Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats
Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats
Authorised
- Dexamethasone sodium phosphate
Product identification
Medicine name:
Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats
Dexaject 2 mg/ml injektionsvæske, opløsning
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 phosphate2.63milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intraarticular use
- Horse
-
Meat and offal8day
-
-
Intramuscular use
- Cattle
-
Meat and offal8day
-
Milk72hour
-
- Dog
- Horse
-
Meat and offal8day
-
- Cat
- Pig
-
Meat and offal2day
-
-
Intravenous use
- Horse
-
Meat and offal8day
-
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:
- Cardboard box with 1 colourless, type I glass vial of 50 ml which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
- Cardboard box with 1 colourless, type I glass vial of 100 ml which is closed with 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:
- Danish Medicines Agency
Authorisation number:
- 49408
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 11/02/2022
Danish (PDF)
Published on: 26/09/2023
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