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.

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

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 revaccination.

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.

None.

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.

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.

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

Cattle:

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

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.

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 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 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 : 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.

Reconstitute the lyophilisate with the solvent.

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

- 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.

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.

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

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.

- In solvent: colourless to slightly opaque suspension.

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

Zero days.