Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Doxycycline Hyclate
Ceva Animal Health Ltd
QJ01AA02
Doxycycline Hyclate
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs
Antimicrobial
Expired
2011-09-06
Revised: July 2016 AN: 01402/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Doxyval 500 mg/g powder for use in drinking water for pigs and chickens Sogedoxy 500 mg/g powder for use in drinking water for pigs and chickens (CZ) Doxyval Vet (DK) Doxyval 433 mg/g powder for use in drinking water for pigs and chickens (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per gram: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline base) EXCIPIENTS: For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for use in drinking water Yellow to pale yellow powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens (broiler, pullet, breeder). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by _ Actinobacillus pleuropneumoniae, Pasteurella multocida_, and _Mycoplasma hyopneumoniae _susceptible to doxycycline. Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by _Pasteurella multocida _ or to reduce morbidity and lesions in respiratory infections caused by _Ornithobacterium rhinotracheale (ORT)_. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of excipients. Do not use in animals with an impaired liver function. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES. None. Revised: July 2016 AN: 01402/2015 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially susceptibility of _A. pleuropneumoniae _and _O. rhinotracheale _ may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended. Use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on Read the complete document