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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 4 ml contains:
Active substances:
Lyophilisate
Bovine Parainfluenza 3 virus (Pi3V), modified live strain RLB 103 105.0 - 108.6 CCID50
Bovine Respiratory Syncytial Virus (BRSV), modified live strain 375 105.0 - 107.2 CCID50
CCID50 = Cell Culture Infectious Dose 50%
Adjuvant:
Aluminium hydroxide gel 0.8 ml (equivalent to 24.36 mg of aluminium hydroxide)
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Slightly whitish to yellowish freeze-dried pellet.
Solvent: Pinkish to orange-brown turbid liquid, which might contain loose sediment. On shaking well, the sediment is easily resuspended.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle
4.2 Indications for use, specifying the target species Active immunisation of cattle from 12 weeks of age to:
- reduce virus excretion caused by bovine Pi3 virus 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 Pi3 virus.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use Special precautions for use in animals:
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.
4.6 Adverse reactions (frequency and seriousness)
Transient and mild hyperthermia which can last for 2 days and a transient, minor local inflammation reaction of up to 0.5 cm which disappears within 15 days can occur very commonly after administration of the vaccine. Very rarely, the vaccine may cause hypersensitivity reactions. In case of anaphylactic reaction, symptomatic treatment should be provided.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 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.
4.8 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 decided on a case by case basis.
4.9 Amounts to be administered and administration route
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 10ml 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.
Dose: 4 ml
Route: Intramuscular use Vaccination scheme:
Basic vaccination: Two doses of Rispoval 2, 3-4 weeks apart from 12 weeks of age. Re-vaccination: If continued protection against BRSV is required, then animals should be revaccinated after 6 months. The duration of immunity of the Pi3 component is not known.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Reactions after administration of an overdose of vaccine are not different from those after the single dose.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for bovidae, live viral vaccines for cattle. ATC vet code: QI02AD07
To stimulate an active immunity against Pi3 and BRSV.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilisate:
Lactose Monohydrate
Potassium hydrogen phosphate
Dipotassium phosphate
Monopotassium L-glutamate
Water, purified
Gelatin
Casein hydrolysate solution HALS medium
Solvent:
Aluminium hydroxide gel HALS medium
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent recommended for use with the veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after reconstitution according to directions: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.
6.5 Nature and composition of immediate packaging
- Type I glass vial containing 5 or 25 doses (20 or 100 ml) of solvent, closed with chlorobutyl rubber stopper and sealed with aluminium cap.
- Type I glass vial containing 5 or 25 doses of lyophilisate, closed with bromobutyl rubber stopper and sealed with aluminium cap.
Cardboard box with 1 vial of lyophilisate (5 doses) and 1 vial of solvent (20 ml).
Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (100 ml).
Not all pack sizes may be marketed
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/4212
9. DATE OF FIRST AUTHORISATION
02 February 2021
10. DATE OF REVISION OF THE TEXT
February 2021
Approved 02 February 2021
| Art. Nr. | 42058/5144 |
|---|---|
| EAN | 5414736050515 |
