Porcilis PRRS and Porcilis M Hyo

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1 Porcilis PRRS and Porcilis M Hyo can now be mixed Protect against two top respiratory pathogens with one less injection

2 Two important respiratory vaccines can now be mixed Porcilis PRRS and can now be safely mixed together with no loss of efficacy, for more convenient dosing. By reducing the number of injections, there is less stress on the animal. It saves time and labor while providing protection against two of the top three respiratory pathogens. The efficacy and safety of this simultaneous administration are supported by the results from vaccine challenge studies and officially approved within the EU. Porcilis PRRS A live vaccine for the immunization of pigs against Porcine Reproductive and Respiratory Syndrome. The vaccine contains PRRS virus strain DV dissolved in Diluvac Forte. For gilts and sows: A well-proven safe MLV vaccine (6) MLV vaccines are much more efficacious than inactivated PRRSV vaccines (17) European strain with demonstrated broad protection (12, 2, 13) More pigs born alive per litter (14, 1, 15, 9, 22) Fewer days to return to estrus (1) For piglets: Reduces mortality (11) Improves ADG and FCR Substantial reduction in the use of antibiotics (11) The above will result in a favorable cost-benefit analysis (7). For programs to produce PRRSV-free progeny by continuously reducing: The number of viremic pigs The amount and duration of virus circulation Virus shedding Infection pressure Transmission rates Porcilis PRRS combined with good management makes regional eradication programs feasible (7, 23, 15, 21).

3 An inactivated bacterial vaccine for the immunization of finishing pigs to reduce pulmonary lesions caused by Mycoplasma hyopneumoniae infection. Contains whole cell concentrate of Mycoplasma hyopneumoniae strain 11 suspended in Diluvac Forte. improves ADG and FCR resulting in better profitability (4, 20, 16, 3, 19) Reduces lung lesions caused by Mycoplasma hyopneumoniae (20, 16, 3, 19) Counteracts the immunosuppressive effect of Mycoplasma hyopneumoniae that increases susceptibility to other PRDC pathogens (10) Immunity last at least until 20 weeks after second dose Duration of immunity is unaffected by the presence of MDA Excellent immunity 2 weeks after second dose Onset of immunity is unaffected by the presence of MDA Tendency to improve ADG even on farms with low M. hyo challenge (3) No more labor involved than in reconstituting Porcilis PRRS, but protection against both Porcilis PRRS and with one less injection.

4 Porcilis PRRS and mixture makes your life easier PRRS Efficacy Studies Materials and Methods 1 st Vaccination 1-week of age Non-vac Control 1 3 Weeks observation period after challenge 2 nd Vaccination 4-weeks of age + Porcilis PRRS mixed Pigs Challenge 1 14 Porcilis PRRS 14 Non-vac Control 14 PRRSV I.N. 4 weeks p.v. (8 weeks of age) The excellent efficacy of Porcilis PRRS remains unaffected by mixing it with and given at 4 weeks of age. Good Porcilis PRRS protection after PRRSV challenge when mixed with In this laboratory experiment to check the PRRS efficacy in the Porcilis PRRS and mixture, Porcilis PRRS was given in such a manner so that the worst case scenario to test the Porcilis PRRS efficacy, was created (5). Fig. 1: Results - PRRS virus titration from serum Log 10 TCID 50 /ml Days post challenge (challenge at 8 wk of age) Fig. 2: Results - Accumulated quantity of PRRS virus found in serum during the trial period Porcilis PRRS + Porcilis PRRS Controls Log 10 TCID 50 /ml days post challenge Porcilis PRRS + Porcilis PRRS Controls

5 M Hyo Efficacy Studies Unlike PRRS field virus (18), the unique safety profile of the European strain contained in Porcilis PRRS and its patented adjuvant, allows the efficacy and safety of to be unaffected by the mixture. Fig. 3: Results: Lung Lesion Scores (LLS) in unvaccinated controls, and in animals vaccinated with alone or in mixture with Porcilis PRRS (maximum titer per dose) after M. hyo challenge (5). 15 Optimal protection with the mixture In this laboratory experiment to check the efficacy against M Hyo of the Porcilis PRRS and Porcilis M Hyo mixture, the Porcilis PRRS was given in such a manner that the worst case scenario was created. Mean LLS Experiment 1 Experiment 2 Porcilis PRRS + Controls The safety of Porcilis PRRS was subject of a study performed by Labarque (6). Efficacy and safety characteristics of Porcilis PRRS were studied. It was concluded that even though the vaccine virus was recovered from BAL fluids in rather large quantities, the total number of mononuclear BAL cells remained constant after vaccination. This differs from an infection with wild-type PRRSV strains, which is characterized by a massive influx of monocytes into the lungs (6). These findings demonstrate that the vaccine virus does not induce the attraction of inflammatory cells into the lungs, which may contribute to its safety. Martelli (13) reports the underlying immunological processes induced by Porcilis PRRS and Le Roith (8) reports the way in which a different MLV PRRS vaccine (derived from a type II PRRS field isolate), as well as field strains, negatively affect the immune response to another vaccine (M. hyo). Porcilis PRRS and vaccination schedule: Porcilis PRRS + Mixed 1st 2nd 1 w 2 ws 3 ws 4 ws 5 ws weeks of age Simple, straightforward and convenient mixing

6 Mixing of and Porcilis PRRS Good mixture, fewer injections, less work and great performance. Safe convenient and effective: New strategy to control respiratory disease in pigs Easy way to save time and labor Adjuvanted with patented Diluvac Forte - Prolonged and enhanced immune response - No tissue damage at injection site - Ease of use, with no foaming

7 Instructions for Use Firstly, ensure that the vials have corresponding doses of Porcilis PRRS and so that mixing both vaccines produces the required number of 2ml doses. Use a sterile needle and syringe to mix the products. The mixed product will be in the same vial (the bottle) as a Ready-to-Use product, but a 2 ml intramuscular dose will vaccinate each pig against both PRRSV and Mycoplasma hyopneumoniae at the same time. As simple as using Porcilis PRRS with its regular Diluvac Forte adjuvant. Step 1 Use a syringe and needle to remove a few mls of vaccine from the vial. Step 2 Inject these few mls into the vial containing the freeze-dried Porcilis PRRS. Step 3 Shake the vial to mix the two products. Step 4 Remove all the mixture from the vial. Step 5 Inject the mixture back into the vial and shake again. Step 6 Attach the vial to the injector to begin vaccination. The mixed product is now ready for use. Each intramuscular dose of 2 ml will contain one dose of and one dose of Porcilis PRRS. Porcilis PRRS & mixture

8 Bibliography 1. Alexopoulos, C., Kritas, S.K., Kyriakis, C.S., Tzika E. and Kyriakis, S.C. (2005). Sow performance in an endemically Porcine Reproductive and Respiratory Syndrome (PRRS)-virus infected farm after sow vaccination with an attenuated PRRS vaccine. Vet. Microbiol.,Volume 111, 3-4, p Martelli, P., Gozio, S., Ferrari, L., Rosina, E., De Angelis, E., Quintavalla, C., Bottarelli E. and Borghetti, P. (2009). Efficacy of a modified live PRRSV vaccine in pigs naturally exposed to a heterologous European field strain: clinical protection and cell-mediated immunity.,vaccine Volume 27, p Porcilis PRRS 2. Borghetti, P., de Angelis, E., Bonati, L., Cordioli, P., Alborali, L.G., Lombardi, G., Gozio, S. and Martelli P. (2004). Study on cell-mediated immune response in vaccinated (Porcilis PRRS) piglets challenged with an heterologous Italian-like PRRSV- strain. Proc. 18 th IPVS Congress Hamburg V1, p Bouwkamp, F.T., Bakker, J., Elbers, A,R.W..M.and Smeets, J.F. (2004). A Field efficacy trial of Porcilis M Hyo in fattening pigs in the Netherlands. Proc. 18 th IPVS Congress, Hamburg V1, p Dinslage, T., Bowden, J. and Karriker, L. (2008). An application of evidence based medicine: The impact of Mycoplasma hyopneumoniae vaccine on average daily gain in swine. Proc. AASV Congress San Diego, p Drexler, C.S., Witvliet, M.H., Raes, M., van de Laar, M., Eggen, A.A.S. and, Thacker, E.L. (2010). Efficacy of a combined Porcine Reproductive and Respiratory Syndrome virus and Mycoplasma hyopneumoniae vaccination in piglets. Vet. Rec. Volume 166, p Labarque, G., van Gucht, S., Van Reeth, K., Nauwynck, H., and Pensaert, M. (2003). Respiratory tract protection upon challenge of pigs vaccinated with attenuated Porcine Reproductive and Respiratory Syndrome virus vaccines. Vet. Microbiol. Volume 95, p Lebret, A. and Ridremont, B. (2008). PRRS mass vaccination with a MLV vaccine and unidirectional pig and human flow : cost-benefit analysis. Proc. 20th IPVS Congress Durban. V2, p Le Roith, T., Hammond, S., Todd, S. M., Ni, Y., Cecere, T. and Pelzer, K. D. (2011). A Modified Live PRRSV vaccine and the pathogenic parent strain induce regulatory T cells in pigs naturally infected with Mycoplasma hyopneumoniae. Vet. Imm. and Immunopath. Volume 140, 3-4, p Longo, A., Lopez, J.V. and Perez-Fano. J. L. (2006). Effect of the vaccination of pregnant sows with Porcilis PRRS in a herd with an active PRRS-virus circulation. Proc. 19 th IPVS Congress Copenhagen. V2, p Lorenzo, H., Quesada, O., Assuncao, P., Castro, A. and Rodrıguez, F. (2006). Cytokine expression in porcine lungs experimentally infected with Mycoplasma hyopneumoniae. Vet. Imm. and Immunopath. Volume 109, 3-4, p Martelli, P., Guazzetti, S., Foccoli E., Gozio, S. and Terreni, M. (2002). Efficacy of a live PRRS vaccine in the control of PRDC - A case report. Proc. 17 th IPVS. Congress Ames. V2, p Martelli, P., Cordioli, P., Alborali, L., Gozio, S., De Angelis, E., Ferrari, L., Lombardi, G., and Borghetti, P. (2007). Protection and immune response in pigs intradermally vaccinated against PRRS and subsequently exposed to a heterologous European (Italian cluster) fieldstrain. Vaccine Volume 25, p Composition Per 2 ml dose: Lyophilisate and solvent for suspension for injection for pigs. Active ingredient: live attenuated PRRS virus strain DV. Adjuvant: dl-α-tocopheryl acetate. Indications for use For the active immunization of clinically healthy pigs in a PRRSv-contaminated environment, to reduce viremia caused by infection with the European strains of PRRS virus. Special precautions for use None. Dosage and administration Use sterile syringes and needles. Dosage: Intramuscular injection of 2 ml in the neck behind the ear. Vaccination scheme: A single dose for pigs from 2 weeks of age onwards. Fattening pigs: a single vaccination is sufficient for protection through to slaughter. Pharmaceutical precautions Vaccine: store at 2-8 C (in a refrigerator). Diluent: store at 25 C. EU approval of the simultaneous use with Interaction with other medicinal products and other forms of interaction 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. The vaccine may be reconstituted shortly before vaccination for simultaneous use with in finishing pigs from 4 weeks of age and the following instructions should be followed: 10 doses Porcilis PRRS + 20 ml 25 doses Porcilis PRRS + 50 ml 50 doses Porcilis PRRS ml 100 doses Porcilis PRRS ml A single dose (2 ml) of Porcilis PRRS mixed with is given intramuscularly in the neck. Shelf life After reconstitution: 3 hours at room temperature. After mixing with : 1 hour at room temperature Porcilis M Hyo 14. Pejsak, Z. and Markowska-Daniel, I. (2006). Randomised, placebo-controlled trial of a live vaccine against Porcine Reproductive and Respiratory Syndrome virus in sows on infected farms. The Vet. Rec. Volume 158, p Ridremont, B. and Lebret, A. (2006). Validation of a mass vaccination protocol with a PRRS modified live vaccine to stabilize French breeding herds. Proc. 19 th IPVS Copenhagen, p Ridremont, B. and Volant, L. (2006). Effect of Porcilis M Hyo vaccination on lung lesions of fattening pigs in French farms. Proc. 19 th IPVS Copenhagen, p Scortti, M., Prieto, C., Álvarez, E., Simarro, I. and Castro, J. M. (2007). Failure of an inactivated vaccine against Porcine Reproductive and Respiratory Syndrome to protect gilts against a heterologous challenge with PRRSV. The Vet. Rec. Volume 161, 24, p Thacker, E., Thacker, B., Young, T., and Halbur, P. (2000). Effect of vaccination on the potentiation of porcine reproductive and respiratory syndrome virus (PRRSV)-induced pneumonia by Mycoplasma hyopneumoniae. Vaccine Volume 18, p Tzivara A, Kritas, S.K., Bourriel, A.R., Alexopoulos C. Nell T, and Kyriakis, S.C. (2004). Field evaluation of the efficacy of an inactivated vaccine (Porcilis M Hyo) for the control of enzootic pneumoniae in Mycoplasma hyopneumoniae infected pig units. Proc. 18 th IPVS Congress Hamburg. V1, p Tzivara, A., Kritas, S.K., Bourriel, A.R., Alexopoulos C. and Kyriakis, S.C. (2007). Efficacy of an inactivated aqueous vaccine for the control of enzootic pneumonia in pigs infected with Mycoplasma hyopneumoniae. Vet. Rec. Volume 160, p Van Groenland, G.J., Cruijsen, T. and Geurts, V. (2010). A PRRS vaccination strategy to create PRRS negative growers/gilts in SPF herds (Re) infected with PRRS. Proc. 21 st IPVS Congress Vancouver, p Vilalta, C., Barbosa, J.A., Jimenez, M., Alegre, R. and Mourits, B. (2006). Effect of the vaccination with Porcilis PRRS in a sow herd with an active PRRS virus circulation causing reproductive disorders. Proc. 19 th IPVS Congress Copenhagen, p Voglmayr, T., Sipos, W., Schuh, M., Truschner, K., Griessler, A., Mourits, B. and Schmoll F. (2006). PRRSV-Eradikation in einem geschlossenen Herdebuchzuchtbetrieb ohne Unterbrechung der Produktion mittels Einsatzes einer Lebendvirus (MLV)-Vakzine und Schliessung der Herde. Tieraerzliche Praxis, Volume 34, p Composition Inactivated whole cell concentrate of Mycoplasma hyopneumoniae. Adjuvant: dl-α-tocopheryl acetate. Indications for use For the active immunization of finishing pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae Onset of immunity: 2 weeks after the second injection. Duration of immunity: at least 20 weeks after the second injection. Special precautions for use None. Dosage and administration Dosage: Intramuscular injection of 2 ml in the neck behind the ear. Vaccination scheme: Vaccinate pigs twice with a three-week interval. The first injection can be given from the age of 1 week onwards. Allow the vaccine to reach room temperature (15-25 C) and shake well before use. Use sterile syringes and needles. Avoid the introduction of contaminants. Pharmaceutical precautions Store at 2-8 C. Do not freeze. EU approval for the simultaneous use with Porcilis PRRS Interaction with other medicinal products and other forms of interaction 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 PRRS. The vaccine may be reconstituted shortly before vaccination for simultaneous use with Porcilis PRRS in finishing pigs from 4 weeks of age and the following instructions should be followed: 10 doses Porcilis PRRS + 20 ml 25 doses Porcilis PRRS + 50 ml 50 doses Porcilis PRRS ml 100 doses Porcilis PRRS ml A single dose (2 ml) of Porcilis PRRS mixed with is given intramuscularly in the neck. Shelf life After opening: 3 hours. After mixing with Porcilis PRRS: 1 hour at room temperature. PM10_0098 No part of this brochure may be reproduced in any form without written permission from Intervet/Schering-Plough Animal Health. 1. Intervet International bv, P.O. Box 31, 5830 AA Boxmeer, The Netherlands, Phone +31 (0) , Fax +31 (0) , info@intervet.com, Breathe better. Grow better.