Potassium Chloride in Dextrose and Sodium Chloride
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
f0cc6713-4d47-49be-8116-901c99002b6b
HUMAN PRESCRIPTION DRUG LABEL
Sep 13, 2022
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
INGREDIENTS (5)
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
PRODUCT DETAILS
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
DOSAGE & ADMINISTRATION SECTION
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
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 |
10 mEq Potassium Chloride |
NDC 65219-151-75 |
255310 |
NDC 65219-153-02 |
20 mEq Potassium Chloride |
NDC 65219-153-10 |
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
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
- 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.
- Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
To Add Medication
- Identify WHITE Additive Port with arrow pointing toward container.
- Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
- Hold base of WHITE Additive Port horizontally.
- Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.
- Mix container contents thoroughly.
Preparation for Administration
- Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
- Use a non-vented infusion set or close the air-inlet on a vented set.
- Close the roller clamp of the infusion set.
- Hold the base of BLUE Infusion Port.
- 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:
Lake Zurich, Illinois 60047
Made in Norway
451749
www.fresenius-kabi.com/us
Issued: May 2022