RISPOVAL IBR-MARKER LIVE

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Dostopno od:

Zoetis Ireland Limited

Koda artikla:

QI02AD01

INN (mednarodno ime):

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Odmerek:

Unknown

Farmacevtska oblika:

Lyophilisate and solvent for suspension for injection

Tip zastaranja:

POM(E)

Terapevtska skupina:

Bovine

Terapevtsko območje:

Bovine rhinotracheitis virus vaccine (IBR)

Terapevtske indikacije:

Immunological - Live Vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-12-09

Lastnosti izdelka

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 17/09/2015_
_CRN 7019768_
_page number: 1_
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 field virus.
_Onset of immunity_:
7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscular administration as
demonstrated in seronegative calves.
_Duration of immunity following vaccination before 3 months of age_:
After intranasal vaccination of calves aged 2 weeks or older w