NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Tuesday, May 21, 2024 2:06

Description: MSD-AH
Release 2.72
Bovilis® Bovivac® S
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovilis® Bovivac® S
Product index: Bovilis® Bovivac® S
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
per ml:
Active substances:
Formalin killed cells of Salmonella dublin strain S342/70 1 x 109 cells
Formalin killed cells of Salmonella typhimurium strain S341/70 1 x 109 cells
Adjuvant:
Aluminium hydroxide gel 200 mg
Excipients:
The vaccine contains thiomersal as a preservative
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection.
Clinical particulars
Target Species
Cattle.
Indications for use
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. Bovilis Bovivac S may also contribute to reducing S. typhimurium contamination of the environment.
Specific experimental data to quantify the duration of immunity or the degree of protection from colostral antibodies has not been generated.
Significant levels of immunity cannot be expected until two weeks after the second dose of the primary vaccination course.
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
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.
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.
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.
Operator warnings
Not applicable.
Adverse Reactions
Swellings at the injection site may occur. Typically, these swellings may be warm when compared to 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.
Use during pregnancy or lactation
When vaccinating animals, stress should be avoided, particularly during pregnancy.
The effect of Bovilis Bovivac S administered around service/insemination has not been studied. Limited laboratory and field data suggest that vaccination with Bovilis Bovivac S has no adverse effect on pregnancy and calving.
Interactions
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.
Amounts to be administered and administration route
Vaccination dosage
Calves up to 6 months of age – 2 ml
Adult cattle – 5 ml
Route of administration
Subcutaneous injection preferably in the loose skin on the side of the neck, observing aseptic precautions. The use of automatic vaccination equipment is recommended. The vaccine may be administered using a sterile needle and syringe, providing a fresh sterile needle is used each time the rubber cap is punctured, to avoid contamination of the remaining contents.
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 Bovilis 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 2 ml injections separated by an interval of 14 to 21 days.
Re-vaccination scheme
All cattle vaccinated with the primary vaccination course of Bovilis 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.
The efficacy of Bovilis Bovivac S has been established in the field using the recommended programme of use. No specific experimental data are available in support of the effectiveness of a single dose re-vaccination.
The use of automatic vaccination equipment is recommended. Use a vaccinator with vented draw-off spike or similar device only.
Overdose
Accidental overdose is very unlikely to cause any reaction other than described in point ‘Adverse reactions’, although the swelling may be larger and, together with the associated signs, may last slightly longer. A slightly reduced body weight gain was noticed in some calves that received an overdose. No adverse local or systemic reactions were noted in overdose studies performed in pregnant cows and calves.
Withdrawal periods
Zero days.
Pharmacological particulars
ATC Vet Code: QI02AB05.
Pharmacotherapeutic group
Inactivated bacterial vaccine.
To stimulate active immunity against Salmonella dublin and Salmonella typhimurium infections.
Pharmaceutical particulars
Excipients
Tris
Maleic acid
Sodium chloride
Formaldehyde
Thiomersal
Purified water
Major incompatibilities
Do not mix with any other vaccine or immunological product.
Shelf life
24 months. Do not use after the expiry date stated on the label.
Once opened, use of the vaccine must be completed within 10 hours.
Partially used containers must be discarded at the end of each day’s operation.
Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze.
Immediate packaging
Polyethylene multidose bottles (50 ml) with rubber stoppers sealed with an aluminium crimp cap. The containers and closures comply with the Ph. Eur.
Disposal
Any unused product or waste materials should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4415
Significant changes
Date of the first authorisation or date of renewal
10 August 1999
Date of revision of the text
January 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Bovivac® S 1x50ml:
GTIN:8713184039675