Veterinary Medicines Information website

Synulox Ready to Use Injection 140 mg/ml + 35 mg/ml suspension for injection

Authorised
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Synulox Ready to Use Injection 140 mg/ml + 35 mg/ml suspension for injection
Active substance:
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Cattle
  • Dog
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Potassium clavulanate
    64.21
    milligram(s)
    /
    1.00
    millilitre(s)
  • Amoxicillin trihydrate
    160.70
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        42
        day
      • Milk
        80
        hour
    • Pig
      • Meat and offal
        31
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        42
        day
      • Milk
        80
        hour
    • Pig
      • Meat and offal
        31
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Type III glass vials of 100 ml containing an off-white sterile, non-aqueous suspension. The vials are sealed with a rubber bungand an aluminium seal. Each vial contains a sterile off-white to pale buff coloured, smooth fluid, readily dispersable suspension.
  • Type III glass vials of 40 ml containing an off-white sterile, non-aqueous suspension. The vials are sealed with a rubber bungand an aluminium seal. Each vial contains a sterile off-white to pale buff coloured, smooth fluid, readily dispersable suspension.

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:
  • Zoetis Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/075/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/04/2025
Updated on: 14/03/2026
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