Veterinary Medicines

OPTIPRIME 400 mg/ml + 80 mg/ml, suspensie injectabilă pentru cabaline, bovine, porcine, ovine

Authorised
  • Trimethoprim
  • Sulfadiazine
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Product identification

Medicine name:
OPTIPRIME 400 mg/ml + 80 mg/ml, suspensie injectabilă pentru cabaline, bovine, porcine, ovine
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Cattle
  • Pig
  • Sheep
  • Horse
Route of administration:
  • Intravenous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Trimethoprim
    80.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sulfadiazine
    400.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        3
        day
    • Pig
      • Meat and offal
        28
        day
    • Sheep
      • Meat and offal
        28
        day
      • Milk
        3
        day
  • Intraperitoneal use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        3
        day
    • Pig
      • Meat and offal
        28
        day
    • Sheep
      • Meat and offal
        28
        day
      • Milk
        3
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • PROVET S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • PROVET S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220129
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Romanian (PDF)
Published on: 17/11/2022
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