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Potassium Chloride in Dextrose and Sodium Chloride

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE

Approved
Approval ID

f0cc6713-4d47-49be-8116-901c99002b6b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 13, 2022

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 013547657

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE

PRODUCT DETAILS

NDC Product Code65219-151
Application NumberANDA212348
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 2, 2017
Generic NameDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE

INGREDIENTS (5)

DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 2.25 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE

PRODUCT DETAILS

NDC Product Code65219-153
Application NumberANDA212348
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 2, 2017
Generic NameDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE

INGREDIENTS (5)

SODIUM CHLORIDEActive
Quantity: 2.25 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/3/2019

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose and

0.225% Sodium Chloride Injection, USP Case Label

NDC 65219-153-10

20 mEq Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, USP

1000 mL x 10

Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Protect from freezing. Avoid excessive heat.

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, USP Case Label

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/13/2022

DOSAGE AND ADMINISTRATION

These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24- hour dose should not generally exceed 200 mEq of potassium.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 9/13/2022

HOW SUPPLIED

Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, USP is supplied in single-dosefreeflex® plastic containers as follows:

Product Code

Unit of Use

Strength

Unit of Sale

255175

NDC 65219-151-00
One 500 mLfreeflex® bag

10 mEq Potassium Chloride

NDC 65219-151-75
Package of 20freeflex® bags

255310

NDC 65219-153-02
One 1000 mLfreeflex® bag

20 mEq Potassium Chloride

NDC 65219-153-10
Package of 10freeflex® bags

Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

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

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 9/13/2022

INSTRUCTIONS FOR USE

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.

To Add Medication

  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. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.
  5. Mix container contents thoroughly.

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.

WARNING: Do not use flexible container in series connections.

Manufactured for:

Fresenius Kabi Logo

Lake Zurich, Illinois 60047

Made in Norway

451749
www.fresenius-kabi.com/us

Issued: May 2022

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Potassium Chloride in Dextrose and Sodium Chloride - FDA Approval | MedPath