Porcilis PRRS International Summary of Product Information

Indications

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

For fattening pigs, the respiratory tropism is 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.

For breeding pigs, the reproductive tropism is relevant. A significant improvement of the reproductive performance in PRRSv-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 PRRSv 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 adjuvating diluent (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.

Fattening 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 PRRSv.

It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards. Newly introduced PRRSv-naϊve animals (e.g. replacement gilts from PRRSv-negative herds) should be vaccinated prior to pregnancy.

For intramuscular vaccination of fattening pigs from 4 weeks of age, the vaccine may be reconstituted with Porcilis M Hyo shortly before vaccination for simultaneous use 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 in the neck.

Use sterile syringes and needles or clean intradermal equipment.

Precautions

Porcilis PRRS must only be used in PRRSv-contaminated herds, where prevalence of PRRSv has been established through reliable diagnostic virological methods. Care should be taken to avoid the introduction of the vaccine strain into an area where PRRSv 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 PRRSv. Do not use in boars producing semen for seronegative herds, as PRRSv may be excreted in semen for many weeks. 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.

Undesirable effects

Systemic or local reactions may be observed after vaccination. After intramuscular vaccination a transient hyperthermia may occur. In less than 1% of the cases the vaccination can evoke side effects, like lying down, dyspnoea and hyperaemia. These signs disappear spontaneously and totally within a few minutes after vaccination.

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 and lactation

PRRSv-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 PRRSv 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.

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:

Freeze-dried vaccine
Active substance: live attenuated PRRS virus strain DV: at least 104.0 TCID50 per dose Excipients: add 1 or 2 mL (before freeze-drying)

Diluent (Diluvac Forte)
Adjuvant: dl-α tocopherol acetate: 75 mg/mL Excipients: add 1 mL

finishing pigs

Porcilis PRRS protects against the consequences of PRRSV infection.