Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Doxycycline hyclate
Ecuphar NV
QJ01AA02
Doxycycline hyclate
40 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
doxycycline
Authorised
2019-10-25
Health Products Regulatory Authority 13 January 2022 CRN00CM0V Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Doxycare Flavour 40 mg Tablets for Cats and Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance: Doxycycline 40 mg (equivalent to 47.88 mg of doxycycline hyclate) Excipients: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellowish, round and convex tablet with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs For the treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia caused by _Bordetella _ _bronchiseptica_, and _Pasteurella_ spp susceptible to doxycycline. _ _ For the treatment of canine ehrlichiosis caused by _Ehrlichia canis_. Cats For the treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia caused by _Bordetella _ _bronchiseptica_, and _Pasteurella_ spp susceptible to doxycycline. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with renal or hepatic insufficiency. Do not use in animals with diseases associated with vomiting or dysphagia (see also section 4.6). Do not use in animals with known photosensitivity (see also section 4.6). Do not use in puppies and kittens before completion of teeth enamel formation. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES _Ehrlichia canis_ infection: treatment should be initiated at the onset of clinical signs. Complete eradication of the pathogen is not always achieved, but treatment for 28 days generally leads to a resolution of the clinical signs and a reduction of the bacterial load. A longer duration of treatment, based on a benefit/risk assessment by the responsible veterinarian, may be required particularly in severe or chro read_full_document