Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
DOXYCYCLINE HYCLATE PH. EUR. (EQUIVALENT TO DOXYCYCLINE BASE)
Divasa-Farmavic S.A.
QJ01AA02
DOXYCYCLINE HYCLATE PH. EUR. (EQUIVALENT TO DOXYCYCLINE BASE)
500 mg/g
Powder for use in drinking water
POM
Fowl - Chicken, Porcine
Doxycycline
Antibacterial
Authorised
2012-02-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DFV DOXIVET 500 mg/g, powder for use in drinking water for pigs and chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 g: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline base) EXCIPIENTS: For a 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 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 ________________________________________________________________________________________________________________________ _Date Printed 14/11/2016_ _CRN 7024747_ _page number: 1_ 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, Aqra d-dokument sħiħ