Veterinary Medicines

Heptavac P Plus

Authorised
  • Bibersteinia trehalosi, serotype T15, strain S1105/84, Inactivated
  • Bibersteinia trehalosi, serotype T10, strain S1075/81, Inactivated
  • Bibersteinia trehalosi, serotype T4, strain S1085/81, Inactivated
  • Bibersteinia trehalosi, serotype T3, strain S1109/84, Inactivated
  • Mannheimia haemolytica, serotype A9, strain S994/77, Inactivated
  • Mannheimia haemolytica, serotype A7, strain S1078/81, Inactivated
  • Mannheimia haemolytica, serotype A6, strain S1084/81, Inactivated
  • Mannheimia haemolytica, serotype A2, strain S1126/92, Inactivated
  • Mannheimia haemolytica, serotype A1, strain S1006/77, Inactivated
  • Clostridium chauvoei, strain 1048, cells and equivalent toxoid
  • Clostridium chauvoei, strain 658, cells and equivalent toxoid
  • Clostridium chauvoei, strain 657, cells and equivalent toxoid
  • Clostridium chauvoei, strain 656, cells and equivalent toxoid
  • Clostridium chauvoei, strain 655, cells and equivalent toxoid
  • Clostridium novyi, strain 754, toxoid
  • Clostridium tetani, strain S1123/91, toxoid
  • Clostridium septicum, strain 505, toxoid
  • Clostridium perfringens, type D, strain 603, epsilon toxoid
  • Clostridium perfringens, type C, beta toxoid
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Product identification

Medicine name:
Heptavac P Plus
Active substance:
  • Bibersteinia trehalosi, serotype T15, strain S1105/84, Inactivated
  • Bibersteinia trehalosi, serotype T10, strain S1075/81, Inactivated
  • Bibersteinia trehalosi, serotype T4, strain S1085/81, Inactivated
  • Bibersteinia trehalosi, serotype T3, strain S1109/84, Inactivated
  • Mannheimia haemolytica, serotype A9, strain S994/77, Inactivated
  • Mannheimia haemolytica, serotype A7, strain S1078/81, Inactivated
  • Mannheimia haemolytica, serotype A6, strain S1084/81, Inactivated
  • Mannheimia haemolytica, serotype A2, strain S1126/92, Inactivated
  • Mannheimia haemolytica, serotype A1, strain S1006/77, Inactivated
  • Clostridium chauvoei, strain 1048, cells and equivalent toxoid
  • Clostridium chauvoei, strain 658, cells and equivalent toxoid
  • Clostridium chauvoei, strain 657, cells and equivalent toxoid
  • Clostridium chauvoei, strain 656, cells and equivalent toxoid
  • Clostridium chauvoei, strain 655, cells and equivalent toxoid
  • Clostridium novyi, strain 754, toxoid
  • Clostridium tetani, strain S1123/91, toxoid
  • Clostridium septicum, strain 505, toxoid
  • Clostridium perfringens, type D, strain 603, epsilon toxoid
  • Clostridium perfringens, type C, beta toxoid
Target species:
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bibersteinia trehalosi, serotype T15, strain S1105/84, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Bibersteinia trehalosi, serotype T10, strain S1075/81, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Bibersteinia trehalosi, serotype T4, strain S1085/81, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Bibersteinia trehalosi, serotype T3, strain S1109/84, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Mannheimia haemolytica, serotype A9, strain S994/77, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Mannheimia haemolytica, serotype A7, strain S1078/81, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Mannheimia haemolytica, serotype A6, strain S1084/81, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Mannheimia haemolytica, serotype A2, strain S1126/92, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Mannheimia haemolytica, serotype A1, strain S1006/77, Inactivated
    5000000.00
    cells
    /
    0.01
    millilitre(s)
  • Clostridium chauvoei, strain 1048, cells and equivalent toxoid
    0.50
    Protective Dose
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, strain 658, cells and equivalent toxoid
    0.50
    Protective Dose
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, strain 657, cells and equivalent toxoid
    0.50
    Protective Dose
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, strain 656, cells and equivalent toxoid
    0.50
    Protective Dose
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, strain 655, cells and equivalent toxoid
    0.50
    Protective Dose
    /
    1.00
    millilitre(s)
  • Clostridium novyi, strain 754, toxoid
    3.50
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium tetani, strain S1123/91, toxoid
    2.50
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium septicum, strain 505, toxoid
    2.50
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type D, strain 603, epsilon toxoid
    5.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type C, beta toxoid
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AB05
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Carton with one LDPE bottle containing 500 ml (250 doses) volume. The bottles are closed with a rubber disc/aluminium overseal combination cap
  • Carton with one LDPE bottle containing 250 ml (125 doses) volume. The bottles are closed with a rubber disc/aluminium overseal combination cap
  • Carton with one LDPE bottle containing 100 ml (50 doses) volume. The bottles are closed with a rubber disc/aluminium overseal combination cap
  • Carton with one LDPE bottle containing 50 ml (25 doses) volume. The bottles are closed with a rubber disc/aluminium overseal combination cap

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:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/146/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/09/2024
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