Norbrook Enroflox 100 (Enrofloxacin), Antimicrobial Injectable Solution, 500mL

Enroflox® 100 Injection for Subcutaneous Use In Beef Cattle And Non-Lactating Dairy CattleFor Intramuscular Or Subcutaneous Use In SwineNot For Use In Female Dairy Cattle 20 Months Of Age Or Older Or In Calves To Be Processed For Veal.

Cattle - Single-Dose Therapy: Enroflox 100 (enrofloxacin) 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 (enrofloxacin) 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 (enrofloxacin) is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. See package insert for complete product details.

Enroflox® 100 for cattle:

Three Convenient Dosing and Treatment Options:

Single-Dose Therapy (BRD Treatment):

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.

Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Multiple-Day Therapy (BRD Treatment):

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.

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Single-Dose Therapy (BRD Control in High-Risk Cattle):

Enroflox® 100 is approved 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. Administer a single dose to cattle at high risk of BRD due to stresses including transportation, extreme environmental conditions and processing (e.g. castration, dehorning).

Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Enroflox® 100 is also approved for use in dairy replacement heifers ‹ 20 months of age.

How quickly does Enroflox® 100 start killing BRD-causing bacteria? Enroflox® 100, is concentration-dependent, delivering effective therapeutic drug concentrations with a single dose. In vitro*, enrofloxacin kills 97% of BRD-causing bacteria in 1-2 hours^1,2.

*The clinical significance of in vitro data has not been demonstrated.

Cattle dosing chart:
	Treatment		Control
	Single-Dose Therapy7.5 - 12.5 mg/kg	Multiple-Dose Therapy2.5 - 5.0 mg/kg	Single-Dose Therapy7.5 mg/kg
Weight (lb)	Dose Volume (mL)	Dose Volume (mL)	Dose Volume (mL)
100	3.5-5.5	1.5-2.0	3.5
200	7.0-11.0	2.5-4.5	7.0
300	10.5-17.0	3.5-6.5	10.5
400	14.0-22.5	4.5-9.0	14.0
500	17.0-28.5	5.5-11.5	17.0
600	20.5-34.0	7.0-13.5	20.5
700	24.0-39.5	8.0-16.0	24.0
800	27.5-45.5	9.0-18.0	27.5
900	31.0-51.0	10.0-20.5	31.0
1000	34.0-57.0	11.0-23.0	34.0
1100	37.5-62.5	12.5-25.0	37.5

*Dose volumes have been rounded to the nearest 0.5 mL within the dose range. Administered dose volume should not exceed 20 mL per injection site.

Selection of the appropriate dose and duration of therapy should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response.

Enroflox® 100 for swine:

Enroflox® 100 works as a single-injection for pigs of all ages.

Enroflox® 100is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchisepticaand Mycoplasma hyopneumoniae.

Swine Respiratory Disease (SRD) is the prevalent cause of nursery pig and grower/finisher deaths.3 Primary and secondary bacterial pathogens include Actinobacillus pleuropneumoniae (APP), Pasteurella multocida, Haemophilus parasuis and Streptococcus suis. These infectious agents act together to increase the severity and duration of the disease.

Enroflox® 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage Administration in Swine:

Enroflox® 100 may be administered as a single intramuscular or SQ dose of 7.5 mg/kg of body weight (3.4 mL/100 lbs.)

Swine dosing chart:
Weight (lb)	Dose Volume (mL)
50	1.7
100	3.4
150	5.1
200	6.8
250	8.5

Enroflox® 100 dose volume should not exceed 5 mL per injection site.

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.

To assure responsible antimicrobial drug use, enrofloxacin should only be used as a second-line drug for colibacillosis in swine following consideration of other therapeutic options.

RESIDUE WARNINGS:

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.

Swine: 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. 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 Safety Data Sheet (SDS) 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:

Cattle: 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.

Swine: Subcutaneous Safety: 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.

Intramuscular Safety: Transient decreases in feed and water consumption were observed after each treatment. Mild, transient, post-treatment injection site swellings were observed in pigs receiving the 37.5 mg/kg BW dose. Injection site inflammation was found on post-mortem examination in all enrofloxacin-treated groups.