Naxcel: Product Information (Page 2 of 4)

Day-Old Chicks

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.

Day-Old Turkey Poults

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.

CONTRAINDICATIONS

As with all drugs, the use of NAXCEL Sterile Powder is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS

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.

CONTACT INFORMATION

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.

RESIDUE WARNINGS:

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.

PRECAUTIONS

The effects of ceftiofur on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined.

Cattle

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.

Swine

The safety of ceftiofur has not been determined for swine intended for breeding.

Horses

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.

Dogs

The safety of ceftiofur has not been determined for dogs intended for breeding, or pregnant dogs.

ADVERSE REACTIONS

The use of ceftiofur may result in some signs of immediate and transient local pain to the animal.

CLINICAL MICROBIOLOGY

Summaries of MIC data are presented in Tables 1 and 2. Testing followed Clinical and Laboratory Standards Institute (CLSI) Guidelines.

Table 1. Ceftiofur MIC Values of Bacterial Isolates from Clinical Field Studies in the USA
Animal Organism Number Tested Date Tested MIC90 *(μg/mL) MIC Range(μg/mL)
*
Minimum inhibitory concentration (MIC) for 90% of the isolates.
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
Salmonella choleraesuis 50 1993 1.0 1.0-2.0
beta-hemolytic Streptococcus spp. 24 1993 ≤ 0.03 ≤ 0.03-0.06
Actinobacillus suis 77 1998 0.0078 0.0019-0.0078
Haemophilus parasuis 76 1998 0.06 0.0039-0.25
Sheep Mannheimia haemolytica 39 1992 0.13 ≤ 0.03-0.13
Pasteurella multocida 23 1992 ≤ 0.03 no range
Canine Escherichia coli 44 1992 4.0 0.06-64.0
Escherichia coli 18 1990 0.25 0.13-0.5
Proteus mirabilis 17 1990 ≤ 0.06 ≤ 0.06-0.5
Proteus mirabilis 23 1992 1.0 ≤ 0.06-4.0
Turkey Escherichia coli 1204 1995 1.0 0.13->32.0
Table 2. Ceftiofur MIC Values of Bacterial Isolates from Diagnostic Laboratories in the USA and Canada *
Animal Organism Number Tested Date Tested MIC90 (μg/mL) MIC Range(μg/mL)
*
The following in vitro data are available but their clinical significance is unknown.
Minimum inhibitory concentration (MIC) for 90% of the isolates.
MIC50 is 32 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
Peptostreptococcus anaerobius 12 1994 2.0 0.13-2.0
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
Salmonella choleraesuis 96 1999-2000 1.0 0.03->4.0
Salmonella choleraesuis 101 2000-2001 1.0 0.5-2.0
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
Canine Escherichia coli 26 2000 32 0.25->32
Proteus mirabilis 14 2000 0.25 0.06-0.25
Turkey Escherichia coli 17 1998-1999 1.0 0.25-1.0
Escherichia coli 25 1999-2000 0.50 0.12-0.5
Escherichia coli 20 2000-2001 2.0 0.12-16.0
Citrobacter spp. 37 1995 32.0 0.5->32.0
Enterobacter spp. 51 1995 >32.0 0.13->32.0
Klebsiella spp. 100 1995 1.0 0.13-2.0
Proteus spp. 19 1995 1.0 0.06-32.0
Pseudomonas spp. 31 1995 >32.0 0.06->32.0
Salmonella spp. 24 1995 1.0 0.5-1.0
Staphylococcus spp. (coagulase positive) 17 1995 2.0 1.0-2.0
Staphylococcus spp. (coagulase negative) 26 1995 8.0 0.13->32.0
Chicken Escherichia coli 62 1997-1998 0.50 0.25-2.0
Escherichia coli 53 1998-1999 4.0 0.25->4.0
Escherichia coli 67 1999-2000 0.50 0.12-16.0
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
18-20 4.0 (I) Intermediate
≤ 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.

Table 3. Acceptable quality control ranges for ceftiofur against Clinical and Laboratory Standards Institute recommended American Type Culture Collection (ATCC) reference strains
Organism Name (ATCC Number) Zone Diameter *(mm) MIC Range(μg/mL)
*
All testing performed using a 30μg disk.
Quality control ranges are applicable only to tests performed by disk diffusion test using a chocolate Mueller-Hinton agar, incubated in 5-7% CO2 for 20-24 hours.
MIC quality control ranges are applicable only to tests performed by broth microdilution procedures using veterinary fastidious medium (VFM).
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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