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.

Always read the label and all enclosed information for Leptavoid H before administering to animals!

​Reasons to use Leptavoid-H

How do herds become infected with Leptospirosis?

Vaccination with Lepatvoid-H can increase conception rates.

Features of Leptavoid-H

• injectable vaccine
• For use on both beef and dairy cattle
• Protects against both strains of leptospiia hardjo

Click here to Download Data Sheet

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 
Leptospira interrogans 
serovar hardjo 204 (inactivated) […] 2.0-3.0 x 109 organisms

Adjuvant 
(10% alum) 
Insoluble aluminium salt 
equivalent to aluminium […] 0.5-0.7 mg

Preservative 
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 
Cattle.

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.

4.3 Contraindications
None.

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

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. 
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.

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.

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
Zero days.

5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against Leptospira interrogans serovar hardjo and Leptospira borgpetersenii serovar hardjo.

ATC Vet code:
QI02AB03

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Thiomersal 
Aluminium salt 
Formaldehyde 
Sodium Chloride

6.2 Incompatibilities
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. 
Walton Manor 
Walton 
Milton Keynes 
Bucks MK7 7A 
UK

8. MARKETING AUTHORISATION NUMBER
Vm 01708/4568

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24 October 2005

10. DATE OF REVISION OF THE TEXT
24 November 2010

Legal category
POM-VPS 

 Cattle Injectables
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.
     

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.

All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods, while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover loss of value of goods.

All returns should be complete which includes boxes, manuals and accessories that may have been included with the order.

All returns must be packaged appropriately for shipping, we will not accept responsibility for damages or loss which occur during shipping of a return product.

We accept no responsibility for goods damaged or lost while in transit to us. 

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.

2) To print off your return label click here or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point here.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.