Clavaseptin 750 mg Palatable Tablets for Dogs

Cross-resistance has been shown between amoxicillin/clavulanic acid and β-lactam
antibiotics. Use of the veterinary medicinal product should be carefully considered
when susceptibility testing has shown resistance to βlactam antibiotics because its
effectiveness may be reduced.
Methicillin resistant S. aureus (MRSA) and methicillin resistant S. pseudintermedius
(MRSP) have been isolated in cats and dogs with proportion of resistance that varies
across EU countries.
Do not use in cases of known resistance to the combination of amoxicillin and
clavulanic acid.
Do not use in cases of suspected or confirmed MRSA/MRSP infections, as isolates
should be considered resistant to all β-lactam including amoxicillin/clavulanic acid
combination.
High resistances (up to 100%) have been reported in E. coli isolates from skin and
soft tissue infections in dogs.

Special precautions for safe use in the target species:
In animals with impaired liver and kidney function, the use of the veterinary medicinal
product should be subject to a benefit/risk evaluation by the veterinary surgeon and
the posology evaluated carefully.
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogen(s). If this is not possible, therapy should
be based on epidemiological information and knowledge of susceptibility of the target
pathogens at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national
and regional antimicrobial policies.
Aminopenicillins in combination with beta-lactamase inhibitors are in AMEG category
„C”. An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance
selection should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of the animals.
The potential for allergic cross-reactivity with other penicillins should be considered.
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 veterinary medicinal product if you know you are sensitised, or if
you have been advised not to work with such preparations.
Handle this veterinary medicinal product with great care to avoid exposure, taking all
recommended precautions.
If you develop symptoms following exposure, such as skin rash, you should seek
medical advice and show the doctor this warning.
Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms
and require urgent medical attention.
Wash hands after handling the tablets.
Accidental ingestion of the veterinary medicinal product by a child may be harmful.
To avoid accidental ingestion, particularly by a child, unused part-tablets should be
returned to the open blister space and inserted back into the carton.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.