SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Rispoval 3 BRSV Pi3 BVD

Lyophilisate and suspension for suspension for injection for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (4 ml) contains:

Active Ingredient(s):

Lyophilised fraction

Parainfluenza 3 virus, modified live strain RLB 103 10^5.0to 10^8.6 CCID₅₀

Bovine Respiratory Syncytial Virus, modified live strain 375 10^5.0to 10^7.2CCID₅₀

Liquid fraction

Bovine Virus Diarrhoea Virus Type 1, inactivated strains 5960 (cytopathic) and 6309 (non‑cytopathic), to induce a GMT seroneutralisation titre in guinea pigs of at least 3.0 log₂

Adjuvant:

Alhydrogel 2% 0.8 ml (equivalent to 24.36 mg of aluminium hydroxide)

CCID_{50 =} Cell Culture Infectious Dose 50%

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and suspension for suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle

4.2 Indications for use, specifying the target species

Active immunisation of calves from 12 weeks of age to:

• reduce virus excretion and the clinical signs caused by bovine Pi3 virus,

• reduce virus excretion caused by BRSV infection,

Onset of immunity: 3 weeks after vaccination

Duration of immunity: 6 months(demonstrated by challenge studies) after vaccination for BRSV and BVDV Type 1. Duration of immunity has not been established for bovine Pi3 virus.

Efficacy has not been demonstrated against BVDV Type 2 strains.

4.3 Contraindications

None.

4.4 Special warnings for cattle

None.

4.5 Special precautions for use

Special precautions for use in animals

Do not use in unhealthy animals.

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)

The administration of the vaccine can lead to a transient and mild hyperthermia which can last for 2 days and to a transient, minor local inflammation reaction of up to 0.5 cm which disappears within 15 days. In very rare cases, the vaccine may cause hypersensitivity reactions. In case of anaphylactic reaction, symptomatic treatment should be provided.

4.7 Use during 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 mixing the lyophilised fraction with the solvent in 2 steps:

1. Inject 10ml 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.

Administer one dose (4 ml) of the reconstituted vaccine by intramuscular route according to the following vaccination scheme:

First injection: from 12 weeks of age

Second injection: 3 to 4 weeks later.

Animals should be preferably vaccinated at least 3 weeks before a period of stress or high infection risk like re-grouping or transport of animals, or the start of autumn season. If protection against BRSV and BVDV type 1 is required, then animals should be re-vaccinated after 6 months. The duration of immunity of the Pi3 component is not known.

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

Live and inactivated viral vaccines

ATCvet code: QI02AH

To stimulate an active immunity against Pi3, BRSV and BVDV type 1.

The vaccine has a broad cross-neutralising ability against various current European strains of BVDV type I as measured in vitro by virus neutralisation test. Cross neutralisation at a lower level has also been demonstrated to BVDV Type 2 strains.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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: 24 months

Shelf-life after reconstitution according to directions: 2 hours

6.4. Special precautions for storage

Store and transport refrigerated (+2°C to +8°C). Do not freeze. Protect from heat and light

6.5 Nature and composition of immediate packaging

• Type I glass vial containing 5 or 25 doses (20 or 100 ml) liquid fraction, closed with chlorobutyl rubber stopper and sealed with aluminium cap

• Type I glass vial containing 5 or 25 doses of lyophilised fraction, closed with bromobutyl rubber stopper and sealed with aluminium cap.

Cardboard box with 1 vial of lyophilised fraction (5 doses) and 1 vial of liquid fraction (20 ml).

Cardboard box with 1 vial of lyophilised fraction (25 doses) and 1 vial of liquid fraction (100 ml).

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4124

9. DATE OF FIRST AUTHORISATION

03 May 2005

10. DATE OF REVISION OF THE TEXT

October 2015

Approved: 27 October 2015