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 2023
AN: 03125/2022
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval IBR-Marker Live lyophilisate and diluent for suspension for
injection for cattle_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
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
*
* CCID
50
= Cell culture infective dose 50%.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
FREEZE-DRIED PELLET:
Dextran stabiliser solution
Minimum essential medium with
Earle´s salts
HEPES 2M solution
DILUENT:
Water for injections
2 ml
Lyophilisate: slightly coloured freeze-dried pellet.
Diluent: clear, colourless solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH 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
Revised: November 2023
AN: 03125/2022
Page 2 of 9
the marker deletion, unless the cattle were previously vaccinated with
a conventional
vaccine or infected with field virus.
Onset of immunity: 7 days following a single intranasal
administration.
21 days following a single intramuscular administration.
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