Veterinary Medicine Information website

Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection

Authorised
  • Hyoscine butylbromide
  • Metamizole sodium monohydrate
Download as PDF

Product identification

Medicine name:
Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection
Active substance:
  • Hyoscine butylbromide
  • Metamizole sodium monohydrate
Target species:
  • Cattle
  • Dog
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Hyoscine butylbromide
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Metamizole sodium monohydrate
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
    • Horse
      • Meat and offal
        12
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Pig
      • Meat and offal
        15
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA03DB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID1) 100 millilitre(s): unspecified outer container with 1 Vial (brown glass) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber)
  • (ID2) 500 millilitre(s): unspecified outer container with 5 Vial (brown glass) each with 100 millilitre(s), closed with Stopfen (bromobutyl rubber)

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:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 54527
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0159/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 500 MG-ML+4 MG-ML)
Published on: 7/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 27/03/2026
Download

2402115-paren-20221212.pdf

English (PDF)
Published on: 27/03/2026
Download