Porcilis PRRS EU Summary of Product Information

Indications

For active immunization of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viremia caused by infection with European strains of PRRS virus.

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.

Immunity has been demonstrated via challenge at 28 days post vaccination. A duration of immunity of at least 24 weeks has been demonstrated.

Administration

Reconstitute the vaccine with the corresponding adjuvanting diluent (use only Diluvac Forte).


Number of doses
per vial

Volume (mL) needed for

Intramuscular injection Intradermal application
 10
 25
 50
100
  20
 50
100
200
  2
  5
10
20

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.

It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards. Maternally derived antibodies may interfere with the response to vaccination.

Newly introduced PRRS virus-naϊve animals (e.g., replacement gilts from PRRS virus-negative herds) should be vaccinated prior to pregnancy.

The vaccine may be reconstituted shortly before vaccination for simultaneous use with Porcilis M Hyo in finishing pigs from 4 weeks of age and the following instructions should be used:

Porcilis PRRS             Porcilis M Hyo
10 doses             +      20 mL
25 doses             +      50 mL
50 doses             +      100 mL
100 doses           +      200 mL

A single dose (2 mL) of Porcilis PRRS mixed with Porcilis M Hyo is given intramuscularly in the neck.

Use sterile syringes and needles or clean intradermal equipment.

Precautions

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 program based on serology has been adopted.

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., naϊve 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.

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.

Adverse reactions

Systemic or local reactions may be observed after vaccination. After intramuscular vaccination, a transient hyperthermia may occur. In rare cases, the vaccination can evoke hypersensitivity reactions such as dyspnoea, hyperaemia, decubitus, tremor, excitation and vomiting. These signs normally disappear spontaneously and totally within a few minutes after vaccination; however, in very rare cases, fatal anaphylactic reactions have occurred.

A small, firm intradermal lump (1.5 cm in diameter maximally) observed after the intradermal application is indicative of the appropriate vaccination technique. This dermal lump is generally seen for less than 14 days but may occasionally persist for 29 days or longer.

Use during pregnancy, lactation or lay

PRRS virus-naϊve 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. The vaccine can be used during lactation.

Interactions

Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo. The product literature of Porcilis M Hyo should be consulted before administration of the mixed product.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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.

No information is available on the safety and efficacy of the use of Porcilis PRRS mixed with Porcilis M Hyo in breeding animals or during pregnancy.

Composition

Per dose of 2 mL (intramuscular application) or 0.2 mL (intradermal application) of reconstituted vaccine:

Lyophilisate (active substance) – Live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50*

Solvent (Diluvac Forte adjuvant) – dl-α tocopheryl acetate: 75 mg/mL

*tissue culture infective dose 50%

porcilis prrs

Porcilis PRRS protects against the consequences of PRRSV infection.