Label: ENROFLOXACIN injection, solution

Cattle-Single-Dose Therapy: Enrofloxacin 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: Enrofloxacin 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: Enrofloxacin 100 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. Enrofloxacin 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Cattle:

Swine:

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single 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.

For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.

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.

Cattle: A total of 845 calves with naturally-occurring BRD were treated with enrofloxacin in eight field trials located in five cattle-feeding states. Response to treatment was compared to non-treated controls. Single-dose and multiple-day therapy regimens were evaluated. BRD and mortality were significantly reduced in enrofloxacin-treated calves. No adverse reactions were reported in treated animals.
The effectiveness of enrofloxacin for the control of respiratory disease in cattle at high risk of developing BRD was evaluated in a six-location study in the U.S. and Canada. A total of 1,150 crossbred beef calves at high risk of developing BRD were enrolled in the study. Enrofloxacin (7.5 mg/kg BW) or an equivalent volume of sterile saline was administered as a single subcutaneous injection within two days after arrival. Cattle were observed daily for clinical signs of BRD and were evaluated for success on Day 14 post-treatment. Treatment success in the enrofloxacin group (497/573, 87.83%) was significantly higher (P = 0.0013) than success in the saline control group (455/571, 80.92%). In addition, there were more treatment successes (n = 13) than failures (n = 3) in the group of animals positive for M. bovis on Day 0 that were treated with enrofloxacin. No product-related adverse reactions were reported.

Swine: A total of 590 pigs were treated with enrofloxacin 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°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.
The effectiveness of enrofloxacin administered as a single SC dose of 7.5 mg/kg BW for the treatment and control of SRD associated with M. hyopneumoniae was demonstrated using an induced infection model study and three single-site natural infection field studies. In the model study, 72 healthy pigs were challenged with a representative M. hyopneumoniae isolate and treated with enrofloxacin or saline. A statistically significant (P < 0.0001) decrease in the mean total lung lesion score was observed in the enrofloxacin-treated group (4%) compared with the saline-treated group (27%) at 10 days post-treatment. In two field studies evaluating effectiveness for treatment of SRD, a total of 300 pigs with clinical signs of SRD (moderate depression, moderately increased respiratory rate, and a rectal temperature of ≥ 104°F) were enrolled and treated with enrofloxacin or saline. At 7 days post-treatment, the cure rate was statistically significantly higher at each site (P < 0.0001) in the enrofloxacin-treated groups (61.3% and 92%) compared with the saline-treated groups (26.7% and 33.3%). In one field study evaluating effectiveness for control of SRD, a group of 400 pigs in which > 15% had clinical signs of SRD (moderate depression score, moderately increased respiratory rate, and a rectal temperature of ≥ 104°F) was enrolled and treated with enrofloxacin or saline. At 7 days post-treatment, the cure rate was statistically significantly higher (P < 0.0002) in the enrofloxacin-treated group (70.0%) compared with the saline-treated group (48.5%). In addition to M. hyopneumoniae, B. bronchiseptica was also isolated in sufficient numbers from these field studies to be included in the SRD treatment and control indications.
The effectiveness of enrofloxacin for the control of colibacillosis associated with E. coli was evaluated in a multi-site natural infection field study. At each site, when at least 5% of the pigs were defined as “clinically affected” (presence of diarrhea and either depression or gauntness), all pigs were administered enrofloxacin as a single IM dose of 7.5 mg/kg BW or an equivalent dose volume of saline. At 7 days post-treatment, the success rate was statistically significantly higher (P = 0.0350) in the enrofloxacin-treated group (61.5%) compared with the saline-treated group (44.7%).
The effectiveness of enrofloxacin administered as a single IM dose of 7.5 mg/kg BW for the treatment and control of SRD or as a single SC dose of 7.5 mg/kg BW for the control of colibacillosis was confirmed by demonstrating comparable serum enrofloxacin concentrations following IM or SC injection into the neck of healthy male and female pigs.

Cattle: Safety studies were conducted in feeder calves using single doses of 5, 15 and 25 mg/kg for 15 consecutive days and 50 mg/kg for 5 consecutive days. No clinical signs of toxicity were observed when a dose of 5 mg/kg was administered for 15 days. 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. No drug-related abnormalities in clinical pathology parameters were identified. No articular cartilage lesions were observed after examination of stifle joints from animals administered 25 mg/kg for 15 days.

A safety study was conducted in 23-day-old calves using doses of 5, 15 and 25 mg/kg for 15 consecutive days. No clinical signs of toxicity or changes in clinical pathology parameters were observed. No articular cartilage lesions were observed in the stifle joints at any dose level at 2 days and 9 days following 15 days of drug administration.

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

Swine: Subcutaneous 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.

Intramuscular Safety: A safety study was conducted in 48 weaned, 20- to 22-day-old pigs. Pigs were administered enrofloxacine, at 7.5, 22.5 and 37.5 mg/kg BW by IM injection into the neck once weekly for 3 consecutive weeks. All pigs remained clinically normal throughout the study. 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.