Indications for use, specifying the target species
Treatment of the following infections caused by Beta-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:
•Skin infections (including superficial and deep pyodermas) caused by susceptible Staphylococci
•Urinary tract infection caused by susceptible Staphylococci or Escherichia coli
•Respiratory infections caused by susceptible Staphylococci
•Enteritis caused by susceptible Escherichia coli
It is recommended to carry out suitable tests for sensitivity testing when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.
Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.
Do not use where resistance to this combination is known to occur.
Special Warnings for each target species
Special precautions for use
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid.
In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach.
Caution is advised in the use in small herbivores other than those in section, "Contraindications".
Do not administer to horses and ruminating 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.
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions unrelated to dose can occur with these agents.
Gastrointestinal symptoms (diarrhoea, vomiting) may occur after administration of the product.
Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
In case of occurrence of allergic reaction, the treatment should be withdrawn.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not produced any evidence of teratogenic, effects. 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 effect of penicillins because of the rapid onset of bacteriostatic action.
The potential for allergic cross-reactivity with other penicillins should be considered.
Penicillins may increase the effect of aminoglycosides.
Amounts to be administered and administration route
Administration is via the oral route. The dosage rate is 12.5 mg combined actives/kg bodyweight twice daily. The tablets may be crushed and added to a little food.
The following table is intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives/kg twice daily.
Number of tablets twice daily
More than 50
Duration of therapy:
Routine cases involving all indications: The majority of cases respond to between 5 and 7 days therapy.
Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required in that it allows sufficient time for damaged tissue to repair.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The product is of a low order of toxicity and is well tolerated by the oral route.
In a tolerance study a tested dose of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 8 days did not demonstrate adverse effects.