Pharmacokinetics

The pharmacokinetic studies (data on file) were conducted in calves after oral administration of Baycox® Bovis in calves at a dose of 15 mg/kg. Baycox® (Toltrazuril) and its metabolites toltrazuril sulfoxide and toltrazuril sulfone were measured  till 23 and 45 days respectively after treatment.

After oral administration Baycox® Bovis is absorbed slowly by the gut, resulting in long-lasting distribution among the different compartments of the body. The product does not have significant enterohepatic circulation and its main route of elimination is through faeces.

Safety

Two studies have been conducted to examine the safety of single a dose of Baycox® among calves.

In one study, calves were divided into four groups, first group acted as an untreated control, the second group received 15mg/kg toltrazuril. The third and fourth groups received 45 mg/kg and 75mg/kg Baycox® respectively.
 
In the second study, calves were allocated to three groups, one group acted as an untreated group, while the second and third groups received 15mg/kg and 45mg/kg of Baycox® respectively.

In both the studies haematology, blood chemistry parameters were within normal physiological boundaries. Gross pathological examination and histopathological examination of the rumen, abomasum, duodenum, jejunum, ileum, spleen, liver, kidney, adrenal glands, heart, lung and thyroid showed no systemic abnormalities or group tendencies.

A variety of dairy and beef breeds of cattle such as German black pied, German red pied, Czech red pied, Holstein black pied, German friesian, Spotted mountain cattle and German brindled among others, were treated in the course of several studies and the treatment was very well tolerated.

During the course of several studies concomitant treatments with several drugs and vaccines such as, Baytril, danofloxacin, cefquinom, ceftifur, florfenicol, tilmicosin, benzylpenicillin, oxytettracycline, amoxicillin, meloxicam, metamizol, dexamethasone and doramectin, perfusional solutions such as electrolytes, glucose, vitamins, selenium and different vaccines before and after Baycox® administration did not cause any adverse effect and no interactions were observed.

Baycox® is safe for cattle.