Target species
Pigs (pigs for fattening, gilts and sows).
Indications for use for each target species
For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).
Onset of immunity: 3 weeks.
Duration of immunity: 26 weeks.
Fattening pigs:
In addition, intramuscular vaccination of seronegative 1-day-old piglets was demonstrated to reduce lung lesions against challenge administered at 26 weeks post vaccination. Intramuscular vaccination of seronegative 2-week-old piglets was demonstrated to reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination.
Additionally, nasal vaccination of seronegative 3-day-old piglets reduced viraemia, nasal shedding and lung lesions against challenge administered at 21 days post-vaccination. Nasal vaccination of seropositive 3-day-old piglets reduced viraemia, nasal shedding and lung lesions against challenge administered 10 weeks post-vaccination.
Gilts and sows:
In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to reduce the transplacental infection caused by PRRS virus during the last third of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Contraindications
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.
Special warnings
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.
Special precautions for use
Special precautions for safe use in the target species:
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.
After intramuscular vaccination animals may excrete the vaccine strain for more than 16 weeks. After nasal vaccination animals may excrete 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 airborne 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. This 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 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. Do not routinely rotate two or more commercial PRRS MLV vaccines based on different strains in a herd.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Not applicable.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Pigs for fattening
Very common (>1 animal / 10 animals treated): | Elevated temperature1 |
Common (1 to 10 animals / 100 animals treated): | Injection site swelling2 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Anaphylactic-type reactions (e.g. vomiting, tremors and/or mild depression)3 |
1 Transient; observed within 4 days after vaccination. On average 5 °C and up to 1.4 °C individually.
2 In general below 2 cm in diameter; resolves in 3 days.
3 Observed shortly after vaccination. Resolves without treatment within few hours.
Pre-breeding PRRS virus-naïve gilts and sows
Very common (>1 animal / 10 animals treated): | Elevated temperature1 Injection site swelling2 |
1 Transient; observed 4 hours post vaccination. On average 0.2 °C and up to 1.0 °C individually.
2 In general below 0.5 cm in diameter; resolves spontaneously within 5 days without treatment.
PRRS virus-naïve gilts and sows in the first half of gestation
Very common (>1 animal / 10 animals treated): | Elevated temperature1 Injection site swelling2 |
1 Transient; observed 4 hours post vaccination. On average 0.8 °C and up to 1.0 °C individually.
2 In general, below 1.4 cm in diameter; resolves spontaneously within 9 days without treatment.
Non-PRRS virus-naïve gilts and sows in the second half of gestation
Very common (>1 animal / 10 animals treated): | Elevated temperature1 Injection site swelling2 |
1 Transient; observed 4 hours post vaccination. On average 0.4 °C and up to 0.6 °C individually.
2 In general, below 5 cm in diameter; resolves spontaneously within 32 days without treatment.
Lactating sows:
Very common (>1 animal / 10 animals treated): | Elevated temperature1 Decreased appetite2 Injection site swelling3 |
1 Up to 2.2 ºC. Observed 2 days post vaccination; resolves spontaneously within 4 days without treatment.
2 Observed 1 - 4 days post vaccination and resolves spontaneously within 3 days without treatment.
3 Up to 11 cm in diameter; Resolves spontaneously within 3 days without treatment.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
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:
Can be used during lactation.
Interaction with other medicinal products and other forms of interaction
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.
Administration routes and dosage
Method of administration:
Immunisation must be carried out by intramuscular or nasal administration.
Reconstitute the lyophilisate with the supplied solvent. In cases where the vials containing the solvent and the lyophilisate are stored separately, verify prior to reconstituting the lyophilisate that the lot number mentioned on the vial containing the solvent is identical to the lot number mentioned on the vial containing the lyophilisate.
Reconstitute the vaccine with the corresponding solvent:
Number of doses per vial (lyophilisate) | Number of doses per vial (lyophilisate) |
25 ds | | 50 ml |
50 ds | | 100 ml |
125 ds | | 100 ml |
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and ensure complete reconstitution. Transfer back the reconstituted solution into the solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are reconstituted into 250 ml solvent.
Number of doses per vial (lyophilisate) | Volume of solvent needed |
100 ds | | 50 ml |
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and ensure complete reconstitution. Transfer back the reconstituted solution into the solvent vial (containing the remaining solvent): 100 doses are reconstituted into 50 ml solvent.
After reconstitution, the suspension should be orange coloured liquid which might contain a loose resuspendable sediment.
Dosage:
Intramuscular administration: 2 ml or 0.5 ml in the neck.
Nasal administration: 2 ml administered as 1 ml in each nostril.
Nasal administration: 0.5 ml administered in one nostril.
Vaccination schedule:
Pigs for fattening from 1 day of age onwards:
A single dose of 2 ml or 0.5 ml is given to pigs via intramuscular administration.
Pigs for fattening from 3 days of age onwards:
A single dose of 2 ml is given to pigs via intramuscular administration, or a single dose of 2 ml is given to pigs via nasal route by administering 1 ml in each nostril using a sterile syringe not connected to a needle.
A single dose of 0.5 ml is given to pigs via intramuscular administration, or a single dose of 0.5 ml is given to pigs via nasal route by administration in one nostril using a sterile syringe not connected to a needle.
Gilts and sows:
A single dose of 2 ml or 0.5 ml is given via intramuscular administration prior to introduction into the sow herd, approximately 4 weeks prior to breeding. A single booster dose is given every 6 months.
Use sterile syringes and needles.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions. Needles for administration should be appropriate for the size of the pig.
Symptoms of overdose (and where applicable, emergency procedures, antidotes)
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 under section 3.6. 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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Any person intending to manufacture, import, possess, distribute, sell, supple and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Withdrawal periods
Zero days.