Bovidec
Revised: January 2016
AN: 01318/2015
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovidec
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient per 4 ml dose
Bovine Viral Diarrhoea (BVD) virus 5 x 106 TCID50.
strain KY1203nc (inactivated)
Adjuvant
Quil A 1 mg
Excipients
Thiomersal
For a full list of excipients see Section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection.
Pink, aqueous suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle
4.2 Indications for use (specifying the target species)
Adult female breeding cattle
For the active immunisation of adult female breeding cattle:
Prior to insemination/service to prevent infection of the foetus with BVD Type I virus. Results from studies available to date indicate that the protection afforded against BVDV Type I should exist for at least 420 days post initial vaccination.
It has been shown under field conditions that the vaccine may reduce the incidence of herd infertility when a diagnosis of infertility is associated with clinical manifestations of BVD Type I infection.
ii. Calves from the age of 4 months
For the active immunisation of calves:
To reduce viraemia and viral shedding of BVD Type I virus, once maternal antibodies have declined.
The duration of immunity is 13 months.
To reduce viraemia and the clinical signs of disease caused by BVD virus Type II, once maternal antibodies have declined. Results indicate the reduction in symptoms afforded should persist for at least 21 days after vaccination.
4.3 Contraindications
Do not administer to animals that have previously shown a hypersensitivity reaction.
Avoid vaccination of animals, which have intercurrent disease, are on a course of concomitant therapy or have a poor nutritional status.
4.4 Special warnings (for each target species)
In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence or for some other reason. Satisfactory immune responses will only be attained in healthy animals. When pregnant animals are vaccinated, it should be remembered that the calves they are carrying might have already been exposed to virus if the dam was naïve in the earlier stages of pregnancy.
4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the product to animals
Care should be taken to avoid self injection: if this occurs, seek medical advice and show the package leaflet or label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Occasional hypersensitivity reactions may occur as with all vaccines.
Should anaphylaxis occur, use epinephrine (adrenaline).
Transient pyrexia and injection site inflammatory reactions may occur.
The pyrexia is unassociated with any other clinical illness, the animals continuing to behave and eat normally. The local reaction consists of a diffuse, subcutaneous oedema, which subsides over 2-3 weeks.
4.7 Use during pregnancy and lactation or lay
Can be used during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the compatibility of this vaccine with any other. Therefore, the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
4.9 Amount(s) to be administered and administration route
The dose is 4 ml administered by subcutaneous injection. It is recommended that injection be made high on the side of the neck. Syringes and needles should be sterile and the injection made through an area of clean and dry skin observing aseptic technique.
Shake the container well before use.
Primary Vaccination
Adult Breeding Cattle
Animals should receive 2 doses of vaccine, 3 weeks apart. The vaccination programme should be completed not less than 7 days prior to service.
Calves
Animals should receive 2 doses of vaccine, 3 weeks apart. Calves can be vaccinated from 3.5 months of age once maternal antibody has declined. Where calves are likely to be seropositive, the minimum age of primary vaccination should be 5 months.
Booster Vaccination
A single annual booster dose is recommended. For adult breeding cattle, booster vaccination should be administered not less than 7 days prior to service.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The administration of an overdose via the subcutaneous route will result in marked swelling at the injection site and a transient pyrexia. The duration of the reactions is unknown but can last for at least 2 weeks and the pyrexia will resolve within 12-24 hours. No specific treatment is necessary.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for bovidae, cattle, inactivated viral vaccines.
ATC Vet Code: Q102AA01
To induce active immunity against BVDV in the target species.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Quil A
Thiomersal
Minimal Essential Medium
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: 18 months.
Shelf-life after first opening the immediate packaging: Use immediately.
6.4 Special Precautions for Storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
6.5 Nature and composition of the immediate packaging
Carton with 6 x 20 ml vials:
Container: Clear Type I glass vial.
Closure: Bromobutyl rubber stopper with aluminium overseal
Outer Pack: Cardboard carton with inserted package leaflet
Carton with single 200 ml vial:
Container: Clear type I glass vial
Closure: Bromobutyl rubber stopper with aluminium overseal
Outer Pack: Cardboard carton with inserted package leaflet
6.6 Special Precautions for the Disposal of the Unused Product or Wastes
Materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
7. MARKETING AUTHORISATION HOLDER
Elanco Europe Ltd
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
8. MARKETING AUTHORISATION NUMBER
Vm00879/4032
9. DATE OF FIRST AUTHORISATION
22 September 1995
10. DATE OF REVISION OF THE TEXT
January 2016
Approved: 13 January 2016
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