RISPOVAL IBR-MARKER LIVE

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Sẵn có từ:

Zoetis Ireland Limited

Mã ATC:

QI02AD01

INN (Tên quốc tế):

BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC

Dạng dược phẩm:

Lyophilisate and solvent for suspension for injection

Loại thuốc theo toa:

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

Nhóm trị liệu:

Bovine

Khu trị liệu:

bovine rhinotracheitis virus (IBR)

Chỉ dẫn điều trị:

Immunological - Live Vaccine

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2013-12-09

Đặc tính sản phẩm

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