NAXCEL- ceftiofur sodium powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zoetis Inc.

INN (International Name):

ceftiofur sodium

Composition:

ceftiofur 1000 mg in 1 g

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

NAXCEL Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. NAXCEL Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . NAXCEL 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 . NAXCEL Sterile Powder is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. NAXCEL Sterile Powder is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. NAXCEL Sterile Powder is in

Product summary:

NAXCEL Sterile Powder is available in the following package sizes:

Authorization status:

New Animal Drug Application

Summary of Product characteristics

NAXCEL- CEFTIOFUR SODIUM POWDER
ZOETIS INC.
----------
NAXCEL
NAXCEL
BRAND OF 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 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, swine,
chickens and turkeys
for disease prevention purposes; at unapproved doses, frequencies,
durations, or
routes of administration; and in unapproved major food producing
species/production
classes.
DESCRIPTION
NAXCEL 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-2-
carboxylic acid, 7-[[(2-amino-4-
thiazolyl)(methoxyimino)-acetyl]amino]-3-
[[(2-furanylcarbonyl)thio] methyl]-8-oxo-,
monosodium salt, [6R-[6α,7β(Z)]]-
RECONSTITUTION OF THE STERILE POWDER
®
®
NAXCEL 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
NAXCEL Sterile Powder is indicated for treatment of bovine resp