Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
doxycycline hyclate
Merial Animal Health Limited
QJ01AA02
100 mg/tablet
Tablets
Canine
Antibacterial
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ronaxan 100 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ACTIVE SUBSTANCE : Doxycycline 100 mg (as doxycycline hyclate) For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Round, biconvex, light yellow to yellow scored tablet. The tablets can be divided into equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia in dogs due to organisms sensitive to doxycycline including: _Pasteurella _spp., _Bordetella bronchiseptica_, _Staphylococcus aureus _and other _Staphylococcus _spp, and _Streptococcus _spp. Treatment of arthropod-borne _Ehrlichia canis _infection. 4.3 CONTRAINDICATIONS Do not use in pregnant animals. Do not use in known cases of hypersensitivity to the active ingredient. Vomiting, oesophagitis and oesophageal ulcerations have been reported as side effects following doxycycline therapy, and Ronaxan should not therefore be administered to patients with dysphagia or diseases accompanied by vomiting. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/03/2014_ _CRN 7013952_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not exceed the recommended dosage. Tablets should be administered at feeding time. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash hands thoroughly after use. Handle the tablets with care if you know you are hypersensitive (allergic) to tetracycline. In case of Read the complete document