Veterinary Medicines

Suiseng Coli /C Suspension for injection for pigs

Authorised
  • Clostridium perfringens, type C, beta toxoid
  • Clostridium novyi, type B, alpha toxoid
  • Escherichia coli, fimbrial adhesin F6
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, LT toxoid
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Product identification

Medicine name:
Suiseng Coli /C Suspension for injection for pigs
Suiseng Coli/C injektionsvæske, suspension
Active substance:
  • Clostridium perfringens, type C, beta toxoid
  • Clostridium novyi, type B, alpha toxoid
  • Escherichia coli, fimbrial adhesin F6
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, LT toxoid
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Clostridium perfringens, type C, beta toxoid
    1.05
    relative potency
    /
    1.00
    Dose
  • Clostridium novyi, type B, alpha toxoid
    1.23
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F6
    80.00
    percent
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F5
    79.00
    percent
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F4ac
    78.00
    percent
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F4ab
    65.00
    percent
    /
    1.00
    Dose
  • Escherichia coli, LT toxoid
    55.00
    percent
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB08
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • 20 ml Type-I colourless glass vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 glass vial of 10 doses (20 ml).
  • 50 ml Type-I colourless glass vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 glass vial of 25 doses (50 ml).
  • 100 ml Type-I colourless glass vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 glass vial of 50 doses (100 ml).
  • 250 ml PET plastic vials, closed with type I rubber stoppers and aluminium caps.Pack sizes:Cardboard box with 1 PET vial of 125 doses (250 ml).
  • 100 ml PET plastic vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 PET vial of 50 doses (100 ml).
  • 50 ml PET plastic vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 PET vial of 25 doses (50 ml).
  • 20 ml PET plastic vials, closed with type I rubber stoppers and aluminium caps. Cardboard box with 1 PET vial of 10 doses (20 ml).

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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 63663
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0648/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 20/04/2025
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Danish (PDF)
Published on: 25/11/2024
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Combined File of all Documents

English (PDF)
Published on: 20/04/2025
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