Veterinary Medicines

Oxytocine Kela 10 IU/ml Solution injectable

Authorised
  • Oxytocin
Download as PDF

Product identification

Medicine name:
Oxytocine Kela 10 IU/ml Solution injectable
Oxytocine Kela 10 IU/ml Injektionslösung
Active substance:
  • Oxytocin
Target species:
  • Cattle
  • Sheep
  • Goat
  • Pig
  • Dog
  • Cat
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Oxytocin
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal, milk
        0
        day
    • Sheep
      • Meat and offal, milk
        0
        day
    • Goat
      • Meat and offal, milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Dog
    • Cat
    • Horse
      • Meat and offal, milk
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal, milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal, milk
        0
        day
    • Dog
    • Cat
  • Subcutaneous use
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • Oxytocine Kela 1 x 10 ml Vial Solution for injection
  • Oxytocine Kela 12 x 10 ml Vial Solution for injection
  • Oxytocine Kela 1 x 30 ml Vial Solution for injection
  • Oxytocine Kela 12 x 30 ml Vial Solution for injection
  • Oxytocine Kela 1 x 50 ml Vial Solution for injection
  • Oxytocine Kela 12 x 50 ml Vial Solution for injection
  • Oxytocine Kela 1 x 100 ml Vial Solution for injection
  • Oxytocine Kela 12 x 100 ml Vial Solution for injection

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) 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:
  • Ministry Of Health
Authorisation number:
  • V 188/18/05/1691
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/07/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/07/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/07/2024
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."