Bovidec Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bovine viral diarrhoea virus

Available from:

Benchmark Animal Health Limited

ATC code:

QI02AA01

INN (International Name):

Bovine viral diarrhoea virus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Expired

Authorization date:

1995-09-22

Summary of Product characteristics

Revised: June 2019
AN: 01535/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovidec suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (4 ml) contains:
Active substance:
bovine viral diarrhoea (BVD) virus
5 x 10
6
TCID
50
.
strain KY1203nc (inactivated)
Adjuvant:
Quil A
1 mg.
Excipients:
Thiomersal.
For the 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)
For the active immunisation of adult female breeding cattle:
1.
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.
2.
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.
For the active immunisation of calves from the age of 4 months:
1.
To reduce viraemia and viral shedding of BVD Type I virus, once
maternal
antibodies have declined.
The duration of immunity is 13 months.
Revised: June 2019
AN: 01535/2018
Page 2 of 5
2.
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 r