Veterinary Medicines

Baytril 100 mg/ml solution for injection

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
Baytril 100 mg/ml solution for injection
Baytril 100 mg/ml инжекционен разтвор
Active substance:
  • Enrofloxacin
Target species:
  • Sheep
  • Cattle
  • Goat
  • Pig
Route of administration:
  • Subcutaneous use
  • Intravenous use
  • Subcutaneous use
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        4
        day
      • Milk
        3
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
  • Subcutaneous use
    • Goat
      • Meat and offal
        6
        day
      • Milk
        4
        day
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Brown glass (type I) vials with a chlorobutyl polytetrafluoroethylene (PTFE) stopper and with a flip-off cap with aluminium case and plastic flip-off button.
  • Brown glass (type I) vials with a chlorobutyl polytetrafluoroethylene (PTFE) stopper and with a flip-off cap with aluminium case and plastic flip-off button.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2637
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0126/001
Concerned member states:
  • Bulgaria

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
Download