Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
halofuginone lactate
Emdoka BVBA
QP51AX08
halofuginone
Calves, newborn
halofuginone, Other antiprotozoal agents
In newborn calves:Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, 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 infection. Administration should start within 24 hours after the onset of diarrhoea. In both cases, the reduction of oocysts excretion has been demonstrated.
Revision: 4
Authorised
2016-12-13
15 B. PACKAGE LEAFLET _ _ 16 _ _ PACKAGE LEAFLET: HALAGON 0.5 MG/ML ORAL SOLUTION FOR CALVES 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorisation Holder: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Manufacturer responsible for batch release: Divasa-Farmavic, S.A. Ctra. Sant Hipolit, Km. 71 08503 Gurb-Vic, Barcelona Spain 2. NAME OF THE VETERINARY MEDICINAL PRODUCT HALAGON 0.5 mg/ml oral solution for calves halofuginone (as lactate salt) 3. STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS Each ml contains: ACTIVE SUBSTANCE: Halofuginone (as lactate salt) 0.50 mg Equivalent to 0.6086 mg of halofuginone lactate EXCIPIENTS: Benzoic acid (E210) 1 mg Tartrazine (E102) 0.03 mg Clear yellow oral solution. 4. INDICATION(S) In new-born calves: • Prevention of diarrhoea due to diagnosed _Cryptosporidium parvum _ infection, 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 _ infection. Administration should start within 24 hours after the onset of diarrhoea. In both cases, the reduction of oocysts excretion has been demonstrated. 5. CONTRAINDICATIONS 17 Do not use on an empty stomach. Do not use in case 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. 6. ADVERSE REACTIONS An increase in the level of diarrhoea has been observed in very rare cases in treated animals. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (l Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALAGON 0.5 mg/ml oral solution for calves _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Halofuginone (as lactate salt) 0.50 mg Equivalent to 0.6086 mg of halofuginone lactate EXCIPIENTS: Benzoic acid (E210) 1 mg Tartrazine (E102) 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 newborn calves: • Prevention of diarrhoea due to diagnosed _Cryptosporidium parvum_ infection, 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_ infection. 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. Do not use in case 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 FOR EACH TARGET SPECIES None. 3 4.5. SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Administer after colostrum feeding, or after milk or milk replacer feeding only. An appropriate device for oral administration is included. For treatment of anorexic calves, the product should be administered in half a liter 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 the product may lead to skin allergi Citiți documentul complet