Bacitracin injection

Name: Bacitracin injection

What should I discuss with my health care provider before receiving bacitracin injection?

Your baby should not receive this medicine if he or she is allergic to bacitracin.

To make sure bacitracin is safe for your baby, tell the doctor if your baby has:

  • kidney disease; or

  • any known allergies.

How is bacitracin injection given?

Bacitracin is injected into a muscle. A healthcare provider will give your baby this injection.

Lung infections in infants are serious conditions, and your baby will most likely be kept in the hospital while being treated with bacitracin injection.

While receiving bacitracin, your baby's kidney function will need to be tested daily.

Make sure your baby receives this medicine for the full prescribed length of time. Symptoms may improve before the infection is completely cleared. Skipping doses may also increase the risk of further infection that is resistant to antibiotics. Bacitracin will not treat a viral infection such as the flu or a common cold.

What happens if I miss a dose?

Because your child will receive bacitracin in a clinical setting, he or she is not likely to miss a dose.

Contraindications

This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

How supplied

Product No.

NDC No.

 
302930
63323-329-30
Bacitracin for Injection, USP, 50,000 units per vial, packaged individually.
302931
63323-329-31
Bacitracin for Injection, USP, 50,000 units per vial, 10 vials per tray.

The container closure is not made with natural rubber latex.

Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F).



www.fresenius-kabi.us


45960E/Revised: December 2016

PACKAGE LABEL - PRINCIPAL DISPLAY -  Bacitracin 50,000 Units Vial Label

Bacitracin for Injection, USP

50,000 Units

For Intramuscular Use

Rx only




PACKAGE LABEL - PRINCIPAL DISPLAY -  Bacitracin 50,000 Units Vial Carton Panel

Bacitracin for Injection, USP

50,000 Units

For Intramuscular Use

Rx only




BACITRACIN 
Bacitracin Injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-329
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 50000 [iU]
Packaging
# Item Code Package Description
1 NDC:63323-329-30 1 VIAL in 1 CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
2 NDC:63323-329-31 10 VIAL in 1 CARTON
2 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065116 01/28/2003
Labeler - Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 MANUFACTURE(63323-329)
Revised: 07/2017   Fresenius Kabi USA, LLC

Other Comments

Administration advice:
-Administer IM only.
-Administer in the upper outer quadrant of the buttocks; alternate right and left and avoid multiple injection in the same region (due to transient pain after injection).
-Maintain adequate fluid intake orally or, if required, parenterally.

Storage requirements:
-Unreconstituted vial: Store in refrigerator at 2C to 8C (36F to 46F).
-Reconstituted solution: Stable for 1 week when stored in refrigerator (2C to 8C [36F to 46F]).

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.
-Diluents containing parabens should not be used for reconstitution.

Monitoring:
-Renal: Renal function (before and daily during therapy)

Patient advice:
-Consult physician without delay if watery and bloody stools (with or without stomach cramps and fever) develop.

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