Veterinary Medicines

KESIUM 50 MG / 12,5 MG CHEWABLE TABLETS FOR CATS AND DOGS

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
KESIUM 50 MG / 12,5 MG CHEWABLE TABLETS FOR CATS AND DOGS
Kesium 50 mg + 12,5 mg Tabletki do rozgryzania i żucia
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    57.40
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    14.90
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:
  • Box of 1 blister (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 24 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 10 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 8 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 6 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 4 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 2 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets
  • Box of 48 blisters (PA-AL-PVC – aluminium heat sealed) of 10 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Animal Health Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2174
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0225/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Polish (PDF)
Published on: 2/04/2025
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Package Leaflet

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Polish (PDF)
Published on: 2/04/2025
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Labelling

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Polish (PDF)
Published on: 2/04/2025
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