Target Species
Pigs.
Indications for use
For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus.
Specific claims
For finishing pigs, the effect of the virus on the respiratory system is most relevant. A significant improvement of rearing results (reduced morbidity due to PRRS infection, and a better daily growth and feed conversion) until the end of the fattening period was observed in vaccinated pigs during field trials, particularly in piglets vaccinated at 6 weeks of age.
For breeding pigs, the effect of the virus on the reproductive system is most relevant. A significant improvement of the reproductive performance in PRRS virus contaminated environments and a reduction of transplacental virus transmission after challenge was observed in vaccinated pigs.
The interest of vaccination with Porcilis PRRS lies in obtaining a homogeneous and high immune status against PRRS virus in a herd.
Onset of immunity: 28 days post vaccination.
Duration of immunity: at least 24 weeks.
Contraindications
Do not use in herds where the prevalence of European PRRS virus has not been established through reliable diagnostic methods.
Special warnings for each target species
Porcilis PRRS must only be used in PRRS virus contaminated herds, where prevalence of European PRRS virus has been established through reliable diagnostic virological methods. No data are available on the safety of the vaccine for the reproductive performance in boars. Do not use in herds where a PRRS eradication programme based on serology has been adopted.
Vaccinate healthy animals only.
Special precautions for use
Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present. The vaccine virus may spread to pigs in contact during 5 weeks after vaccination. The most common spreading route is via direct contact,but spreading via contaminated objects or via the air cannot be excluded. Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals (e.g.: naïve pregnant sows) that should remain free from PRRS virus. Do not use in boars producing semen for seronegative herds, as PRRS virus may be excreted in semen for many weeks.
Do not routinely rotate two or more commercial PRRS MLV vaccines based on different strains in a herd.
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 5 weeks following vaccination.
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 5 weeks following vaccination.
Vaccination should aim to achieve a homogenous immunity in the target population at farm level.
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
Pigs:
Very common (>1 animal / 10 animals treated): | Injection site lump.1 |
Rare (1 to 10 animals / 10,000 animals treated): | Hyperthermia2, hypersensitivity reactions (including dyspnoea, hyperaemia, decubitus, muscle tremor, excitation, vomiting).3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reactions.4 |
1 After intradermal vaccination a small firm injection site lump (maximum 1.5 cm in diameter) is observed in fattening pigs and is indicative of the appropriate vaccination technique. In breeding pigs a mean diameter of approximately 2 cm is observed and in individual breeding pigs up to 10 cm. These lumps may be accompanied by other signs of inflammation (pain, reddening, warmth and crusts). This lump is generally seen for less than 14 days but may occasionally persist for 29 days or longer.
2 After intramuscular vaccination.
3 These signs disappear spontaneously and totally within a few minutes after vaccination.
4 Fatal outcome of anaphylactic-type reactions has been reported very rarely.
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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
PRRS virus-naïve gilts and sows should not be vaccinated during pregnancy, as this can have negative effects. Vaccination during pregnancy is safe when it is performed in gilts and sows which are already immunized against European PRRS virus via vaccination or field infection.
Lactation:
The vaccine can be used during lactation.
Interactions
Safety and efficacy data are available for both routes of administration in finishing pigs from 3 weeks of age onwards, which demonstrate that this vaccine can be given with Porcilis PCV M Hyo, with Porcilis Lawsonia, or with a mixture of Porcilis PCV M Hyo and Porcilis Lawsonia, at the same time, but at separate sites (preferably at the opposite side of the neck). In individual pigs the temperature increase after associated use may commonly exceed 2 °C. The temperature returns to normal from 1 to 2 days after the peak temperature is observed. Transient local injection site reactions, which are restricted to a slight injection site lump (maximum 2 cm diameter), may commonly occur from 5 days after vaccination onwards, after intradermal and after intramuscular vaccination. These lumps may occasionally persist until 29 days after vaccination or longer. Hypersensitivity reactions after vaccination may occur uncommonly.
Safety and efficacy data are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be administered intradermally non-mixed with Porcilis PCV ID alone or with Porcilis PCV ID mixed with Porcilis Lawsonia ID and/or non-mixed with Porcilis M Hyo ID ONCE providing that administration site of non-mixed vaccines is separated by at least 3 cm. Adverse events are as described in section “Adverse events”, except for injection site lumps of up to 2.5 cm can be observed in individual pigs. These lumps may last 5 weeks and are very commonly accompanied by redness and crusts. Hyperthermia on the day of vaccination (mean 0.3 °C, individual pigs up to 1.2 °C) is common. Lying down and malaise can be uncommonly observed in vaccinated pigs. The product literature of respective products should be consulted before administration in association with Porcilis PRRS. No information is available on the safety and efficacy of the administration of Porcilis PRRS in association with the above-mentioned products in breeding animals or during pregnancy.
Safety and efficacy data are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be administered intradermally non-mixed with Porcilis PCV M Hyo ID alone or with Porcilis PCV M Hyo ID mixed with Porcilis Lawsonia ID. The administration site of non-mixed vaccines should be separated by approximately 3 cm. Adverse events are as described in section 3.6, except for injection site swellings with a maximum size of up to 15 cm in individual breeding pigs. Injection site swellings may show other signs of inflammation (pain, reddening, warmth and crusts). Elevated temperatures (mean 1.1°C, individual breeding pigs up to 2.4°C) may commonly occur on the day of vaccination. The product literature of Porcilis PCV M Hyo ID and/or Porcilis Lawsonia ID should be consulted before administration.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except the products mentioned above. 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
Dosage and use
Reconstitute the vaccine with the corresponding adjuvanting solvent.
Number of doses per vial | Volume (ml) of solvent needed for |
| Intramuscular injection | Intradermal application |
10 | 20 | 2 |
25 | 50 | 5 |
50 | 100 | 10 |
100 | 200 | 20 |
Before using the vaccine allow it to reach room temperature (15 °C – 25 °C) and shake well before use.
Visual appearance after reconstitution: white suspension.
Dosage
Intramuscular injection: 2 ml in the neck.
Intradermal application: 0.2 ml on top or to the left or right side of the neck, or along the muscles of the back, using an intradermal device.
A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.
Vaccination scheme:
A single dose is given to pigs from 2 weeks of age onwards.
Finishing pigs: a single vaccination is sufficient for protection until slaughter.
Breeding pigs: For gilts a (re)vaccination 2-4 weeks before mating is recommended.
To maintain a high and homologous level of immunity, revaccination at regular intervals is recommended, either before each next gestation or at random at 4 month intervals. Pregnant sows should only be vaccinated after previous exposure to European PRRS virus.
Use sterile syringes and needles or clean intradermal equipment.
Overdose
The effects seen after a ten-fold overdose of vaccine virus and a two-fold overdose of solvent were similar to those seen after a single dose of vaccine.
Withdrawal period
Zero days.