Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in boars producing semen for naïve herds, as PRRSV can be shed in semen.
Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using reliable diagnostic methods.
Precautions should be taken to avoid the transfer of the vaccine virus within the herd, e.g. from positive animals to naïve animals.
Special precautions for use in animals
The vaccine strain can spread up to 5 weeks after vaccination to unvaccinated animals in contact but without any clinical consequence. Vaccinated animals may excrete the vaccine strain by faecal excretion. The potential excretion of the vaccine strain in the urine of vaccinated animals has not been investigated. The vaccine strain has been detected in new-born piglets (blood, lung samples) when vaccinating naïve gilts during last third of gestation but without any clinical consequence. Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals that should remain free from PRRSV. Vaccination should aim to achieve a homogenous immunity in the target population at farm level. 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. This transition period should be longer than the shedding phase of the PRRS MLV vaccine following vaccination.
Do not routinely rotate two or more commercial PRRS MLV vaccines based on different strains in a herd. A PRRS vaccine based on the same strain (strain 94881) and authorised for the immunisation of pigs from 17 days of age until the end of fattening and older can be used on the same farm. 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 based on different strains of the same genotype 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.
A transient increase in body temperature (up to 2°C above the physiological range) commonly occurs up to 5 days post-vaccination.
Temperatures return to the normal range without additional treatment, 1 to 4 days after the maximum temperature increase is observed.
Reduced appetite may be observed commonly after vaccination.
Very minimal swelling or redness of the skin at the injection site may be observed commonly. These reactions (up to 10.5 cm but typically < 2 cm in size) are transient and subside within a short time (maximum of 5 days but typically less than 2 days) without treatment.
Recumbency and accelerated breathing can be observed uncommonly on the day of vaccination. These signs disappear spontaneously without any treatment.
Can be used during pregnancy and lactation.
PRRSV naïve gilts should not be vaccinated during pregnancy.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ReproCyc ParvoFLEX and administered at one injection site. 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.
No adverse events other than those listed above for a single dose were observed following a 10-fold overdose administration.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case adverse reactions develop following accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.
Withdrawal period(s)
Zero days.