Vaccines

HYOGEN® is the unique inactivated vaccine that offers strong fast and long lasting protection by using just ONE dose (2 ml) in the life time of market pigs. This is due to its main components; the antigen originated from Ceva M. hyo strain BA 2940-99 along with the adjuvant, ImuvantTM. ImuvantTM is a unique Ceva adjuvant composed of a non-toxic lipopolysaccharide (LPS) from J5 E. coli together with a mineral oil in water emulsion that forms a complex and highly efficient immunostimulant. These components and balance formulation will enable and appropriate innate, humoral and cell-mediated immune response from the host. Hyogen® provides active immunisation of healthy pigs against Mycoplasma hyopneumoniae INDICATIONS Active immunization of healthy pigs against enzootic pneumonia caused by Mycoplasma hyopneumoniae in herds where the chronic or acute disease causes losses. ADMINISTRATION AND DOSAGE Intramuscularly. Inject ONE dose (2 ml) from 3 weeks of age onwards.

For rinsing Idal intradermal needleless vaccinators

For active immunisation of pigs over the age of 2 weeks against porcine circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduced PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

For active immunisation of pigs over the age of 2 weeks against porcine circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduced PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

For active immunization of animals to reduce clinical signs (abortion, stillbirth, early mortality and hyperthermia) caused by Chlamydia abortus, abortions caused by Salmonella Abortusovis and to reduce shedding of both pathogens from infected animals. Vaccination covers the whole gestation period when administered according to the approved schedule. Dosage & Administration For use in ewes from 5 months of age onwards. Dose: 2ml by subcutaneous injection, behind the shoulder in the rib area (lateral thoracic region). Basic Vaccination: Animals should receive 2 vaccine doses with an interval of 3 weeks. The first dose should be administered at least 5 weeks before artificial insemination or mating. Administer the second dose 3 weeks after the first dose. Revaccination: A single booster dose (2ml) should be administered 2 weeks before each artificial insemination or mating, but no later than 1 year after initial basic vaccination. Shake well before use and occasionally during administration. Allow the vaccine to reach room temperature (15-25 °C) before administration. Administer under aseptic conditions. Only sterile syringes and needles should be used.

For active immunization of animals to reduce clinical signs (abortion, stillbirth, early mortality and hyperthermia) caused by Chlamydia abortus, abortions caused by Salmonella Abortusovis and to reduce shedding of both pathogens from infected animals. Vaccination covers the whole gestation period when administered according to the approved schedule. Dosage & Administration For use in ewes from 5 months of age onwards. Dose: 2ml by subcutaneous injection, behind the shoulder in the rib area (lateral thoracic region). Basic Vaccination: Animals should receive 2 vaccine doses with an interval of 3 weeks. The first dose should be administered at least 5 weeks before artificial insemination or mating. Administer the second dose 3 weeks after the first dose. Revaccination: A single booster dose (2ml) should be administered 2 weeks before each artificial insemination or mating, but no later than 1 year after initial basic vaccination. Shake well before use and occasionally during administration. Allow the vaccine to reach room temperature (15-25 °C) before administration. Administer under aseptic conditions. Only sterile syringes and needles should be used.

Live, freeze-dried vaccine aganist avian rhinotraceheitis. Each dose of vaccine contains at least 101.5-3.7 TCID50 avian rhinotraceheitis vaccine virus. The vaccine pellet contains stabilizers.

Sheep For the active immunisation of sheep to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney); • induce a serological response against the beta toxin of Clostridium perfringens (Struck, Lamb dysentery). The vaccine may be used in pregnant ewes to provide passive immunisation of lambs, provided that the lambs receive sufficient immune colostrum during the first 12 hours of life, to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney); • induce a serological response against the beta toxin of Clostridium perfringens (Lamb dysentery). Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in lambs and sheep is expected to last one year. The duration of passive protection in lambs is approximately 12 weeks provided that the lambs receive sufficient immune colostrum during the first 12 hours of life. Pigs For active immunisation of sows against tetanus caused by Clostridium tetani. Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in pigs is expected to last one year. The vaccine may be used in pregnant sows to provide passive immunisation of piglets, provided that the piglets receive sufficient immune colostrum during the first 12 hours of life, to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • induce a serological response against the toxin of Clostridium perfringens type C (enterotoxaemia). The duration of the passive protection in piglets is 14 days. Dosage & Administration The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions. Ewes and sows can be vaccinated during late pregnancy. • Sheep and lambs: 2 ml/dose. • Pigs: 5 ml/dose. Sheep • All sheep from 3 weeks of age onwards and not previously vaccinated with Lambivac must receive two injections separated by an interval of 4-6 weeks to be completed before onset of the period of risk. • Thereafter they should receive booster injections 2-3 weeks prior to identified risk periods with intervals of not more than 12 months. • In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4-6 weeks pre-lambing, to allow passive protection of lambs via colostrum. Pigs • Two injections with an interval of at least 3 weeks between injections, the second dose to be administered at least 3 weeks before farrowing. • The preferred schedule is vaccination at 6 and 3 weeks prior to the expected date of farrowing. • Only a single booster dose is required in subsequent pregnancies at approximately 3-4 weeks pre-farrowing.

Sheep For the active immunisation of sheep to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney); • induce a serological response against the beta toxin of Clostridium perfringens (Struck, Lamb dysentery). The vaccine may be used in pregnant ewes to provide passive immunisation of lambs, provided that the lambs receive sufficient immune colostrum during the first 12 hours of life, to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney); • induce a serological response against the beta toxin of Clostridium perfringens (Lamb dysentery). Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in lambs and sheep is expected to last one year. The duration of passive protection in lambs is approximately 12 weeks provided that the lambs receive sufficient immune colostrum during the first 12 hours of life. Pigs For active immunisation of sows against tetanus caused by Clostridium tetani. Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in pigs is expected to last one year. The vaccine may be used in pregnant sows to provide passive immunisation of piglets, provided that the piglets receive sufficient immune colostrum during the first 12 hours of life, to: • reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); • induce a serological response against the toxin of Clostridium perfringens type C (enterotoxaemia). The duration of the passive protection in piglets is 14 days. Dosage & Administration The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions. Ewes and sows can be vaccinated during late pregnancy. • Sheep and lambs: 2 ml/dose. • Pigs: 5 ml/dose. Sheep • All sheep from 3 weeks of age onwards and not previously vaccinated with Lambivac must receive two injections separated by an interval of 4-6 weeks to be completed before onset of the period of risk. • Thereafter they should receive booster injections 2-3 weeks prior to identified risk periods with intervals of not more than 12 months. • In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4-6 weeks pre-lambing, to allow passive protection of lambs via colostrum. Pigs • Two injections with an interval of at least 3 weeks between injections, the second dose to be administered at least 3 weeks before farrowing. • The preferred schedule is vaccination at 6 and 3 weeks prior to the expected date of farrowing. • Only a single booster dose is required in subsequent pregnancies at approximately 3-4 weeks pre-farrowing.

• For the active immunization of cattle from 1 month of age against Leptospira interrogans serovar hardjo and Leptospira borgpetersenii serovar hardjo. • To reduce shedding of Leptospira interrogans serovar hardjo in urine. • To improve herd fertility when infertility is diagnosed as caused by Leptospira hardjo. Circulating antibody is detectable 14 days following the first injection and persists for 12 months following completion of the primary course. Conjunctival challenge demonstrates 12 months cross protection against Leptospira borgpetersenii serovar hardjo (hardjo Bovis). In addition to circulating antibody response, vaccination with Leptavoid-H also stimulates cell-mediated immunity to Leptospira borgpetersenii serovar hardjo which is maintained for at least five months and responds in the event of a challenge five months post vaccination. Dosage & Administration Dose: • Cattle 2 ml. Minimum age of administration: 1 month. Administration: • By subcutaneous injection. • The container should be well shaken to resuspend the precipitate before doses are withdrawn. • The vaccine should be deposited beneath the skin covering the chest wall, well behind the shoulder, or beneath the skin covering the side of the neck. Dosage schedule: • The primary course consists of two doses with an interval of at least 4 weeks and not more than 6 weeks between them. • Ideally the course should be completed in the spring before the main season of transmission of Leptospira hardjo. Booster vaccination: • Re-vaccination with a single dose should be given annually to maintain protection against infection and progressively reduce exposure in the herd. • If the primary course is given later than the spring, the first booster should be given in the following spring and annually thereafter. Youngstock vaccination: • If the calves are inoculated before 5 months of age, a further primary course should be given at that age (allowing an interval of 4 weeks between vaccinations), as otherwise maternally derived antibodies may interfere with the immune response. • Older calves not immediately exposed to infection can be given the initial course at any time, but it is advisable to complete vaccination shortly before the main season of transmission of leptospirosis. To improve herd fertility: • For maximum benefit the primary course should be completed within 12 months of infertility being diagnosed as caused by Leptospira hardjo.

• For the active immunization of cattle from 1 month of age against Leptospira interrogans serovar hardjo and Leptospira borgpetersenii serovar hardjo. • To reduce shedding of Leptospira interrogans serovar hardjo in urine. • To improve herd fertility when infertility is diagnosed as caused by Leptospira hardjo. Circulating antibody is detectable 14 days following the first injection and persists for 12 months following completion of the primary course. Conjunctival challenge demonstrates 12 months cross protection against Leptospira borgpetersenii serovar hardjo (hardjo Bovis). In addition to circulating antibody response, vaccination with Leptavoid-H also stimulates cell-mediated immunity to Leptospira borgpetersenii serovar hardjo which is maintained for at least five months and responds in the event of a challenge five months post vaccination. Dosage & Administration Dose: • Cattle 2 ml. Minimum age of administration: 1 month. Administration: • By subcutaneous injection. • The container should be well shaken to resuspend the precipitate before doses are withdrawn. • The vaccine should be deposited beneath the skin covering the chest wall, well behind the shoulder, or beneath the skin covering the side of the neck. Dosage schedule: • The primary course consists of two doses with an interval of at least 4 weeks and not more than 6 weeks between them. • Ideally the course should be completed in the spring before the main season of transmission of Leptospira hardjo. Booster vaccination: • Re-vaccination with a single dose should be given annually to maintain protection against infection and progressively reduce exposure in the herd. • If the primary course is given later than the spring, the first booster should be given in the following spring and annually thereafter. Youngstock vaccination: • If the calves are inoculated before 5 months of age, a further primary course should be given at that age (allowing an interval of 4 weeks between vaccinations), as otherwise maternally derived antibodies may interfere with the immune response. • Older calves not immediately exposed to infection can be given the initial course at any time, but it is advisable to complete vaccination shortly before the main season of transmission of leptospirosis. To improve herd fertility: • For maximum benefit the primary course should be completed within 12 months of infertility being diagnosed as caused by Leptospira hardjo.

For active immunisation of cats from eight weeks of age against: -feline calicivirosis to reduce clinical signs. -feline viral rhinotracheitis to reduce clinical signs and viral excretion. -feline panleucopaenia to prevent leucopenia and to reduce clinical signs. -feline leukaemia to prevent persistent viraemia and clinical signs of the related disease. -Onset of immunity: 3 weeks after the primary vaccination for the panleucopaenia and leukaemia components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components. -After the primary vaccination course, the duration of immunity lasts for one year for all components. -Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component. Subcutaneous use. Reconstitute one dose of lyophilisate with one dose of solvent, shake gently and administer immediately. Administer subcutaneously one dose of the veterinary medicinal product according to the following regimen of vaccination. Primary vaccination: -first injection in kittens from 8 weeks of age -second injection 3 or 4 weeks later Maternally derived antibodies can negatively influence the immune response to vaccination. In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age. Revaccination: Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component. In this case, since annual revaccination is required for calcivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of Feligen RCP can be used annually. This vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.