Naxcel: Product Information (Page 4 of 4)

Cattle

A radiolabeled residue metabolism study established tolerances for ceftiofur residues in cattle kidney, liver and muscle. These tolerances of ceftiofur residues are 0.4 ppm in kidney, 2.0 ppm in liver, 1.0 ppm in muscle, and 0.1 ppm in milk.

A pivotal tissue residue decline study was conducted in cattle. In this study, cattle received an intramuscular injection of 1.0 mg of ceftiofur per lb body weight (2.2 mg of ceftiofur per kg body weight) for five consecutive days. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in tissues such as kidney, liver and muscle by 4 days after dosing. These data collectively support a 4-day pre-slaughter withdrawal period in cattle when used according to label directions.

Swine

Radiolabeled residue metabolism studies established tolerances for ceftiofur residues in swine kidney, liver, and muscle. These tolerances of ceftiofur residues are 0.25 ppm in kidney, 3.0 ppm in liver and 2.0 ppm in muscle.

A pivotal tissue residue decline study was conducted in swine. In this study, pigs received 2.27 mg of ceftiofur per lb body weight (5 mg of ceftiofur per kg body weight) per day for three consecutive days. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in tissues such as kidney, liver and muscle by 4 days after dosing. These data collectively support a 4-day pre-slaughter withdrawal period in swine when used according to label directions.

STORAGE CONDITIONS

Store unreconstituted product at controlled room temperature 20° to 25° C (68° to 77° F).

Store reconstituted product either in a refrigerator 2° to 8° C (36° to 46° F) for up to 7 days or at controlled room temperature 20° to 25° C (68° to 77° F) for up to 12 hours.

Protect from light. Color of the cake may vary from off-white to a tan color. Color does not affect potency.

ONE-TIME SALVAGE PROCEDURE FOR RECONSTITUTED PRODUCT

At the end of the 7-day refrigeration or 12-hour room temperature storage period following reconstitution, any remaining reconstituted product may be frozen for up to 8 weeks without loss in potency or other chemical properties. This is a one-time only salvage procedure for the remaining product. To use this salvaged product at any time during the 8-week storage period, hold the vial under warm running water, gently swirling the container to accelerate thawing, or allow the frozen material to thaw at room temperature. Rapid freezing or thawing may result in vial breakage. Any product not used immediately upon thawing should be discarded.

HOW SUPPLIED

NAXCEL Sterile Powder is available in the following package sizes:

  • 1 gram vial
  • 4 gram vial

Approved by FDA under NADA # 140-338
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: May 202240039129

PRINCIPAL DISPLAY PANEL — 1 g 12 Vial Carton

1 g 12 Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 g 6 Vial Carton

4 g 6 Vial Carton
(click image for full-size original)

NAXCEL ceftiofur sodium powder
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-3362
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTIOFUR SODIUM (CEFTIOFUR) CEFTIOFUR 1000 mg in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3362-1 12 VIAL in 1 CARTON contains a VIAL
1 1 g in 1 VIAL This package is contained within the CARTON (54771-3362-1)
2 NDC:54771-3362-2 6 VIAL in 1 CARTON contains a VIAL
2 4 g in 1 VIAL This package is contained within the CARTON (54771-3362-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140338 01/25/1988
Labeler — Zoetis Inc. (828851555)

Revised: 09/2022 Zoetis Inc.

Page 4 of 4 1 2 3 4

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2022. All Rights Reserved.