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Porcilis AR-T DF

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Summary for the public


What is Porcilis AR-T DF?

Porcilis AR-T DF is a vaccine for use in pigs. It is a vial containing a suspension for injection. Porcilis AR-T DF contains a non-toxic recombinant derivative (see ‘How does Porcilis AR-T DF work?’) of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.


What is Porcilis AR-T DF used for?

Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets. The vaccine is given to sows (female pigs) only. Their piglets then become immunised when they drink the colostrum (first milk).

Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older. The vaccine is given just behind the ear. The first injection should be given 6 weeks before the expected date of farrowing (giving birth to the piglets). The first dose is followed by a second injection 4 weeks later. To maintain the immunity, a single injection of one dose should be carried out 2 – 4 weeks before each subsequent farrowing.


How does Porcilis AR-T DF work?

Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida. Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells. This bacterium is often present with Pasteurella multocida and makes the disease worse. When the sow is injected, this small exposure helps the pig’s immune system to recognise and attack the bacteria. When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection. This immunity is passed onto the sow’s piglets through her colostrum.

An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘recombinant technology’. The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.


How has the effectiveness of Porcilis AR-T DF been studied?

Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis. In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.

The length of time that Porcilis AR-T DF is effective has also been studied. The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.


What benefit has Porcilis AR-T DF shown during the studies?

The trials showed good protection against the clinical signs of progressive atrophic rhinitis. The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.

In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).


What are the side effects of Porcilis AR-T DF?

Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5 °C, and in some pigs of up to 3°C on the day of vaccination or the following day. Other side effects are reduced activity and lack of appetite in 10-20 % of the pigs on the day of vaccination and/or a temporary swelling (max diameter: 10 cm) for up to two weeks at the injection site.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Porcilis AR-T DF contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.


Why has Porcilis AR-T DF been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF are greater than any risks to reduce the clinical signs of progressive atrophic rhinitis in piglets. They recommended that Porcilis AR-T DF should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Porcilis AR-T DF

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B.V. on 16 November 2000. Information on the prescription status of this product may be found on the outer package.

Authorisation details
Name: Porcilis AR-T DF
EMEA Product number: EMEA/V/C/000055
Active substance: Protein dO (non-toxic deletion derivative of Pasteurella multocida
dermonecrotic toxin),inactivated Bordetella bronchiseptica cells
INN or common name: Adjuvanted vaccine againts progressive atrophic rhinitis in piglets
Species: Pigs (gilts and sows)
ATCvet Code: QI09AB04
Marketing Authorisation Holder: Intervet International BV
Revision: 4
Date of issue of Market Authorisation valid throughout the European Union: 16/11/2000
Contact address:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis AR-T DF suspension for injection
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substances:
    Per dose of 2 ml
    - Protein dO (non-toxic deletion derivative of Pasteurella multocida
    dermonecrotic toxin)
    ≥
    5.9 log2 TN titre 1
    4.2 log 2 Aggl. titre 2
    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:
    Per dose of 2 ml
    - 150 mg dl-α-tocopherol acetate.
    Excipients:
    Per dose of 2 ml
    max 1.0 mg free formaldehyde.
    3.
    PHARMACEUTICAL FORM
    Suspension for injection.
    4.
    CLINICAL PARTICULARS
    4.1 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 Contra-indications
    None.
    4.4 Special warnings for each target species
    None.
    4.5 Special precautions for use
    Before using the vaccine allow it to reach room temperature (15
    °
    C - 25
    °
    C) and shake vigorously.
    Vaccinate only healthy animals. Avoid introduction of contamination.
    2/17
    - Inactivated Bordetella bronchiseptica cells.
    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 can generally be
    measured on the day of vaccination or the following day. Reduced activity and lack of appetite in 10-20 %
    of the animals may occur on the day of vaccination and/or a transient swelling (max diameter : 10 cm) for
    up to two weeks may arise at the site of injection.
    4.7 Use during pregnancy, lactation or lay
    This product can be used during pregnancy.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the safety and efficacy from the concurrent use of this vaccine with any
    other. It is therefore recommended that no other vaccines should be administered within 14 days before or
    after vaccination with this product.
    4.9 Amounts to be administered and administration route
    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:
    Basic vaccination: inject one dose 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 should be carried out 2 – 4 weeks prior to each subsequent
    farrowing.
    4.10 Overdose(symptoms,emergencyprocedures, 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 already mentioned under point 4.6 can be expected.
    4.11 Withdrawalperiod
    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
    3/17
    immunogens are incorporated in an adjuvant based on dl-α-tocopherol. Neonatal piglets derive passive
    immunity via ingestion of colostrum from vaccinated sows/gilts.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 Incompatibilities
    Do not mix with any other vaccine or immunological product.
    6.2 Shelf-life
    5 years.
    Shelf-life after first opening the vial: 10 hours.
    6.3 Special precautions for storage
    Store in a refrigerator (2°C - 8°C).
    Do not freeze.
    6.4 Nature and composition of immediate packaging
    Cardboard box containing one 20 or 50 ml multi-dose vial of hydrolytic Type I glass or polyethylene
    terephthalate [PET] , closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
    Not all pack sizes may be marketed.
    6.5 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 Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBERS
    EU/2/00/026/001-004
    9.
    DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    Date of first authorisation: 16 November 2000
    Date of last renewal: 8 February 2006
    4/17
    10. DATE OF REVISION OF THE TEXT
    02/2006
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Porcilis AR-T DF is or may be prohibited in certain Member
    States on the whole or part of their territory pursuant to national animal health policy. Any person
    intending to import, sell, supply and/or use Porcilis AR-T DF must consult the relevant Member State’s
    competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
    5/17
    ANNEX II
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY AND USE
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D. STATEMENT OF THE MRLs
    6/17
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substances:
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    Name and address of the manufacturer responsible for batch release:
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY AND USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
    amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
    medicinal product on the whole or part of their territory if it is established that:
    a) the administration of the veterinary medicinal product to animals will interfere with the
    implementation of national programmes for the diagnosis, control and eradication of animal
    diseases, or will cause difficulties in certifying the absence of contamination in live animals or in
    foodstuffs or other products obtained from treated animals.
    b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
    absent from the territory.
    D. STATEMENT OF THE MRLs
    The active substance being a principle of biological origin intended to produce active immunity is not
    in the scope of Council Regulation (EEC) 2377/90.
    7/17
    The MRL status of the excipients is as follows:
    Annex II of Council Regulation (EEC) No 2377/90
    Substance
    MRL status
    Comments
    Sodium chloride
    All food-producing animals
    OJ No. L 290 of 5.12.95
    Formaldehyde
    OJ No. L 290 of 5.12.95
    dl-α-tocopherol acetate
    OJ No. L 122 of 12.05.99
    Simethicone (Dimethicone)
    OJ No L 290 of 5.12.95
    Disodium phosphate
    dihydrate
    OJ No L 272 of 25.10.96
    Potassium dihydrogen
    phosphate
    OJ No L 272 of 25.10.96
    Polysorbate 80
    OJ No L 290 of 05.12.95
    8/17
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9/17
    A. LABELLING
    10/17
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis AR-T DF suspension for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml:
    -
    ≥
    5.9 log2 TN titre 1 Protein dO
    4.2 log 2 Aggl. Titre 1 inactivated B. bronchiseptica cells
    1 See package leaflet.
    ≥
    150 mg dl-α-tocopherol acetate
    3.
    PHARMACEUTICAL FORM
    Suspension for injection.
    4.
    PACKAGE SIZE
    20 ml (10 doses) Glass vial
    50 ml (25 doses) Glass vial
    20 ml (10 doses) PET vial
    50 ml (25 doses) PET vial
    5.
    TARGET SPECIES
    Pigs (sows and gilts).
    6.
    INDICATION(S)
    Vaccine against progressive atrophic rhinitis.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    i.m. injection of 2 ml
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Zero days.
    11/17
    -
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    10. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 10 hours.
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator.
    Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    NL-5831 AN Boxmeer
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/026/001
    EU/2/00/026/002
    EU/2/00/026/003
    EU/2/00/026/004
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    12/17
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis AR-T DF
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Read the package leaflet before use.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    20 ml (10 doses of 2 ml)
    50 ml (25 doses of 2 ml)
    4.
    ROUTE(S) OF ADMINISTRATION
    i.m. injection
    5.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP {month/year}
    Once broached, use within 10 hours.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    13/17
     
    B. PACKAGE LEAFLET
    14/17
    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
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis AR-T DF suspension for injection
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Active substances:
    Per dose of 2 ml
    - Protein dO (non-toxic deletion derivative of Pasteurella multocida )
    ≥
    5.9 log2 TN titre 1
    dermonecrotic toxin)
    - inactivated Bordetella bronchiseptica cells.
    4.2 log 2 Aggl. titre 2
    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
    Per dose of 2 ml
    - 150 mg dl-α-tocopherol acetate.
    Preservatives
    Per dose of 2 ml
    max 1.0 mg free formaldehyde.
    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 can generally be
    measured on the day of vaccination or the following day. Reduced activity and lack of appetite in 10-20 %
    15/17
    of the animals may occur on the day of vaccination and/or a transient swelling (max diameter : 10 cm) for
    up to two weeks may arise at the site of injection.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Pigs (sows and gilts).
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    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:
    Basic vaccination: inject one dose 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 should be carried out 2 – 4 weeks prior to each subsequent
    farrowing.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    - Before using the vaccine allow it to reach room temperature (15
    °
    C - 25
    °
    C).
    - Shake vigorously before use and at intervals during use.
    - Avoid introduction of contamination.
    - Vaccinate only healthy animals.
    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.
    Keep the container in the outer carton.
    Do not use after the expiry date stated on the label.
    Shelf-life after first opening the container: 10 hours.
    12. SPECIAL WARNING(S)
    No information is available on the safety and efficacy from the concurrent use of this vaccine with any
    other. It is therefore recommended that no other vaccines should be administered within 14 days before or
    after vaccination with the product.
    16/17
    Do not mix with any other veterinary medicinal products.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or the
    label to the physician.
    The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
    certain Member States on the whole or part of their territory pursuant to national animal health policy.
    Any person intending to import, sell, supply and/or use the veterinary medicinal product must consult
    the relevant Member State’s Competent Authority on the current vaccination policies prior to the
    import, sale, supply and/or use.
    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
    02/2006
    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.
    For animal treatment only.
    Not all pack sizes may be marketed.
    17/17


    Source: European Medicines Agency


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