Plasma-Lyte 56

Plasma-Lyte 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.

Post-marketing Adverse Reactions

The following adverse reactions have been reported with PLASMA-LYTE products with 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: Hypotension, Chest discomfort, Dyspnea, Wheezing, Flushing, Hyperemia, Asthenia, Urticaria, Cold sweat, Pyrexia, Chills
• Metabolism and Nutrition Disorders: Hyperkalemia, Hyperglycemia
• General Disorders and Administration Site Conditions: Infusion site reactions (e.g., Burning sensation)

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

• Other manifestations of hypersensitivity/infusion reactions: Tachycardia, Palpitations, Chest Pain, Respiratory rate increased, Feeling abnormal, Piloerection, Edema peripheral
• Infusion site pain

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.

The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

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. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

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

Additives may be incompatible with Plasma-Lyte 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose 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 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is appropriate. After addition, check for 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 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP), aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.