Porcilis AR-T DF - summary of medicine characteristics

Summary of medicine characteristics - Porcilis AR-T DF

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis AR-T DF suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 2 ml contains:

Active substances:

– Protein dO (non-toxic deletion derivative of Pasteurella >6.2 log2 TN titre1

multocida dermonecrotic toxin)

– 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-a-tocopherol acetate 150 mg

Excipient:

Formaldehyde <1 mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS4.1 Target species

Pigs (sows and gilts).

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

None.

4.4 Special warnings

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals

Special precautions to be taken by the person administering the 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)

A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day. Reduced activity and lack of appetite on the day of vaccination very commonly occurs and/or a transient swelling (max diameter: 10 cm) for up to two weeks may arise at the site of injection. In very rare cases other immediate hypersensitivity reactions, e.g. vomiting, dyspnoea and shock, may occur.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy (see details under section 4.9).

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

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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 4.6 can be expected following the administration of a double dose of vaccine.

4.11 Withdrawal period

Zero days

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: inactivated bacterial vaccine.

ATCvet code: QI09AB04.

To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis.

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

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Sodium chloride

Phosphate buffer

Simethicone

Polysorbate 80

Formaldehyde

Water for injections

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 years

Shelf life after first opening the vial: 10 hours.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Protect from light

Do not freeze.

6.5 Nature and composition of immediate packaging

Cardboard box containing one glass vial (Hydrolytic Type I) of 20 ml or 50 ml.

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

Vials are closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

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

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

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

8. MARKETING AUTHORISATION NUMBERS

EU/2/00/026/001–006

9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION