Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Halofuginone
Virbac
QP51AX08
Halofuginone
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antiprotozoal
Authorized
2019-02-08
Unlimited Renewal: August 2023 AN: 01398/2023 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Halofuginone 0.50 mg (as lactate salt) EXCIPIENTS: Benzoic acid (E 210) 1.00 mg Tartrazine (E 102) 0.03 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (newborn calves). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In new born calves: - Prevention of diarrhoea due to diagnosed _Cryptosporidium parvum_, in farms with history of cryptosporidiosis. Administration should start in the first 24 to 48 hours of age. - Reduction of diarrhoea due to diagnosed _Cryptosporidium parvum_. Administration should start within 24 hours after the onset of diarrhoea. In both cases, the reduction of oocysts excretion has been demonstrated. 4.3 CONTRAINDICATIONS Do not use on an empty stomach. Unlimited Renewal: August 2023 AN: 01398/2023 Page 2 of 7 Do not use in cases of diarrhoea established for more than 24 hours and in weak animals. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration. Do not use on an empty stomach. For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. The animals should receive enough colostrum according to good breeding practice. Special precautions to be taken by the person administering the veterinary medicinal product to animals - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution. - Repetitive contact with Citiți documentul complet