Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
Huvepharma NV
QJ01AA02
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
500 mg/g
Powder for use in drinking water
POM
Bovine, Fowl - Chicken, Fowl - Turkey
Doxycycline
Antibiotics
Authorised
2017-02-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GalluDoxx 500 mg/g powder for use in drinking water/milk replacer for calves, chickens and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline) EXCIPIENT: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for use in drinking water/milk replacer. Yellowish powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminant calves) Chickens (broilers, breeders, replacement pullets) and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle (pre-ruminant calves) For the treatment of: - Pneumonia and shipping fever caused by_ Pasteurella_ spp and_ Mannheimia haemolytica_ infections. Chickens (broilers, breeders, replacement pullets) and turkeys For the treatment of: - Ornithosis caused by_ Chlamydophila psittaci_ in turkeys; - Colibacillosis caused by_ E. coli_ in chickens and turkeys; - Chronic Respiratory Disease caused by_ Mycoplasma gallisepticum_ in chickens and turkeys. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to tetracyclines or the excipient. Do not administer to animals with severe liver or kidney insufficiency. Do not use when tetracycline resistance has been detected in the herd/flock due to the potential for cross resistance 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of drinking water or medicated milk replacer, animals should be treated parenterally. It is necessary to administer medicated milk to calves on an individual basis. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lesen Sie das vollständige Dokument