Veterinary Medicines

Lactovac Suspension for injection

Not authorised
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5 and F41), strain S1091/83, Inactivated
  • Bovine coronavirus, strain 800, Inactivated
  • Bovine rotavirus A, strain Holland, Inactivated
  • Bovine rotavirus A, strain 1005/78, Inactivated
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Product identification

Medicine name:
Lactovac Suspension for injection
LACTOVAC suspenzija za injiciranje
Active substance:
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5 and F41), strain S1091/83, Inactivated
  • Bovine coronavirus, strain 800, Inactivated
  • Bovine rotavirus A, strain Holland, Inactivated
  • Bovine rotavirus A, strain 1005/78, Inactivated
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5 and F41), strain S1091/83, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine coronavirus, strain 800, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine rotavirus A, strain Holland, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine rotavirus A, strain 1005/78, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovenia
Package description:
  • Type I glass vial containing 5 ml. The glass vial is closed with a type I rubber stopper, sealed with an aluminium crimp cap. Cardboard box with 10 glass vials of 1 dose (5 ml).
  • Type I glass vial containing 25 ml. The glass vial is closed with a type I rubber stopper, sealed with an aluminium crimp cap. Cardboard box with 1 glass vial of 5 doses (25 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:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0525/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0417/001

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
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