EXCEDE STERILE- ceftiofur injection, suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zoetis Inc.

Designación común internacional (DCI):

CEFTIOFUR

Composición:

CEFTIOFUR 200 mg in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION

indicaciones terapéuticas:

EXCEDE Sterile Suspension is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica , Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. EXCEDE Sterile Suspension is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica , P. multocida, and H. somni . EXCEDE Sterile Suspension is also indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle. EXCEDE Sterile Suspension is also indicated for treatment of acute metritis (0-10 days post-partum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle. As with all drugs, the use of EXCEDE Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug. EXCEDE Sterile Suspension is contraindicated in horses with known allergy to ceftiofur or to ß-lactam (penicillins and cephalosporins) group antimicrobials. Due to the extended exposure in horses, based on the drug's pharmacokinetic properties, adverse reactions may require prolonged care.

Resumen del producto:

EXCEDE Sterile Suspension is available in the following package sizes: 100 mL vial 250 mL vial EXCEDE Sterile Suspension is available in the following package sizes: 100 mL vial 250 mL vial

Estado de Autorización:

New Animal Drug Application

Ficha técnica

EXCEDE STERILE- CEFTIOFUR INJECTION, SUSPENSION
ZOETIS INC.
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EXCEDE
(CEFTIOFUR CRYSTALLINE FREE ACID)
STERILE SUSPENSION
FOR SUBCUTANEOUS INJECTION IN THE POSTERIOR ASPECT OF THE EAR WHERE IT
ATTACHES TO THE HEAD (BASE OF THE EAR) IN LACTATING DAIRY CATTLE. FOR
SUBCUTANEOUS INJECTION IN THE MIDDLE THIRD OF THE POSTERIOR ASPECT OF
THE EAR
OR IN THE POSTERIOR ASPECT OF THE EAR WHERE IT ATTACHES TO THE HEAD
(BASE OF
THE EAR) IN BEEF AND NON-LACTATING DAIRY CATTLE. NOT FOR USE IN CALVES
TO BE
PROCESSED FOR VEAL.
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 cattle for
disease prevention
purposes; at unapproved doses, frequencies, durations, or routes of
administration;
and in unapproved major food producing species/production classes.
DESCRIPTION
EXCEDE Sterile Suspension 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 200 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 Sterile Suspension is indicated for treatment of bovine
respiratory disease
(BRD, shipping fever, pneumonia) associated with _Mannheimia
haemolytica_, _Pasteurella_
_multocida,_ and _Histophilus somni _in beef, non-lactating dairy, and
lactating dairy cattle.
EXCEDE Sterile Suspension is also indicated for the control of
r