Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Doxycycline Hyclate
Krka d.d., Novo Mesto
QJ01AA02
Doxycycline Hyclate
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs
Antimicrobial
Authorized
2016-09-08
Revised: September 2021 AN: 01652/2020 & 01663/2020 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Doxatib 500 mg/g powder for use in drinking water for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of powder contains: ACTIVE SUBSTANCE: Doxycycline hyclate 500 mg (corresponding to 433 mg of doxycycline) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for use in drinking water. Pale yellow to yellow powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens (broilers, pullets, broiler breeders). 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 known cases of hypersensitivity to tetracyclines or to any of the excipients. Do not use in animals with an impaired liver function. Do not use in animals with renal disorders. Do not use when tetracycline resistance has been detected in the herd/flock due to the potential for cross resistance. Revised: September 2021 AN: 01652/2020 & 01663/2020 Page 2 of 7 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 Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the Read the complete document