Rispoval 4

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Infectious bovine rhinotraceitis virus

제공처:

Zoetis UK Limited

ATC 코드:

QI02AH

INN (국제 이름):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Infectious bovine rhinotraceitis virus

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cattle

치료 영역:

Live and Inactivated Viral Vaccine

승인 상태:

Authorized

승인 날짜:

2001-05-31

제품 특성 요약

Revised: May 2020
AN: 00066/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval 4
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains:
Suspension fraction:
-
Infectious Bovine Rhinotracheitis (IBR) virus, strain Cooper, > GMT 2
log
2
*.
-
Bovine
Viral
Diarrhoea
(BVD)
virus,
cytopathic
strain
5960,
and
Bovine Viral Diarrhoea (BVD) virus, non-cytopathic strain 6309, >
GMT 5 log
2
*
* GMT Serological titre induced after injection to calves.
Lyophilisate fraction:
-
Bovine Parainfluenza 3 (PI3) virus, thermosensitive strain RLB103,
minimum titre at the end of shelf life, > or equal 10
5.0
CCID
50
-
Bovine Respiratory Syncytial Virus (BRSV) strain 375, minimum titre
at the end of shelf life, > or equal 10
5.0
CCID
50
Adjuvant:
Aluminium hydroxide (2 % Al
2
O
3
)
≤ 5.2 mg Al
2
0
3
per ml
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle to reduce infection, clinical signs
and respiratory
disease caused by Bovine Respiratory Syncytial virus (BRSV),
Infectious Bovine
Rhinotracheitis (IBR, commonly known as BHV-1) virus and Parainfluenza
virus
type 3 (PI3); and leucopaenia and viraemia caused by the Bovine Viral
Diarrhoea
virus
(BVDV)
Type
I,
cytopathic
and
non-cytopathic
strains.
A
duration
of
immunity of at least 6 months has been demonstrated.
Revised: May 2020
AN: 00066/2020
Page 2 of 5
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special
precautions
to
be
taken
by
the
person
administering
the
veterinary
medicinal product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Very rarely, administration of the vaccine may be followed by a mild
transient
reaction at the injection site up to 0.5