Rispoval IBR-Marker Live

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Infectious bovine rhinotraceitis virus

Disponível em:

Zoetis UK Limited

Código ATC:

QI02AD01

DCI (Denominação Comum Internacional):

Infectious bovine rhinotraceitis virus

Forma farmacêutica:

Powder and solvent for solution for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Cattle

Área terapêutica:

Live Viral Vaccine

Status de autorização:

Authorized

Data de autorização:

1999-02-10

Características técnicas

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