Bovilis IBR Marker Inac Suspension for Injection for Cattle

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Infectious bovine rhinotraceitis virus

متاح من:

MSD Animal Health UK Limited

ATC رمز:

QI02AA03

INN (الاسم الدولي):

Infectious bovine rhinotraceitis virus

الشكل الصيدلاني:

Suspension for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cattle

المجال العلاجي:

Inactivated Viral Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2006-07-19

خصائص المنتج

Revised: July 2020
AN: 00391/2020
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.
Revised: July 2020
AN: 00391/2020
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 appropriate
symptomati