Bovilis IBR Marker Inac Suspension for Injection for Cattle

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Infectious bovine rhinotraceitis virus

थमां उपलब्ध:

MSD Animal Health UK Limited

ए.टी.सी कोड:

QI02AA03

INN (इंटरनेशनल नाम):

Infectious bovine rhinotraceitis virus

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cattle

चिकित्सीय क्षेत्र:

Inactivated Viral Vaccine

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

2006-07-19

उत्पाद विशेषताएं

Amended pages: October 2023
AN: 01481/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR marker inac suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCE:
Inactivated bovine herpesvirus type 1 (BHV-1) strain GK/D (gE¯)
*
: 60 ELISA units
**
.
*
gE¯: glycoprotein E negative
**
inducing 6.1 - 11.1 log
2
virus neutralising units in mouse potency test
ADJUVANT:
Aluminium-phosphate and -hydroxide (Al
3+
)
6.0 - 8.8 mg
EXCIPIENT:
Formaldehyde
0.6 - 1.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Pink turbid suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle to reduce the intensity and duration
of clinical signs
(pyrexia) induced by an infection with bovine herpesvirus type 1
(BHV-1) as well as to
reduce the replication and nasal excretion of the field virus.
Onset of immunity:
- 3 weeks
Duration of immunity:- 6 months
The schedule using Bovilis IBR marker live for primary vaccination and
revaccination after
6 months with Bovilis IBR marker inac, will result in protective
immunity that lasts for 12
months.
Amended pages: October 2023
AN: 01481/2023
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Efficacy has not been demonstrated in the face of maternally derived
antibodies.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In the case of accidental self-injection, seek medical advice
immediately and show the
package leaflet or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A local reaction at the injection site may occur in very rare cases.
Hypersensitivity reactions can occur in very rare cases. In such cases
an appr