Target species
Clavudale 40 mg/10 mg - Cats and dogs.
Clavudale 200 mg/50 mg and 400 mg/100 mg - Dogs
Indications for use
For the treatment of bacterial infections susceptible to amoxicillin in combination with clavulanic acid where clinical experience and/or sensitivity testing indicates the product as the drug of choice.
Uses include:
Skin infections (including deep and superficial pyodermas) associated with Staphylococcus spp. and Streptococcus spp.;
Infections of the oral cavity (mucous membrane) associated with Clostridium spp., Corynebacterium spp., Staphylococcus spp., Streptococcus spp., Bacteroides spp. and Pasteurella 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.;
Gastrointestinal infections associated with Escherichia coli and Proteus mirabilis.
Contraindications
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in animals with known hypersensitivity to penicillin or substances of the ?-lactam group or any of the excipients.
Do not use in animals with either oliguria or anuria associated with renal dysfunction.
Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.
Special precautions for use in animals
Caution is advised on the use of the product in small herbivores other than those listed in Contraindications.
In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated.
Use of the product should be based on susceptibility testing and should take into account official national and regional policies with respect to the use of broad spectrum antibiotics. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin and clavulanic acid, and may decrease the effectiveness of treatment with other ?-lactam antibiotics, due to the potential for cross-resistance.
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.
Adverse reactions
Mild gastrointestinal signs (diarrhoea and vomiting) may occur after administration of the product.
Allergic reactions (skin reactions, anaphylaxis), blood dyscrasia and colitis may occasionally occur. In these cases, discontinue administration and give symptomatic treatment.
Use during pregnancy and lactation
Laboratory studies in rats and mice have not produced any evidence of teratogenic or foetotoxic effects. No studies have been conducted in pregnant or lactating dogs or cats. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
Bacteriostatic antibiotics (e.g. chloramphenicol, macrolides, sulfonamides and tetracyclines) may inhibit the antibacterial effects of penicillins.
The potential for allergic cross-reactivity with other penicillins should be considered.
Penicillins may increase the effect of aminoglycosides.