Plasma-Lyte A

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L.

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.

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is contraindicated in patients with a known hypersensitivity to the product.

Post-Marketing Adverse Reactions

The following adverse reactions have been reported with PLASMA-LYTE products without Dextrose. Adverse reactions are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.

• Immune System Disorders: Hypersensitivity/infusion reactions, including Anaphylactoid reaction, and the following manifestations: Tachycardia, Palpitations, Chest pain, Chest discomfort, Dyspnea, Respiratory rate increased, Flushing, Hyperemia, Asthenia, Feeling abnormal, Piloerection, Edema peripheral, Pyrexia • General Disorders and Administration Site Conditions: Infusion site reactions (e.g., Infusion site pain, Burning sensation)

Other adverse reactions reported with PLASMA-LYTE products with Dextrose are:

• Other manifestations of hypersensitivity/infusion reactions: Hypotension, Wheezing, Urticaria, Cold sweat, Chills • Hyperkalemia

Overdose

Excessive administration of Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia as well as a decrease in ionized serum calcium and magnesium.

An excessive volume of Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.

Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.

Excessive administration of magnesium may lead to hypermagnesemia.

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.

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX plastic containers is available as shown below:

Code	Size (mL)	NDC
2B2544	1000	NDC 0338-0221-04
2B2543	500	NDC 0338-0221-03

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

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

*BAR CODE POSITION ONLY
071968963

07-19-00-0102

Rev. August 2017

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