Target species
Pigs
Indications for use, specifying the target species
Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.
Onset of immunity: 21 days after vaccination.
Duration of immunity:
--- For GB only: 112 days after vaccination.
--- For NI only: 16 weeks after vaccination.
Contra-indications
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
Adverse reactions (frequency and seriousness)
(For GB only; GB SPC version to date)
Pigs:
Very common adverse reactions:
•Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment.
•Mild depression during the day of vaccination.
•Temperature rise of maximum 1.1 °C was observed. Temperatures returned to normal within 24 hrs.
Emesis, recumbency, convulsion, lethargy and loss of consciousness occur in very rare occasions within a few minutes after vaccination. The animals mostly start to recover within around 15 minutes. In case of severe anaphylactic-type reactions appropriate treatment is recommended.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals treated displaying adverse reaction(s))
•common (more than 1 but less than 10 animals in 100 animals treated)
•uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
•rare (more than 1 but less than 10 animals in 10,000 animals treated)
•very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
--- (end of GB only segment)---
(For NI only; NI SPC version to date)
Pigs:
Very common (> 1 animal / 10 animals treated): | Injection site inflammation1 Depression2, Elevated temperature3 |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction (e.g. Emesis, recumbency, convulsion, lethargy and loss of consciousness)4 |
1Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment.
2Mild depression during the day of vaccination.
3Temperature rise of maximum 1.1 °C was observed. Temperatures returned to normal within 24 hrs.
4 Hypersensitivity reactions may occur within a few minutes after vaccination. The animals mostly start to recover within around 15 minutes. In case of severe anaphylactic-type reactions appropriate treatment is recommended.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
--- (end of NI only segment)--- The following text applies to all UK.
Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Pregnancy and lactation: The use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Intramuscular use.
Allow the vaccine to reach room temperature (15-25°C) before administration.
Shake well before use.
Administer a single intramuscular injection of 1 ml in the neck muscles.
Overdose
No information is available.
Withdrawal period(s)
Zero days