Veterinary Medicines

COLISUIN-CL

Authorised
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F6
  • Escherichia coli, LT toxoid
  • Clostridium perfringens, type C, beta1 toxoid
  • Clostridium novyi, type B, alpha toxoid
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Product identification

Medicine name:
COLISUIN-CL
Active substance:
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F6
  • Escherichia coli, LT toxoid
  • Clostridium perfringens, type C, beta1 toxoid
  • Clostridium novyi, type B, alpha toxoid
Target species:
  • Pig (young female)
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, fimbrial adhesin F4ab
    80.00
    percentage protection
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F4ac
    80.00
    percentage protection
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F5
    80.00
    percentage protection
    /
    1.00
    Dose
  • Escherichia coli, fimbrial adhesin F6
    80.00
    percentage protection
    /
    1.00
    Dose
  • Escherichia coli, LT toxoid
    80.00
    percentage protection
    /
    1.00
    Dose
  • Clostridium perfringens, type C, beta1 toxoid
    10.00
    international unit(s)
    /
    1.00
    Dose
  • Clostridium novyi, type B, alpha toxoid
    3.50
    international unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (young female)
      • Meat and offal
        0
        day
    • Pig (sow)
      • 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:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (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:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2551 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 9/11/2022
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Package Leaflet

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Spanish (PDF)
Published on: 9/11/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/11/2022
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