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BIOSUIS Respi E Emulsja do wstrzykiwań

Authorised
  • Actinobacillus pleuropneumoniae, serovar 2, Inactivated
  • Actinobacillus pleuropneumoniae, serovars 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
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Product identification

Medicine name:
BIOSUIS Respi E Emulsja do wstrzykiwań
Active substance:
  • Actinobacillus pleuropneumoniae, serovar 2, Inactivated
  • Actinobacillus pleuropneumoniae, serovars 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, serovar 2, Inactivated
    1.00
    relative potency
    /
    1.00
    millilitre(s)
  • Actinobacillus pleuropneumoniae, serovars 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
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Labelling

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Polish (PDF)
Published on: 16/03/2022
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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
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