RISPOVAL IBR-MARKER LIVE

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Dostępny od:

Zoetis Ireland Limited

Kod ATC:

QI02AD01

INN (International Nazwa):

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Forma farmaceutyczna:

Lyophilisate and solvent for suspension for injection

Typ recepty:

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

Grupa terapeutyczna:

Bovine

Dziedzina terapeutyczna:

bovine rhinotracheitis virus (IBR)

Wskazania:

Immunological - Live Vaccine

Status autoryzacji:

Authorised

Data autoryzacji:

2013-12-09

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval IBR-Marker Live.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Composition for 2 ml dose:
ACTIVE SUBSTANCE:
Freeze-dried pellet
Bovine Herpes Virus type 1 (BHV-1), strain Difivac (gE-negative),
min. 10
5.0
CCID
50
modified live (attenuated) virus
max. 10
7.0
CCID
50
EXCIPIENT:
Diluent
Water for injections
2 ml
*CCID
50
= Cell culture infective dose 50%
For a full list of excipients, see section 6.1.
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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
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 fiel