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 infections 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 when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.
Do not use in animals with known cases of hypersensitivity to penicillins 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 kidneys accompanied by anuria or oliguria.
Do not use where resistance to the 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, "Containdications".
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.
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 package leaflet or the label to the physician. 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 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 risk/benefit assessment by the responsible veterinarian.
Interactions with Other Medicinal Products and Other Forms of Interaction
Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillin because of the rapid onset of bacteriostatic action.
The potential for allergic cross-reactivity with other penicillins should be considered.
Penicillins may increase the effects of aminoglycoside.
Amounts to be Administered and Administration
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
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/kg twice daily.
Number of tablets (500 mg) per dose twice daily
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
No adverse effects have been reported after the daily administration of 3 times the recommended dose for 8 days, and after the daily administration of the recommended dose for 21 days.