18 Nebraska Cattleman November 2023 Consider This Each mL contains 300 mg of oxytetracycline base (equivalent to 323.5 mg of oxytetracycline dihydrate). For Use in Beef Cattle, Non-lactating Dairy Cattle, Calves, Including pre-ruminating (veal) calves BRIEF SUMMARY (For full Prescribing Information, see package insert.) Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: NOROMYCIN 300 LA is intended for use in treatment for the following diseases when due to oxytetracycline-susceptible organisms: Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves: NOROMYCIN 300 LA is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. NOROMYCIN 300 LA is indicated for the treatment of infectious bovine keratoconjunctivitis (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 staphylococcal and streptococcal organisms sensitive to oxytetracycline. Swine: NOROMYCIN 300 LA 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 NOROMYCIN 300 LA is indicated as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli. PRECAUTIONS: Exceeding the highest recommended level of drug per pound of bodyweight 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 nonlactating dairy cattle and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal time. Consult with 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 attributable 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 non-susceptible organisms, including fungi. The absence of a favorable response following treatment, or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving NOROMYCIN 300 LA in conjunction with penicillin. WARNINGS: Warnings: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Not for use in lactating dairy animals. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. CAUTION: Intramuscular or subcutaneous injection may result in local tissue reactions which persists beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter. Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site. Subcutaneous injection in the neck area may cause swelling at the injection site. 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. To report a suspected adverse reaction call 1-866-591-5777. Livestock Drug - Not for Human Use. Manufactured by: Norbrook Laboratories Limited, Newry, BT35 6QQ, Co. Down, Northern Ireland MADE IN THE UK Rev: March 2023 Version: I01 Approved by FDA under NADA # 141-143
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