Rispoval IBR-Marker Live

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Infectious bovine rhinotraceitis virus

Dostopno od:

Zoetis UK Limited

Koda artikla:

QI02AD01

INN (mednarodno ime):

Infectious bovine rhinotraceitis virus

Farmacevtska oblika:

Powder and solvent for solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle

Terapevtsko območje:

Live Viral Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

1999-02-10

Lastnosti izdelka

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