Cefotetan how supplied

Cefotetan
CEFOTETAN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Compatibility and Stability
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

HOW SUPPLIED

CEFOTAN (cefotetan disodium for injection) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should not be stored at temperatures above 22°C (72°F) and should be protected from light.

1 g ADD-Vantage Vial (NDC 0310-0376-31)

2 g ADD-Vantage Vial (NDC 0310-0377-32)

1 g Vial (NDC 0310-0376-10)

2 g Vial (NDC 0310-0377-20)

1 g Piggyback Vial (NDC 0310-0376-11)

2 g Piggyback Vial (NDC 0310-0377-21)

CEFOTAN is also available as a 10 g pharmacy bulk package.

10 g in 100 mL Vial (NDC 0310-0375-10)

CEFOTAN (cefotetan injection) is supplied as a frozen, iso-osmotic, premixed solution in single dose Galaxy® plastic containers (PL 2040) as follows:

1 g in 50 mL plastic container (NDC 0310-0378-51)

2 g in 50 mL plastic container (NDC 0310-0379-51)

Store containers at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CEFOTAN (cefotetan injection) IN GALAXY® PLASTIC CONTAINER (PL 2040)].

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf