BOVIDEC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bovine viral diarrhoea (bvd) virus strain ky1203nc (inactivated):

Available from:

Benchmark Animal Health Ltd

ATC code:

QI02AA01

INN (International Name):

Bovine viral diarrhoea (bvd) virus strain ky1203nc (inactivated):

Dosage:

5 x 10^6 tissue culture infective dose 50/dose

Pharmaceutical form:

Suspension for injection

Prescription type:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Therapeutic area:

bovine viral diarrhea (BVD)

Authorization status:

Authorised

Authorization date:

2000-08-08

Summary of Product characteristics

Health Products Regulatory Authority
05 December 2018
CRN008QFP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVIDEC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
per dose (4 ml)
Bovine Viral Diarrhoea (BVD) virus
strain KY1203nc (inactivated)5 x 10
6
TCID
50
*.
TCID
50
* = 50% Tissue culture infectious dose
Excipients:
Quil A (Adjuvant)1.0 mg
Thiomersal (Preservative)0.044 – 0.060 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
A pink aqueous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Female breeding cattle and calves from 4 months of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
(i) Adult breeding cattle
For the active immunisation of female breeding cattle:
1. Prior to insemination/service to protect the foetus against
infection with BVD Type
I virus.
2. Prior to service in the management of herd fertility when diagnosis
of infertility is
associated with clinical manifestations of BVD Type I virus infection.
Health Products Regulatory Authority
05 December 2018
CRN008QFP
Page 2 of 6
(ii) Calves
The vaccine is also for the active immunisation of calves to reduce
infection with BVD
Type I virus. Animals younger than 4 months of age should not be
vaccinated due to
the possible interference of maternally derived antibodies with
vaccine efficacy once
maternal antibodies have declined.
Results from calf studies to date indicate antibodies are detectable
28 days after
completion of the initial vaccination procedure and protection has
been
demonstrated at 42 days after completion of the initial vaccination
procedure.The
active protection afforded by vaccination of calves against Type I
should exist for at
least 420 days post the initial calf vaccination procedure.
The vaccine also affords cross protection against Bovine Viral
Diarrhoea Virus Type II
infection, with reduction of viraemia and clinical signs of disease
being observed in
animals vaccinated when maternal antibodies have d