Bovilis IBR Marker Live, Lyophilisate and Solvent for Suspension for Cattle

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Infectious bovine rhinotraceitis virus

제공처:

MSD Animal Health UK Limited

INN (국제 이름):

Infectious bovine rhinotraceitis virus

약제 형태:

Nasal drops, suspension

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cattle

치료 영역:

Live Viral Vaccine

승인 상태:

Authorized

승인 날짜:

2002-02-13

제품 특성 요약

Revised: July 2020
AN: 00391/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR marker Live lyophilisate and solvent for suspension for
cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml reconstituted vaccine contains:
ACTIVE SUBSTANCE(S)
Live bovine herpesvirus type 1 (BHV-1), strain GK/D (gE¯ )
*
: 10
5.7
- 10
7.3
TCID
50
**
.
*
gE¯: glycoprotein E negative
**
TCID
50
: tissue culture infective doses 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension.
Lyophilisate: off-white to light pink-coloured pellet.
Solvent: colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce the intensity and duration of
the clinical
respiratory signs induced by an infection with BHV-1 and to reduce
nasal excretion
of field virus.
Onset of immunity:
An increase in immunity was demonstrated 4 days after intranasal
vaccination and
14 days after intramuscular vaccination of 3 month old seronegative
animals.
Duration of immunity:
After intranasal administration to 2 week old calves immunity lasts at
least until the
age of 3-4 months. In the presence of maternally derived antibodies,
the protection
of the vaccine may not be complete until a second vaccination. This
second
vaccination should be administered at 3-4 months of age and will
result in protective
immunity that lasts for at least 6 months.
Revised: July 2020
AN: 00391/2020
Page 2 of 7
Single intranasal or intramuscular vaccination of 3 months old animals
provides
protective immunity (reduction of clinical signs and reduction of
viral excretion),
which was demonstrated via challenge 3 weeks after vaccination.
Reduction of viral
excretion is maintained for at least 6 months after single
vaccination.
Revaccination to ensure protection after the initial 6 month
protection period has
elapsed will result in protective immunity that last