NADA Number: 097-452

Proprietary Name Oxyject® 100
Sponsor Boehringer Ingelheim Vetmedica, Inc.
Sponsor Address 2621 North Belt Highway
St.Joseph, MO    64502
USA
Ingredients Oxytetracycline Hydrochloride
Species Cattle, dairy, not lactating
Cattle, beef
Swine, sows with litters or about to farrow
Cattle, calves, excluding veal calves
Swine, no use class stated or implied
Routes of Administration Intramuscular
Dose Form Liquid (solution)
Drug Form Liquid (solution)
Dispensing Status OTC
Patent Number 3712949
Exclusivity Granted for the addition of the subcutaneous route in cattle, with a withdrawal period of 2 days, and a withdrawal period for intramuscular and intravenous routes of 13 days in cattle.
Withdrawal Time Cattle: 13 days before slaughter for IM or IV treatment, 2 days for SQ treatment. A withdrawal time for pre-ruminating veal calves has not been established. Swine: 20 days before slaughter.
Dosage Amount,
Indications
& Limitations

522.1662a Oxytetracycline hydrochloride injection.

Specifications: Each milliliter of sterile solution contains 100 milligrams of oxytetracycline as oxytetracycline hydrochloride.

Conditions of use:

Cattle (beef, beef calves, nonlactating dairy, and dairy calves)

Amount: 3 to 5 milligrams of oxytetracycline per pound of body weight per day. Administer by intramuscular, intravenous, or subcutaneous injection.

Indications: For the treatment of pneumonia and shipping fever complex associated with Pasteurella species Hemophilus species, or Klebsiella species.

Limitations: In severe forms of the indicated diseases, administer 5 milligrams of oxytetracycline per pound of body weight per day. Continue treatment 24 to 48 hours following remission of disease symptoms not to exceed a total of 4 consecutive days. If no improvement is noted within 48 hours, consult a veterinarian. Do not inject more than 10 milliliters per injection site intramuscularly in adult cattle, no more than 1 milliliter per site in calves weighing 100 pounds or less. A withdrawal period has not been established for use of this product in preruminating calves. Do not use in calves to be processed for veal. Exceeding the highest recommended dosage or duration of treatment (not more than 4 consecutive days) may result in residues beyond the withdrawal period. Discontinue treatment at least 18 days prior to slaughter. Not for use in lactating dairy cattle.

Swine

Amount: 3 to 5 milligrams of oxytetracycline per pound of body weight per day. Administer intramuscularly.

Indications: For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.

Limitations: If no improvement is noted within 24 hours, consult a veterinarian. Do not inject more than 5 milliliters per site. Discontinue treatment at least 20 days prior to slaughter.

Swine (sows)

Amount: Administer once 3 milligrams of oxytetracycline per pound of body weight, approximately 8 hours before farrowing or immediately after completion of farrowing. Administer intramuscularly.

Indications: As an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

Limitations: If no improvement is noted within 24 hours, consult a veterinarian. Do not inject more than 5 milliliters per site. Discontinue treatment at least 20 days prior to slaughter.

Tolerances

Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.