Rispoval IBR-Marker Live

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Infectious bovine rhinotraceitis virus

Tersedia dari:

Zoetis UK Limited

Kode ATC:

QI02AD01

INN (Nama Internasional):

Infectious bovine rhinotraceitis virus

Bentuk farmasi:

Powder and solvent for solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cattle

Area terapi:

Live Viral Vaccine

Status otorisasi:

Authorized

Tanggal Otorisasi:

1999-02-10

Karakteristik produk

Revised: November 2023
AN: 03127/2022
Page 1 of 10
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
* CCID
50
= Cell culture infective dose 50%.
min. 10
5.0
CCID
50
*
max. 10
7.0
CCID
50
*
EXCIPIENT:
DILUENT:
Water for injections
2 ml
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
Revised: November 2023
AN: 03127/2022
Page 2 of 10
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 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 via
intramuscular injection.
A proportion of young calves may have maternally derived antibodies to
BoHV-1, which
may affect the immune response to vaccination.