Country: Ungverjaland
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
doxycycline hyclate 500 mg/ml
Eurovet Animal Health
QJ01AA02
Powder for oral solution
doxycycline
Turkeys
2012-05-07
Issued: August 2012 AN: 01495/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for turkeys _FR: Soludox 433 mg/g powder for use in drinking water for turkeys _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of powder contains: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline _FR: Doxycycline _ _ _ _433 mg, corresponding to 500 mg doxycycline hyclate _ EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for use in drinking water Yellow crystalline powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Turkeys (broilers, breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Turkeys: treatment of clinical respiratory infections associated with Mycoplasma gallisepticum susceptible to doxycycline 4.3 CONTRA-INDICATIONS Do not use in case of known hypersensitivity to the active substance or to any of the excipients. Do not use in animals with hepatic dysfunction. 4.4 SPECIAL WARNING FOR EACH TARGET SPECIES. The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of drinking water, turkeys should be treated parenterally. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Inappropriate use of the product may increase the prevalence of bacteria resistant to tetracycline due to the potential for cross resistance. Do not use when tetracycline resistance has been detected in the herd/flock. Issued: August 20 Lestu allt skjalið