Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Toltrazuril
Industrial Veterinaria, S.A.
QP51AJ01
Toltrazuril
50 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
toltrazuril
Coccidiostats
Authorised
2014-07-04
Health Products Regulatory Authority 10 June 2019 CRN008PQK Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Espacox 50 mg/ml oral suspension for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Toltrazuril 50 mg EXCIPIENTS: Sodium benzoate (E211) 2.1 mg Sodium propionate (E281) 2.1 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. White or yellowish suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (Piglets, 3 - 5 days old). 4.2 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 _Cystoisospora suis_ (_Isospora suis_). 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As with any antiparasiticide, frequent and prolonged use of an antiprotozoal of the same class of active substance and underdosing due to underestimation of the live weight may result in the development of resistances. It is recommended to treat all piglets in a litter. 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. Health Products Regulatory Authority 10 June 2019 CRN008PQK Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the perso Olvassa el a teljes dokumentumot