Țară: Irlanda
Limbă: engleză
Sursă: 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, Turkeys
doxycycline
Antibacterial
Authorised
2016-10-21
Health Products Regulatory Authority 23 July 2021 CRN00C433 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Altidox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Doxycycline 433 mg (equivalent todoxycycline hyclate 500 mg) 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 (post-weaning), chickens (broilers, pullets, breeders) and turkeys (broilers, pullets, breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: treatment of clinical respiratory infections caused by _Mycoplasma hyopneumoniae_ and _Pasteurella multocida_ susceptible to doxycycline. Chickens and turkeys: treatment of clinical respiratory infections associated with _Mycoplasma gallisepticum_ susceptible to doxycycline. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to tetracyclines or to the excipients. Do not use when tetracycline resistance has been detected in the herd/flock due to the potential for cross-resistance. Do not use in animals with impaired liver or kidney function. 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, animals should be treated parenterally. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety of the product has not been established in piglets before weaning. Inappropriate use of the product may increase the prevalence of bacteria resistant to tetracyclines due to the potential for cross-resistance. Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased animals on farm are highly recommended. Use of the product should be based o Citiți documentul complet