SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovilis IBR Marker Live lyophilisate and solvent for suspension for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) of reconstituted vaccine contains:

Active substance:

Live bovine herpesvirus type 1 (BHV-1), strain GK/D (gE¯ )^*: 10^5.7 - 10^7.3 TCID₅₀^**.

^* gE¯: glycoprotein E negative

^** TCID₅₀: tissue culture infective doses 50%

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate: off-white to light pink-coloured pellet. Solvent: colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

Active immunisation of cattle to reduce the intensity and duration of the clinical respiratory signs induced by an infection with BHV-1 and to reduce nasal excretion of field virus.

Onset of immunity:

An increase in immunity was demonstrated 4 days after intranasal vaccination and 14 days after intramuscular vaccination of 3 month old seronegative animals.

Duration of immunity:

After intranasal administration to 2 week old calves immunity lasts at least until the age of 3-4 months. In the presence of maternally derived antibodies, the protection of the vaccine may not be complete until a second vaccination. This second vaccination should be administered at 3-4 months of age and will result in protective immunity that lasts for at least 6 months.

Single intranasal or intramuscular vaccination of 3 month old animals provides protective immunity (reduction of clinical signs and reduction of viral excretion), which was demonstrated via challenge 3 weeks after vaccination. Reduction of viral excretion is maintained for at least 6 months after single vaccination.

Revaccination to ensure protection after the initial 6 months protection period has elapsed will result in protective immunity that lasts for 1 year.

Specific information:

No information is available on the efficacy of the vaccine to prevent a latent wild virus infection or to prevent wild virus re-excretion in the latent carrier.

4.3 Contraindications

None.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

The presence of maternal antibodies can influence the efficacy of the vaccination. Therefore, it is recommended to ascertain the immune status of calves before vaccination is started.

4.5 Special precautions for use

Special precautions for use in animals

After intranasal administration, the vaccine virus can spread to in-contact cattle. Cattle which need to remain totally free from BHV-1 antibodies should be separated from intranasally vaccinated animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment Not applicable.

Other precautions Not applicable.

4.6 Adverse reactions (frequency and seriousness)

Cattle:

Common (1 to 10 animals / 100 animals treated):	Elevated temperature1, Nasal discharge2.
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Hypersensitivity reaction.

¹ A rise of 1 °C may occur up to 5 days post vaccination. ² After intranasal vaccination.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

4.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Fertility:

No information is available on the use of this vaccine in breeding bulls.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data - in cattle from 3 weeks of age onwards - are available which demonstrate that this vaccine can be administered on the same day but not mixed with Bovilis Bovipast RSP.

Safety and efficacy data are available which demonstrate that for the intramuscular revaccination - in cattle from 15 months of age onwards (i.e. those that have previously been vaccinated separately with Bovilis IBR Marker Live and Bovilis BVD) - this vaccine can be mixed and administered with Bovilis BVD. The product literature of Bovilis BVD should be consulted before administration of the mixed products. The adverse effects observed after administration of one dose or an overdose of the mixed vaccines are not different from those described for the vaccines administered separately.

When mixed with Bovilis BVD at revaccination, the demonstrated efficacy claims for Bovilis IBR Marker Live are as follows:

- Active immunisation of cattle to reduce the fever induced by an infection with BHV-1 and to reduce nasal excretion of field virus.

- Duration of immunity: 12 months demonstrated by serological data.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.

Do not use together with immunosuppressive agents.

4.9 Amount(s) to be administered and administration route

Reconstitute the lyophilisate with the solvent:

Number of doses per Volume (ml) of solvent

vial needed

5 10

10 20

25 50

50 100

100 200

Dosage: a single dose of 2 ml reconstituted vaccine per animal.

Method of administration:

- from the age of 3 months onwards: intranasal use or intramuscular use.

- at an age between 2 weeks and 3 months: intranasal use.

For intranasal use (1 ml in each nostril), the use of a nozzle is recommended.

Primary vaccination:

- Basic vaccination:

Vaccinate each animal from 3 months of age onwards with one single dose.

- Early protection schedule:

When the first vaccination is given between the age of 2 weeks and 3 months, a second vaccination should be given at an age of 3-4 months.

First revaccination:

The first revaccination should be given 6 months after primary vaccination. Bovilis IBR Marker Inac can alternatively be used for this revaccination.

Subsequent revaccinations:

All following revaccinations should be given at an interval no greater than 12 months. Bovilis IBR Marker Inac can alternatively be used for these revaccinations.

The product literature of Bovilis IBR Marker Inac should be consulted before using it for revaccination.

For revaccination, the lyophilisate may be reconstituted shortly before use with Bovilis BVD for use in cattle from 15 months of age (i.e. those that have previously been vaccinated separately with Bovilis IBR Marker Live and Bovilis BVD). The following instructions should be used:

Bovilis IBR Marker Live Bovilis BVD

5 doses	+ 10 ml
10 doses	+ 20 ml
25 doses	+ 50 ml
50 doses	+ 100 ml

A single dose (2 ml) of Bovilis IBR Marker Live mixed with Bovilis BVD is given intramuscularly.

Shelf life after mixing with Bovilis BVD: 3 hours.

Use sterile vaccination equipment free from disinfectants. To prevent the spread of any infective agents the intranasal equipment should be changed at each animal.

Visual appearance after reconstitution:

- In solvent: colourless to slightly opaque suspension.

- In Bovilis BVD: as specified in the product information for Bovilis BVD alone.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

At a 10-fold overdose, no effects other than those described in section 4.6 have been observed.

4.11 Withdrawal period(s) Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Live herpes virus vaccine. ATCvet code: QI02AD01.

To stimulate active immunity against BHV-1. The vaccine does not elicit antibodies to glycoprotein E of BHV-1 (marker vaccine). This enables discrimination between cattle vaccinated with this product and cattle infected with BHV-1 field virus or vaccinated with conventional non-marker BHV-1 vaccines.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lyophilisate:

Veggie medium

Sorbitol

Monosodium glutamate

Glycine

Amine#1

Disodium phosphate dihydrate Water for injections

Solvent:

Sucrose

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Sodium chloride

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product or with Bovilis BVD (for revaccination only).

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:

Lyophilisate: 36 months.

Solvent: in glass vials: 60 months; in PET vials: 18 months.

Shelf life after reconstitution according to directions: 3 hours.

6.4 Special precautions for storage

Lyophilisate:

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

Solvent:

Store below 25 °C if stored independently from the lyophilisate. Do not freeze.

6.5 Nature and composition of immediate packaging

Lyophilisate:

Vials of glass (hydrolytic type I) closed with a rubber stopper and metal cap.

Solvent:

Vials of glass (hydrolytic type II) or plastic (polyethylene terephthalate) closed with a rubber stopper and metal cap. Solvent may be packed together with the lyophilisate or separately.

Pack sizes:

Cardboard box with 1 glass vial of lyophilisate (5 doses) and 1 glass vial of solvent (10 ml).

Cardboard box with 1 glass vial of lyophilisate (10 doses) and 1 glass vial of solvent (20 ml).

Cardboard box with 1 glass vial of lyophilisate (25 doses) and 1 glass vial of solvent (50 ml).

Cardboard box with 1 glass vial of lyophilisate (50 doses) and 1 glass vial of solvent (100 ml).

Cardboard box with 1 glass vial of lyophilisate (50 doses) and 1 PET vial of solvent (100 ml).

Cardboard box with 1 glass vial of lyophilisate (100 doses) and 1 glass vial of solvent (200 ml).

Cardboard box with 10 glass vials of lyophilisate (5 doses) and a cardboard box with 10 glass vials of solvent (10 ml).

Cardboard box with 10 glass vials of lyophilisate (10 doses) and a cardboard box with 10 glass vials of solvent (20 ml).

Cardboard box with 10 glass vials of lyophilisate (25 doses) and a cardboard box with 10 glass vials of solvent (50 ml).

Cardboard box with 10 glass vials of lyophilisate (50 doses) and a cardboard box with 10 glass vials of solvent (100 ml).

Cardboard box with 10 glass vials of lyophilisate (50 doses) and a cardboard box with 10 PET vials of solvent (100 ml).

Cardboard box with 10 glass vials of lyophilisate (100 doses) and a cardboard box with 10 glass vials of solvent (200 ml).

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 06376/5021

9. DATE OF FIRST AUTHORISATION

13 February 2002

10. DATE OF REVISION OF THE TEXT

January 2025

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

Gavin Hall Approved: 13 January 2025