RISPOVAL IBR-MARKER LIVE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Available from:

Zoetis Ireland Limited

ATC code:

QI02AD01

INN (International Name):

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM(E)

Therapeutic group:

Bovine

Therapeutic area:

Bovine rhinotracheitis virus vaccine (IBR)

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval IBR-Marker Live.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and diluent for suspension for injection.
Lyophilisate: Slightly coloured freeze-dried pellet.
Diluent: Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
Composition for 2 ml dose:
ACTIVE SUBSTANCE:
Freeze-dried pellet
Bovine Herpes Virus type 1 (BHV-1), strain Difivac (gE-negative),
min. 10
5.0
CCID
50
modified live (attenuated) virus
max. 10
7.0
CCID
50
EXCIPIENT:
Diluent
Water for injections
2 ml
*CCID
50
= Cell culture infective dose 50%
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 17/09/2015_
_CRN 7019768_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical
signs including, in female cattle, abortions associated with BoHV-1 infection. A reduction of abortion associated with
BoHV-1 infections has been demonstrated during the second trimester of gestation upon challenge 28 days after
vaccination. Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless
the cattle were previously vaccinated with a conventional vaccine or infected with field virus.
_Onset of immunity_:
7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscular administration as
demonstrated in seronegative calves.
_Duration of immunity following vaccination before 3 months of age_:
After intranasal vaccination of calves aged 2 weeks or older w