Veterinary Medicines

Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Authorised
  • Dexamethasone sodium phosphate
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Product identification

Medicine name:
Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats
Dexa-ject 2 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Dexamethasone sodium phosphate
Target species:
  • Horse
  • Cattle
  • Dog
  • Cat
  • Pig
Route of administration:
  • Intraarticular use
  • Intramuscular use
  • Intravenous 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
    • Horse
      • Meat and offal
        8
        day
    • Pig
      • Meat and offal
        2
        day
  • Intravenous 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:
  • Poland
Available in:
  • Poland
Package description:
  • Cardboard box with 1 colourless, type I glass vial of 50 ml which is closedwith a bromobutyl rubber stopper and sealed with an aluminium cap.
  • Cardboard box with 1 colourless, type I glass vial of 100 ml which is closedwith a bromobutyl rubber stopper and sealed with an aluminium cap.

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2258
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0293/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Polish (PDF)
Published on: 18/11/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 26/04/2022
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