ANADA 200-495, Approved by FDA

For Subcutaneous Use in Swine Only.

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:

Enroflox™ 100 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent. Therapeutic treatment with Enroflox 100 is administered as a single dose for one day in swine. 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.

CHEMICAL NOMENCLATURE AND STRUCTURE:

1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1, 4-dihydro-4-oxo-3-quinolinecarboxylic acid.

INDICATIONS:

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.

DOSAGE AND ADMINISTRATION:

Enroflox 100 is administered as a single dose for one day in swine.

Administer once, behind the ear, a subcutaneous dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Administered dose volume should not exceed 5 mL per injection site.

RESIDUE WARNINGS:

Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose.

HUMAN WARNINGS:

For use in animals only.

PRECAUTIONS:

The effects of enrofloxacin on 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 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.

MICROBIOLOGY:

Enrofloxacin is bactericidal and exerts its antibacterial effect by inhibiting bacterial DNA gyrase (a type II topoisomerase) thereby preventing DNA supercoiling and replication which leads to cell death.1 Enrofloxacin is active against Gram-negative and Gram-positive bacteria.

EFFECTIVENESS:

A total of 590 pigs were treated with enrofloxacin injection or saline in two separate natural infection SRD field trials. For the treatment of SRD, the success rate of enrofloxacin-treated pigs that were defined as “sick and febrile” (increased respiratory rate, labored or dyspneic breathing, depressed attitude and a rectal temperature _ 104.0°F) was statistically significantly greater than the success rate of saline-treated “sick and febrile” pigs. For the control of SRD, mean rectal temperature, mortality (one trial) and morbidity were statistically significantly lower for enrofloxacin-treated pigs in pens containing a percentage of “sick and febrile” pigs compared to saline-treated pigs.

TOXICOLOGY:

The oral LD50 for laboratory rats was greater than 5000 mg/kg of body weight. Ninety-day feeding studies in dogs and rats revealed no observable adverse effects at treatment rates of 3 and 40 mg/kg respectively. Chronic studies in rats and mice revealed no observable adverse effects at 5.3 and 323 mg/kg respectively. There was no evidence of carcinogenic effect in laboratory animal models. A two-generation rat reproduction study revealed no effect with 10 mg/kg treatments. No teratogenic effects were observed in rabbits at doses of 25 mg/kg or in rats at 50 mg/kg.

ANIMAL SAFETY:

A safety study was conducted in 32 pigs weighing approximately 57 kg (125 lb) using single doses of 5, 15, or 25 mg/kg daily for 15 consecutive days. 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.

A second study was conducted in two pigs weighing approximately 23 kg (50 lb), treated with 50 mg/kg for 5 consecutive days. There were no clinical signs of toxicity or pathological changes.

An injection site study conducted in pigs demonstrated that the formulation may induce a transient reaction in the subcutaneous tissue. No painful responses to administration were observed.

STORAGE CONDITIONS:

Protect from direct sunlight. Do not refrigerate or freeze. Store below 77°F (25°C). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.

HOW SUPPLIED:

Enroflox 100:

100 mg/mL 100     mL Bottle
100 mg/mL 250     mL Bottle

REFERENCES:

1. Hooper, D. C., Wolfson, J. S., Quinolone Antimicrobial Agents, 2nd ed, 59 - 75,1993.

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.

Restricted Drug - California. Use Only as Directed.

Made in the UK.

Norbrook Laboratories Limited
Newry, BT35 6PU, Co. Down,
Northern Ireland

Norbrook®

052670101

Principal Display Panel – 250 mL Vial Label

NDC 55529-153-04

Enroflox™ 100
(enrofloxacin)

100 mg/mL Antimicrobial
Injectable Solution

For Subcutaneous Use in Swine Only

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.

ANADA 200-495, Approved by FDA

250 mL

Principal Display Panel – 250 mL Carton Label

NDC 55529-153-04

Enroflox™ 100
(enrofloxacin)

100 mg/mL Antimicrobial
Injectable Solution

For Subcutaneous Use in Swine Only

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.

ANADA 200-495,

Approved by FDA

250 mL