NADA 095-642, Approved by FDA

Antibiotic for Beef Cattle, Non-Lactating Dairy Cattle and Swine

For use in animals only

Each mL contains

100 mg of oxytetracycline base as oxytetracycline hydrochloride; magnesium chloride hexahydrate 5% w/v; sodium formaldehyde sulfoxylate 0.5% w/v; povidone 18% w/v; monoethanolamine to adjust pH; water for injection, q.s.

Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

General Information

Bio-Mycin® C (oxytetracycline hydrochloride) is a sterile, ready-to-use preparation for administration of the broad-spectrum antibiotic oxytetracycline by injection. This antibiotic has been established as having a wide range of antimicrobial activity against susceptible gram-positive and gram-negative bacteria and spirochetes.

Povidone is used as a carrier for oxytetracycline as it aids in reducing post injection inflammation.

The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum, or exudates.

Warning

Not for lactating dairy cattle. Discontinue use 18 days in cattle and 26 days in swine before slaughter to permit elimination of the drug from edible tissues. Do not use for more than 4 days. Do not inject more than 10 mL (cc) per site intramuscularly in mature cattle or 5 mL (cc) per site intramuscularly in swine. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Rapid intravenous administration may result in animal collapse.

Caution

If no improvement occurs within 48 hours the diagnosis should be redetermined.

Do not use for more than 4 days.

When administered to cattle within 20 days of slaughter, muscle discoloration may necessitate trimming of the injection site(s) and surrounding tissues during the dressing procedure.

Exceeding the highest recommended dosage level or duration of treatment (not more than 4 days) may result in antibiotic residues beyond the withdrawal time.

Precautions

As with any intramuscular injection, some local tissue irritation may result, manifested by temporary swelling and discoloration at site of injection. Pain can be minimized by injecting the solution at body temperature and by avoiding faulty injection techniques.

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.

Because bacteriostatic drugs interfere with the bactericidal action of penicillin, do not give penicillin in conjunction with oxytetracycline hydrochloride.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms. If any unusual symptoms occur, discontinue use immediately.

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.

Indications

Bio-Mycin C may be used for the treatment of diseases due to oxytetracycline-susceptible organisms in beef cattle, non-lactating dairy cattle, and swine.

Beef Cattle and Non-Lactating Dairy Cattle: Bio-Mycin C is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., Klebsiella spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresi, acute metritis, anaplasmosis caused by Anaplasma marginale, and wound infections caused by Staphylococcal and Streptococcal organisms. In some forms of foot-rot surgical procedures may be indicated when recovery is not satisfactory.

Swine: In swine, Bio-Mycin C 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 C is indicated for aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

Dosage

Beef Cattle and Non-Lactating Dairy Cattle: The injection of 3 to 5 mg of oxytetracycline intramuscularly per lb of body weight per day [3 to 5 mL of Bio-Mycin C per 100 lb of body weight] is the recommended dosage. In severe forms of foot-rot, anaplasmosis, and other severe disease forms 5 mg per lb of body weight is indicated [5 mL of Bio-Mycin C per 100 lb of body weight].

In disease treatment the daily dose of Bio-Mycin C should be continued 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 days.

The volume administered per injection site should be reduced according to age and size so that only 0.5 to 2 mL is injected in the case of smaller animals. No more than 10 mL should be injected per site in adult cattle.

Swine: In swine administer 3 to 5 mg oxytetracycline per lb of body weight intramuscularly daily [3 to 5 mL of Bio-Mycin C per 100 lb body weight]. No more than 5 mL of Bio-Mycin C should be injected intramuscularly per site in swine.

For sows administer 3 mg oxytetracycline per lb of body weight [3 mL of Bio-Mycin C per 100 lb of body weight] intramuscularly to the sow approximately 8 hours before farrowing or immediately after completion of farrowing. Not more than 5 mL of Bio-Mycin C should be injected intramuscularly per site in sows.

Directions for Use

Treat at the first clinical signs of disease.

The use of antibiotics, like most medications in the management of disease, is based on an accurate diagnosis and adequate treatment. When properly used in the treatment of diseases caused by oxytetracycline-susceptible organisms, animals usually show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis should be redetermined. Good management, housing, sanitation, and nutrition are essential in the care of animals and in the successful treatment of disease.

Package Information

Bio-Mycin C is available in 500-mL bottles containing 100 mg oxytetracycline base (as oxytetracycline hydrochloride) per mL.

Storage

Store product below 77°F (25°C) in a dark place. Keep from freezing.

Keep out of the reach of children.

Handle aseptically.

Restricted Drug (California): Use only as directed.

Hazardous Livestock Remedy - Not for human use.

Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.

344105L-06-0404

500 mL Bottle Label