Target species
Cattle.
Indications for use for each target species
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.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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.
Administration routes and dosage
Posology:
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.
Basic immunisation:
Cattle at 3 months of age or older at first vaccination
Two doses, each of 2 ml, 3-5 weeks apart.
Booster vaccinations:
Booster vaccinations of cattle having been administered the primary vaccination scheme using Rispoval IBR-Marker Inactivatum:
One dose of 2 ml at 6 month intervals.
Booster Vaccinations of cattle having been administered the primary vaccination scheme using Rispoval IBR-Marker Vivum*:
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.
For female cattle for protection against abortion:
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.
Method of administration:
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.
Vaccination schemes summary:
From 2 weeks to 3 months of age
Rispoval IBR-Marker vaccine used |
Primary vaccination | Revaccination Intervals |
First dose (vaccine, route of administration) | Second dose (vaccine, route of administration) | Interval to next booster vaccination (vaccine, route of administration) | All subsequent booster vaccinations (vaccine, route of administration) |
2 weeks (Vivum*, intranasal) | 3 months (Vivum*, intramuscular) | 6 months (Vivum*, intramuscular) | 6 months (Vivum*, intramuscular) |
2 weeks (Vivum*, intranasal) | 3 months (Vivum*, intramuscular) | 6 months (Inactivatum, subcutaneous) | 12 months (Inactivatum, subcutaneous) |
From 3 months of age
Rispoval IBR-Marker vaccine used |
Primary Vaccination (number of doses, route of administration) | Revaccination Intervals |
Interval to first booster vaccination (vaccine, route of administration) | All subsequent booster vaccinations (vaccine, route of administration) |
Vivum* (one dose, intramuscular or intranasal) | 6 months (Vivum*, intramuscular) | 6 months (Vivum*, intramuscular) |
Vivum* (one dose, intramuscular) | 6 months (Inactivatum, subcutaneous) | 12 months (Inactivatum, subcutaneous) |
Inactivatum (two doses, subcutaneous, with 3-5 week interval) | 6 months (Inactivatum, subcutaneous) | 6 months (Inactivatum, subcutaneous) |
For female cattle for protection against abortion
Rispoval IBR-Marker vaccine used |
Primary Vaccination (number of doses, route of administration) recommended to be applied no later than by the start of second trimester of pregnancy | Revaccination |
Vivum* (two doses, intramuscular, with 3-5 weeks interval) | Inactivatum (one dose, subcutaneous) recommended to be applied no later than by the start of the second trimester of each pregnancy |
Vivum* (one dose, intramuscular) followed by Inactivatum (one dose, subcutaneous), with 6 months interval |
Inactivatum (two doses, subcutaneous, with 3-5 week interval) |
For vaccination in known high BoHV-1 infection pressure
Rispoval IBR-Marker vaccine used |
Primary Vaccination (number of doses, route of administration) | Revaccination Intervals |
Interval to first booster vaccination (vaccine, route of administration) | All subsequent booster vaccinations (vaccine, route of administration) |
Vivum* (one dose, intranasal), followed by Vivum* (one dose, intramuscular) with 3-5 weeks interval | 6 months (Vivum*, intramuscular, OR Inactivatum, subcutaneous) | 6 months (Vivum*, intramuscular) OR 12 months (Inactivatum, subcutaneous) |
* Where this veterinary medicinal product is authorised.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those mentioned in section "Adverse events" were observed after administration of a double dose of the vaccine.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Zero days.