Presentation

Bovivac S is a suspension for injection containing inactivated cells of Salmonella dublin, strain S342/70 (1 x 10⁹ cells/ml) and inactivated cells of Salmonella typhimurium, strain S341/70 (1 x 10⁹ cells/ml). Bovivac S contains aluminium hydroxide as an adjuvant and thiomersal as a preservative.

Uses

For the active immunisation of cattle in order to induce serological and colostral antibody production against Salmonella dublin and Salmonella typhimurium and in the face of an outbreak to reduce Salmonella typhimurium  infections when used under field conditions as part of an overall herd management programme. Bovivac S may also contribute to reducing S. typhimurium contamination of the environment.

Dosage and administration

Vaccination dosage

Calves up to 6 months of age – 2ml

Adult cattle – 5ml

Route and method of administration

Subcutaneous injection preferably in the loose skin on the side of the neck, observing aseptic precautions. Shake the vaccine bottle before use.

Primary vaccination course

Where diagnosis of salmonellosis caused by S. dublin and/or S. typhimurium has been confirmed, all at risk adult cattle, including lactating cows, dry cows, heifers, barren cows and in-contact bulls (but excluding any with overt clinical signs of salmonellosis), should receive two 5ml injections separated by an interval of 21 days.  

For pregnant cows, this primary vaccination course can be given irrespective of the reproductive status.   Any pregnant cows that have not calved within 8 weeks of the second dose of vaccine should receive a further 5ml dose of Bovivac S 3-4 weeks pre-calving.

Healthy calves from approximately 3 weeks of age may also be given a primary vaccination course.   Calves should be given two 2ml injections separated by an interval of 14 to 21 days. 

Re-vaccination scheme

All cattle vaccinated with the primary vaccination course of Bovivac S should receive a 5ml injection at least two weeks prior to each period of risk or at intervals of not more than 12 months thereafter.  

As part of an overall herd management programme, for pregnant cattle, it is advised that for each subsequent pregnancy, in order to maintain a sufficient level of active immunisation to reduce S. dublin and S. typhimurium infections under field conditions, a single injection of 5ml should be administered approximately 3-4 weeks before calving.

Advice on correct administration

The use of automatic vaccination equipment is recommended. Use a vaccinator with vented draw-off spike or similar device only.

The vaccine may be administered using a sterile needle and syringe, provided a fresh sterile needle is used each time the rubber cap is punctured, to avoid contamination of the remaining contents.

Contra-indications, warnings, etc.

Swellings at the injection site may occur.   Typically, these swellings may be warm when compared with the surrounding area for up to 5 days after vaccination, reach a maximum size within 1-6 days after vaccination and completely disappear or reduce to clinically insignificant reactions within 2-3 weeks after vaccination.   In addition, swellings may be slightly painful on palpation for 1-2 days after vaccination, although this will not require veterinary intervention. 

Occasional hypersensitivity reactions may occur.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

All stock showing overt clinical signs of salmonellosis at the time of the initial vaccination programme should receive appropriate treatment and be fully vaccinated once they have recovered.   Any unvaccinated stock must be managed separately to vaccinated stock, with no contact between the groups.   Hygiene precautions must be instituted, where possible, to prevent transfer of infection from one group to another. All animals of a herd should be vaccinated.

Significant levels of immunity cannot be expected until two weeks after the second dose of the primary vaccination course. 

The effect of maternally derived antibodies has not been studied, but it is likely that high levels of maternally derived antibodies may interfere with the development of active immunity in calves.

The efficacy of Bovivac S has been established in the field using the recommended programme of use.  

Specific experimental data to quantify the duration of immunity, the effectiveness of a single dose re-vaccinationor the degree of protection from colostral antibodies has not been generated.

When vaccinating animals, stress should be avoided, particularly during pregnancy.

The effect of Bovivac S administered around service/insemination has not been studied. Limited laboratory and field data suggest that vaccination with Bovivac S has no adverse effect on pregnancy and calving.

A small number of individuals may fail to respond to vaccination as a result of immunological incompetence or for some other reason. In the face of an outbreak of disease, it is therefore important to avoid vaccination of animals which have overt clinical salmonellosis or intercurrent disease or which have a poor nutritional status.   Such animals must be isolated and treated as appropriate and then vaccinated upon clinical recovery.

No information is available on the safety and efficacy from concurrent use of this vaccine with any other. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product.

Do not mix with any other vaccine or immunological product.

Operator warnings:

There are no special warnings applicable to people administering the vaccine.

Withdrawal period:

Zero days

FOR ANIMAL TREATMENT ONLY. 

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store in a refrigerator. Do not freeze. Protect from light. 

Do not use after the expiry date stated on the label.

Once broached, use within 10 hours.   Partially used containers must be discarded at the end of each day’s operations.

Any unused product or waste materials should be disposed of in accordance with local requirements.

Legal category

POM-V           To be supplied only on veterinary prescription.

Package quantities

50 ml polyethylene multidose bottles.

Further information 

For any information about this veterinary medicinal product, please contact the marketing authorisation holder.

Marketing Authorisation number

Vm 01708/4415         UK authorised veterinary medicinal product.

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks MK7 7AJ

Licensed distributor in Northern Ireland

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation 

August 2006