Rocuronium Bromide

ROCURONIUM BROMIDE — rocuronium bromide injection, solution
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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• WARNINGS AND PRECAUTIONS

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

Warning: Rocuronium Bromide Injection may cause respiratory depression. Facilities for artificial respiration must be immediately available.

• ADVERSE EVENTS

To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

• HOW SUPPLIED

Rocuronium bromide is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, in a 5 mL Single Use Syringe.

This product is Preservative-Free and Latex-Free.

• INGREDIENTS

Each 1 mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.

• STORAGE AND HANDLING

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

• DOSAGE AND ADMINISTRATION.

FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

Rx Only


Rev. 01/15


CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

ROCURONIUM BROMIDE
rocuronium bromide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-064
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROCURONIUM BROMIDE (ROCURONIUM) ROCURONIUM BROMIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 3.1 mg in 1 mL
SODIUM ACETATE 2 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52533-064-15 5 mL in 1 SYRINGE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/29/2015
Labeler — Cantrell Drug Company (035545763)

Revised: 02/2015 Cantrell Drug Company

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