Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
halofuginone
Intervet International BV
QP51AX08
halofuginone
Calves, newborn
Antiprotozoals
In newborn calvesPrevention 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 oocyst excretion has been demonstrated.
Revision: 9
Authorised
1999-10-29
12 B. PACKAGE LEAFLET 13 PACKAGE LEAFLET: HALOCUR 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: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release: Intervet Productions S.A. Rue de Lyons 27460 Igoville France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS The veterinary medicinal product is a canary yellow oral solution. HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt). 4. INDICATION(S) 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 5. 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. 6. ADVERSE REACTIONS An increase in the level of diarrhoea has been observed in treated animals in very rare cases. 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 ) 14 - 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 (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Halofuginone base 0.50 mg/ml (as lactate salt) EXCIPIENTS: Benzoic acid (E 210) 1.00 mg/ml Tartrazine (E 102) 0.03 mg/ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral solution Canary yellow homogenous clear solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES New born calves. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. Do not use in case of diarrhoea established for more than 24 hours and in weak animals. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 3 Administer after colostrum feeding, or after milk or milk replacer feeding only, using either a syringe or any 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 Repetitive contact with the product may lead to skin allergies. Avoid skin, eye or mucosal contact with the product. Wear protective gloves while handling the product. In case of skin and eye contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Přečtěte si celý dokument