Label: POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium chloride injection, solution

Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

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 the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Potassium Chloride in Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with:

• Known hypersensitivity to potassium chloride and/or sodium chloride (see WARNINGS).
• Clinically significant hyperkalemia (see WARNINGS).

The following adverse reactions associated with the use of Potassium Chloride in Sodium Chloride Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

General disorders and administration site conditions: Chills, and infusion site pain.

Hypersensitivity reactions: generalized papules and erythema, rash, fever, vomiting, hypertension, tachycardia.

Metabolism and nutrition disorders: Hyperkalemia, hyponatremia, hypernatremia, hyperchloremia acidosis, fluid overload.

Cardiac disorders: Cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia.

Nervous System Disorders: Hyponatremic encephalopathy.

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.

An increased infusion rate of Potassium Chloride in Sodium Chloride Injection, USP can cause:

• hyperkalemia, manifestations may include disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation.
  
  The presence of any ECG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency.
  
  If hyperkalemia is present or suspected, discontinue the infusion immediately and institute close ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium concentrations.
  
  Muscle weakness (up to and including muscular and respiratory paralysis, paresthesia of extremities) may occur as a complication of hyperkalemia.
• hyponatremia, manifestations may include seizures, coma, cerebral edema and death.
• hypernatremia, especially in patients with severe renal impairment.
• hypotension.
• gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain).
• fluid overload (which can lead to central and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS.

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 Potassium Chloride in Sodium Chloride Injection, USP administration, 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

• Potassium Chloride in Sodium Chloride Injection, USP is intended for intravenous infusion using sterile equipment.
• To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device (see WARNINGS).
• 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.
• The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate. Solutions with osmolarity of greater than or equal to approximately 900 mOsm/L must be infused through a central catheter.
• 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.
• Use of final filter is recommended during administration of all parenteral solutions, where possible.

Potassium Chloride in Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40°C (104°F) does not adversely affect the product.

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

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

Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.

Flexible Plastic Container (freeflex® bag)

To Open

1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
3. Do not use if the solution is cloudy or a precipitate is present.

Preparation for Administration

1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from 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.
5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set.

To Add Medication Prior to Solution Administration

1. Identify WHITE Additive Port with arrow pointing toward container.
2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
3. Hold base of WHITE Additive Port horizontally.
4. Prepare medication site
5. Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives.
6. Mix 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 Additive Port with arrow pointing toward container
3. Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port cap with the arrow pointing toward container.
4. Hold base of WHITE Additive Port horizontally.
5. Prepare medication site.
6. Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives.
7. Remove container from IV pole and/or turn to an upright position.
8. Mix container contents thoroughly.
9. Using aseptic technique, repeat steps 4-7 as necessary.
10. Return container to in use position and continue administration.

WARNING: Do not use flexible container in series connections.

Manufactured for:

Lake Zurich, IL 60047
Made in Norway

www.fresenius-kabi.com/us

451701
Issued: February 2021

freeflex®

NDC 63323-683-01       1000 mL

20 mEq Potassium Chloride

(20 mEq/L)

Potassium Chloride in 0.45% Sodium Chloride

Injection, USP

For Intravenous Use.        Rx only

freeflex®

NDC 63323-686-01       1000 mL

20 mEq Potassium Chloride

(20 mEq/L)

Potassium Chloride in 0.9% Sodium Chloride

Injection, USP

For Intravenous Use.        Rx only

freeflex®

NDC 63323-688-01       1000 mL

40 mEq Potassium Chloride

(40 mEq/L)

Potassium Chloride in 0.9% Sodium Chloride

Injection, USP

For Intravenous Use.        Rx only