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Leptavoid H is a vaccine for the immunisation of cattle against the two most important forms of Leptospirosis. The vaccine can improve herd fertility and reduce urine shedding of Leptospire organisms. Protection from the vaccine lasts for about 5 months.
Leptospira interrogans serovar hardjo 204 (inactivated) 2.0-3.0 x 109 organisms.
(10% alum) Insoluble aluminium salt equivalent to aluminium 0.5-0.7 mg.
Thiomersal 0.085 mg – 0.115 mg.
For a full list of excipients, see section "Pharmaceutical particulars".
Suspension for injection. Aqueous fluid with precipitate that resuspends on shaking.
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.
Vaccinated cattle may be positive for diagnostic tests and therefore unacceptable for export to some countries.
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.
In the case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of the product literature.
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.
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.
Can be used during pregnancy but should not be administered within two weeks of breeding (see section "Special precautions for use").
Safety and efficacy data are available which demonstrate that this vaccine can be administered to animals of 8 month 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.
Dose: Cattle 2 ml.
Minimum age of administration: 1 month.
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.
Syringes and needles should be sterilised before use and the injection made subcutaneously through an area of clean, dry skin taking precautions against contamination. Exercise care with part used containers and discard all part used containers within 8 hours of opening to reduce the potential for contamination.
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.
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.
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.
A greater proportion of animals may show a transient rise in temperature of 1 - 2°C lasting 24 - 48 hours after an overdose administration. Injection site swellings are similar to those seen with a single dose.
ATC Vet code: QI02AB03
To stimulate active immunity against Leptospira interrogans serovar hardjo and Leptospira borgpetersenii serovar hardjo.
Thiomersal, Aluminium salt, Formaldehyde and Sodium Chloride.
Do not mix with any other veterinary medicinal product.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after opening the immediate packaging: 8 hours.
Store and transport at +2°C to + 8°C. Protect from light. Do not freeze.
i) Glass vial, Type I (Ph. Eur.), with a rubber stopper and aluminium cap. 20 ml (10 doses).
ii) Flexible low density polyethylene bottle (Ph. Eur.), with a rubber stopper and aluminium cap. 50 ml bottle (25 doses).
iii) Pack sizes of 1 x 20 ml vial (10 doses) and 1 x 50 ml bottle (25 doses).
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
24 October 2005
24 November 2010.
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