Rispoval IBR-Marker Live
Active substance
ATC code
Species
Cattle.
Indications
For 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 of abortion associated with BoHV-1 infections has been 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.
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 Vivum with Rispoval IBR-Marker Inactivatum*:
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 Inactivatum*, which was administered 6 months after a single dose primary vaccination by the intramuscular route using Rispoval IBR-Marker Vivum.
* Where this veterinary medicinal product is authorised.
Dose to be administered and administration route
Posology:
The dose for cattle, over 2 weeks of age, is 2 ml of the reconstituted vaccine for intranasal inoculation and/or intramuscular injection.
After reconstitution, the suspension should be a colourless clear liquid, which might contain a loose resuspendable sediment.
The vaccination scheme consists of basic immunisation and booster vaccinations.
Basic immunisation:
Calves of 2 weeks to 3 months of age at first vaccination
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.
Cattle at 3 months of age or older at first vaccination
Animals should be given one intramuscular 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.
For female cattle for protection against abortion
To prevent abortions associated with BoHV-1, female cattle require a primary course of two intramuscular doses of Rispoval IBR-Marker Vivum 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 intramuscular doses of Rispoval IBR-Marker Vivum 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.
Cattle at immediate risk of IBR
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.
Booster vaccinations:
Animals should be given a single dose booster vaccination 6 months after their initial vaccination course. Animals initially vaccinated with Rispoval IBR-Marker Vivum may be given a single dose booster vaccination with either Rispoval IBR-Marker Vivum to provide 6 months of protection or Rispoval IBR-Marker Inactivatum* to provide a duration of immunity of 12 months of protection. Thereafter, single dose booster vaccinations should be administered every 6 months (if using Rispoval IBR-Marker Vivum) or every 12 months (if using Rispoval IBR-Marker Inactivatum*).
Method of administration:
The freeze-dried pellet should be reconstituted aseptically just prior to use. The vaccine is prepared as follows:
For 10 and 50 dose vials approx. 4 ml of the respective diluent are transferred to the vial containing the freeze-dried pellet and then mixed.
The reconstituted virus fraction is finally transferred back into the respective 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 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.
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 (Live, intranasal) |
3 months, (Live, intramuscular) |
6 months (Live , intramuscular) |
6 months (Live, intramuscular) |
2 weeks (Live, intranasal) |
3 months (Live, intramuscular) |
6 months (Inactivated*, subcutaneous) |
12 months (Inactivated*, 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) |
|
Live (one dose, intramuscular or intranasal) |
6 months (Live, intramuscular) |
6 months (Live, intramuscular) |
Live (one dose, intramuscular) |
6 months (Inactivated*, subcutaneous) |
12 months (Inactivated*, subcutaneous) |
Inactivated* (two doses, subcutaneous, with 3-5 week interval) |
6 months (Inactivated*, subcutaneous) |
6 months (Inactivated*, 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 |
Live (two doses, intramuscular, with 3-5 weeks interval) |
Inactivated* (one dose, subcutaneous) recommended to be applied no later than by the start of the second trimester of each pregnancy |
Live (one dose, intramuscular) followed by Inactivated* (one dose, subcutaneous), with 6 months interval |
|
Inactivated* (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) |
|
Live (one dose, intranasal), followed by Live (one dose, intramuscular) with 3-5 weeks interval |
6 months (Live, intramuscular, OR Inactivated*, subcutaneous) |
6 months (Live, intramuscular) OR 12 months (Inactivated*, subcutaneous) |
Where this veterinary medicinal product is authorised.
Adverse reactions
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): |
Nasal discharge1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling2, Hypersensitivity reaction3 |
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.