NOAH Compendium

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Date: Wednesday, June 26, 2019 0:51

Release 3.158
Baycox 50 mg/ml Oral Suspension for Piglets, Calves and Lambs
 
Species: Cattle, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Coccidiocides
Active ingredient: Toltrazuril
Product:Baycox® 50 mg/ml Oral Suspension for Piglets, Calves and Lambs
Product index: Baycox 50 mg/ml Oral Suspension for Piglets, Calves and Lambs
Cattle - milk: See notes
Cattle - meat: 63 days
Sheep - meat: 42 days
Pig - meat: 77 days
Withdrawal notes: Do not use in milking cows or sheep producing milk for human consumption.
Presentation
Baycox 50 mg/ml oral suspension for Piglets, Calves and Lambs is a white or 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
Target species - Pig (Piglet)
Cattle (Calves - on dairy farms)
Sheep (Lambs)
Piglets
For the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.
Calves
For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in housed 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.
Lambs
For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in lambs on farms with a confirmed history of coccidiosis caused by Eimeria crandallis and Eimeria ovinoidalis.
Dosage and administration
The ready-to-use oral suspension must be shaken before use.
Piglets: Individual animal treatment. Each pig to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. Due to the small volumes required to treat individual piglets, use of dosing equipment with a dose accuracy of 0.1 ml is recommended. Treatment during an outbreak will be of limited value for the individual piglet because of damage to the small intestine having already occurred.
Calves: 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.
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.
Lambs: Each animal should be treated with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period.
If animals are to be treated collectively rather than individually, they should be grouped according to their body weight and dosed accordingly, in order to avoid under- or over-dosing.
Use during pregnancy and lactation
Laboratory studies in rat and rabbit have not produced any evidence of a teratogenic, foetotoxic or maternotoxic effect.
Contra-indications, warnings, etc
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.
For more details see environmental safety.
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 animals in a pen.
Hygienic measures may reduce the risk of 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 healthy piglets and calves without signs of intolerance.
No signs of overdose have been observed in lamb safety studies with threefold overdose at a single treatment and twofold overdose treatment on 2 consecutive days.
 
Withdrawal period(s)
Piglets
Meat and offal: 77 days
Calves
Meat and offal: 63 days
Not permitted for use in lactating animals producing milk for human consumption.
Lambs
Meat and offal: 42 days
Not permitted for use in lactating sheep producing milk for human consumption.
User Safety
Wash any splashes from skin or eyes immediately with water.
Environmental Safety
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.
For environmental reasons:
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.
Lambs kept throughout the whole life span indoors under an intensive rearing system must not be treated beyond the age of 6 weeks or body weight of more than 20 kg at treatment. Manure from these animals should only be applied to the same piece of land every third year.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Pharmaceutical precautions
No special precautions for storage.
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf-life after first opening the container: 3 months.
Legal category
Legal category: POM-V
Packaging quantities
High density polyethylene bottles containing 250 or 1,000 ml of a white or yellowish suspension with a green polypropylene screw cap.
Further information
Pharmacotherapeutic group: Antiprotozo-products, ATCvet code: QP51AJ01
Toltrazuril is a triazinon derivative. It acts against coccidia of the genus Isospora and Eimeria. It is acting against all intracellular development stages of coccidia of the merogony (asexual multiplication) and gamogony (sexual phase). All stages are destroyed, thus the mode of action is coccidiocidal.
Piglets
After oral administration toltrazuril is slowly absorbed with a bioavailability of ≥70%. The main metabolite is characterised as toltrazuril sulfone. The elimination of toltrazuril is slow with a half-life elimination time around 3 days. The major route of excretion is via the faeces.
Calves
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.
Lambs
After oral administration toltrazuril is slowly absorbed in mammals. The main metabolite is characterised as toltrazuril sulfone. The maximal plasma concentration (Cmax = 62 mg/L) was observed 2 days following oral administration. The elimination of toltrazuril is slow with an elimination half-life time of approximately 9 days. The major route of excretion is via the faeces.
Environmental properties
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.
Marketing Authorisation Number
Vm 00010/4170
Significant changes
GTIN
GTIN description:Baycox 50 mg/ml oral suspension for Piglets, Calves and Lambs (250ml)
GTIN:04007221028598
GTIN description:Baycox 50 mg/ml oral suspension for Piglets, Calves and Lambs (1 Litre)
GTIN:04007221028581