Msd Leptavoid H 20Ml (Pom-Vps)

Target species Cattle Indications for use For the active immunisation 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 subtype Hardjobovis. In addition to the 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. Contraindications None. Special warnings for each target species Vaccinated cattle may be positive for diagnostic tests and therefore unacceptable for export to some countries. Special precautions for use The vaccine should not be administered within two weeks of breeding as this may reduce conception rates. This may be due to handling stress rather than a specific vaccine effect. Such effects are transient, are unlikely to be above 10% and are minor when compared with the potential overall increase in conception rates demonstrated in Leptospira Hardjo infected herds. However, it should be considered when timing A.I. especially with valuable semen. Maternally derived antibody may interfere with the performance of the vaccine in young animals. Refer to section "Amounts to be administered and administration route" for appropriate dosing recommendations. Operator warnings In the case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical advice immediately and show the package leaflet or the label to the physician. Even though animals may have been vaccinated it should be remembered that no vaccine is 100 % effective and that the risk, albeit very much reduced, of transmission of leptospirosis from cattle to their handlers, remains. Appropriate precautions should be maintained at all times and prompt medical advice sought in the event of clinical signs of possible infection. Adverse reactions A transient rise in temperature of 1 – 1.3°C lasting 24 - 48 hours after vaccination may occur, particularly after the second dose. This reaction is very common. Administration of the first and second dose may produce swellings in most animals with diameters of up to 7.5 and 8.5cm respectively. These local reactions normally resolve over several weeks after administration, but may persist for longer in a small number of animals. Local reactions are very common. Occasional hypersensitivity reactions may occur. In the case of hypersensitivity the use of adrenaline or other appropriate treatment is recommended. Youngstock vaccination: The sizes of the reactions seen in the second primary course may be larger than those seen in the first primary course (up to 17cm after 5 vaccinations 28 days apart). There may also be an increased sensitivity at the injection site compared to the primary vaccination. Animals may also exhibit a transient rise in temperature of 1.2 - 2.6°C following the second primary course. See section "Amounts to be administered and administration route" for dosing recommendations. 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). Use during pregnancy or lactation Can be used during pregnancy but should not be administered within two weeks of breeding (see section "Special precautions for use"). Interactions Safety and efficacy data are available which demonstrate that this vaccine can be administered to animals of 8 months of age or older on the same day, with Bovilis BVD vaccine. The two vaccines should be administered at separate sites. For the concurrent use of Leptavoid H and Bovilis BVD vaccines in naïve animals, the primary vaccination course must be completed at least 4 weeks before the expected gestation, in order that foetal protection can be established. 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.