SUMMARY OF PRODUCT CHARACTERISTICS

Rispoval Pasteurella

Active Substance(s): Per dose (2 ml)

Inactivated antigens of Pasteurella haemolytica
biotype A, serotype 1, strain NL 1009.

Leukotoxoid 380 – 1276 R.U*

Capsular antigens 565 – 10208 R.U*

*Results are expressed as ELISA relative units (R.U.) per dose.

Solvent:

Adjuvants:

Liquid paraffin and aluminium hydroxide.

For a full list of excipients, see Section 6.1.

Lyophilisate and emulsion for injection.

Cattle from 3 months of age.

For active immunisation of cattle to reduce lesions and respiratory disease caused by Pasteurella haemolytica biotype A, serotype 1.

Studies carried out show that a single dose is sufficient to confer protection from challenge by Pasteurella haemolytica within 7 days of vaccination. The vaccine will protect animals for at least 17 weeks.

Do not vaccinate unhealthy animals, pregnant animals or heifers at the time of breeding.

Calves should be vaccinated at least 7 days 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 for at least 17 weeks, which will cover the period of risk from pasteurellosis.

None.

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self injection.

To the user:

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek further medical advice.

To the doctor:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Very rarely hypersensitivity reactions may occur. In such cases, appropriate treatment e.g. adrenaline and/or antihistamine should be given without delay.

A mild, transient fever might be observed 24 to 48 hours after vaccination in some animals. Temperatures return to normal in the following 24 to 48 hours, without remedial action.

A mild, transient local swelling might be observed at the site of injection 24 to 48 hours after vaccination in a small number of animals. These swellings do not generally cause discomfort to the animals even on palpation. The average size of reaction 48 hours after vaccination was 5 cm in diameter, reducing to half that size by day 5. In the majority of cases site reactions are undetectable by 14 days after vaccination but very occasionally might be observed for up to 48 days.

Short-term discomfort around the injection site and muscular trembling have been noted very rarely.

Do not vaccinate pregnant animals and heifers at the time of breeding.

This vaccine can safely be administered, but not mixed with, Rispoval RS. Except for Rispoval RS, no information is available on the compatibility of this vaccine with any other. 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 first shaking the vial containing the emulsion, and then aseptically withdraw and add all of the emulsion to the vial containing the lyophilisate. Shake well and aseptically administer 2 ml intramuscularly.

Do not use chemically sterilised syringes or needles.

Vaccination programme

A single two ml dose of reconstituted vaccine to be given to healthy cattle over the age of 3 months.

A single dose of vaccine will protect animals for at least 17 weeks. Should cattle be at risk from pasteurellosis at a subsequent time, a single vaccination is recommended at least 7 days prior to the period of expected disease challenge.

Administration of an overdose is not expected to result in adverse effects other than those described in Section 4.6 for a single dose.

Zero days

ATCVet Code:QI02AB04

Rispoval Pasteurella induces specific antibodies against Pasteurella haemolytica biotype A, serotype 1 in vaccinated animals.

Liquid paraffin

Aluminium hydroxide

Soya lecithin

Polysorbate 80

Sorbitan oleate

Phophate Buffered Saline

Do not mix with any other product except the emulsion supplied with the product.

Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.

Shelf-life after first opening the immediate container: Use immediately after reconstitution.

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

A Type I glass vial containing 5, 10, 25 or 50 doses of lyophilisate component accompanied by a Type I glass vial of emulsion containing 10ml, 20ml, 50ml or 100ml. Not all pack sizes may be marketed.

Any unused product or waste materials should be disposed of in accordance with national requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4128

Date:2 July 1999

Date:April 2014

14 April 2014