This product is only licensed for sale in the Republic Of Ireland
Active Ingredient: Leptospira interrogans
Target Species: Cattle
Treats and Controls: Leptospiia hardjo, Leptospira interrogans serovar hardjo (hardjo Prajitno) and L. borgpetersenii serovar hardjo (hardjo Bovis)
Administration Method: Subcutaneous injection (under the skin)
Withdrawal Time: There is no withdrawal time for this product
Dosage for cattle: 2 ml per animal.After the initial vaccination a second dose should be given no less than 4 weeks and no more than 6 weeks after.
|Body Weight||Dose Volume||Doses Per Pack|
Always read the label and all enclosed information for Leptavoid H before administering to animals!
Reasons to use Leptavoid-H
Summary of Products Characteristics
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Leptavoid™ – H
Suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituents per ml
serovar hardjo 204 (inactivated) […] 2.0-3.0 x 109 organisms
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 6.1
3. PHARMACEUTICAL FORM
Suspension for injection.
Aqueous fluid with precipitate that resuspends on shaking.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
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 toLeptospira borgpetersenii serovar hardjo which is maintained for at least five months and responds in the event of a challenge five months post vaccination.
4.4 Special warnings for each target species
Vaccinated cattle may be positive for diagnostic tests and therefore unacceptable for export to some countries.
4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals
Special precautions for use in animals
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 4.9 for appropriate dosing recommendations.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
4.6 Adverse reactions (frequency and seriousness)
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 4.9 for dosing recommendations.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy but should not be administered within two weeks of breeding (see section 4.5).
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 Amounts to be administered and administration route
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period
5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against Leptospira interrogans serovar hardjo and Leptospira borgpetersenii serovar hardjo.
ATC Vet code:
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after opening the immediate packaging: 8 hours.
6.4 Special precautions for storage
Store and transport at +2°C to + 8°C.
Protect from light. Do not freeze.
6.5 Nature and composition of immediate packaging
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).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Intervet UK Ltd.
Bucks MK7 7A
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24 October 2005
10. DATE OF REVISION OF THE TEXT
24 November 2010
Injectables should be given according to the manufacturer’s instructions at the recommended injection site.
• Always use a clean, sterile syringe and needle. If using a multiple injection gun, ensure the needle is disinfected between injections, e.g. with an automatic sterilisation system.
• If the site to be injected is dirty, clean the skin and swab with an alcohol-impregnated wipe or cotton wool
• Before injecting, check the expiry date and read the instructions of the product to be used. Some products need to be shaken before use.
• Use the correct-sized needle according to the size of the animal and site of injection.
• Ensure the animal is adequately restrained before attempting the injection.
• Take care to ensure it is given subcutaneously and not intramuscularly. Raise a fold of skin at the injection site (mainly neck but some are ear) recommended by the product manufacturer and inject carefully into the space created.
• If a large dose is to be delivered, it may be advisable to split the dose between two injection sites. After the injection, briefly massage the site to improve the dispersal of the injected material.
• Dispose of the needle and syringe in appropriate clinical waste and sharps containers.
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