NADA Number: 055-089

Proprietary Name Amoxi-Inject (Cattle)
Sponsor Pfizer, Inc.
Sponsor Address 235 East 42d St.
New York, NY    10017
USA
Ingredients Amoxicillin Trihydrate
Species Cattle, no use class stated or implied
Routes of Administration Intramuscular
Subcutaneous
Dose Form Liquid (suspension)
Drug Form Liquid (suspension)
Dispensing Status RX
Patent Number APPL 098326
RE28744
Withdrawal Time Cattle: 25 days before slaughter. Milk: 96 hours (8 milkings) before being used for food.
Dosage Amount,
Indications
& Limitations

522.88 Sterile amoxicillin trihydrate for suspension.

Specifications: Each vial contains 25 grams of amoxicillin as the trihydrate. The vial is reconstituted with sterile water for injection USP to a concentration of 250 milligrams per milliliter.

Conditions of use:

Cattle

Amount: 3 to 5 milligrams per pound of body weight once a day according to the animal being treated, the severity of infection, and the animal's response.

Indications: Treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to Pasteurella multocida, P. hemolytica, Hemophilus species Staphylococci species, and Streptococci species and acute necrotic pododermatitis (foot rot) due to Fusobacterium necrophorum.

Limitations: Administer once daily for up to 5 days by intramuscular or subcutaneous injection. Continue treatment for 48 to 72 hours after the animal has become afebrile or asymptomatic. Do not continue treatment beyond 5 days. Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Maximum volume per injection site should not exceed 30 milliliters. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tolerances

A tolerance of 0.01 part per million is established for negligible residues of amoxicillin in milk and in the uncooked edible tissues of cattle.