Vaccination of sows and gilts for the passive immunization of piglets against colibacillosis caused by enteropathogenic and enterotoxigenic E. coli strains expressing F4ac, F5, F6, F18ac and F41 adhesins, against oedema disease caused by E. coli strain expressing F18ab adhesin and against necrotic enteritis caused by C. perfringens type C.

Neonatal piglets

- The vaccine reduces mortality and clinical signs (severe diarrhoea) due to colibacillosis.

- The vaccine reduces mortality and clinical signs due to necrotic enteritis caused by C. perfringens type C.

Weaned piglets

- The vaccine reduces mortality and clinical signs due to oedema disease

- The vaccine reduces clinical signs (severe diarrhoea) of colibacillosis

- The vaccine reduces clinical signs of chronic enteritis due to C. perfringens type C

Duration of immunity:

- 21 days for infections caused by F4ac, F18ac, (colibacillosis) and Clostridium perfringens type C (necrotic enteritis)

- 21 days for antibodies against F5, F6 and F41, however the protective efficacy of the antibody levels was not established

- 28 days for infections caused by F18ab (oedema disease)

Dose to be administered and administration route

Intramuscular use.

Shake vigorously before use and at intervals during use.

Avoid introduction of contamination during use.

Doses

Sows and gilts: 2 ml.

Before use, allow the vaccine to reach room temperature and shake the bottle vigorously. Inoculate the corresponding dose by deep intramuscular injection in the neck muscles. It is very important to use needles of appropriate length according to the weight of the animal.

It is recommended that the second dose should be given preferably on the alternate side.

Vaccination schedule

Pregnant sows: The initial course consists of two doses. Administer one dose 7 weeks before farrowing followed by a second dose 4 weeks before farrowing.

Revaccinate with a single dose 4 weeks before farrowing in subsequent gestation periods.

Adverse reactions

Pigs:

Very common (>1 animal / 10 animals treated):	Hyperthermia¹
Common (1 to 10 animals / 100 animals treated):	Apathy²
Rare (1 to 10 animals / 10,000 animals treated):	Injection site swelling, injection site reddening³
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Anaphylactic-type reaction⁴

¹Transient, maximum 2 ºC, between 4 – 24 hours after vaccination. Temperatures return to normal values within 24 – 48 hours.

²Between 1- and 2-days post-vaccination, uncommonly may last for up to 7 days after vaccination.

³With a maximum diameter of 3 cm and a maximum of 10 days of duration.

⁴May be fatal. 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.