BOVIDEC.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BOVINE VIRAL DIARRHOEA (BVD) VIRUS STRAIN KY1203NC (INACTIVATED):

Available from:

Novartis Animal Vaccines Ltd

ATC code:

QI02AA01

INN (International Name):

BOVINE VIRAL DIARRHOEA (BVD) VIRUS STRAIN KY1203NC (INACTIVATED):

Dosage:

Unknown

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM(E)

Therapeutic group:

Bovine

Therapeutic area:

Bovine viral diarrhea vaccine (BVD)

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Transfer Pending

Authorization date:

2000-08-08

Summary of Product characteristics

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.
IRISH MEDICINES BOARD
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_Date Printed 01/05/2013_
_CRN 7014801_
_page number: 1_
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.
(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 po