Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
Krka, d.d., Novo mesto
QJ01AA02
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
500 mg/g
Powder for use in drinking water
POM
Fowl - Chicken, Porcine
Doxycycline
Antibacterial
Authorised
2016-09-09
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 1 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 12/09/2016_ _CRN 7021913_ _page number: 1_ 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 Lesen Sie das vollständige Dokument