Espacox 50 mg/ml oral suspension for pigs.
Pigs (Piglets, 3 - 5 days old).
Indications for use, specifying the target species
For the prevention of clinical signs of coccidiosis in neonatal piglets (3 - 5 days old) on farms with a confirmed history of coccidiosis caused by Isospora suis.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
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.
Special precautions for use
Special precautions for use in animals
To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.
As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to toltrazuril, or any of the excipients, should avoid contact with the veterinary medicinal product.
Avoid skin and eye contact with the product.
Wash any splashes from skin or eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Adverse reactions (frequency and seriousness)
Use during pregnancy, lactation or lay
Interaction with other medicinal products and other forms of interaction
There is no interaction in combination with iron supplementation.
Amounts to be administered and administration route
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.
The oral suspension must be shaken before use.
Treatment during an outbreak will be of limited value for the individual piglet because of damage to the small intestine having already occurred.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of intolerance were observed in piglets up to threefold overdose.
Meat and offal: 73 days
ATCvet code: QP51AJ01
Toltrazuril is a triazinon derivative. It acts against coccidia of the genus Isospora. 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.
After oral administration toltrazuril is slowly absorbed with a bioavailability of 70%. The maximum concentration (Cmax) of toltrazuril is of 15.1 µg/ml and is obtained after around 24 h. 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.
List of excipients
Sodium benzoate (E211)
Sodium propionate (E281)
Citric acid, anhydrous
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 6 months.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
The product is filled into high density polyethylene (HDPE) bottles with a nominal capacity of 250 or 1000 ml. The bottles are heat-sealed with a polyethylene (PE) foil and are closed with a screw cap made of HDPE equipped with a security system to give an airtight sealing.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
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