Bovilis Blue-8 Suspension for Injection for Cattle and Sheep

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Bluetongue virus

थमां उपलब्ध:

MSD Animal Health UK Limited

INN (इंटरनेशनल नाम):

Bluetongue virus

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cattle, Sheep

चिकित्सीय क्षेत्र:

Inactivated Viral Vaccine

प्राधिकरण का दर्जा:

Expired

प्राधिकरण की तारीख:

2017-11-21

उत्पाद विशेषताएं

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