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:

Active substance:

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.

Adjuvant:

Al³⁺(as Aluminium-phosphate and -hydroxide) 6.0-8.8 mg

Excipient:

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

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 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

4.3 Contraindications

None.

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 - 25C).

Shake well before use.

Intramuscular injection, 2 ml per animal.

All cattle can be vaccinated from an age of three months onwards.

Basic vaccination:

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)

Zero days.

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

Formaldehyde,

culture medium,

trometamol,

sodium chloride,

water for injections.

6.2 Incompatibilities

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

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 06376/4053

9. DATE OF RENEWAL OF THE AUTHORISATION

24 September 2010

10. DATE OF REVISION OF THE TEXT

December 2010

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.