Veterinary Medicines

Dexafast 2 mg/ml solution for injection for horses, cattle, goats, pigs, dogs and cats

Authorised
  • Dexamethasone sodium phosphate
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Product identification

Medicine name:
Dexafast 2 mg/ml solution for injection for horses, cattle, goats, pigs, dogs and cats
Dexafast 2 mg/ml injektionsvæske, opløsning
Active substance:
  • Dexamethasone sodium phosphate
Target species:
  • Horse
  • Cattle
  • Dog
  • Goat
  • Cat
  • Pig
Route of administration:
  • Intraarticular use
  • Intramuscular use
  • Intravenous use
  • Periarticular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Dexamethasone sodium phosphate
    2.63
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intraarticular use
    • Horse
      • Meat and offal
        8
        day
  • Intramuscular use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Goat
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Horse
      • Meat and offal
        8
        day
    • Pig
      • Meat and offal
        2
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Goat
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Horse
      • Meat and offal
        8
        day
    • Pig
      • Meat and offal
        6
        day
  • Periarticular use
    • Horse
      • Meat and offal
        8
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Clear glass (Type I Ph. Eur.) vial of 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 12 x 100 ml
  • Clear glass (Type I Ph. Eur.) vial of 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 6 x 100 ml
  • Clear glass (Type I Ph. Eur.) vial of 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 1 x 100 ml
  • Clear glass (Type I Ph. Eur.) vial of 50 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 12 x 50 ml
  • Clear glass (Type I Ph. Eur.) vial of 50 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of ml, 6 x 50 ml
  • Clear glass (Type I Ph. Eur.) vial of 50 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 1 x 50 ml
  • Clear glass (Type I Ph. Eur.) vial of 20 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 12 x 20 ml
  • Clear glass (Type I Ph. Eur.) vial of 20 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 6 x 20 ml
  • Clear glass (Type I Ph. Eur.) vial of 20 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Carton of 1 x 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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 60463
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0390/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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Danish (PDF)
Published on: 7/04/2025
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Combined File of all Documents

English (PDF)
Published on: 9/11/2025
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