SUMMARY OF PRODUCT CHARACTERISTICS

Rispoval 4

Each 5 ml dose contains:

Suspension fraction:

• Infectious Bovine Rhinotracheitis (IBR) virus, strain Cooper, > GMT 2 log₂*.

• Bovine Viral Diarrhoea (BVD) virus, cytopathic strain 5960, and Bovine Viral Diarrhoea (BVD) virus, non-cytopathic strain 6309, > GMT 5 log₂*

* GMT Serological titre induced after injection to calves.

Lyophilisate fraction:

• Bovine Parainfluenza 3 (PI3) virus, thermosensitive strain RLB103, minimum titre at the end of shelf life, > or equal 10^5.0 CCID₅₀

• Bovine Respiratory Syncytial Virus (BRSV) strain 375, minimum titre at the end of shelf life, > or equal 10^5.0 CCID₅₀

Adjuvant:

Aluminium hydroxide (2 % Al₂O₃) ≤ 5.2 mg Al₂0₃per ml

For a full list of excipients, see Section 6.1.

Lyophilisate for suspension in diluent.

Cattle

For active immunisation of cattle to reduce infection, clinical signs and respiratory disease caused by Bovine Respiratory Syncytial virus (BRSV), Infectious Bovine Rhinotracheitis (IBR, commonly known as BHV-1) virus and Parainfluenza virus type 3 (PI3); and leucopaenia and viraemia caused by the Bovine Viral Diarrhoea virus (BVDV) Type I, cytopathic and non-cytopathic strains. A duration of immunity of at least 6 months has been demonstrated.

None

None.

None.

None

Very occasionally, administration of the vaccine may be followed by a mild transient reaction at the injection site up to 0.5 cm and completely resolved within 15 days.

Do not use during pregnancy.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other product except Rispoval™ Pasteurella. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.

Reconstitute the vaccine by mixing the lyophilised fraction with the suspension 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.

Vaccination programme:

For cattle over 3 months of age:

Two doses of 5ml of reconstituted vaccine should be given three to four weeks apart to cattle over the age of 3 months, via the intramuscular route.

Ideally, calves should be vaccinated at least 2 weeks before transport, mixing of animals of different origins, housing, or any other event which may cause the animals to be stressed or exposed to new infections. Calves are usually most susceptible during early autumn. The vaccine will protect animals against BRSV, PI3, IBR and BVD for at least 6 months, which will cover the period of risk from respiratory infections.

Should cattle be at risk from these respiratory diseases at a subsequent time, the same vaccination scheme is recommended at least 14 days prior to the period of expected disease challenge.

For cattle over 3 weeks of age:

For cattle from 3 weeks of age, vaccination leads to seroconversion of seronegative calves vaccinated at 3 and 6 weeks of age. The influence of maternally derived antibodies has not been studied in detail and it is therefore recommended that calves vaccinated before 12 weeks of age are re-vaccinated at 12 weeks of age.

No symptoms other than those mentioned in Section 4.6.

Zero days

ATCVet code:QI02AH

To stimulate active immunity against BRSV, PI3, IBR (BHV-1) and cytopathic and non-cytopathic strains of BVD Type I viruses in cattle.

Aluminium hydroxide.

Do not mix with any other vaccine/immunological product.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years (lyophilisate).

Shelf life of the veterinary medicinal product as packaged for sale: 3 years (suspension)

Reconstituted vaccine should be used within 2 hours.

Store and transport away from light and between + 2°C and + 8°C. Do not freeze.

Cardboard box with 1 glass vial containing 5 doses of lyophilisate accompanied by 1 glass vial containing 5 doses (25 ml) of suspension.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm 42058/4125

31 May 2001

December 2015

22 December 2015