Terra-Vet 200: Product Information

TERRA-VET 200- oxytetracycline injection, solution
Aspen Veterinary Resources, Ltd.

ANTIBIOTIC

Each mL contains 200 mg of oxytetracycline. For use in beef cattle; dairy cattle; calves, including preruminating (veal) calves; and swine.

For animal use only.

Read Entire Package Insert Carefully Before Using This Product.

Terra-Vet® 200 (oxytetracycline injection) is a sterile, ready-to-use solution for the administration of the broad-spectrum antibiotic oxytetracycline by injection.

Terra-Vet® 200 does not require refrigeration; however, it is recommended that it be stored at controlled room temperature 20-25°C (68-77°F); excursions permitted 15-30°C (59-86°F). The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum, or exudates.

CAUTION: When administered to cattle, muscle discoloration may necessitate trimming of the injection site(s) and surrounding tissues during the dressing procedure.

WARNINGS:

Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes.

PRECAUTIONS:

Exceeding the highest recommended dosage level of drug per lb of body weight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef and dairy cattle, and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal period.

Consult your veterinarian prior to administering this product in order to determine the proper treatment required in the event of an adverse reaction. At the first sign of any adverse reaction, discontinue use of the product and seek the advice of your veterinarian. Some of the reactions may be attributed either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection, treated animals may have transient hemoglobinuria resulting in darkened urine.

As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs, may suggest that an overgrowth of nonsusceptible organisms has occurred. If any of these conditions occur, consult your veterinarian.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Terra-Vet® 200 in conjunction with penicillin.

ADVERSE REACTIONS:

Reports of adverse reactions associated with oxytetracycline administration include injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse and possibly death. Some of these reactions may be attributed to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), call 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

STORAGE CONDITIONS: Store at controlled room temperature 20-25°C (68-77°F); excursions permitted 15-30°C (59-86°F). Protect from freezing. For 100 mL size: Use within 60 days of first puncture and puncture a maximum of 36 times. For 250 mL and 500 mL sizes: Use within 60 days of first puncture and puncture a maximum of 36 times. If using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use.

CARE OF SICK ANIMALS:

The use of antibiotics in the management of diseases is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by oxytetracycline-susceptible organisms, most animals that have been treated with Terra-Vet® 200 show a noticeable improvement within 24-48 hours. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals, and are essential in the treatment of diseased animals.

INDICATIONS:

Terra-Vet® 200 is intended for use in the treatment of the following diseases in beef cattle; dairy cattle; calves, including preruminating (veal) calves; and swine when due to oxytetracycline-susceptible organisms:

Cattle: Terra-Vet® 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; infectious bovine keratoconjuctivitis (pink eye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.

Swine: Terra-Vet® 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona.

In sows, Terra-Vet® 200 is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

DOSAGE:

Cattle: Terra-Vet® 200 is to be administered by intramuscular, subcutaneous (SC, under the skin) or intravenous injection to beef cattle; dairy cattle; and calves, including preruminating (veal) calves according the Beef Quality Assurance Guidelines.

A single dosage of 9 mg of Terra-Vet® 200 per lb of body weight administered intramuscularly or subcutaneously is recommended in the treatment of the following conditions:

(1)
bacterial pneumonia caused by Pasteurella spp. (shipping fever) in calves and yearlings, where retreatment is impractical due to husbandry conditions, such as cattle on range, or where repeated restraint is inadvisable.
(2)
infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis.

Terra-Vet® 200 can also be administered by intravenous, subcutaneous, or intramuscular injection at a level of 3-5 mg of oxytetracycline per lb of body weight per day. In the treatment of severe foot rot and advanced cases of other indicated diseases, a dosage level of 5 mg/lb of body weight per day is recommended. Treatment should be continued 24-48 hours following remission of disease signs; however, not to exceed a total of 4 consecutive days. Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning of treatment.

Swine: A single dosage of 9 mg of Terra-Vet® 200 per lb of body weight administered intramuscularly in the neck region is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where re-treatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Terra-Vet® 200 can also be administered by intramuscular injection at a level of 3-5 mg of oxytetracycline per lb of body weight per day. Treatment should be continued 24-48 hours following remission of disease signs; however, not to exceed a total of 4 consecutive days. Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning of treatment.

For sows, administer once intramuscularly in the neck region 3 mg of oxytetracycline per lb of body weight approximately 8 hours before farrowing or immediately after completion of farrowing.

For swine weighing 25 lb of body weight and under, Terra-Vet® 200 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

* To prepare dilutions, add one part of Terra-Vet® 200 to 3, 5, or 7 parts of sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately.

9 mg/lb Dosage Volume of Undiluted Terra-Vet® 200 3 or 5 mg/lb Dosage Volume of Diluted Terra-Vet® 200
Body weight 9 mg/lb 3 mg/lb Dilution* 5 mg/lb
5 lb 0.2 mL 0.6 mL 1:7 1.0 mL
10 lb 0.5 mL 0.9 mL 1:5 1.5 mL
25 lb 1.1 mL 1.5 mL 1:3 2.5 mL
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