Veterinary Medicines

Kelacyl 100 mg/ml Solution for Injection for Cattle and Pigs

Authorised
  • Marbofloxacin
Download as PDF

Product identification

Medicine name:
KELACYL 100 mg/ml solution for injection for cattle and pigs
Kelacyl 100 mg/ml Solution for Injection for Cattle and Pigs
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig (sow)
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Marbofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • box containing 12 vials of 250 ml individually packed in a carton box
  • box containing 12 vials of 100 ml individually packed in a carton box
  • box containing 10 vials of 250 ml individually packed in a carton box
  • box containing 10 vials of 100 ml individually packed in a carton box
  • box containing 6 vials of 250 ml individually packed in a carton box
  • box containing 6 vials of 100 ml individually packed in a carton box
  • cardboard box containing 1 vial of 250 ml
  • cardboard box containing 1 vial of 100 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Kela Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
  • Kela - Kempisch Laboratorium - Kela Laboratoria
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 06126/4006
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0189/001
Concerned member states:
  • Belgium
  • Germany
  • Luxembourg
  • Poland
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0189001-dcp-kelacyl-100-mg-ml-en.pdf

English (PDF)
Published on: 22/12/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."