Veterinary Medicines

Biotropina Zawiesina do wstrzykiwań

Authorised
  • Streptococcus dysgalactiae, Inactivated
  • Streptococcus agalactiae, Inactivated
  • Streptococcus equisimilis, Inactivated
  • Streptococcus equi, Inactivated
  • Streptococcus zooepidemicus, Inactivated
  • STAPHYLOCOCCUS AUREUS
  • Escherichia coli (inactivated)
  • Pasteurella multocida, Inactivated
  • Erysipelothrix rhusiopathiae, Inactivated
  • SUS SCROFA SPLEEN
Download as PDF

Product identification

Medicine name:
Biotropina Zawiesina do wstrzykiwań
Active substance:
  • Streptococcus dysgalactiae, Inactivated
  • Streptococcus agalactiae, Inactivated
  • Streptococcus equisimilis, Inactivated
  • Streptococcus equi, Inactivated
  • Streptococcus zooepidemicus, Inactivated
  • STAPHYLOCOCCUS AUREUS
  • Escherichia coli (inactivated)
  • Pasteurella multocida, Inactivated
  • Erysipelothrix rhusiopathiae, Inactivated
  • SUS SCROFA SPLEEN
Target species:
  • Pig
  • Horse
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Streptococcus dysgalactiae, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus agalactiae, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus equisimilis, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus equi, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus zooepidemicus, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • STAPHYLOCOCCUS AUREUS
    74.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Escherichia coli (inactivated)
    123.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Pasteurella multocida, Inactivated
    123.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, Inactivated
    49.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • SUS SCROFA SPLEEN
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        5
        week
    • Horse
      • Meat and offal
        5
        week
    • Cattle
      • Meat and offal
        5
        week
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL03A
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 0547
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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."