(enrofloxacin) 100 ANADA 200-495, Approved by FDA
Enroflox®
100 mg/mL Antimicrobial Injectable Solution
For Subcutaneous Use in Beef Cattle, Non-Lactating Dairy Cattle and Swine Only.
Brief Summary: Before using Enroflox® 100, consult the product insert, a summary of which follows.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. Federal (U.S.A.) law prohibits the extra-label use of this drug in food-producing animals.
PRODUCT DESCRIPTION: Each mL of Enroflox 100 contains 100 mg of enrofloxacin. Excipients are L-arginine base 200 mg, n-butyl alcohol 30 mg, benzyl alcohol (as a preservative) 20 mg and water for injection q.s.
INDICATIONS:
Cattle - Single-Dose Therapy: Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.
Cattle - Multiple-Day Therapy: Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.
Swine: Enroflox 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
calves. Do not use in calves to be processed for veal. Swine: Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.
Cattle: Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating
RESIDUE WARNINGS:
HUMAN WARNINGS: For use in animals only. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. For customer service, to obtain a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions, call Norbrook at 1-866-591-5777.
PRECAUTIONS:
The effects of enrofloxacin on cattle or swine reproductive performance, pregnancy and lactation have not been adequately determined.
The long-term effects on articular joint cartilage have not been determined in pigs above market weight. Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter. Enroflox 100 contains different excipients than other enrofloxacin products. The safety and efficacy of this formulation in species other than cattle and swine have not been determined. Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures. Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. See Animal Safety section for additional information.
ADVERSE REACTIONS: No adverse reactions were observed during clinical trials.
ANIMAL SAFETY:
In cattle safety studies, clinical signs of depression, incoordination and muscle fasciculation were observed in calves when doses of 15 or 25 mg/kg were administered for 10 to 15 days. Clinical signs of depression, inappetance and incoordination were observed when a dose of 50 mg/kg was administered for 3 days. An injection site study conducted in feeder calves demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue and underlying muscle. In swine safety studies, incidental lameness of short duration was observed in all groups, including the saline-treated controls. Musculoskeletal stiffness was observed following the 15 and 25 mg/kg treatments with clinical signs appearing during the second week of treatment. Clinical signs of lameness improved after treatment ceased and most animals were clinically normal at necropsy. An injection site study conducted in pigs demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue.
Norbrook Laboratories Limited,
The Norbrook logos and Enroflox® are registered trademarks of Norbrook Laboratories Limited.
Newry, BT35 6PU, Co. Down, Northern Ireland I01 March 2015
Not for Use in Female Dairy Cattle 20 Months of Age or Older Or In Calves To Be Processed For Veal.
NAMES IN THE NEWS
Christina Hayes, Ph.D., has joined Purina Animal Nutrition as the product manager for the beef technical sales and marketing services team. Hayes received her Bachelor of Science in biological sciences, as well as Master of Science and Ph.D. degrees in animal science from North Dakota State University. Her master’s program focused on fetal programming and the infl uence of maternal protein supplementation on fetal muscle growth and development in livestock. Her Ph.D. work focused on growth promotant pro- grams during the fi nishing period, use of genetic technologies and breeding programs to maximize profi t potential and processing procedures to improve beef palatability. Dr. John C. Tracy is the director of the Texas Water Resources Institute (TWRI) at Texas A&M University. Tracy, a civil engineer, has extensive experience relating to water resources management. He most recently served as director of the Idaho Water Resources Research Institute at the University of Idaho. Dr. Larry Redmon, Texas A&M AgriLife Extension Service state forage spe- cialist, is the associate department head and AgriLife Extension program leader of soil and crop sciences at Texas A&M University. In this position, Redmon will lead soil and crop science faculty across the state, including budget development, evaluation, commodity group relations, industry part- nerships, response coordination and visioning for the future. Redmon earned a bachelor of science in agronomy from Stephen F. Austin State University and a doctorate in range science from Texas A&M. He spent 6 years with Oklahoma State University before joining AgriLife Extension in 1999 as a for- age specialist at Overton. Dave True, Casper, Wyo., is the 2015 National Golden Spur Award winner. National Cattlemen’s Foundation Past President Clark Willingham, Dallas, presented the award at the Oct. 17 Golden Spur Dinner at the National Ranch- ing Heritage Center, Lubbock. This honor is given by the ranching and livestock industries in recognition of accomplishments by an individual. True is joint own- er of True Companies, a family business that includes True Ranches, a multi- segmented beef operation that spans the eastern third of Wyoming. DuPont has named Timothy P. Glenn as president of its Crop Protection business, succeeding Rik Miller who has elected to retire after 31 years of service to the company. Glenn will report to DuPont Executive Vice President James C. Borel.
Glenn has served as vice president, Integrated Operations & Commercial Effectiveness with DuPont Pioneer. Glenn also was regional business direc- tor for Canada and Latin America, and director, Marketing & Sales Effective- ness for North America. Prior to joining DuPont, he held a series of business, sales and marketing leadership roles with Dow AgroSciences. Glenn earned a Bachelor of Science from Iowa State University and an MBA from Santa Clara University. Dr. Leonardo Brito has joined STgenetics (STg) as director of global quality assurance. He has 18 years of experience in animal reproduction research, production of biological materials, clinical practice and teaching in industry and academic settings. Before joining STg, he was a research scientist and U.S. production laboratory manager with ABS Global.
48 The Cattleman December 2015
thecattlemanmagazine.com
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