Rispoval IBR-Marker Inactivated

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Infectious bovine rhinotraceitis virus

제공처:

Zoetis UK Limited

ATC 코드:

QI02AA03

INN (국제 이름):

Infectious bovine rhinotraceitis virus

약제 형태:

Suspension for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cattle

치료 영역:

Inactivated Viral Vaccine

승인 상태:

Authorized

승인 날짜:

1999-02-05

제품 특성 요약

Revised: November 2019
AN: 01038/2019
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval IBR-Marker Inactivated
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCE:
Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative), to
induce a
geometric mean seroneutralizing titre of at least 1:160 in cattle.
ADJUVANT(S):
Aluminium hydroxide
14-24 mg
Quil A
0.25 mg
EXCIPIENT(S):
_Preservative_
Thiomersal
0.2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Pinkish liquid suspension, which might contain loose sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle against Infectious Bovine
Rhinotracheitis (IBR), to
reduce the clinical signs and virus shedding and, in female cattle, to
prevent
abortions associated with BoHV-1 infection. The vaccination of
pregnant cattle will
prevent abortion associated with BoHV-1 infections as 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
Revised: November 2019
AN: 01038/2019
Page 2 of 8
deletion, unless the cattle were previously vaccinated with a
conventional vaccine or
infected with field virus.
Duration of immunity:6 months
- For booster immunisation after primovaccination with Rispoval
IBR-Marker Vivum
(in member states where this product is authorized) to reduce the
virus shedding and
the clinical signs associated with BoHV-1 infection in cattle and, in
female cattle, to
prevent abortions associated with BoHV-1 infection. This vaccination
of cattle will
prevent abortion associated with BoHV-1 infections as demonstrated
during the third
trimester of gestation upon challenge 86 days after the booster
vaccination.
Duration of immunity: 6 months after complete primovaccination with
Rispoval IBR-
Marker Vivum follow