Veterinary Medicines Information website

Biotropina Zawiesina do wstrzykiwań

Authorised
  • Streptococcus dysgalactiae subsp. dysgalactiae, Inactivated
  • Streptococcus agalactiae, Inactivated
  • Streptococcus dysgalactiae subsp. equisimilis, Inactivated
  • Streptococcus equi subsp. equi, Inactivated
  • Streptococcus equi subsp. 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 subsp. dysgalactiae, Inactivated
  • Streptococcus agalactiae, Inactivated
  • Streptococcus dysgalactiae subsp. equisimilis, Inactivated
  • Streptococcus equi subsp. equi, Inactivated
  • Streptococcus equi subsp. 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 subsp. dysgalactiae, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus agalactiae, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus dysgalactiae subsp. equisimilis, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus equi subsp. equi, Inactivated
    24.60
    milligram(s)
    /
    1.00
    millilitre(s)
  • Streptococcus equi subsp. 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 Zaklady Przemyslu 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