Label: MULTIPLE ELECTROLYTES PH 5.5- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 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 hydrochloric acid. The pH is 5.5 (4.0 to 8.0).

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 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 approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L.

The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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. 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.

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 produces a metabolic alkalinizing effect. Acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is contraindicated in patients with a known hypersensitivity to the product. See WARNINGS.

Excessive administration of Multiple Electrolytes Injection, Type 1, USP, pH 5.5 can cause:

• fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.
• hypernatremia and hyperkalemia, especially in patients with severe renal impairment.
• hypermagnesemia. See WARNINGS and ADVERSE REACTIONS
• metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations.

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.

Interventions include discontinuation of Multiple Electrolytes Injection, Type 1, USP, pH 5.5, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

Important Administration Instructions

• Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is intended for intravenous administration using sterile equipment.
• Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
• Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
• Use a dedicated line without any connections to avoid air embolism.
• Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
• Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
• Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. Multiple Electrolytes Injection, Type 1, USP, pH 5.5 and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 in freeflex® plastic containers is available as shown below:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief exposure up to 40°C does not adversely affect the product.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION.

Check solution container composition, lot number, and expiry date.

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

Do not use solution containers in series connections.

Do not remove solution container from its overwrap until immediately before use.

The intact port caps provide visual tamper evidence. Do not use if a port cap is prematurely removed. Maintain strict aseptic technique during handling.

TO OPEN

1. Always inspect the solution container before and after removal from the overwrap.
2. Place the solution container on a clean, flat surface. Using the pre-cut corner tabs, peel open the overwrap and remove the solution container from the overwrap.
3. Check the solution container for leaks by squeezing firmly. If leaks are found, discard as sterility may be impaired.
4. Do not use if the solution is cloudy or a precipitate is present.

TO PREPARE FOR ADMINISTRATION

1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
2. Use a non-vented infusion set or close the air-inlet on a vented set.
3. Close the roller clamp of the infusion set.
4. Hold the base of BLUE Infusion Port, twist and push the spike until the spike is fully inserted. Refer to complete directions accompanying set.
5. The BLUE infusion port contains a self‐sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
6. Suspend solution container from hanger hole.

If supplemental medication is desired, follow directions below.

TO ADD MEDICATION BEFORE SOLUTION ADMINISTRATION

1. Identify WHITE Injection Port with arrow pointing toward solution container.
2. Immediately before injecting additives, break off WHITE Injection Port Cap with the arrow pointing toward solution container.
3. Hold base of WHITE Injection Port.
4. Insert needle (18 to 23 gauge) through the center of WHITE Injection Port's septum and inject additives.
5. Mix solution container contents 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 the clamp on the set.
2. Identify WHITE Injection Port with arrow pointing toward solution container.
3. Immediately before injecting additives, break off WHITE Injection Port cap with the arrow pointing toward solution container.
4. Hold base of WHITE Injection Port.
5. Insert needle (18 to 23 gauge) through the center of WHITE Injection Port's septum and inject additives.
6. Remove container from IV pole and/or turn to an upright position.
7. Evacuate both ports by squeezing them while container is in the upright position.
8. Mix solution container contents thoroughly.
9. Return container to in use position and continue administration.

For Single Use Only. Discard unused portion.

Manufactured for:

Lake Zurich, IL 60047

Made in Germany

451766

www.fresenius-kabi.com/us

Issued: September 2022

500 mL

NDC 65219-387-00
Multiple Electrolytes Injection, Type 1, USP pH 5.5

Rx only

Each 100 mL contains: 526 mg Sodium Chloride, USP; 502 mg Sodium Gluconate, USP; 368 mg Sodium Acetate Trihydrate, USP; 37 mg Potassium Chloride, USP; 30 mg Magnesium Chloride, USP

pH adjusted with Hydrochloric acid.

Electrolytes per 1,000 mL: Sodium 140 mEq; Potassium 5 mEq;

Magnesium 3 mEq; Chloride 98 mEq; Acetate 27 mEq; Gluconate

23 mEq

294 mOsmol/Liter (Calc.)         pH 5.5 (4.0 to 8.0)

NDC 65219-387-05       387150

Multiple Electrolytes Injection, Type 1, USP pH 5.5

500 mL x 20

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] until ready to use. Avoid excessive heat.

1000 mL

NDC 65219-387-02
Multiple Electrolytes Injection, Type 1, USP pH 5.5

Rx only

Each 100 mL contains: 526 mg Sodium Chloride, USP; 502 mg Sodium Gluconate, USP; 368 mg Sodium Acetate Trihydrate, USP; 37 mg Potassium Chloride, USP; 30 mg Magnesium Chloride, USP

pH adjusted with Hydrochloric acid.

Electrolytes per 1,000 mL: Sodium 140 mEq; Potassium 5 mEq; Magnesium 3 mEq; Chloride 98 mEq; Acetate 27 mEq; Gluconate 23 mEq

294 mOsmol/Liter (Calc.)         pH 5.5 (4.0 to 8.0)

NDC 65219-387-10       387100

Multiple Electrolytes Injection, Type 1, USP pH 5.5

1000 mL x 10

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] until ready to use. Avoid excessive heat.