Nacellate Solution 0.9% – 100mL (Page 2 of 2)

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.

The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

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.

OVERDOSAGE

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition, and institute appropriate corrective treatment.

DOSAGE AND ADMINISTRATION

This solution is for intravenous use only.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

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

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

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

HOW SUPPLIED

0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers.

NDC REF Fill/Container (mL)
0.9% Sodium Chloride Injection USP
70529-021-01 S8004-5264 100

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Rx only

Revised: October 2016

Directions For Use of PAB® Container

Partial Additive Bag

Aseptic technique is required.

Caution: Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.

Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact. Single dose container. Discard unused portion. Consult Package Insert for complete product information.

The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.

Do not use plastic container in series connection.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Physicochemical studies have shown that the container and solution can withstand freezing.

1. Identify Two Ports (See Figure A).

Figure A
(click image for full-size original)

2. To Add Medication
Remove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward (See Figure B). Swab exposed additive port. Using a syringe with 18 gauge or smaller needle, insert cannula through resealable additive port and add desired drug. Mix thoroughly.
Note: Partial fill bags have been designed to accept an overfill of up to 50 mL.

Figure B
(click image for full-size original)

3. To Attach Administration Set

To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure C Steps 1 and 2.

Figure C
(click image for full-size original)

4. Push spike through the diaphragm of the port (See Figure D). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.

Figure D
(click image for full-size original)

When the container is to be used as a diluent and delivery system for intermittent intravenous administration of compatible drug additives, consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

Y36-002-925 LD-224-5

Assembled and Distributed by IT3 Medical, LLC 190 E Stacy Road; STE 306-298, Allen, TX 75002-8734
For questions or comments: info@IT3-Medical.com, www.IT3-Medical.com

Packaging

image description
(click image for full-size original)

NACELLATE SOLUTION 0.9% — 100ML
sodium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70529-021
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70529-021-01 1 CONTAINER in 1 PACKAGE contains a CONTAINER
1 100 mL in 1 CONTAINER This package is contained within the PACKAGE (70529-021-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017464 03/01/2017
Labeler — IT3 Medical LLC (079971231)

Revised: 02/2022 IT3 Medical LLC

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