Bovilis Blue-8 Suspension for Injection for Cattle and Sheep

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Bluetongue virus

から入手可能:

MSD Animal Health UK Limited

INN（国際名）:

Bluetongue virus

医薬品形態:

Suspension for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cattle, Sheep

治療領域:

Inactivated Viral Vaccine

認証ステータス:

Expired

承認日:

2017-11-21

製品の特徴

Unlimited Renewal: March 2022
AN: 02869/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Blue-8 suspension for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of vaccine contains:
ACTIVE SUBSTANCE:
Bluetongue virus inactivated, serotype 8: 10
6.5
CCID
50
*
(* equivalent to titre prior to inactivation)
ADJUVANTS:
Aluminium hydroxide
6 mg
Purified saponin (Quil A)
0.05 mg
EXCIPIENT:
Thiomersal
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White or pinkish-white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep
For the active immunisation of sheep from 2.5 months of age to prevent
viraemia*
and to reduce clinical signs caused by bluetongue virus serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating
no presence of
viral genome)
Onset of immunity:
20 days after the second dose.
Duration of immunity:
1 year after the second dose.
Unlimited Renewal: March 2022
AN: 02869/2021
Page 2 of 5
Cattle
For the active immunisation of cattle from 2.5 months of age to
prevent viraemia*
caused by bluetongue virus serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating
no presence of
viral genome)
Onset of immunity:
31 days after the second dose.
Duration of immunity:
1 year after the second dose.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Occasionally, the presence of maternally derived antibodies in ovines
of minimum
recommended age might interfere with the protection induced by the
vaccine.
No information is available on the use of the vaccine in seropositive
bovines,
including those with maternally derived antibodies.
If used in other domestic and wild ruminant species that are
considered at risk of
infection, its use in these species should be undertaken with care and
it is advisable
to test the va