Veterinary Medicine Information website

Dofatrim-Ject 40 mg - 200 mg Oplossing voor injectie

Authorised
  • Trimethoprim
  • Sulfadoxine
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Product identification

Medicine name:
Dofatrim-Ject 40 mg - 200 mg Oplossing voor injectie
Active substance:
  • Trimethoprim
  • Sulfadoxine
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Intravenous use

Product details

Active substance and strength:
  • Trimethoprim
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sulfadoxine
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        8
        day
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        2
        day
  • Subcutaneous use
    • Pig
      • Meat and offal
        8
        day
    • Cattle
      • Milk
        2
        day
      • Meat and offal
        8
        day
  • Intravenous use
    • Pig
      • Meat and offal
        8
        day
    • Cattle
      • Milk
        2
        day
      • Meat and offal
        8
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Dofatrim-Ject 250 ml Vial Solution for injection
  • Dofatrim-Ject 100 ml Vial Solution for injection

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma Research B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V215555
Date of authorisation status change:

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Package Leaflet

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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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