Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding animals.
Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using reliable diagnostic methods.
Adverse Reactions:
Slight transient increases (not greater than 1.5°C) in body temperature can be observed very commonly following vaccination. Temperatures return to normal without additional treatment, 1 to 3 days after the maximum temperature increase is observed. Injection site reactions are uncommon. Transient minimal swelling or redness of the skin may be observed. These reactions disappear spontaneously without any additional treatment.
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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Special warnings for each target species:
Vaccinate healthy animals only. Do not use in boars producing semen for naïve herds, as PRRSV can be shed in semen.
Maternally derived antibodies have been shown to interfere with vaccine efficacy. In the presence of maternally derived antibodies, timing of initial vaccination of piglets should be planned accordingly.
Special precautions for use in animals:
The vaccine strain can spread to unvaccinated animals in contact with vaccinated animals up to 3 weeks post vaccination. Special precautions should be taken to avoid spreading of the vaccine strain within the herd, e.g. from positive to naïve animals. Vaccinated animals may excrete the vaccine strain by faecal excretion and in some cases by oral secretions. Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals that should remain free from PRRS virus. Vaccination should aim to achieve a homogenous immunity in the target population at farm level. In the sow herd it is recommended to use a vaccine strain licensed for use in sows. 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 gilts and sows 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Interactions (with other medicinal products and other forms of interaction):
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim’s Ingelvac CircoFLEX and administered at one injection site The product literature of Ingelvac CircoFLEX should be consulted before administration. In individual pigs the temperature increase after associated use rarely exceeds 1.5°C but stays below an increase of 2°C. The temperature returns to normal within 1 day after the peak temperature is observed. Transient local injection site reactions, which are restricted to a slight redness, may rarely occur directly after vaccination. Reactions resolve within 1 day. Immediate mild hypersensitivity-like reactions were commonly observed after vaccination, resulting in transient clinical signs such as vomiting and rapid respiration, which resolved within a few hours without treatment. Transient purple skin discoloration was uncommonly observed and resolved without treatment. Appropriate precautions to minimise handling stress during the administration of the product may lower the frequency of hypersensitivitylike reactions. 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.
Overdose (symptoms, emergency procedures, antidotes):
No additional negative effects have been observed following the administration of a 10-fold overdose in naïve piglets of two weeks of age with regard to systemic and local reactions.
Incompatibilities:
Do not mix with any other veterinary medicinal product except solvent supplied for use with the veterinary medicinal product or Boehringer Ingelheim´s Ingelvac CircoFLEX (both mixtures not for use in pregnant or lactating pigs).
Withdrawal Period:
Zero days.