Rispoval RS + PI3 IntraNasal
Active substance
ATC code
Species
Cattle.
Indications
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.
Dose to be administered and administration route
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.
Adverse reactions
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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval RS+PI3 IntraNasal
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml:
Powder
Active substance:
- Modified live Bovine Parainfluenza type 3 virus (PI3V), thermosensitive strain RLB103, ≥105.0 and ≤108.6 CCID50*
- Modified live Bovine Respiratory Syncytial virus (BRSV) strain 375, ≥105.0 and
≤107.2 CCID50*
*CCID50: Cell Culture Infective Dose 50%
|
Diluent: |
|
|
- Sodium chloride |
18 mg |
|
- Water for injection |
2 ml |
Excipients:
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and diluent for suspension for intranasal application. Slightly coloured powder and clear colourless diluent. The reconstituted, dissolved vaccine is a pinkish suspension.
4. CLINICAL PARTICULARS
4.1 Target Species
Cattle
4.2 Indications for Use, Specifying the Target Species
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 protective immunity: 5 days for BRSV and 10 days for PI3V after a single vaccination.
Duration of protective immunity: 12 weeks following a single dose. The duration of protective immunity against the PI3V fraction may be reduced in MDA positive calves vaccinated before 3 weeks of age.
4.3 Contraindications
None.
4.4 Special warnings for Cattle None.
4.5 Special precautions for use Special precautions for use in animals
Vaccinate only healthy animals.
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.
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 to be taken by the person administering the veterinary medicinal product to animals
None
4.6 Adverse reactions (frequency and seriousness)
Published evidence shows that on rare occasions repeated exposure to RSV may trigger hypersensitivity reactions. In colostrum-deprived animals vaccinated before 3 weeks of age with a 10x overdose of vaccine, transient temperature increase, nutritional scour, abnormal faeces and demeanour were observed.
4.7 Use during pregnancy, lactation or lay
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 made on a case by case basis.
4.9 Amounts to be administered and administration route
Reconstitute the 1 dose and 5 dose presentations by aseptically adding all the liquid to the vial containing the powder components. 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 liquid fraction on the lyophilised plug in the freeze dried vial.
2. Shake well and extract the reconstituted lyophilised fraction from the freeze dried vial and mix with the liquid fraction in the liquid fraction vial. Shake well before use.
Vaccination programme:
A single dose of 2 ml of reconstituted vaccine should be given intranasally using the intranasal applicators provided to cattle from the age of 9 days. It is recommended to change applicators between animals to avoid transmitting infectious organisms.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In colostrum-deprived animals vaccinated before 3 weeks of age with a 10x overdose of vaccine, transient temperature increase, nutritional scour, abnormal faeces and demeanour were observed.
4.11 Withdrawal Period(s)
Zero days
5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against BRSV and PI3V.
ATC Vet code: QI02AD07 (immunologicals for bovidae, cattle, live viral vaccines, bovine Respiratory syncytial virus + bovine Parainfluenza virus).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Powder:
Buffered lactose solution
Gelatin solution
Casein hydrolysate solution
HALS medium
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale (5 and 25 doses presentations): 2 years.
Shelf-life of the veterinary medicinal product as packaged for sale (1 dose presentation): 1 year.
Shelf-life after reconstitution according to directions: 2 hours.
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
Cardboard box with 1 glass vial of 5 or 25 doses of powder accompanied by 1 vial containing respectively 10 or 50 ml liquid component. Both vials have rubber stopper and aluminium cap.
Plastic box with 5 glass vial(s) of 1 dose of powder accompanied by 5 vial(s) containing 2 ml liquid component. Both vials have rubber stopper and aluminium cap. Nasal applicators for vaccination are also provided.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/4130
9. DATE OF THE FIRST AUTHORISATION
11 October 2005
10. DATE OF REVISION OF THE TEXT
10 January 2020
Approved 10 January 2020
| Art. Nr. | 42058/5145 |
|---|---|
| EAN | 5013457079562 |
