Target species: Dogs 4.2. Indications for use, specifying the target species: For the treatment of the following infections caused by -lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice: - Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.. - Urinary tract infections associated with Staphylococcus spp., Streptococcus spp., Escherichia coli and Proteus mirabilis. - Respiratory tract infections associated with Staphylococcus spp., Streptococcus spp. and Pasteurella spp.. - Digestive tract infections associated with Escherichia coli. - Infections of the oral cavity (mucous membrane) associated with Pasteurella spp., Streptococcus spp., Escherichia coli. 4.3. Contraindications Do not use in animals with hypersensitivity to penicillins or other substances of the β-lactam group or to any excipients. Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria. Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals. Do not use where resistance to this combination is known to occur. 4.4. Special warnings for each target species None known. 4.5. Special precautions for use Special precautions for use in animals Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics. In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon. Caution is advised in the use in small herbivores other than those in the section 4.3. The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the 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 penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a 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. Wash hands after use. 4.6. Adverse Reactions (frequency and seriousness) Mild gastrointestinal signs (diarrhoea, and vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon. Allergic reactions (skin reactions, anaphylaxis) may occasionally occur. 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 Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the product has not been assessed in pregnant and lactating bitches. In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian. 4.8. Interaction with other medicinal products and other forms of interaction Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. Penicillins may increase the effect of aminoglycosides.