Veterinary Medicines

BIOSUIS Respi E Emulsja do wstrzykiwań

Authorised
  • Actinobacillus pleuropneumoniae, Serotype 2, Inactivated
  • Actinobacillus pleuropneumoniae, serotypes 9 and 11, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Erysipelothrix rhusiopathiae, serotype 1 and 2, Inactivated
  • Haemophilus parasuis, serotype 1, 5 and 13, Inactivated
Download as PDF

Product identification

Medicine name:
BIOSUIS Respi E Emulsja do wstrzykiwań
Active substance:
  • Actinobacillus pleuropneumoniae, Serotype 2, Inactivated
  • Actinobacillus pleuropneumoniae, serotypes 9 and 11, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Erysipelothrix rhusiopathiae, serotype 1 and 2, Inactivated
  • Haemophilus parasuis, serotype 1, 5 and 13, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, Serotype 2, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serotypes 9 and 11, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX I toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX II toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, APX III toxoid
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 1 and 2, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Haemophilus parasuis, serotype 1, 5 and 13, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection/infusion
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB
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:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2969
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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: 16/03/2022
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."