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Porcilis Pesti

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Summary for the public


What is Porcilis Pesti?

Porcilis Pesti is an emulsion for injection. Porcilis Pesti contains Classical Swine Fever Virus -E2 subunit antigen.


What is Porcilis Pesti used for?

Porcilis Pesti is used to immunise healthy pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever (CSF). It is also used to reduce infection with CSF and excretion of CSF virus into the environment.

The vaccine is shaken before use and an intramuscular (into a muscle) injection of one dose (2 ml) is given in the neck behind the ear. This first dose is followed by a second injection 4 weeks later. The pigs should be re-vaccinated every 6 months. Protection from CSF starts after 2 weeks and lasts for 6 months.


How does Porcilis Pesti work?

Porcilis Pesti contains an antigen – E2 (a substance that stimulates an immune response) to CSF. When this antigen is injected, this small exposure helps the pig’s immune system to recognise and attack CSF. When exposed to CSF later in life, the pig will either not become infected or have a much less serious infection.


How has Porcilis Pesti been studied?

Porcilis Pesti has been studied in two safety field trials, one in finishing pigs and one in sows using different vaccination doses. The field trials confirm the results obtained in the laboratory safety experiments and show that the product is safe for the target animal (piglets from 5 weeks of age onwards) and in the most sensitive category of animals (pregnant sows).

The main measure of effectiveness in a field trial with piglets was the survival of the piglets when exposed to the CSF virus later in life. The piglets were also tested for viraemia (presence of virus in their blood). The start and length of immunity was measured by antibodies produced by the piglets to the CSF antigen (E2). Maternally derived antibodies did not interfere with vaccination.


What benefit has Porcilis Pesti shown during the studies?

All the vaccinations prevented death when the piglets were exposed to CSF virus at a later date. Viraemia was only prevented by two injections (as recommended in the vaccination schedule for Porcilis Pesti). Antibodies to the CSF antigen showed that the piglets developed immunity after 2 weeks, which was maintained for 6 months.


What is the risk associated with Porcilis Pesti?

Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine. Temporary hyperthermia (increased temperature) may occur after the second injection. Abscesses may be seen at the injection site. It is recommended that the second vaccination is given at a different site than the first vaccination.


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

Porcilis Pesti 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 Pesti been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever. They recommended that Porcilis Pesti should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Porcilis Pesti

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B.V. on 9 February 2000, which was renewed in February 2005.

The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.

Authorisation details
Name: Porcilis Pesti
EMEA Product number: EMEA/V/C/000046
Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen
INN or common name: Adjuvanted vaccine against classical swine fever
Species: Pigs
ATCvet Code: QI09AD04
Marketing Authorisation Holder: Intervet International BV
Revision: 11
Date of issue of Market Authorisation valid throughout the European Union: 09/06/2000
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 Pesti emulsion for injection
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance:
    Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU) per dose of 2 ml
    Adjuvant:
    941.4 mg liquid paraffin per dose of 2 ml
    For a full list of excipients, see section 6.1
    3. PHARMACEUTICAL FORM
    Emulsion for injection.
    4. CLINICAL PARTICULARS
    4.1 Target species
    Pigs.
    4.2 Indications for use, specifying the target species
    Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical
    signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
    The onset of protection is 2 weeks.
    The duration of protection is 6 months.
    4.3 Contraindications
    None
    4.4 Special warnings for each target species
    None
    4.5 Special precautions for use
    Special precautions for use in animals
    Not applicable
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    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
    2/17
    leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical
    advice again.
    To the physician:
    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.
    4.6 Adverse reactions (frequency and seriousness)
    A local and in most cases transient swelling at the injection site may occur up to 4 weeks after
    administration of each dose of the vaccine. Transient hyperthermia may occur post the second dose.
    Abscesses may be observed at the injection site. Since safety after giving both inoculations at the same
    site has not been examined, it is advised to carry out the second vaccination at a different site than the
    first vaccination.
    4.7 Use during pregnancy, lactation or lay
    Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever
    field virus from the sow to foetuses.
    4.8 Interaction with other medicinal product 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 can be administered concurrently with the
    product.
    4.9 Amounts to be administered and administration route
    Shake well before use.
    Intramuscular injection of one dose (2 ml) in the neck in the area behind the ear.
    Vaccination scheme:
    Basic vaccination:
    Inject one dose per pig followed by a second injection 4 weeks after the first
    injection.
    Re-vaccination: Every 6 months, using a single dose.
    Allow the vaccine to reach a temperature of 15°C-25°C before use.
    Use sterile syringes and needles. Avoid the introduction of contamination.
    Vaccinate healthy animals only.
    It is recommended to use a closed multiject vaccination system.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    After administration of an overdose, local reactions at the injection site may be more pronounced.
    4.11 Withdrawal period(s)
    Zero days
    5. IMMUNOLOGICAL PROPERTIES
    Classical Swine Fever vaccine, ATC vet code: QI09AD04
    The active substance stimulates active immunity against Classical Swine Fever (CSF). The product
    contains Classical Swine Fever virus E2 immunogen incorporated in an emulsion in order to prolong
    stimulation of the immune system of the target species. As a consequence of the subunit nature of the
    vaccine, vaccination does not induce production of antibodies against CSF virus antigens, other than E2.
    3/17
    6. PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Polysorbate 80
    Sorbitan oleate
    6.2 Incompatibilities
    Do not mix with any other vaccine or immunological product.
    6.3 Shelf life
    12 months
    Shelf life after first broaching the bottle: 3 hours.
    6.4 Special precautions for storage
    Store in a refrigerator (2°C to 8°C). Do not freeze.
    6.5 Nature and composition of immediate packaging
    Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses,
    100 ml for 50 doses and 250 ml for 125 doses presentation.
    The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
    The bottles are packed individually in a carton box.
    6.6 Special precautions for the disposal of unused veterinary medicinal product 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 NUMBER(S)
    EU/2/99/016/001-006
    9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    06/2000 - 06/2005
    10. DATE OF REVISION OF THE TEXT
    01/09/2010
    4/17
    Detailed information on this product is available on the website of the European Medicines Agency
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions
    established by European Community legislation on the control of CSF (Council Directive 80/217/EEC,
    as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product
    must be authorised by the competent authority of the Member State.
    5/17
    ANNEX II
    A.
    MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR 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(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Manufacturer of the biological active substance:
    Nobilon International BV
    Exportstraat 39b
    5830 AH Boxmeer
    The Netherlands
    or
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer responsible for batch release
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as
    amended), in the European Union:
    a)
    The use of classical swine fever vaccines is prohibited. However, the use of vaccines may be
    authorised in the framework of an emergency vaccination plan, implemented by the competent
    authority of a Member State following confirmation of disease, in accordance with Community
    Legislation on control and eradication of classical swine fever;
    b)
    The storage, supply, distribution and sale of classical swine fever vaccines must be carried out
    under the control of and in accordance with the eventual instructions established by the
    competent authority of the Member State;
    c)
    Special provisions regulate the movement of pigs from areas where classical swine fever
    vaccine is being or has been used and the marking of pig meat from vaccinated pigs.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council,
    Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the
    whole or part of their territory if it is established that:
    a)
    the administration of the product to animals will interfere with the implementation of national
    programmes for the diagnosis, control and elimination of animal diseases, or will cause
    7/17
     
    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 product is intended to confer immunity is largely absent from the
    territory.
    D. STATEMENT OF THE MRLs
    The following constituents of Porcilis Pesti are included in table 1 of the annex to Commission
    Regulation (EU) No 37/2010 as follows:
    Pharmacologically
    active substance
    Marker
    residue
    Animal
    species
    MRL
    Target
    tissues
    Other
    provisions
    Therapeutic
    classification
    Liquid paraffin
    (Mineral
    hydrocarbons 1 )
    Not
    applicable
    All food-
    producing
    species
    No MRL
    required
    Not
    applicable
    Excludes
    aromatic and
    unsaturated
    compounds
    No entry
    Polysorbate 80
    Not
    applicable
    All food-
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry
    No entry
    Food additives
    (substances with a
    valid E number
    approved as
    additives in
    foodstuffs for
    human
    consumption)
    Not
    applicable
    All food-
    producing
    species
    No MRL
    required
    Not
    applicable
    Only
    substances
    approved as
    additives in
    foodstuffs for
    human
    consumption,
    with the
    exception of
    preservatives
    listed in part C
    of Annex III to
    European
    Parliament and
    Council
    Directive
    95/2/EC.
    No entry
    1 Mineral hydrocarbons, low to high viscosity including micorcristalline waxes, approximately C10-C60, aliphatic, branched
    aliphatic and alicyclic compounds.
    8/17
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9/17
    A. LABELLING
    10/17
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {50ml Bottle/ 100ml Bottle/250ml Bottle}
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Pesti
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml: 120 Elisa Units CSF-E2 antigen.
    Liquid paraffin : 941.4 mg
    3. PHARMACEUTICAL FORM
    Emulsion for injection
    4. PACKAGE SIZE
    50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses)
    5. TARGET SPECIES
    Pigs
    6. INDICATION(S)
    Vaccine against Classical Swine Fever
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    IM injection of 2 ml
    8. WITHDRAWAL PERIOD
    Withdrawal period -Zero days
    9. SPECIAL WARNING(S), IF NECESSARY
    Accidental self-injection is dangerous
    10. EXPIRY DATE
    <EXP {month/year}>
    11/17
     
    Once broached, use within 3 hours.
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2°C to 8°C). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    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/2/99/016/001 - EU/2/99/016/006
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    12/17
     
    MINIMUM PARTICULARS TO APPEAR ON Bottle Label
    {50ml/100ml/250ml }
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Pesti
    2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
    120 Elisa Units CSF E2 antigen/2ml.
    3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses)
    4. ROUTE(S) OF ADMINISTRATION
    IM injection
    5. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    6. BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    7. EXPIRY DATE
    <EXP {month/year}>
    Once broached, use within 3 hours.
    8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    13/17
     
    B. PACKAGE LEAFLET
    14/17
    PACKAGE LEAFLET
    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 Pesti emulsion for injection
    3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Per dose of 2 ml:
    120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen
    Liquid paraffin as adjuvant: 941.4 mg/2 ml
    4. INDICATION(S)
    Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical
    signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
    The onset of protection is 2 weeks.
    The duration of protection is 6 months.
    5. CONTRAINDICATIONS
    None
    6. ADVERSE REACTIONS
    A local and in most cases transient swelling at the injection site may occur up to 4 weeks after
    administration of each dose of the vaccine. Transient hyperthermia may occur post the second dose.
    Abscesses may be observed at the injection site. Since safety after giving both inoculations at the same
    site has not been examined, it is advised to carry out the second vaccination at a different site than the
    first vaccination.
    After administration of an overdose, local reactions at the injection site may be more pronounced.
    If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7. TARGET SPECIES
    Pigs
    15/17
    8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
    2 ml
    Intramuscular use
    Vaccination scheme:
    Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first
    injection.
    Re-vaccination: Every 6 months, using a single dose.
    9. ADVICE ON CORRECT ADMINISTRATION
    Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
    Administer 2 ml of vaccine deep intramuscularly in the neck area behind the ear. Use sterile syringes and
    needles.
    It is recommended to use a closed multiject vaccination system.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store in a refrigerator (2°C to 8°C). Do not freeze.
    Shelf-life after first broaching the bottle: 3 hours.
    Do not use after the expiry date which is stated on the label.
    12. SPECIAL WARNINGS
    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 medical
    advice again.
    To the physician:
    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.
    Vaccinate healthy animals only.
    The product can be used during pregnancy but may not prevent transplacental transmission of Classical
    swine fever field virus from the sow to foetuses.
    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 can be administered concurrently with the
    product.
    Do not mix with any other vaccine or immunological product.
    16/17
    The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the
    particular conditions established by European Community legislation on the control of CSF (Council
    Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the
    veterinary medicinal product must be authorised by the competent authority of the Member State.
    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
    01/09/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    For animal treatment only.
    As a consequence of the subunit nature of the vaccine, vaccination does not induce production of
    antibodies against CSF virus antigen, other than E2.
    50 ml/100 ml/250 ml multidose glass bottle
    50 ml/100 ml/250 ml multidose PET bottle
    Not all pack sizes may be marketed.
    17/17


    Source: European Medicines Agency


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