国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Toltrazuril
Elanco GmbH
QP51AJ01
Toltrazuril
50 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
toltrazuril
Authorised
2009-01-30
Health Products Regulatory Authority 16 October 2020 CRN009PNN Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Sheep, 50 mg/ml oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 ml contains: Toltrazuril 50.0 mg EXCIPIENTS: Sodium benzoate (E211) 2.1 mg Sodium propionate (E281) 2.1 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM White or yellowish oral suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES For Sheep (lambs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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_. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 lambs in a pen. Hygienic measures may reduce the risk of ovine 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION FOR USE IN ANIMAL None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash any splashes from skin or eyes immediately with water. For environmental reasons: Health Products Regulatory Authority 16 October 2020 CRN009PNN Page 2 of 4 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. The major metabolite of toltrazuril, toltrazuril sulfone (pona 完全なドキュメントを読む