SUMMARY OF PRODUCT CHARACTERISTICS

Bovilis IBR Marker Live, Lyophilisate and Solvent for Suspension for Cattle

Per dose of 2 ml reconstituted vaccine:

Active substances

BHV-1, strain GK/D (gE¯ ): 10^5.7 - 10^7.3 TCID₅₀.

TCID₅₀: tissue culture infective doses 50%

For the full list of excipients, see section 6.1.

Lyophilisate and solvent for suspension.

Lyophilisate: off-white to light pink-coloured pellet.

Solvent: colourless solution

Cattle

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 without maternal antibodies, immunity lasts at least until the age of 3-4 months, when the animals should be revaccinated. In the presence of maternally derived antibodies, the protection of the vaccine may not be complete until this revaccination.

Revaccination at 3-4 months of age results 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.

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.

None

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.

Animals between the age of 2 weeks and 3 months should be vaccinated via the intranasal route only and the animals should be revaccinated via the intranasal or intramuscular route when the animals are 3-4 months old.

Vaccinate only healthy animals.

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

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

A slight transient rise in temperature (1C) can occur up to 5 days post vaccination.

An increase of nasal discharge can be observed after intranasal vaccination.

Can be used during pregnancy and lactation.

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

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 6-monthly intramuscular re-vaccination -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 re-vaccination, 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: 6 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

Reconstitute the vaccine with the solvent Unisolve

Number of doses per vial Volume (ml) of solvent needed

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

Method of administration:

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

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

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

Vaccination schedule:

- Basic vaccination:

Vaccinate each animal with one single dose.

- Revaccination:

When the first vaccination is given between the age of 2 weeks and 3 months, the animals should be revaccinated with a single dose at the age of 3-4 months. Afterwards, revaccinate every 6 months.

When vaccination is started after the animals are 3 months old, the animals should be revaccinated with a single dose every 6 months.

For the 6-monthly revaccination, the vaccine 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) and 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.

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 Unisolve: colourless to slightly opaque solution

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

At 10-fold overdose, no other effects than described under section 4.6 have been observed

Zero days.

Pharmacotherapeutic group: live herpes virus vaccine

ATC-vet code: QI02AD01

To stimulate active immunity 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 this product and cattle infected with BHV-1 field virus or vaccinated with conventional non-marker BHV-1 vaccines.

Lyophilisate:

Veggie medium, chemically defined stabiliser CD#156 (patented)

Solvent (Unisolve):

Sucrose, potassium and sodium phosphate buffers, sodium chloride, water for injections.

Do not mix with any other veterinary medicinal product, except the diluent supplied for use with the veterinary medicinal product or with Bovilis BVD (for 6-monthly revaccination only).

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.

Shelf life after mixing with Bovilis BVD: 3 hours

Lyophilisate:

Store in a refrigerator (2°C - 8°C).

Do not freeze

Protect from light

Solvent:

Store below 25°C.

Do not freeze

Vaccine after reconstitution: below 25°C

After mixing with Bovilis BVD: below 25°C

Freeze-dried vaccine:

Cardboard box with 1 or 10 vials of glass (hydrolytic type I) with rubber stopper and metal cap.

Contents per vial: 5, 10, 25, 50 or 100 doses

Solvent:

Cardboard box with 1 or 10 vials of glass (hydrolytic type II) or plastic (polyethylene terephthalate) with rubber stopper and metal cap.

Contents per vial:

Glass: 10, 20, 50, 100 or 200 ml

PET: 100 ml

Not all pack sizes may be marketed

Dispose of waste material by boiling, incineration, or immersion in an appropriate disinfectant in accordance with national requirements.

Intervet International BV

Represented by:

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

Vm 06376/4032

Date: 13 February 2002

Date: December 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Subject to medical prescription (NL: UDD)

According to article 71 of Council Directive 2001/82/EC, Member States may prohibit the import, sale, supply and/or use of Bovilis IBR marker on the whole or part of their territory pursuant to national animal health policy.

Revised (typographical error 4.8):

01 December 2014