Plasma-Lyte 148

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.

The administration of acetate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

Drug Interactions

Caution is advised when administering Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.

Caution is advised when administering Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) to patients treated with drugs which renal elimination is pH dependent. Due to its alkalinizing effect (formation of bicarbonate), Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of such drugs.
- Renal clearance of acidic drugs such as salicylates and barbiturates may be increased.
- Renal clearance of alkaline drugs such as sympathomimetics (e.g., ephedrine, pseudoephedrine), quinidine, or dextroamphetamine (dexamphetamine) sulfate, may be decreased.

Renal clearance of lithium may also be increased. Caution is advised when administering Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) to patients treated with lithium.

Because of its potassium content, Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.

Drug/Laboratory Test Interactions

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing Plasmalyte solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing Plasmalyte solutions should be interpreted cautiously and confirmed by other diagnostic methods.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known where this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is administered to a nursing mother.

Pediatric Use

The use of Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients is based on clinical practice.

Geriatric Use

Clinical studies of Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, 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 other drug therapy.

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 dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

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.

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

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

Additives may be incompatible with Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, 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 Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is appropriate. After addition, check for a possible color change 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 Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP), aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

For Information on Risk of Air Embolism – see PRECAUTIONS

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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

1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

To add medication before solution administration

1. Prepare medication site. 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3. 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

1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-00-0101
Rev. August 2017

Baxter, Plasma-Lyte, Viaflex, and PL 146 are trademarks of Baxter International Inc.