Excenel Sterile Suspension

FDA Approved Animal Drug Products
Online Database System
Drug Product Abstract
Please note that the US Code of Federal Regulations (21 CFR version April 1, 2000) is the official source of regulatory information concerning approved animal drug products.


140-890 (Rx)
Tradename(s) Excenel Sterile Suspension
Sponsor Pharmacia & Upjohn Co.
Ingredient(s) Ceftiofur Hydrochloride
Species Cattle, any use class, excluding veal calves; Swine, no use class stated or implied
Route(s) Intramuscular; Subcutaneous (cattle)
DoseForm(s) Liquid (suspension)

CFR Indications
 
 
 
 
 
522.314 Ceftiofur Sterile Suspension.

Specifications:
Each milliliter contains ceftiofur hydrochloride equivalent to 50 milligrams per milliliter ceftiofur.

Conditions of use:

Swine

Amount:
1.36 - 2.27 milligrams per pound (3 to 5 milligrams/kilograms) body weight. For intramuscular use.

Indications:
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.

Limitations:
Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Do not use in animals previously found to be hypersensitive to the drug. Use of dosages in excess of those indicated or route of administration other than that recommended may result in illegal residues in tissues. Safety of ceftiofur has not been determined in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Amount:
1.1 to 2.2 milligrams per kilogram (0.5 to 1.0 milligrams per pound) of body weight, at 24-hour intervals for 3 to 5 consecutive days. In addition, for bovine respiratory disease, administer 2.2 milligrams per kilogram (1.0 milligram per pound) of body weight every other day on days 1 and 3 (48-hour interval). For intramuscular or subcutaneous use.

Indications:
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus and acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Limitations:
Do not inject more than 15 milliliters at each intramuscular injection site. Do not slaughter treated cattle for 48 hours (2 days) after last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
 
 
 
 
 
 
 

To see the complete 21 CFR Part 522 314
CFR Tolerance
For Ceftiofur Hydrochloride:
 
 
 
 
Ceftiofur.

A tolerance for residues of ceftiofur in edible tissue is not required for cattle, swine, poultry, and sheep.
 
 
 
 
 
Agricultural Research Service

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