CEFTIFLEX- ceftiofur sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFTIOFUR SODIUM (UNII: NHI34IS56E) (CEFTIOFUR - UNII:83JL932I1C)

Available from:

Aspen Veterinary Resources Ltd.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Cattle Ceftiofur Sodium Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , Pasteurella multocida and Histophilus somni . Ceftiofur Sodium Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Swine Ceftiofur Sodium Sterile Powder is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae , Pasteurella multocida , Salmonella choleraesuis and Streptococcus suis . Sheep Ceftiofur Sodium Sterile Powder is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida . Goat Ceftiofur Sodium Sterile Powder is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia ha

Product summary:

Ceftiofur Sodium Sterile Powder is available in the following package sizes: 1 gram vial 4 gram vial 1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard - Second Edition. NCCLS document M31-A2. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, 2002. ANADA 200-420, Approved by FDA Mfd for: Aspen Veterinary Resources Ltd.                      By: Cephazone Pharma LLC Liberty, MO 64068                                                             Pomona, CA 91767

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CEFTIFLEX- CEFTIOFUR SODIUM INJECTION, POWDER, FOR SOLUTION
ASPEN VETERINARY RESOURCES LTD.
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CEFTIOFUR SODIUM STERILE POWDER
FOR INTRAMUSCULAR AND SUBCUTANEOUS INJECTION IN CATTLE ONLY. FOR
INTRAMUSCULAR INJECTION IN SWINE,
SHEEP, GOATS, AND HORSES. FOR SUBCUTANEOUS INJECTION ONLY IN DOGS,
DAY-OLD CHICKENS AND DAY-OLD
TURKEY POULTS. THIS PRODUCT MAY BE USED IN LACTATING DAIRY CATTLE,
SHEEP, AND GOATS.
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.
DESCRIPTION
Ceftiofur Sodium Sterile Powder contains the sodium salt of ceftiofur
which is a broad spectrum
cephalosporin antibiotic active against gram-positive and
gram-negative bacteria including β-lactamase-
producing strains. Like other cephalosporins, ceftiofur is
bactericidal _in vitro_, resulting from inhibition
of cell wall synthesis.
Each mL of the reconstituted drug contains ceftiofur sodium equivalent
to 50 mg ceftiofur. The pH was
adjusted with sodium hydroxide and monobasic potassium phosphate.
Chemical structure of Ceftiofur Sodium
Chemical Name of Ceftiofur Sodium
5-Thia-1-azabicyclo [4.2.0] oct-2-ene-carboxylic acid,
7-[[(2-amino-4-thiazoly)(methoxyimino)-
acetyl]amino]-3-[[(2-furanylcarbonyl)thio] methyl]-8-oxo-, monosodium
salt, [6R-[6α,7β(Z)]]-
RECONSTITUTION OF THE STERILE POWDER
Ceftiofur Sodium Sterile Powder should be reconstituted as follows:
1 GRAM VIAL- Reconstitute with 20 mL Sterile Water for Injection. Each
mL of the resulting solution
contains ceftiofur sodium equivalent to 50 mg ceftiofur.
4 GRAM VIAL- Reconstitute with 80 mL Sterile Water for Injection. Each
mL of the resulting solution
contains ceftiofur sodium equivalent to 50 mg ceftiofur.
Shake thoroughly prior to use.
INDICATIONS
CATTLE
Ceftiofur Sodium Sterile Powder is indicated for treatment of bovine
respiratory disease (shipping
fever, pneumonia) associated with _Mannheimia haemolytica_,
_Pasteurella multocida _and _Histophilus somni_.
Ceftiofur Sodium Sterile Powder is also indicated for treatment of
acute bovi