Pays: Irlande
Langue: anglais
Source: 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)
200 Mg/Ml
Infus/Pdr/Oral Soln
POM
Fowl - Chicken, Porcine
Doxycycline
Antibacterial
Authorised
2011-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DFV DOXIVET 200 mg/ml, solution for use in drinking water for pigs and chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 ml: ACTIVE SUBSTANCE: Doxycycline hyclate 230 mg Equivalent to 200 mg doxycycline base EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for use in drinking water Clear yellow-brown solution. 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, Lire le document complet