EXCEDE FOR SWINE STERILE- ceftiofur injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFTIOFUR (UNII: 83JL932I1C) (CEFTIOFUR - UNII:83JL932I1C)

Available from:

Zoetis Inc.

INN (International Name):

CEFTIOFUR

Composition:

CEFTIOFUR 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis in groups of pigs where SRD has been diagnosed. As with all drugs, the use of EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is contraindicated in animals previously found to be hypersensitive to the drug.

Product summary:

EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is available in the following package size: 100 mL vial

Authorization status:

New Animal Drug Application

Summary of Product characteristics

EXCEDE FOR SWINE STERILE- CEFTIOFUR INJECTION, SUSPENSION
ZOETIS INC.
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EXCEDE
FOR SWINE (CEFTIOFUR CRYSTALLINE FREE ACID)
STERILE SUSPENSION, 100 MG/ML
FOR
SWINE
FOR INTRAMUSCULAR ADMINISTRATION IN THE POST-AURICULAR REGION OF THE
NECK OF SWINE.
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian. Federal law
prohibits extra-label use of this drug in swine for disease prevention
purposes; at unapproved doses,
frequencies, durations, or routes of administration; and in unapproved
major food producing species/
production classes.
DESCRIPTION
EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is a ready-to-use
formulation that contains the
crystalline free acid of ceftiofur, which is a broad spectrum
cephalosporin antibiotic active against
gram-positive and gram-negative bacteria including
ß-lactamase-producing strains. Like other
cephalosporins, ceftiofur is bactericidal _in vitro_, resulting from
inhibition of cell wall synthesis.
Each mL of this ready-to-use sterile suspension contains ceftiofur
crystalline free acid equivalent to
100 mg ceftiofur, in a Caprylic/capric triglyceride and cottonseed oil
based suspension.
Figure 1. Structure of ceftiofur crystalline free acid:
Chemical name of ceftiofur crystalline free acid:
7-[[2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-3-[[(2-furanylcarbonyl)thio]methyl]-8-oxo-
5-thia-1-azabicyclo[4.2.0]oct-2-ene 2-carboxylic acid
INDICATIONS
EXCEDE FOR SWINE Sterile Suspension 100 mg/mL is indicated for the
treatment of swine
respiratory disease (SRD) associated with _Actinobacillus
pleuropneumoniae, Pasteurella multocida,_
_Haemophilus parasuis,_ and _Streptococcus suis;_ and for the control
of SRD associated with _Actinobacillus_
_pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,_ and
_Streptococcus suis_ in groups of pigs
where SRD has been diagnosed.
®
DOSAGE
Administer by intramuscular (IM) injection in the post-auricular
region of the neck as a single dosage of
2.27 mg ceftiofur equivalents (CE)/l