Do not use in herds where European PRRS virus has not been detected by reliable diagnostic methods.
Do not use in boars producing semen, as PRRS virus can be shed in semen.
Do not use in PRRS virus-naïve pregnant gilts and sows in the second half of gestation because the vaccine strain may cross the placenta. The administration of the vaccine to pregnant PRRS virus-naïve gilts and sows in the second half of gestation may have an impact on their reproductive performance.
Vaccinate healthy animals only.
Do not vaccinate pigs younger than 3 days by nasal route since the concurrent intake of colostrum may interfere with the efficacy of the vaccine.
Vaccination should aim to achieve a homogenous immunity in the target population at farm level.
Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present.
Animals vaccinated via intramuscular route may excrete the vaccine strain for more than 16 weeks following vaccination. Animals vaccinated via nasal route may exrete the vaccine strain for more than 10 weeks. The vaccine strain can spread to in contact pigs. The most common spreading route is via direct contact but spreading via contaminated objects or an airbourne spread cannot be excluded.
Special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated animals (e.g. PRRS virus-naïve pregnant gilts and sows in the second half of gestation) that should remain free from PRRS virus.
PRRS virus-naïve breeding animals (e.g. replacement gilts from PRRS virus-negative herds) which are introduced into a PRRSV-infected herd should be vaccinated prior to first insemination.
Vaccination should preferably be done in a separated quarantine unit. A transition period should be respected between vaccination and moving the animals to the breeding unit. The transition period should be longer than the shedding phase of the PRRS MLV vaccine following vaccination.
In order to limit the potential risk of recombination between PRRS MLV vaccine strains of the same genotype do not use different PRRS MLV vaccines on the same farm at the same time. In the case of transitioning from one PRRS MLV vaccine to another PRRS MLV vaccine, a transition period should be respected between the last administration of the current vaccine and the first administration of the new vaccine. This transition period should be longer than the shedding period of the current vaccine following vaccination. Do not routinely rotate two or more commercial PRRS MLV vaccines based on different strains in a herd.
Pregnancy:
Can be used in PRRS virus-naïve gilts and sows pre-breeding or in the first half of gestation.
Can be used in non-PRRS virus-naïve gilts and sows in the second half of gestation.
Lactation:
The safety of the vaccine has not been established during lactation.
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.
Do not mix with any other veterinary medicinal product.
Adverse reactions
A transient increase in rectal temperature (0.5°C on average, and up to 1.4°C individually) may very commonly occur within 4 days after vaccination. Local reactions in the form of swellings are common and resolve spontaneously within 3 days. The area of local tissue reaction is in general below 2 cm in diameter. Anaphylactic-type reactions (vomiting, tremors and/or mild depression) may uncommonly occur in piglets shortly after vaccination. These resolve without treatment within few hours.
A minor and transient increase in rectal temperature (0.2°C on average, and up to 1.0°C individually) may very commonly occur 4 hours post vaccination in pre-breeding PRRS virus-naïve gilts and sows. Local reactions in the form of swellings are very common and resolve spontaneously within 5 days. The area of local tissue reaction is in general below 0.5 cm in diameter.
A minor and transient increase in rectal temperature (0.8°C on average, and up to 1.0°C individually) may very commonly occur 4 hours post vaccination in PRRS virus-naïve gilts and sows in the first half of gestation. Local reactions in the form of swellings are very common and resolve spontaneously within 9 days. The area of local tissue reaction is in general below 1.4 cm in diameter.
A minor and transient increase in rectal temperature (0.4°C on average, and up to 0.6°C individually) may very commonly occur 4 hours post vaccination in non-PRRS virus-naïve gilts and sows in the second half of gestation. Local reactions in the form of swellings are very common and resolve spontaneously within 32 days. The area of local tissue reaction is in general below 5 cm in diameter.
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).
Upon administration of a 10-fold overdose in piglets, anaphylactic-type reactions (tremor, apathy and/or vomiting) were very commonly observed shortly after vaccination; these signs resolved without treatment within a few hours. A transient increase in rectal temperature (0.3°C on average, and up to 1.2°C individually) very commonly occurred 24 hours post vaccination. Local reactions, in the form of soft/hard swelling (below or equal to 0.7 cm diameter) without heat or pain, were very commonly observed at the injection site and resolved within 5 days.
The administration of a 10-fold overdose to PRRS virus-naïve pre-breeding or pregnant gilts and sows in the first or second half of pregnancy induced similar adverse reactions as those described above under adverse reactions. The maximum size of the local reactions was bigger (2 cm) and the maximum duration was in general longer (up to 9 days in pre-breeding sows).
After the administration of a 10-fold overdose to non-PRRS virus-naïve gilts and sows in the second half of pregnancy, a transient increase in rectal temperature (0.3°C on average, and up to 0.6°C individually) occurred 4 hours post vaccination. A local reaction involving transiently the whole neck region was very commonly observed (red-purple dark, erythematous swelling, causing itching, vesicle formation, increased local temperature, and, occasionally, pain). The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days.
Withdrawal period
Zero days.