For active immunisation of clinically healthy pigs at 17 days of age and older from farms affected with genotype 1 PRRSV.
From the Nursery
Clinical signs:
Ingelvac PRRSFLEX® EU maximises performance in the NURSERY.
Clinical signs after PRRSV challenge are reduced among piglets vaccinated with Ingelvac PRRSFLEX® EU.
Lung Lesions:
Lung lesions after PRRSV challenge are reduced among piglets vaccinated with Ingelvac PRRSFLEX® EU
Results from 3 laboratory studies conducted with 15-20 seronegative animals per treatment group, vaccinated at 2 weeks of age and challenged with heterologous PRRSV Type 1 isolate (88,3% sequence homology at ORF%) 2,3,4 weeks post vaccination
Increased ADG:
Average weight gain after PRRSV challenge is greater among piglets vaccinated with Ingelvac PRRSFLEX® EU
Results from 3 laboratory studies conducted with 15-20 seronegative animals per treatment group, vaccinated at 2 weeks of age and challenged with heterologous PRRSV Type 1 isolate (88,3% sequence homology at ORF%) 2,3,4 weeks post vaccination
Until end of Fattening
Reduced viremia:
Viraemia is reduced throughout production among pigs vaccinated with Ingelvac PRRSFLEX® EU2
Results from 3 laboratory studies conducted with 22 seronegative animals per treatment group, vaccinated at 2 weeks of age and challenged with heterologous PRRSV type 1 isolate (88,3% sequence homology at ORF5) 20, 24, 26 week post vaccination
Lung Lesions:
Lung lesions are reduced throughout production among pigs vaccinated with Ingelvac PRRSFLEX® EU
Results from 3 laboratory studies conducted with 22 seronegative animals per treatment group, vaccinated at 2 weeks of age and challenged with heterologous PRRSV type 1 isolate (88,3% sequence homology at ORF5) 20, 24, 26 week post vaccination
Increased ADG:
Average growth throughout production is improved among piglets vaccinated with Ingelvac PRRSFLEX® EU
Results from 3 laboratory studies conducted with 22 seronegative animals per treatment group, vaccinated at 2 weeks of age and challenged with heterologous PRRSV type 1 isolate (88,3% sequence homology at ORF5) 20, 24, 26 week post vaccination
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The only piglet-specific PRRS vaccine designed to maximise pig performance in all stages of production:
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- For active immunisation of clinically healthy pigs from 17 days of age from farms affected with PRRSV type I
- One 1 ml dose administered via a single intramuscular injection
- Onset of immunity at 3 weeks with a duration of 26 weeks
Ingelvac PRRSFLEX® EU summary of product information
Composition
Each dose (1 ml) contains:
Lyophilisate: Active substance Live attenuated Porcine Respiratory and Reproductive Syndrome Virus (PRRSV), strain 94881 (genotype 1): 104.4-106.6 TCID50 (Tissue Culture Infectious Dose 50%)
Target species
Pigs (from 17 days of age until the end of fattening)
Indications for use
For active immunisation of clinically healthy pigs at 17 days of age and older from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce virus load in blood in seropositive animals under field conditions.
Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces lung lesions, virus load in blood and lung tissues as well as negative effects of infection on daily weight gain. A significant reduction of the respiratory clinical signs could additionaly be demonstrated at the onset of immunity.
Onset of immunity: 3 weeks
Duration of immunity: 26 weeks
Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in breeding animals. Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using reliable diagnostic methods.
Special warnings for each target species
Precautions should be taken to avoid the transfer of the vaccine virus within the herd, e.g. from positive animals to naïve animals.
Do not use in boars producing semen for naïve herds, as PRRSV can be shed in semen. Maternally derived antibodies have been shown to interfere with vaccine efficacy. In the presence of maternally derived antibodies, timing of initial vaccination of piglets should be planned accordingly.
Special precautions for use in animals
Vaccinate only clinically healthy animals.
The vaccine strain may spread to unvaccinated animals in contact with vaccinated animals up to 3 weeks post vaccination. Vaccinated animals may excrete the vaccine strain by faecal excretion and in some cases by oral secretions.
Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals that should remain free from PRRS virus.
For optimum PRRS control programme, all animals in a herd should be vaccinated. In the sow herd it is recommended to use a vaccine licensed for use in sows.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case adverse reactions develop following accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.
Adverse reactions
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Very commonly, slight transient increases (not greater than 1.5°C) in body temperature can be observed following vaccination. Temperatures return to normal without additional treatment, 1 to 3 days after the maximum temperature increase is observed.
Injection site reactions are uncommon. Transient minimal swelling or redness of the skin may be observed. These reactions disappear spontaneously without any additional treatment.
Use during pregnancy, lactation and lay
The safety of this veterinary medicinal product has not been established during pregnancy or 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.
Amounts to be administered and administration route
Dosage and method of administration:
Single intramuscular injection of one dose (1 ml), irrespective of body weight.
For reconstitution, transfer the entire content of the solvent vial to the vial containing the lyophilisate and reconstitute the lyophilisate as follows: 10 doses in 10 ml, 50 doses in 50 ml, 100 doses in 100 ml and 250 doses in 250 ml of the solvent.
Ensure that the lyophilisate is completely reconstituted before use.
Avoid introduction of contamination during use.
Use sterile equipment.
Avoid multiple broaching, for example by using automatic injectors.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No additional negative effects have been observed following the administration of a 10-fold overdose in naïve piglets of two weeks of age with regard to systemic and local reactions.
Withdrawal period
Zero days.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Special precautions for the disposal of unused medicinal product or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.