Target species
Pigs for reproduction.
Indications for use
For the active immunisation of pigs:
- to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
- to reduce transplacental infection, viral load and foetal mortality caused by Porcine parvovirus.
- 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
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Pigs 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 |
1. The observed mean increase was 0.5 °C (in individual cases the maximum increase was 1.5 °C) up until two days after vaccination.
2. Local 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.
3. Feed intake and activity are completely restored within a week.
4. Intermediate 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.
Use during pregnancy and lactation
Can be used during pregnancy and lactation.
Interactions
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
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.
Overdose
No adverse reactions other than those mentioned in section 'Adverse Reactions' were observed after the administration of a double dose of vaccine.
Withdrawal period
Zero days.