Veterinary Medicines

Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Oplossing voor injectie

Authorised
  • Procaine hydrochloride
  • EPINEPHRINE BITARTRATE
Download as PDF

Product identification

Medicine name:
Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Oplossing voor injectie
Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Injektionslösung
Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Solution injectable
Active substance:
  • Procaine hydrochloride
  • EPINEPHRINE BITARTRATE
Target species:
  • Cattle
  • Sheep
  • Pig
  • Horse
Route of administration:
  • Epidural use
  • Intramuscular use
  • Subcutaneous use
  • Perineural use

Product details

Active substance and strength:
  • Procaine hydrochloride
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • EPINEPHRINE BITARTRATE
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Epidural use
    • Cattle
      • Meat and offal
        3
        day
  • Intramuscular use
    • Sheep
      • Meat and offal
        3
        day
    • Pig
      • Meat and offal
        3
        day
    • Cattle
      • Meat and offal
        3
        day
    • Horse
      • Meat and offal
        3
        day
  • Subcutaneous use
    • Pig
      • Meat and offal
        3
        day
    • Sheep
      • Meat and offal
        3
        day
    • Cattle
      • Meat and offal
        3
        day
    • Horse
      • Meat and offal
        3
        day
  • Perineural use
    • Cattle
      • Meat and offal
        3
        day
    • Horse
      • Meat and offal
        3
        day
    • Pig
      • Meat and offal
        3
        day
    • Sheep
      • Meat and offal
        3
        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
Available in:
  • Belgium
Package description:
  • Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Solution for injection Vial of 500 ml
  • Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Solution for injection Vial of 250 ml
  • Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Solution for injection Vial of 100 ml
  • Procainii Chloridum 4 % + Adrenalinum 40 mg/ml Solution for injection Vial of 50 ml

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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V093335
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.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

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

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