Cattle (cows and heifers).

For active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with bovine viral diarrhoea virus.

None.

Vaccinate healthy animals only.

Not applicable.

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

Cattle:

1 Observed for 14 days.

2 Transient and mild.

3 In the event of anaphylactic type reactions appropriate treatment with antihistamine, corticosteroid or

adrenaline is recommended.

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.

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

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

Before using the vaccine allow it to reach ambient temperature (15 °C – 25 °C).

Shake well before use. Use sterile syringes and needles.

Intramuscular injection. 2 ml per animal.

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

Foetal protection can be expected if the primary immunisation has been finalised 4 weeks before start of the gestation. Animals which are vaccinated later than 4 weeks before gestation or during the early gestation will not be protected against foetal infection.

Two vaccinations with an interval of 4 weeks. The second vaccination should be given not later than 4 weeks before the start of the gestation. Revaccination

One vaccination 4 weeks before start of the next gestation.

Two vaccinations with an interval of 4 weeks. For use in cattle from eight months of age, all animals should be vaccinated.

One vaccination 6 months after basic vaccination with next re-vaccinations at an interval no greater than 12 months.

For revaccination, the vaccine may be used for reconstitution of Bovilis IBR Marker Live for use in cattle from 15 months of age (i.e. those that have previously been vaccinated separately with Bovilis BVD and Bovilis IBR Marker Live) 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 BVD mixed with Bovilis IBR Marker Live is given intramuscularly.

Visual appearance after reconstitution of Bovilis IBR Marker Live in Bovilis BVD:

As specified for Bovilis BVD alone.

No adverse effects other than those mentioned in section “Adverse reactions” were observed after

administration of a 2-fold overdose of the vaccine.

Zero days.