Rispoval IBR-Marker Live

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bovine rhinotraceitis virus

Available from:

Zoetis UK Limited

ATC code:

QI02AD01

INN (International Name):

Infectious bovine rhinotraceitis virus

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

1999-02-10

Summary of Product characteristics

Revised: November 2019
AN: 01038/2019
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval IBR-Marker Live
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 2 ml dose:
ACTIVE SUBSTANCE:
_Freeze-dried pellet_
Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative),
modified live (attenuated) virus
min. 10
5.0
CCID
50
*
max. 10
7.0
CCID
50
*
EXCIPIENT(S):
_Diluent_
Water for injections
2 ml
* CCID50 = Cell culture infective dose 50%
For a full list of excipients, see section 6.1.
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
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.
Revised: November 2019
AN: 01038/2019
Page 2 of 8
_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 without
maternally derived
antibodies, immunity lasts until at least 3 months of age, when the
animals should be
revaccinated via intramuscular injection.
A proportion of young calves may have maternally derived antibodies to
BoHV-1, which
may affect the immune response to vaccination. Conseque