Introduction

vet004

Company name: Bayer plc

Address: Animal Health Division

Bayer House, Strawberry Hill,

Newbury

Berkshire RG14 1JA

Telephone: 01635 563000

Fax: 01635 563622

Email: animal.health@bayerhealthcare.com

Website: www.bayer.co.uk/products/animalhealth.html

Presentation

Baycox Bovis is a white to yellowish oral suspension containing as active ingredient 50 mg/ml toltrazuril with sodium benzoate (E211) 2.1 mg/ml and sodium propionate (E281) 2.1 mg/ml

Uses

For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in housed dairy calves replacing cows producing milk for human consumption (dairy cows) on farms with a confirmed history of coccidiosis caused by Eimeria bovis or Eimeria zuernii.

Dosage and administration

Each animal should be treated with a single oral dose of 15 mg toltrazuril/kg body weight corresponding to 3.0 ml oral suspension per 10 kg body weight.

The ready-to-use oral suspension must be shaken before use.

For the treatment of a group of animals of the same breed and same or similar age, the dosing should be done according to the heaviest animal of this group.

To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period.

Contra-indications, warnings, etc

As with any antiparasiticide frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.

It is recommended to treat all calves in a pen.

Hygienic measures may reduce the risk of bovine coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness.

To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period.

To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.

A threefold overdose is well tolerated by calves without signs of intolerance.

Consumer Safety Withdrawal period: Meat and offal: 63 days Not permitted for use in lactating animals producing milk for human consumption.

User Safety: Wash any splashes from skin or eyes immediately with water.

Environmental Safety: For environmental reasons:

• Do not use in calves weighing more than 80 kg bodyweight.

• Do not use in fattening units such as veal or beef calves.

The major metabolite of toltrazuril, toltrazuril sulfone (ponazuril), has been shown to be both persistent (half-life >1 year) and mobile in soil and to be toxic to plants.

In order to prevent any adverse effects on plants and possible contamination of groundwater manure from treated calves must not be spread onto land without dilution with manure from untreated cows. Manure from treated calves must be diluted with at least 3 times the weight of manure from mature cows before it can be spread onto land.

Any unused product or waste materials should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf-life after first opening the container: 3 months.

Legal category

POM-V

Packaging Quantities

High density polyethylene bottles containing 250 or 1000 ml of a white or yellowish suspension with a green polypropylene screw cap.

Further information

Pharmacotherapeutic group: Antiprotozo-products, ATCvet code: QP 51 AJ 01

Toltrazuril is a triazinon derivative. It acts against coccidia of the genus Eimeria. It is active against all intracellular development stages of coccidia of the merogony (asexual multiplication) and gamogony (sexual phase). All stages are destroyed, and hence the mode of action is coccidiocidal.

After oral administration in cattle toltrazuril is slowly absorbed. The maximal plasma concentration (Cmax = 36.6 mg/l) was observed between 24 and 48 hours (geometric mean 33.9 hours) following oral administration. The elimination of toltrazuril is slow with a terminal half-life time of approximately 2.5 days (64.2 hours). The main metabolite is characterised as toltrazuril sulfone. The major route of excretion is via the faeces.

The metabolite of toltrazuril, toltrazuril sulfone (ponazuril) is a persistent (half-life >1 year) and mobile compound and has adverse effects on both the growth and emergence of plants. Given the persistent properties of ponazuril repeated spreading of manure from treated animals may lead to an accumulation in the soil and consequently a risk to plants. The accumulation of ponazuril in soil together with its mobility also leads to a risk of leaching to groundwater.