Target species Dogs 4.2 Indications for use, specifying the target species In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Streptococcus spp and Escherichia coli. 4.3 Contraindications Do not use in cases of hypersensitivity to penicillins or other substances of the β-lactam group or to any of the excipients. Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not administer to horses and ruminating animals. Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria. Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid. 4.4 Special warnings for each target species None 4.5 Special precautions for use Special precautions for use in animals In animals with impaired liver and kidney function, the use of the product should be subject to a risk/benefit evaluation by the veterinary surgeon and the posology evaluated carefully. Caution is advised in the use in small herbivores other than those in 4.3. Use of the product should be based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other β-lactam antibiotics, due to the potential for cross resistance. Use of the product should take into account official and local antimicrobial policies. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance. 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 penicillins may lead to cross reactions to cephalosporins 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. 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 breathing are more serious symptoms and require urgent medical attention. Wash hands after handling the tablets. 4.6 Adverse reactions (frequency and seriousness) Vomiting and diarrhoea may be observed very rarely. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon. Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may be observed very rarely. In these cases, administration should be discontinued and a symptomatic treatment given. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay The safety of the product has not been established during pregnancy and lactation. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only in accordance with the the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction The bactericidal activity of amoxicillin may be reduced by the simultaneous use of bacteriostatic substances such as macrolides, tetracyclines, sulfonamides and chloramphenicol. The potential for allergic cross-reactivity with other penicillins should be considered. Penicillins may increase the effect of aminoglycosides.