Each dose of 2 ml contains:

- Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) ≥6.2 log2 TN titre1

- Inactivated Bordetella bronchiseptica cells ≥5.5 log2 Aggl. Titre2

1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.

2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits.

Adjuvant: dl-α-tocopherol acetate 150 mg.

Excipient: Formaldehyde ≤1 mg.

For a full list of excipients, see section “Pharmaceutical Particulars”.

Suspension for injection.

Aqueous, white or nearly white suspension.

Pigs (sows and gilts).

For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.

None.

None.

Vaccinate only healthy animals.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

1. Transient; mean increase of 1.5 °C, in some pigs up to 3 °C, could lead to an abortion, and can generally be measured on the day of vaccination or the following day.

2. On the day of vaccination.

3. Transient (max diameter: 10 cm) for up to two weeks.

4. e.g. vomiting, dyspnoea and shock, may occur.

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.

Can be used during pregnancy.

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.

Before use, allow the vaccine to reach room temperature. Shake vigorously before and at intervals during use. Avoid introduction of contamination. Administer one dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older. The vaccine should preferably be administered just behind the ear.

Vaccination scheme:

Primary vaccination: inject one dose (2 ml) per pig, followed by a second injection 4 weeks after the first injection. The first injection should be administered 6 weeks before the expected date of farrowing.

Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.

Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than those mentioned under section "Adverse reactions" can be expected following the administration of a double dose of vaccine.

Zero days.

ATCvet code: QI09AB04.

Inactivated bacterial vaccine.

To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis. Dermonecrotic toxin producing P. multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis. Colonisation of the surface of the nasal mucosa by P. multocida is most often promoted by B. bronchiseptica. The vaccine contains a non-toxic recombinant derivative of the P. multocida toxin and inactivated B. bronchiseptica cells. The immunogens are incorporated in an adjuvant based on dl-α-tocopherol. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.

Sodium chloride

Phosphate buffer

Simethicone

Polysorbate 80

Water for injections

Do not mix with any other veterinary medicinal product.

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening the vial: 10 hours.

Store in a refrigerator (+2 °C and +8 °C). Protect from light. Do not freeze.

Glass vial (Hydrolytic Type I) containing 20 ml or 50 ml, or PET vial containing of 20 ml, 50 ml, 100 ml or 250 ml. The vials are closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

Cardboard box containing one glass vial of 20 ml or 50 ml.

Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

UK(NI): Intervet International B.V., The Netherlands

UK(GB): Vm 01708/5052

30 September 2010.

May 2024.

For animal treatment only. Keep out of the sight and reach of children.