Rispoval IBR-Marker Live

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Bovine herpes virus type 1 (BHV-1), strain difivac (gE-negative), modified live (attenuated) virus

Διαθέσιμο από:

Zoetis Belgium S.A.

Φαρμακολογική κατηγορία (ATC):

QI02AD01

INN (Διεθνής Όνομα):

Bovine herpes virus type 1 (BHV-1), strain difivac (gE-negative), modified live (attenuated) virus

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Lyophilisate and solvent for suspension for injection

Τρόπος διάθεσης:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

bovine rhinotracheitis virus (IBR)

Θεραπευτικές ενδείξεις:

Immunological - Live Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-12-09

Αρχείο Π.Χ.Π.

1
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 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 im