Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Doxycycline hyclate
Eurovet Animal Health B.V.
QJ01AA02
Doxycycline hyclate
500 milligram(s)/gram
Powder for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Pigs
doxycycline
Antibacterial
Authorised
2018-02-09
Health Products Regulatory Authority 12 February 2018 CRN000W4C Page 1 of 7 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g powder contains: Active substance: Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline Excipients: For the 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 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, clinical signs and to reduce lesions due to Pasteurellosis caused by _Pasteurella _ _multocida_, or to reduce morbidity and lesions due to respiratory infections caused by _Ornithobacterium rhinotracheale_ (ORT). 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with an impaired liver function. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 12 February 2018 CRN000W4C Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Due to likely variability (time, geographical) in susceptibility of bacteria to doxycycline, especially susceptibility of A. _pleuropneumoniae_ and O. _rhinotracheale_ which 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 the culture and sensitivity of micro-organisms from diseased cases on farms. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about su Read the complete document