CATTLE RAISERS COMMUNITY
ANADA 200-495, Approved by FDA Enroflox 100 (enrofloxacin)
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: 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.
Enroflox 100 is administered as a single dose for one day (swine) or for multiple days (cattle) of therapy. Enroflox 100 is not approved for a one-day, single dose of therapy in cattle.
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 calves. Do not use in calves to be processed for veal.
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.
PRECAUTIONS:
The effects of enrofloxacin on cattle or swine reproductive performance, pregnancy and lactation have not been adequately determined.
Not for Use in Female Dairy Cattle 20 Months of Age or Older Or In Calves To Be Processed For Veal.
INDUSTRY NEWS
Voting for State Beef Checkoff Program Set for June 2-6
A
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.
T THE REQUEST OF TEXAS CATTLE INDUSTRY ASSOCIATIONS, AND IN ACCORDANCE with Texas law, the Texas Department of Agriculture will conduct a
producer referendum that, if approved, would create a state beef checkoff program for beef promotion, marketing, research and consumer educa- tion. This proposed program, to be called the Texas Beef Checkoff, would be funded and managed by Texas beef producers. Voting will take place June 2 through June 6 to approve a refundable
maximum assessment of $1 per head of cattle to fund this program. If approved, the assessment will be collected at each point of ownership transfer in Texas. Eligible producers can vote at any Texas A&M AgriLife Extension Ser-
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 Newry, BT35 6PU, Co. Down, Northern Ireland
I02 Mar 2013
vice county offi ce during each offi ce’s regular business hours. Eligible producers are strongly encouraged to vote in person. If an eligible producer is unable to access an extension service offi ce,
a mail-in ballot may be requested from TDA between May 19 and June 2. Mail-in ballots must be postmarked no later than close of business Friday, June 6, in order to be counted. The Texas Beef Checkoff would be funded solely through this assess-
ment on cattle. It is not paid for by taxpayer dollars and is not a govern- ment program. If approved, any assessments collected would be refund- able upon request. The program would be managed by Texas cattlemen and -women serv-
ing on the Beef Promotion and Research Council of Texas. Any producer regardless of age who has owned cattle in Texas anytime
between June 6, 2013, and June 6, 2014, is eligible to vote. Youth younger than 16 years of age must have a parent or guardian co-sign their ballot. If approved, collection of the assessment will begin Oct. 1. For more information about the Texas Beef Checkoff and the referen- dum, including voting locations and hours, visit
texasagriculture.gov.
20 The Cattleman May 2014
thecattlemanmagazine.com
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