RISPOVAL IBR-MARKER LIVE

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Tersedia dari:

Zoetis Ireland Limited

Kode ATC:

QI02AD01

INN (Nama Internasional):

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Bentuk farmasi:

Lyophilisate and solvent for suspension for injection

Jenis Resep:

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

Kelompok Terapi:

Bovine

Area terapi:

bovine rhinotracheitis virus (IBR)

Indikasi Terapi:

Immunological - Live Vaccine

Status otorisasi:

Authorised

Tanggal Otorisasi:

2013-12-09

Karakteristik produk

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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_7_
_/_
_0_
_9_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_1_
_9_
_7_
_6_
_8_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_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 fiel