Porcilis PRRS Lyophilisate and solvent for suspension for injection for pigs.
Presentation
Porcilis PRRS is a live attenuated lyophilised vaccine containing per dose (2 ml IM or 0.2 ml ID) 104.0 TCID50 to 106.3 TCID50* of PRRS virus strain DV to be reconstituted with Diluvac Forte containing 75 mg/ml dl-a-tocopherol acetate to a suspension for injection.
*tissue culture infective dose 50 %
Uses
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 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 finishing 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 objective of vaccination with Porcilis PRRS lies in obtaining a homogenous 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.
Dosage and administration
Reconstitute the vaccine with the adjuvanting diluent supplied (use only Diluvac Forte). Inject a few ml of diluent into the vaccine vial and shake gently until the vaccine is completely dissolved. Then transfer the concentrated vaccine to the rest of the diluent and mix well.
| Number of doses per vial | Volume (ml) of diluent needed Intramuscular injection | Volume (ml) of diluent needed Intradermal application |
| 10 25 50 100 | 20 50 100 200 | 2 5 10 20 |
Dosage
Intramuscular injection: 2 ml in the neck area behind the ear.
Intradermal application: 0.2 ml on the 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 homogeneous 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-naïve animals (e.g. replacement gilts from PRRS virus-negative herds) should be vaccinated prior to pregnancy.
The vaccine can be used during lactation.
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.
Contra-indications, warnings, etc
Do not use in herds where the prevalence of European PRRS virus has not been established through reliable diagnostic methods.
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.
The effects seen after a ten-fold overdose of vaccine virus and a two-fold overdose of diluent were similar to those seen after a single dose of vaccine.
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.
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 also 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 decided 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. Do not mix with any other veterinary medicinal product, except the diluent supplied with the product or with Porcilis M Hyo.
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. 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. 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.
Intramuscular or intradermal administration of Porcilis PRRS results in the production of specific antibodies and active immunisation against infection caused by European strains of Porcine Reproductive and Respiratory Syndrome virus. Immunity is enhanced by the adjuvant dl-a-tocopherol acetate included in the diluent for reconstitution.
On the basis of antibodies induced by vaccination, it is not possible to discriminate vaccinated animals from those naturally infected with European strains of PRRS virus.
Operator warning:
In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.
Pharmaceutical precautions
Store vaccine at +2°C to +8°C (in a refrigerator). Diluent should be stored below 25°C.
Protect from light. Reconstituted vaccine should be used within 3 hours at room temperature.
After mixing with Porcilis M Hyo: 1 hour at room temperature.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, in accordance with the national requirements.
Legal category
POM-V
Packaging Quantities
IM presentation
Boxes with 1 or 10 type I glass or PET vials with 10, 25, 50 or 100 doses of freeze-dried vaccine.
Boxes with 1 or 10 type II glass or PET vials with 20, 50, 100 or 200 ml of Diluvac Forte.
ID presentation
Boxes with 1 or 5 type I glass or PET vials with 10, 25, 50 or 100 doses of freeze-dried vaccine plus 1 or 5 type II glass or PET vials with 2, 5, 10 or 20 ml of Diluvac Forte.
Not all presentations may be marketed.
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