Veterinary Medicines

KETEXX 100 MG/ML SOLUTION FOR INJECTION

Authorised
  • Ketamine hydrochloride
Download as PDF

Product identification

Medicine name:
Ketexx, 100mg/ml, Injekční roztok
KETEXX 100 MG/ML SOLUTION FOR INJECTION
Active substance:
  • Ketamine hydrochloride
Target species:
  • Cattle
  • Rat
  • Mouse
  • Hamster
  • Guinea pig
  • Rabbit (exclusively kept as pet)
  • Cat
  • Horse
  • Dog
  • Sheep
  • Goat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    115.30
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Rat
    • Mouse
    • Hamster
    • Guinea pig
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
    • Cat
    • Horse
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Dog
  • Intravenous use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Rat
    • Mouse
    • Hamster
    • Guinea pig
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
    • Cat
    • Horse
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Sheep
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Goat
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Dog
  • Intraperitoneal use
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
    • Rat
    • Mouse
    • Hamster
    • Guinea pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Polystyrene box holding 15 vials of 50 ml
  • Carton box holding 1 vial of 10 ml
  • Carton box holding 1 vial of 20 ml
  • Carton box holding 1 vial of 50 ml
  • Carton box holding 5 vials of 10 ml
  • Carton box holding 5 vials of 20 ml
  • Carton box holding 5 vials of 50 ml
  • Polystyrene box holding 35 vials of 10 ml
  • Polystyrene box holding 28 vials of 20 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:
  • Alfasan International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/016/22-C
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0435/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 21/03/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 21/03/2025
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."