Animal Safety
Extensive safety studies in pigs and laboratory animals have demonstrated that Enrofloxacin offers a wide margin of safety.
After oral administration in doses up to 100 mg/kg bw in rats, Baytril had no significant effect on blood composition, blood coagulation, diuresis or the central nervous system.
In specific trials it was also shown that Enrofloxacin does not elicit any allergic or pseudo-allergic reactions.
The acute toxicity is very low. The LD50 values were determined in a variety of species. Various safety studies in sows and pigs of different weights demonstrated a wide margin of safety:
Example 1: Sows with MMA Syndrome were treated i.v. with Baytril in different concentrations (2.5%, 5% and 10% inj. sol.) and dosages up to 9.1 mg/kg bw on three consecutive days. No local or general signs of intolerance were observed.
Example 2: Pigs in a weight range from 10.6 to 15 kg were treated with Baytril 5% inj. solution via s.c. route on 5 consecutive days. The injection site was changed from day to day (left neck, right neck, right buttocks, right neck, right buttocks). The animals were divided in three treatment groups, that received 5 mg/kg bw (twice the recommended standard dose), 15 mg/kg bw, and 45 mg/kg bw.
Haematological parameters did not show alterations in the different dosage groups. There was no occurrence of generalised adverse reactions. The biochemical findings showed a dose-dependent increase in CPK, and higher values for GOT (45 mg group). Necropsy of joints revealed no changes. In the 45 mg group transient limping in the hind leg from the fifth day of administration to the first day of discontinuation was observed. Necropsy findings showed cellular infiltration and muscle fibril degeneration at the injection sites. Histopathological findings showed a healing tendency on the 7th day of discontinuation, suggesting that they were reversible alterations.
Example 3: 139 pigs received Baytril Max (Baytril 100) as a one-shot treatment for naturally occurring bacterial respiratory disease. The dose was 7.5 mg/kg bw. Besides the efficacy of the treatment, no adverse reactions, either local or systemic, were observed.
Example 4: 24 pigs divided into three groups received Baytril 10% inj. solution on 15 consecutive days via the s.c. route. The dosage was 5, 15 and 25 mg/kg bw. No clinically significant effects occurred in the clinical chemistry or haematology parameters over the duration of treatments in the 5 and 15 mg groups. A clinically significant decrease in daily weight gain was observed in the 25 mg group, which was associated with general body stiffness. Consideration for inducement of these clinical signs must be given to the trauma associated with the large volumes of injected product. It was concluded that treatment with up to 15 mg/kg bw for 15 consecutive days has no effect upon clinical or performance parameters.
The injectable formulations show good local tolerance. Pain at the time of injection was not observed in the test animals. Mild to moderate swelling can occur, depending on the doses administered.
Only high overdosing causes transient clinical signs. | 
