Cattle.

For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce the clinical signs and virus shedding and, in female cattle, to prevent abortions associated with BoHV-1 infection.

The vaccination of pregnant cattle will prevent abortion associated with BoHV-1 infections as demonstrated during the second trimester of gestation upon challenge 28 days after vaccination. Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless the cattle were previously vaccinated with a conventional vaccine or infected with field virus.

Duration of immunity: 6 months.

Additional information on protection afforded by combined vaccination of Rispoval IBR-Marker Vivum* with Rispoval IBR-Marker Inactivatum: for booster immunisation after primary vaccination with Rispoval IBR-Marker Vivum* to reduce the virus shedding and the clinical signs associated with BoHV-1 infection in cattle and, in female cattle, to prevent abortions associated with BoHV-1 infection. This vaccination of cattle will prevent abortion associated with BoHV-1 infections as demonstrated during the third trimester of gestation upon challenge 86 days after the booster vaccination.

Duration of immunity: 6 months after complete primary vaccination with Rispoval IBR-Marker Vivum* followed by 12 months after annual booster with Rispoval IBR-Marker Inactivatum.

In order to prevent abortion in female cattle that have received basic immunisation, a single dose revaccination with Rispoval IBR-Marker Inactivatum is recommended to be applied no later than by the start of the second trimester of each further pregnancy.

* Where this veterinary medicinal product is authorised.

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.

Not applicable.

Cattle:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Injection site swelling1 Allergic reaction2

1Transient subcutaneous, up to 5 cm, which subsides within 14 days.

2Vaccinated animals should be observed for approximately 30 minutes following immunisation. If such reactions occur, antiallergics should be administered.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Can be used during pregnancy and lactation.

Immunosuppressive substances, i.e. corticosteroids or Bovine Virus Diarrhoea modified live vaccines, should be avoided in a period of 7 days prior to and after vaccination as this may impair the development of the immunity.

No information is available on the safety and efficacy of this vaccine 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.

The dose of vaccine is 2 ml for cattle over 3 months of age, for subcutaneous use.

The vaccination scheme consists of basic immunisation and booster vaccinations.

Two doses, each of 2 ml, 3-5 weeks apart.

One dose of 2 ml at 6 month intervals.

Cattle having been administered the primary vaccination scheme using Rispoval IBR-Marker Vivum* (according to the product information for this veterinary medicinal product) may be given booster vaccinations with Rispoval IBR-Marker Inactivatum. These animals should be given a single dose booster vaccination with Rispoval IBR-Marker Inactivatum 6 months after their initial vaccination course with Rispoval IBR-Marker Vivum*. Thereafter, single dose booster vaccinations with Rispoval IBR-Marker Inactivatum should be administered every 12 months.

If calves under the age of 3 months should be vaccinated the development of immunity may be impaired by maternal antibodies. These calves should be revaccinated when they are over 3 months of age.

It is recommended to vaccinate all cattle of a herd.

To prevent abortions associated with BoHV-1 female cattle require a primary course of two subcutaneous doses of vaccine 3-5 weeks apart, or alternatively a primary course of a single intramuscular dose of Rispoval IBR-Marker Vivum* followed 6 months later by a single dose booster using Rispoval IBR-Marker Inactivatum. In order to cover the main abortion risk period, it is recommended that the second dose of the primary course of two subcutaneous doses or the single dose booster using Rispoval IBR-Marker Inactivatum is administered no later than by the start of the second trimester of each pregnancy.

Shake the vaccine well before use. Use only sterile needles and syringes for administration. Avoid the introduction of contamination during use. The liquid suspension is injected aseptically via the subcutaneous route.

* Where this veterinary medicinal product is authorised.

No adverse events other than those mentioned in section "Adverse events" were observed after administration of a double dose of the vaccine.

Not applicable.

Zero days.