Target species
Pig for reproduction.
Indications for use
For the active immunization 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: 12 months
Leptospira serogroup Australis: 6 months
Leptospira serogroups Canicola, Icterohaemorrhagiae, Grippotyphosa, Pomona and Tarassovi: 12 months
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
An increase in body temperature may very commonly occur up until two days after vaccination. The observed mean increase was 0.5°C (in individual cases the maximum increase was 1.5°C). Transient local reactions, mostly consisting of red, mild to hard, non-painful swellings are a very common observation. 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. In individual animals intermediate systemic reactions, such as vomiting, redness,
rapid breathing and twitching, may rarely be observed, which resolve in a few minutes. In individual animals transient reductions in feed intake or activity may uncommonly occur. Feed intake and activity are completely restored within a week.
In post marketing experience:
A hypersensitivity reaction may occur in very rare cases.
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).
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 Erysipelotrix rhusiopathiae containing product should be given to maintain immunity against Erysipelotrix 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.