Veterinary Medicines

Xyla, 20 mg/ml solution for injection for cattle, horses, dogs and cats

Authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
Xyla, 20 mg/ml solution for injection for cattle, horses, dogs and cats
Sedachem 20 mg/ml Oplossing voor injectie
Sedachem 20 mg/ml Solution injectable
Sedachem 20 mg/ml Injektionslösung
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cattle
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    23.32
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Dog
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Dog
    • Cat
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 50 ml clear, type II glass bottle, closed with a bromobutyl rubber stopper and secured with an aluminium cap. Package size: 5x50 ml in a cardboard box.
  • 50 ml clear, type II glass bottle, closed with a bromobutyl rubber stopper and secured with an aluminium cap. Package size: 1x50 ml in a cardboard box.

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:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V574533
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0105/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
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German (PDF)
Published on: 19/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
Download
German (PDF)
Published on: 19/03/2025
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