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CUBOLAC BG инжекционна суспензия на водна основа за овце и говеда

Authorised
  • Clostridium chauvoei, cells and toxin, Inactivated
  • Clostridium sordellii, toxoid
  • Clostridium novyi, type B, toxoid
  • Clostridium septicum, toxoid
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type C, beta toxoid
  • Clostridium perfringens, type A, alpha toxoid
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Product identification

Medicine name:
CUBOLAC BG инжекционна суспензия на водна основа за овце и говеда
Active substance:
  • Clostridium chauvoei, cells and toxin, Inactivated
  • Clostridium sordellii, toxoid
  • Clostridium novyi, type B, toxoid
  • Clostridium septicum, toxoid
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type C, beta toxoid
  • Clostridium perfringens, type A, alpha toxoid
Target species:
  • Sheep
  • Cattle
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Clostridium chauvoei, cells and toxin, Inactivated
    100.00
    100% protective dose
    /
    1.00
    Dose
  • Clostridium sordellii, toxoid
    100.00
    100% protective dose
    /
    1.00
    Dose
  • Clostridium novyi, type B, toxoid
    3.50
    international unit(s)
    /
    1.00
    Dose
  • Clostridium septicum, toxoid
    2.50
    international unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type D, epsilon toxoid
    5.00
    international unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type C, beta toxoid
    10.00
    international unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type A, alpha toxoid
    0.30
    international unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB01
  • QI04AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
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:
  • Asklep-Pharma OOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2182
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.
Bulgarian (PDF)
Published on: 7/06/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 30/12/2022
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