Rispoval 2 / BRSV + Pi3
Active substance
ATC code
Species
Cattle
Indications
For vaccination with Rispoval 2 only:
Active immunisation of cattle from 12 weeks of age to: - reduce virus excretion caused by bovine Pi3V and - reduce virus excretion caused by BRSV infection.
Onset of immunity: 3 weeks after the basic vaccination scheme.
Duration of immunity: 6 months after the basic vaccination scheme for BRSV.
Duration of immunity has not been established for bovine Pi3V.
For active immunisation with Rispoval RS+Pi3 IntraNasal* as basic vaccination and Rispoval 2 as booster vaccination from 13 weeks of age to:
- reduce the virus excretion caused by bovine Pi3V and BRSV infection and
- reduce the clinical signs (cough, depression, dyspnea, increased respiratory rate, elevated rectal temperature) associated with BRSV infection.
Onset of Immunity: 3 weeks after the booster vaccination.
Duration of Immunity: 6 months for BRSV and 3 months for Pi3V after the booster vaccination.
* Where this veterinary medicinal product is authorised.
Dose to be administered and administration route
Dose: 4 ml.
Route: intramuscular use.
Reconstitution of the vaccine:
Reconstitute the vaccine by adding the solvent to the vial containing the lyophilisate.
When the lyophilisate and solvent are filled in equally sized vials, inject the entire solvent into the vial containing the lyophilisate.
When the lyophilisate is filled in a smaller vial size than the solvent, the reconstitution of the vaccine is carried out 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-orange turbid suspension with loose sediment.
Vaccination scheme:
For vaccination with Rispoval 2 only:
Basic vaccination: two doses 3-4 weeks apart from 12 weeks of age.
Re-vaccination: if continued protection against BRSV is required, then animals should be revaccinated with two doses after 6 months. The duration of immunity of the Pi3V component is not known.
For use as a booster vaccination after basic vaccination with Rispoval RS+Pi3 IntraNasal*: A single dose of Rispoval 2 three months after the basic vaccination with Rispoval RS+Pi3 IntraNasal*.
If continued protection against BRSV is required, then animals should be revaccinated with a single dose after 6 months. If continued protection against Pi3V is required, then animals should be revaccinated with a single dose after 3 months.
* Where this veterinary medicinal product is authorised.
Animals should preferably be vaccinated at least 3 weeks before a period of stress or high infection risk such as re-grouping or transport of animals, or the start of autumn season.
Adverse reactions
Cattle:
|
Very common (>1 animal / 10 animals treated): |
Hyperthermia1 Injection site inflammation2 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hypersensitivity reaction (e.g. anaphylactic-type reaction)3 |
1Transient and mild; can last for 2 days
2Transient and minor; up to 0.5 cm which disappears within 15 days.
3In case of anaphylactic reaction, symptomatic treatment should be provided.
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.
TRUSTED SOURCE
