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Porcilis AR-T DF (protein dO (non-toxic deletion derivative...) – Package leaflet - QI09AB04

Updated on site: 09-Feb-2018

Medication name: Porcilis AR-T DF
ATC: QI09AB04
Substance: protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) / inactivated Bordetella bronchiseptica cells
Manufacturer: Intervet International BV

PACKAGE LEAFLET

Porcilis AR-T DF suspension for injection for pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer: Intervet International B.V.

Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis AR-T DF suspension for injection for pigs

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

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

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

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

Adjuvant:

 

dl-α-tocopherol acetate

150 mg

Excipient:

 

Formaldehyde

≤1 mg

4.INDICATION(S)

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.

5.CONTRAINDICATIONS

None.

6.ADVERSE REACTIONS

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.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Pigs (sows and gilts).

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

9.ADVICE ON CORRECT ADMINISTRATION

Before use, allow the vaccine to reach room temperature.

Shake vigorously before use and at intervals during use.

Avoid introduction of contamination.

10.WITHDRAWAL PERIOD

Zero days

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

Do not use after the expiry date stated on the label.

Shelf life after first opening the vial: 10 hours.

12.SPECIAL WARNING(S)

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.

Use during pregnancy, lactation or lay

Can be used during pregnancy

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.

Incompatibilities

Do not mix with any other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER INFORMATION

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-α-tocopherol. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.

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.

Not all pack sizes may be marketed.

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