Each 2 ml dose contains:

Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative), modified live (attenuated) virus min. 105.0 CCID50*

max. 107.0 CCID50*

* CCID50 = Cell culture infective dose 50%.

Water for injections 2 ml

For the active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical signs including, in female cattle, abortions associated with BoHV-1 infection. A reduction in abortions associated with BoHV-1 infection has been demonstrated during the second trimester of gestation following 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.

Onset of immunity: 7 days following a single intranasal administration.

21 days following a single intramuscular administration.

Duration of immunity following vaccination before 3 months of age: after intranasal vaccination of calves aged 2 weeks or older without maternally derived antibodies, immunity lasts until at least 3 months of age, when the animals should be revaccinated via intramuscular injection.

A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age. Duration of immunity: following vaccination at or after 3 months of age: 6 months

Additional information on protection from abortion afforded by combined vaccination of Rispoval IBR-Marker Live with Rispoval IBR-Marker Inactivated*: prevention of abortion has been demonstrated during the third trimester of gestation upon BoHV-1 challenge applied 86 days after a single dose booster vaccination using Rispoval IBR-Marker Inactivated, which was administered 6 months after a single dose primary vaccination using Rispoval IBR-Marker Live.

*Where this veterinary medicinal product is authorised.

2 ml reconstituted vaccine.

Intranasal and/or intramuscular inoculation. The vaccine is injected aseptically via the intramuscular route (2 ml) or sprayed into the nostrils (1 ml per nostril during aspiration) with the intranasal applicator available from Zoetis.

Once resuspended the vaccine remains potent for max. 8 hours when the veterinary medicinal product is withdrawn sterile and refrigerated.

The freeze-dried product should be reconstituted aseptically just prior to use. The vaccine is prepared as follows:

For 10 and 50 dose vials approximately 4 ml of the respective diluent are transferred into the vial containing freeze-dried pellet and mixed well.

The reconstituted virus fraction is then transferred back into the remaining diluent and mixed well. The veterinary medicinal product is then ready for use.

The needles and syringes used for application of the vaccine must not be sterilised by chemical disinfectants as this may impair the efficacy of the vaccine.

The first vaccination should be applied intranasally, followed by a second vaccination intramuscularly at 3 months of age.

A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age. As an extra precaution in situations of high challenge with BoHV-1, maternal antibody positive animals that have been initially vaccinated at around 2 weeks of age may be given an additional vaccination between the first vaccination and vaccination at 3 months of age. This additional vaccination may be given via either intranasal or intramuscular administration and may be given from 3 weeks after the first vaccination.

Animals should be given one intramuscular vaccination or intranasal vaccination.

Beef cattle and fattening bulls are vaccinated preferably just prior to housing (crowding) or at transfer to new groups, while taking into account the interval needed for the onset of protection following the basic vaccination scheme.

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

In the case of known high BoHV-1 infection pressure, the first dose in cattle (including pregnant females) should be administered intranasally in order to stimulate local immunity followed 3-5 weeks later by the second dose administered intramuscularly to complete the primary vaccination course.

Animals should be given a single dose booster vaccination 6 months after their initial vaccination course. Animals initially vaccinated with Rispoval IBR-Marker Live may be given a single dose booster vaccination with either Rispoval IBR-Marker Live to provide 6 months of protection or Rispoval IBR-Marker Inactivated to provide a duration of protective immunity of 12 months. Thereafter, single dose booster vaccinations should be administered every 6 months (if using Rispoval IBR-Marker Live) or every 12 months (if using Rispoval IBR-Marker Inactivated).

*Where this veterinary medicinal product is authorised.

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.

Vaccinate healthy animals only.

In some cases, the vaccine virus may be excreted after intranasal administration from vaccinated animals. After intranasal administration of a 10-fold overdose, the vaccine virus was detected for up to 9 days after vaccination. In very young calves and in rare cases, vaccine virus was excreted until day 18 post intramuscular vaccination with a 10-fold overdose. Exceptional transmission of the virus from intranasally-vaccinated animals to non-vaccinated in-contact animals may occur due to the nature of the vaccine even though no verified data available would indicate that spreading of the vaccine virus occurs in a group of animals.

It is recommended to vaccinate all the cattle in the herd.

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

Can be used during pregnancy and lactation.

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

Interferon sensitive products should not be applied intranasally following 5 days after intranasal vaccination.

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 decided on a case by case basis.

Do not mix with any other veterinary medicinal product except diluent supplied for use with the product.

After intranasal administration of a 10-fold overdose, a transient hyperthermia (> 39.5°C) was observed in some calves for up to 3 consecutive days. After intramuscular administration of a 10-fold overdose, a transient hyperthermia (> 39.5°C) was observed in some calves for up to 4 consecutive days. In another study, a transient (one day) slight serous ocular discharge was observed in some calves after intramuscular administration of a 10-fold overdose.

Otherwise reactions after administration of an overdose of the vaccine are not different from those after the single dose.

1Slight transient, serous discharge may occur for up to 7 days following intranasal inoculation.

2Transient swelling up to 3 cm which generally subsides within 7 days; when injected intramuscularly.

3Vaccinated 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.

Zero days.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after reconstitution according to directions: 8 hours.

Medicines should not be disposed of via wastewater.

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

For animal treatment only.

Keep out of the sight and reach of children.

1 box with 1 glass vial, type 1, freeze-dried pellet (10 doses) and 1 glass vial, type 1, containing 20 ml (10 doses) diluent, each closed respectively with bromobutyl and chlorobutyl rubber stopper and an aluminium flip-off cap.

1 box with 1 glass vial, type 1, freeze-dried pellet (50 doses) and 1 glass vial, type 1, containing 100 ml (50 doses) diluent, each closed respectively with bromobutyl and chlorobutyl rubber stopper and an aluminium flip-off cap.

Not all pack sizes may be marketed.

Glycoprotein gE is absent in virus particles of Rispoval IBR-Marker Live. Therefore the vaccine virus, and the antibodies against it, can be clearly differentiated from field strains, or antibodies against the latter by serological methods, unless the cattle were previously vaccinated with a conventional vaccine or infected with field virus.

The vaccine induces immunity in cattle against clinical respiratory symptoms caused by the Infectious Bovine Rhinotracheitis (IBR) virus. After a single dose vaccination, a significant reduction of virus shedding duration has been demonstrated upon challenge. After two doses of vaccine, the intensity and duration of clinical symptoms as well as the titre and duration of virus shedding are significantly reduced following infection. As with other vaccines, vaccination may not completely prevent but does reduce the risk of infection.

The veterinary medicinal product induces antibodies in vaccinated cattle, which are detectable in serum neutralisation tests and in conventional ELISA tests. With specific test kits these antibodies can be differentiated - due to the lack of antibodies against gE - from those of field virus infected animals or animals vaccinated with conventional vaccines.

Vaccination of all cattle in a herd, both infected and uninfected, is recommended. Following use of Rispoval IBR-Marker Live the risk of infection, titre and duration of virus shedding are all reduced. The duration of a programme to achieve the status of a BoHV-1 free herd is dependent on the initial level of BoHV-1 infection in the herd and the culling of remaining BoHV-1 positive animals.