Negara: Italia
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
diclazuril 2.5 mg/ml
LILLY FRANCE
QP51AJ03
Oral solution
diclazuril
Cattle Young, Sheep Young
2011-07-24
_ _ _[12480 DICLAZURIL FINAL SPC Renewal ] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Diclazuril ELANCO 2.5 mg/ml Oral Suspension for lambs and calves 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: _ACTIVE SUBSTANCE: _ Diclazuril 2.5 mg _ _ _EXCIPIENTS: _ Methyl parahydroxybenzoate (E218) 1.8 mg Propyl parahydroxybenzoate (E216) 0.2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, oral suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Ovine (lambs) and bovine (calves). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In lambs: Prevention of coccidiosis caused by _Eimeria crandallis_ and _Eimeria ovinoidalis_. In calves: Prevention of coccidiosis caused by _Eimeria bovis_ and _Eimeria zuernii_. If there is no recent and confirmed history of clinical coccidiosis, the presence of coccidia in the flock or herd should be confirmed by faecal sampling prior to treatment. 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 Calves: in certain cases, only a transient reduction of oocyst shedding may be achieved. Avoid underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anticoccidials should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the Baca dokumen lengkapnya