Veterinary Medicines

Procaine HCl 4 % + Adrenaline Oplossing voor injectie

Authorised
  • EPINEPHRINE BITARTRATE
  • Procaine hydrochloride
Download as PDF

Product identification

Medicine name:
Procaine HCl 4 % + Adrenaline Oplossing voor injectie
Procaine HCl 4 % + Adrenaline Solution injectable
Procaine HCl 4 % + Adrenaline Injektionslösung
Active substance:
  • EPINEPHRINE BITARTRATE
  • Procaine hydrochloride
Target species:
  • Horse
  • Cattle
Route of administration:
  • Perineural use
  • Infiltration
  • Epidural use
  • Subcutaneous use

Product details

Active substance and strength:
  • EPINEPHRINE BITARTRATE
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Procaine hydrochloride
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Perineural use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Infiltration
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Epidural use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01BA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Procaine HCl 4 % + Adrenaline 1 Vial with 250 ml 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:
  • Prodivet Pharmaceuticals
Marketing authorisation date:
Manufacturing sites for batch release:
  • Prodivet Pharmaceuticals
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V107791
Date of authorisation status change:

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: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download