Administer by subcutaneous injection in the neck region of day-old chicks at the dosage of 0.08 to 0.20 mg ceftiofur/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.
Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only. A sterile 26 gauge needle and syringe or properly cleaned automatic injection machine should be used.
Administer by subcutaneous injection in the neck region of day-old turkey poults at the dosage of 0.17 to 0.5 mg ceftiofur/poult. One mL of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.
Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only.
As with all drugs, the use of NAXCEL Sterile Powder is contraindicated in animals previously found to be hypersensitive to the drug.
NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN.
Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth, and clothing.
Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.
In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.
For a copy of the Safety Data Sheet or to report adverse reactions, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Cattle: When used according to label indications, dosage and routes of administration, treated cattle must not be slaughtered for 4 days following the last treatment. When used according to label indications, dosage and routes of administration, a milk discard time is not required. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.
Swine: When used according to label indications, dosage and route of administration, treated pigs must not be slaughtered for 4 days following the last treatment. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues.
Sheep: Neither a pre-slaughter drug withdrawal interval nor a milk discard time is required when this product is used according to label indications, dosage, and route of administration. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.
Goats: Neither a pre-slaughter drug withdrawal interval nor a milk discard time is required when this product is used according to label indications, dosage, and route of administration. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.
Horses: Do not use in horses intended for human consumption.
The effects of ceftiofur on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined.
Following subcutaneous administration of ceftiofur sodium in the neck, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter.
As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence.
The safety of ceftiofur has not been determined for swine intended for breeding.
The safety of ceftiofur has not been determined for horses intended for breeding. The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhea that could be fatal. If acute diarrhea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.
The safety of ceftiofur has not been determined for dogs intended for breeding, or pregnant dogs.
The use of ceftiofur may result in some signs of immediate and transient local pain to the animal.
Summaries of MIC data are presented in Tables 1 and 2. Testing followed Clinical and Laboratory Standards Institute (CLSI) Guidelines.
|Animal||Organism||Number Tested||Date Tested||MIC90 *(μg/mL)||MIC Range(μg/mL)|
|Bovine||Mannheimia haemolytica||461||1988-1992||0.06||≤ 0.03-0.13|
|Mannheimia haemolytica||42||1993||0.015||≤ 0.003-0.03|
|Pasteurella multocida||318||1988-1992||0.06||≤ 0.03-0.25|
|Pasteurella multocida||48||1993||≤ 0.003||≤ 0.003-0.015|
|Histophilus somni||109||1988-1992||0.06||≤ 0.03-0.13|
|Histophilus somni||59||1993||≤ 0.0019||no range|
|Fusobacterium necrophorum||17||1994||≤ 0.06||no range|
|Swine||Actinobacillus pleuropn.||83||1993||≤ 0.03||≤ 0.03-0.06|
|Pasteurella multocida||74||1993||≤ 0.03||≤ 0.03-0.06|
|Streptococcus suis||94||1993||0.25||≤ 0.03-1.0|
|beta-hemolytic Streptococcus spp.||24||1993||≤ 0.03||≤ 0.03-0.06|
|Sheep||Mannheimia haemolytica||39||1992||0.13||≤ 0.03-0.13|
|Pasteurella multocida||23||1992||≤ 0.03||no range|
|Proteus mirabilis||17||1990||≤ 0.06||≤ 0.06-0.5|
|Proteus mirabilis||23||1992||1.0||≤ 0.06-4.0|
|Animal||Organism||Number Tested||Date Tested||MIC90 †(μg/mL)||MIC Range(μg/mL)|
|Bovine||Mannheimia haemolytica||110||1997-1998||0.06||≤ 0.03-0.25|
|Mannheimia haemolytica||139||1998-1999||≤ 0.03||≤ 0.03-0.5|
|Mannheimia haemolytica||209||1999-2000||≤ 0.03||≤ 0.03-0.12|
|Mannheimia haemolytica||189||2000-2001||≤ 0.03||≤ 0.03-0.12|
|Pasteurella multocida||107||1997-1998||≤ 0.03||≤ 0.03-0.25|
|Pasteurella multocida||181||1998-1999||≤ 0.03||≤ 0.03-0.5|
|Pasteurella multocida||208||1999-2000||≤ 0.03||≤ 0.03-0.12|
|Pasteurella multocida||259||2000-2001||≤ 0.03||≤ 0.03-0.12|
|Histophilus somni||48||1997-1998||≤ 0.03||≤ 0.03-0.25|
|Histophilus somni||87||1998-1999||≤ 0.03||≤ 0.03-0.125|
|Histophilus somni||77||1999-2000||≤ 0.03||≤ 0.03-0.06|
|Histophilus somni||129||2000-2001||≤ 0.03||≤ 0.03-0.12|
|Bacteroides fragilis group||29||1994||16.0||≤ 0.06->16.0|
|Bacteroides spp., non-fragilis group||12||1994||16.0||0.13->16.0|
|Swine||Actinobacillus pleuropn.||97||1997-1998||≤ 0.03||no range|
|Actinobacillus pleuropn.||111||1998-1999||≤ 0.03||≤ 0.03-0.25|
|Actinobacillus pleuropn.||126||1999-2000||≤ 0.03||≤ 0.03-0.06|
|Actinobacillus pleuropn.||89||2000-2001||≤ 0.03||≤ 0.03-0.06|
|Pasteurella multocida||114||1997-1998||≤ 0.03||≤ 0.03-1.0|
|Pasteurella multocida||147||1998-1999||≤ 0.03||≤ 0.03-0.5|
|Pasteurella multocida||173||1999-2000||≤ 0.03||≤ 0.03-0.06|
|Pasteurella multocida||186||2000-2001||≤ 0.03||≤ 0.03-0.12|
|Streptococcus suis||106||1997-1998||0.5||≤ 0.03-4.0|
|Streptococcus suis||142||1998-1999||0.25||≤ 0.03-1.0|
|Streptococcus suis||146||1999-2000||0.06||≤ 0.03-4.0|
|Streptococcus suis||167||2000-2001||0.06||≤ 0.03-4.0|
|Equine||Streptococcus equi subsp. equi||12||1994||≤ 0.0019||no range|
|Streptococcus equi subsp. equi||29||2002||≤ 0.03||≤ 0.03-0.05|
|Streptococcus zooepidemicus||48||1994||≤ 0.0019||no range|
|Streptococcus zooepidemicus||59||2002||≤ 0.03||≤ 0.03-0.25|
|Rhodococcus equi||66||1998||4.0||≤ 0.03-16.0|
|Rhodococcus equi||42||2002||8.0||≤ 0.03->32.0|
|Bacteroides fragilis group||32||1995||>16.0||0.13->16.0|
|Bacteroides spp., non-fragilis group||12||1995||4.0||0.25-4.0|
|Fusobacterium necrophorum||16||1995||≤ 0.06||no range|
|Staphylococcus spp. (coagulase positive)||17||1995||2.0||1.0-2.0|
|Staphylococcus spp. (coagulase negative)||26||1995||8.0||0.13->32.0|
|Escherichia coli||90||2000-2001||1.0||≤ 0.03-8.0|
Based on the pharmacokinetic studies of ceftiofur in swine and cattle after a single intramuscular injection of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (swine) or 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (cattle) and the MIC and disk (30 μg) diffusion data, the following breakpoints are recommended by CLSI.
|Zone Diameter (mm)||MIC (μg/mL)||Interpretation|
|≥ 21||≤ 2.0||(S) Susceptible|
|≤ 17||≥ 8.0||(R) Resistant|
A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “Intermediate” is a technical buffer zone and isolates falling into this category should be retested. Alternatively the organism may be successfully treated if the infection is in a body site where drug is physiologically concentrated. A report of “Resistant” indicates that the achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected.
Based on the pharmacokinetic studies of ceftiofur in horses after a single intramuscular injection of 1 mg ceftiofur equivalents/lb (2.2 mg/kg) BW, clinical effectiveness data and MIC data, the following breakpoint is recommended by CLSI.
|Zone Diameter (mm)||MIC (μg/mL)||Interpretation|
|≥ 22||≤ 0.25||(S) Susceptible|
The susceptible only category is used for populations of organisms (usually one species) for which regression analysis (disk vs. MIC) cannot be performed. These breakpoints will permit detection of strains with decreased susceptibility as compared to the original population.
Standardized procedures 1 require the use of laboratory control organisms for both standardized diffusion techniques and standardized dilution techniques. The 30 μg ceftiofur sodium disk should give the following zone diameters and the ceftiofur sodium standard reference powder (or disk) should provide the following MIC values for the reference strain. Ceftiofur sodium disks or powder reference standard is appropriate for both ceftiofur salts.
|Organism Name (ATCC Number)||Zone Diameter *(mm)||MIC Range(μg/mL)|
|Escherichia coli (25922)||26–31||0.25–1.0|
|Staphylococcus aureus (29213)||—||0.25–1.0|
|Staphylococcus aureus (25923)||27–31||—|
|Pseudomonas aeruginosa (27853)||14–18||16.0–64.0|
|Actinobacillus pleuropneumoniae (27090)||34–42†||0.004–0.015‡|
|Histophilus somni (700025)||36–46†||0.0005–0.004‡|
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