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POLYPLEUROSIN APX PLUS IM, Injekční emulze

Authorised
  • Actinobacillus pleuropneumoniae, serovar 9, strain WSLB 3013, Inactivated
  • Actinobacillus pleuropneumoniae, serovar 2, strain WSLB 3012, Inactivated
  • Bordetella bronchiseptica, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Pasteurella multocida, serogroup A, Inactivated
  • Pasteurella multocida, serogroup D, Inactivated
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Product identification

Medicine name:
POLYPLEUROSIN APX PLUS IM, Injekční emulze
Active substance:
  • Actinobacillus pleuropneumoniae, serovar 9, strain WSLB 3013, Inactivated
  • Actinobacillus pleuropneumoniae, serovar 2, strain WSLB 3012, Inactivated
  • Bordetella bronchiseptica, Inactivated
  • Actinobacillus pleuropneumoniae, APX I toxoid
  • Actinobacillus pleuropneumoniae, APX II toxoid
  • Actinobacillus pleuropneumoniae, APX III toxoid
  • Pasteurella multocida, serogroup A, Inactivated
  • Pasteurella multocida, serogroup D, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Actinobacillus pleuropneumoniae, serovar 9, strain WSLB 3013, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, serovar 2, strain WSLB 3012, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bordetella bronchiseptica, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX I toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX II toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Actinobacillus pleuropneumoniae, APX III toxoid
    1.00
    relative potency
    /
    1.00
    Dose
  • Pasteurella multocida, serogroup A, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Pasteurella multocida, serogroup D, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
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:
  • Czechia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/032/03-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 11/04/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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