Negara: Irlandia
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
doxycycline hydrate 500 mg/g
Vetpharma Animal Health S.L
QJ01AA02
Oral powder
doxycycline
Chicken Food, Pigs Food, Turkeys Food
2012-10-24
Baca dokumen lengkapnya 200 g and 1 kg bags 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Powdox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys [DE, DK, EL, ES, FR, HU, IT, NL, PL, PT] Doxycycline Powdox Doxycycline 500 mg/g powder for use in drinking water for pigs, chickens and turkeys [IE, UK] 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES One gram contains: ACTIVE SUBSTANCE: Doxycycline 500.0 mg (equivalent to Doxycycline hyclate 580.0 mg) 3. PHARMACEUTICAL FORM Powder for use in drinking water. Yellowish powder. 4. PACKAGE SIZE 200g bag 1kg bag 5. TARGET SPECIES Pigs (fattening pigs after weaning), Chickens (broilers, broiler breeders) and turkeys (broilers, breeders). 6. INDICATION(S) Pigs (fattening pigs after weaning): treatment of clinical respiratory infections caused by _Mycoplasma hyopneumoniae_ and _Pasteurella multocida_ susceptible to doxycycline. Chickens (broilers, broiler breeders) and turkeys (broilers, breeders): treatment of clinical respiratory infections associated with _Mycoplasma gallisepticum_ susceptible to doxycycline. 7. METHOD AND ROUTE(S) OF ADMINISTRATION To be administered in drinking water. In pigs and chickens, 23.1 mg doxycycline hyclate per kg of body weight daily (equivalent to 40.0 mg product per kg of body weight), administered in the drinking water for 5 consecutive days. In turkeys, 28.8 mg doxycycline hyclate per kg of body weight daily (equivalent to 50.0 mg product per kg of body weight)
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Powdox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys [DE, DK,EL,ES,FR; HU, , IT,NL,PL,PT,] Powdox Doxycycline 500 mg/g powder for use in drinking water for pigs, chickens and turkeys [IE, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram contains: ACTIVE SUBSTANCE: Doxycycline 500.0 mg (equivalent to Doxycycline hyclate 580.0 mg) For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for use in drinking water Yellowish powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (fattening pigs after weaning), chickens (broilers, broilers breeders) and turkeys (broilers, breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs (fattening pigs after weaning): treatment of clinical respiratory infections caused by _Mycoplasma hyopneumoniae_ and _Pasteurella multocida_ susceptible to doxycycline. Chickens (broilers, broiler breeders ) and turkeys (broilers, breeders): treatment of clinical respiratory infections associated with _Mycoplasma gallisepticum_ susceptible to doxycycline. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with hepatic dysfunction. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Page 2 of 6 The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of drinking water, Baca dokumen lengkapnya