Veterinary Medicines

Synulox Lactating Cow Intramammary suspension.

Authorised
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Synulox Lactating Cow Intramammary suspension.
Avuloxil, suspensie voor intramammair gebruik voor melkgevende runderen
Active substance:
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Prednisolone
    10.00
    milligram(s)
    /
    1.00
    Syringe
  • Amoxicillin trihydrate
    200.00
    milligram(s)
    /
    1.00
    Syringe
  • Potassium clavulanate
    59.56
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Milk
        60
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RV01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Low density polyethylene syringes packed in cartons containing 12 syringes.
  • Low density polyethylene syringes packed in cartons containing 24 syringes.
  • Low density polyethylene syringes packed in cartons containing 300 syringes.
  • Low density polyethylene syringes packed in cartons containing 3 syringes.

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 B.V.
Marketing authorisation date:
This information is not available for this product.
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 9427
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0605/001
Concerned member states:
  • Austria
  • Bulgaria
  • Cyprus
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 25/07/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."