- to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), infection and bacterial excretion caused by L. interrogans serogroup Canicola serovar Canicola.

- to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), severity of infection and foetal mortality caused by L. interrogans serogroup Pomona serovar Pomona.

- to reduce infection caused by L. interrogans serogroup Icterohaemorrhagiae serovars Copenhageni and Icterohaemorrhagiae, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovars Grippotyphosa and Bananal/Liangguang, L. weilii serogroup Tarassovi serovar Vughia and L. borgpetersenii serogroup Tarassovi serovar Tarassovi.

Onset of immunity:

E. rhusiopathiae: 3 weeks

Porcine parvovirus: 10 weeks Leptospira serogroups: 2 weeks

Duration of immunity:

E. rhusiopathiae: 6 months Porcine parvovirus: 1 year

Leptospira serogroup Australis: 6 months

Leptospira serogroups Canicola, Icterohaemorrhagiae,

Grippotyphosa, Pomona and Tarassovi: 1 year

Dose to be administered and administration route

Before use allow the vaccine to reach room temperature.

Shake well before use.

Avoid introduction of contamination by multiple broaching.

For intramuscular use.

Administer a single dose of 2 ml in the neck region.

Basic vaccination scheme: Pigs which have not yet been vaccinated shall be given a primary injection 6 to 8 weeks before the expected date of insemination and a booster injection 4 weeks later.

Revaccination: A single revaccination with the veterinary medicinal product should be given once a year. Six months post each vaccination with the veterinary medicinal product, a single revaccination with an Erysipelothrix rhusiopathiae containing product should be given to maintain immunity against Erysipelothrix rhusiopathiae. In case of known infection pressure with L. interrogans serogroup Australis, a single revaccination with the veterinary medicinal product should be given every six months, as it is unknown if or for how long the duration of immunity for this serogroup persists beyond six months.

Adverse reactions

Pig for reproduction:

Very common

(>1 animal / 10 animals treated):

Elevated temperature¹

Injection site swelling²

Uncommon

(1 to 10 animals / 1,000 animals treated):

Decreased activity³, reduced food intake³

Rare

(1 to 10 animals / 10,000 animals treated):

Vomiting⁴, reddening of the skin⁴, tachypnoea⁴, twitching⁴

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Hypersensitivity reaction

¹The observed mean increase was 0.5 °C (in individual cases the maximum increase was 1.5 °C) up until two days after vaccination.

²Local reactions, mostly consisting of red, mild to hard, non-painful swellings. In general, local reactions may have a diameter of ≤ 5 cm, in very rare cases local reactions in individual animals can be up to 20 cm in diameter. All local reactions disappear completely within approximately 2 weeks after vaccination.

³Feed intake and activity are completely restored within a week. ⁴Intermediate systemic reactions, resolve in a few minutes.

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 section “Contact details” of the package leaflet.