RILEXINE PALT TABS 300MG X 210

Target species Dogs. 4.2 Indications for use, specifying the target species For the treatment of bacterial skin infections in dogs (including deep and superficial pyodermas) caused by organisms susceptible to Cefalexin. For the treatment of urinary-tract infections in dogs (including nephritis and cystitis) caused by organisms susceptible to Cefalexin. 4.3 Contra-indications Do not use in animals known to be hypersensitive to penicillins and cephalosporins. Do not use in rabbits, guinea pigs, hamsters and gerbils. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In case of known renal insufficiency, the dose should be reduced and antimicrobials known to be nephrotoxic should not be administered concurrently. This product should not be used to treat puppies of less than 1 kg of bodyweight. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to Cefalexin and may decrease the effectiveness of treatment with penicillins due to the potential for cross-resistance. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information. Official, national and regional antimicrobial policies should be taken into account when the product is used. As the tablets are palatable to animals there is a danger of excessive ingestion. The tablets must therefore be stored out of the reach of animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. 1- Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations. 2- Handle this product with great care to avoid exposure, taking all recommended precautions. Wash hands after use. 3- If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more-serious symptoms and require urgent medical attention. 4.6 Adverse reactions (frequency and seriousness) Hypersensitivity to Cefalexin is rare, however, the product should not be administered to animals which are known to be hypersensitive to Cefalexin or penicillins. Refer also to section 4.3. Allergic cross-reactivity with other β-lactam may occur. Very rare cases of soft faeces and vomiting may be observed in animals during treatment. 4.7 Use during pregnancy, lactation or lay This product can be used in pregnant and lactating animals. 4.8 Interaction with other medicinal products and other forms of interaction The association of first-generation cephalosporins with aminoglycoside antibiotics and some diuretics such as furosemide can enhance nephrotoxicity risks. The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (tetracyclines, chloramphenicol, macrolides and rifampicin).