Pl 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo BAXTER HEALTHCARE CORPORATIONDEERFIELD l60015 USAMADE IN USA07-25-34-139 Carton Label 2B1313Q 24-500 MLVIAFLEX® CONTAINER0.45% SODIUM CHLORIDE INJECTION, USPEXPXXXXXSECONDARY BAR CODE(17) YYMMOO (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380043038 Container Label LOT EXP 2B1356 NDC 0333-1452-02 0.45% Sodium Chloride Injection USP 250 mL EACH 100 ml CONTAINS 450 MG SODIUMCHLORIDE USP pH 5.0 (4.5 TO 7.0) mEq/LSODIUM 77 CHLORIDE 77 HYPOTONICOSMOLARITY 154 mOsmol/L (CALC) STERILE NONPYROGENICSINGLE DOSE CONTAINER ADDITIVES MAY VE INCOMPATIBLECONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCINGADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIANSEE DIRECTIONSCAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINSPRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Rx ONLY Baxter Logo BAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USAVIAFLEX CONTAINERPL 146 PLASTICFOR PRODUCT INFORMATION1-800-933-0303BAXTER VIAFLEX ANDPL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INC 50 100 150 200 07-25-22-599 Carton Label

0.45% SODIUM CHLORIDE INJECTION, USP

2B-13-56

24-250 ML VIAFLEX CONTAINER

07-22-22-600

Sodium Chloride

Sodium Chloride INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0338-0049
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE 9 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-0049-01 150 in 1 BAG
2 NDC:0338-0049-02 250 in 1 BAG
3 NDC:0338-0049-03 500 in 1 BAG
4 NDC:0338-0049-04 1000 in 1 BAG
5 25 in 1 BAG
6 50 in 1 BAG
7 50 in 1 BAG
8 50 in 1 BAG
9 100 in 1 BAG
10 100 in 1 BAG
11 100 in 1 BAG
12 NDC:0338-0049-38 16 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016677 1970-12-09


Sodium Chloride

Sodium Chloride INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0338-0043
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE 4.5 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-0043-03 500 in 1 BAG
2 NDC:0338-0043-04 1000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018016 1979-02-02


Sodium Chloride

Sodium Chloride INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0338-1452
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE 5 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-1452-48 100 in 1 BAG
2 NDC:0338-1452-02 250 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018016 1979-02-02


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