Target species
Cattle.
Indications for use for each target species
For vaccination with Rispoval RS+PI3 IntraNasal only:
For active immunisation of maternally derived antibody positive or negative calves from 9 days of age against BRSV and PI3V, to reduce the mean titre and duration of excretion of both viruses.
Onset of immunity: 5 days for BRSV and 10 days for PI3V after a single vaccination.
Duration of immunity: 12 weeks after a single vaccination. The duration of protective immunity against the PI3V fraction may be reduced in MDA positive calves vaccinated before 3 weeks of age.
For primary vaccination using Rispoval RS/Pi3 IntraNasal and booster vaccination with Rispoval 2/BRSV + Pi3*, refer to the Rispoval 2/BRSV Pi3* product information for specific details on indications.
* Where this veterinary medicinal product is authorised.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Animals should preferably be vaccinated at least 10 days before a period of stress or high infection risk like re-grouping or transport of animals, or at the start of the autumn season. To achieve optimal results, it is recommended to vaccinate all the calves within the same herd.
Special precautions for use
Special precautions for safe use in the target species:
Vaccinal viruses can spread from vaccinated to non-vaccinated calves and may cause a serological response, but without causing clinical signs. In laboratory experiments based on the data using 3 week-old animals, shedding was observed for BRSV and PI3V up to 11 and 7 days respectively after vaccination with one dose containing the maximal virus content.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction(e.g. anaphylactic-type reaction) |
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:
The safety and efficacy of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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
Dose: 2 ml.
Route: nasal use.
Reconstitution of the vaccine:
Reconstitute the 1 dose and 5 dose presentations by aseptically adding the solvent to the vial containing the lyophilisate. Shake well before use.
Reconstitute the 25 dose presentation by mixing the lyophilised fraction with the solvent in 2 steps:
1. Inject 10 ml of the solvent on the lyophilised plug in the vial containing the lyophilisate.
2. Shake well and extract the reconstituted lyophilised fraction from the vial and mix with the remaining solvent in the liquid fraction vial.
Shake well before use.
Reconstituted product: pink to orange liquid, which might contain a loose resuspendable sediment.
Vaccination programme:
Basic vaccination: A single dose of 2 ml of reconstituted vaccine should be given using the intranasal applicator available from Zoetis to cattle from the age of 9 days.
It is recommended to change applicators between animals to avoid transmitting infectious organisms.
For primary vaccination using Rispoval RS/Pi3 IntraNasal and booster vaccination with Rispoval 2/BRSV + Pi3*, refer to the Rispoval 2/BRSV Pi3* product information for specific details on vaccination programme.
* Where this veterinary medicinal product is authorised.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In colostrum-deprived animals vaccinated before 3 weeks of age with a 10-fold overdose of vaccine, transient temperature increase, nutritional scour, abnormal faeces and demeanour were observed.
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.