Veterinary Medicines

OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats

Authorised
  • Oxytetracycline hydrochloride
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Product identification

Medicine name:
OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats
Oxtra DD 100 mg/ml injektionsvæske, opløsning
Active substance:
  • Oxytetracycline hydrochloride
Target species:
  • Cattle
  • Dog
  • Sheep
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Oxytetracycline hydrochloride
    107.93
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        35
        day
      • Meat and offal
        35
        day
      • Milk
        72
        hour
    • Sheep
      • Meat and offal
        53
        day
      • Meat and offal
        18
        day
      • Milk
        120
        hour
    • Horse
      • Meat and offal
        6
        month
    • Pig
      • Meat and offal
        14
        day
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        35
        day
      • Milk
        72
        hour
    • Sheep
      • Meat and offal
        53
        day
      • Milk
        120
        hour
    • Horse
      • Meat and offal
        6
        month
    • Pig
      • Meat and offal
        14
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • 20 ml amber type II glass vial closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 20 ml glass vial
  • 50 ml amber type II glass vial closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 50 ml glass vial
  • 100 ml amber type II glass vial, closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 100 ml glass vial
  • 250 ml amber type II glass vial ,closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 250 ml glass vial
  • 100 ml amber type II glass vials, closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:10 x 100 ml glass vial
  • 100 ml amber PET vial, closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 100 ml PET vial
  • 250 ml amber PET vial, closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 250 ml PET vial
  • 100 ml amber PET vials, closed with chlorobutyl rubber stopper type I and sealed with an aluminium collar with a tamper-evident polypropylene seal, in a cardboard box.Pack-size:10 x 100 ml PET vial

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 62786
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0521/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 30/11/2025
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Danish (PDF)
Published on: 4/05/2022
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Combined File of all Documents

English (PDF)
Published on: 30/11/2025
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