Bio-Mycin 200: Product Information

BIO-MYCIN 200- oxytetracycline injection
Boehringer Ingelheim Animal Health USA Inc.

Approved by FDA under ANADA # 200-008

Antibiotic

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Each mL contains 200 mg oxytetracycline.

For the treatment of disease in beef cattle, dairy cattle and swine.

For animal use only

Read entire insert carefully before using this product.

BIO-MYCIN 200 is a sterile, ready-to-use solution of the broad spectrum antibiotic oxytetracycline by injection. Oxytetracycline injection administered to cattle or swine for the treatment of bacterial pneumonia at a dosage of 9 mg of oxytetracycline per lb of body weight has been demonstrated in clinical trials to be as effective as 2 or 3 repeated, daily treatments at 3-5 mg/lb of body weight. Each mL contains 200 mg of oxytetracycline; magnesium oxide 1.7% w/v; sodium formaldehyde sulfoxylate 0.5% w/v; polyethylene glycol 400 30% w/v; monoethanolamine to adjust pH; water for injection USP qs. 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.

Warning:

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 pound 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 cattle and dairy cattle, and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal period.

At the first sign of any adverse reaction, discontinue use of 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 BIO-MYCIN 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 either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Storage:

Store at controlled room temperature 15°-25°C (59°-77°F). Exposure to colder temperatures may cause cloudiness. Gently warm the product to restore clarity. Use within 12 months of first puncture. Handle aseptically.

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 oxytetracycline injection show a noticeable improvement within 24 to 48 hours.

Indications:

BIO-MYCIN 200 is intended for use in the treatment of the following diseases in beef cattle, dairy cattle and swine when due to oxytetracycline-susceptible organisms:

Cattle: In cattle, BIO-MYCIN 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) 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: In swine, BIO-MYCIN 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, BIO-MYCIN 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: BIO-MYCIN 200 is to be administered by intramuscular, subcutaneous, or intravenous injection. Intramuscular administration is not recommended according to Beef Quality Assurance Guidelines.

A single dosage of 9 milligrams of BIO-MYCIN 200 per pound 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 their repeated restraint is inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

Discontinue treatment at least 28 days prior to slaughter of cattle. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food.

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

Swine: In swine a single dosage of 9 milligrams of BIO-MYCIN 200 per pound of body weight administered intramuscularly is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Discontinue treatment 28 days prior to slaughter of swine.

BIO-MYCIN 200 can also be administered by intramuscular injection at a level of 3 to 5 milligrams of oxytetracycline per pound of body weight per day.

Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four consecutive days. Consult your veterinarian if improvement is not noted within 24 to 48 hours of the beginning of treatment.

For sows, administer once intramuscularly 3 milligrams of oxytetracycline per pound of body weight approximately 8 hours before farrowing or immediately after completion of farrowing.

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