מדינה: הולנד
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
doxycycline hyclate 500 mg/g
Eurovet Animal Health
QJ01AA02
Powder for oral solution
doxycycline
Chicken Food, Pigs Food
2011-08-25
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 2/19 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens _Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only) _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of powder contains: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline _France: 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 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 CONTRA-INDICATIONS 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 WARNING FOR EACH TARGET SPECIES. None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to likely variability (time, geographica קרא את המסמך השלם