Bovilis Ibr Marker Inac Suspension For Injection For Cattle
Revised: December 2010
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR marker inac
Suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
per dose of 2 ml:
Inactivated antigen of BHV-1 (gE¯) strain GK/D 60 Elisa units for induction of
6.1 - 11.1 log2VN-units* in
mouse potency test.
Al3+(as Aluminium-phosphate and -hydroxide) 6.0-8.8 mg
Formaldehyde 0.03 - 0.05%
* virus neutralising units
For a list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection
4. CLINICAL PARTICULARS
4.1 Target species
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 BHV-1 as well as to reduce the replication and nasal excretion of the field virus.
Onset of immunity: 3 weeks after basic vaccination
Duration of immunity: 6 months after basic vaccination
4.4 Special warnings
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)
Occasionally a hypersensitivity reaction may occur. In such cases an appropriate symptomatic treatment should be administered. At the injection site a local reaction may occur.
4.7 Use during pregnancy and lactation
Can be used during pregnancy and lactation
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amounts to be administered and administration route
Use sterile vaccination equipment.
Before use, allow the vaccine to reach ambient temperature (15°C - 25C).
Shake well before use.
Intramuscular injection, 2 ml per animal.
All cattle can be vaccinated from an age of three months onwards.
Two inoculations with an interval of 4 weeks.
Re-vaccination (after basic vaccination with Bovilis IBR marker inac or with Bovilis IBR marker live):
One inoculation every 6 months.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of a double dose does not causeother effects than after a single dose.
4.11 Withdrawal period(s)
5. IMMUNOLOGICAL PROPERTIES
Bovilis IBR marker inac is an inactivated adjuvanted vaccine for active immunisation of cattle against bovine herpesvirus type 1 (BHV-1). The vaccine does not elicit antibodies to glycoprotein E of BHV-1 (marker vaccine). This enables discrimination between cattle vaccinated with the product and cattle infected BHV-1 field virus.
Pharmacotherapeutic group: inactivated viral vaccine, ATCvet code: QI02AA03
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
water for injections.
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 8-10 hours.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze.
6.5 Nature and composition of immediate packaging
Hydrolytical glass type I (PhEur) or polyethylene-terephthalate (PET) vials with 5, 10, 25, 50 or 100 doses closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Presentations: Cardboard boxes with 1 or 10 vials.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International BV represented by:
Intervet UK Ltd
8. MARKETING AUTHORISATION NUMBER
9. DATE OF RENEWAL OF THE AUTHORISATION
24 September 2010
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Bovilis IBR marker inac is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Bovilis IBR marker inac must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Page 4 of 4