Clavubactin Tablets are indicated for the treatment of infections in dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, particularly urinary tract, respiratory, gastrointestinal, oral and skin infections. It is highly effective against common bacteria including Staphylococci, Clostridia, Corynebacteria, Streptococci, and gram-negative bacteria including Bacteroides spp, Pasteurellae, and Proteus spp.
Clavubactin Tablets are presented as yellowish-white to light yellow round tablets with a cross shaped break mark on one side. They can be divided equally into 4 parts for easy and accurate dosing.
Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or any of the excipients.
Do not use in serious dysfunction of the kidneys accompanied by anuria and oliguria.
Do not use in rabbits, guinea pigs, hamsters, chinchillas and gerbils.
Do not use in case of known resistance to the combination.
Special warnings for each target species
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
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 β-lactam antibiotics due to the potential for cross-resistance.
In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.
Caution is advised in the use in small herbivores other than those in the section 4.3.
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 (frequency and seriousness)
Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product.
Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.
Use during pregnancy, lactation or lay
Laboratory studies in rats and mice have not produced any evidence of teratogenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
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.
Overdose (symptoms, emergency procedures, antidotes)
Mild gastrointestinal symptoms (diarrhea, nausea and vomiting) may occur more frequently after overdose of the product.