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Porcilis Porcoli

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Summary for the public


What is Porcilis Porcoli?

Porcilis Porcoli and Porcilis Porcoli Diluvac Forte are vaccines for use in pigs. Porcilis Porcoli is an emulsion for injection and Porcilis Porcoli Diluvac Forte is a suspension for injection. Both products contain the active substances F4ab, F4ac, F5, F6, and LT toxoid.


What is Porcilis Porcoli used for?

Both types of Porcilis Porcoli are used to immunise piglets to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria during the first days of their life. Enterotoxicosis is a reaction in the intestines to toxins produced by some bacteria.  Porcilis Porcoli is used to immunise against E. coli which have the adhesins (surface components) F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P). The vaccine is given to sows (female pigs) only. Their piglets then become immunised when they drink the colostrum (first milk).

Both types of Porcilis Porcoli are given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs. The vaccine is given in the neck in the area behind the ear. Female pigs that have not been vaccinated should be given two injections with an interval of six weeks between them. To maintain the immunity, a single injection should be given before each subsequent farrowing (giving birth to the piglets). It is preferable to vaccinate female pigs during the second half of their pregnancy, but not within two weeks before the expected date of farrowing.


How does Porcilis Porcoli work?

Porcilis Porcoli contains adhesins that are found on the surface of E. coli bacteria. When the sow is injected, this small exposure helps the pig’s immune system to recognise and attack the E. coli 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.


How has the effectiveness of Porcilis Porcoli been studied?

The Porcilis Porcoli vaccines (or parts of the vaccines) have been studied in several trials in pregnant pigs of various breeds. These pigs were given two injections of the vaccine and then the litters of these pigs, as well as litters where the mother had not been vaccinated (controls), were exposed to E. coli containing the adhesins or LT toxin present in the vaccine. The main measure of effectiveness was the percentage cumulative mortality (overall death rate) of the piglets.


What benefit has Porcilis Porcoli shown during the studies?

Porcilis Porcoli reduced the death rate in all the studies when compared with the control piglets.


What are the side effects of Porcilis Porcoli?

Porcilis Porcoli can cause mild, temporary clinical reactions (fever, lethargy, reduced food intake) during the first 24 hours after vaccination. There may be a swelling at the injection site, for up to 6 weeks after vaccination with Porcilis Porcoli, but only up to 2 weeks after vaccination with Porcilis Porcoli Diluvac Forte. Abscesses around the injection site may occur frequently with Porcilis Porcoli.


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

Porcilis Porcoli 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 Porcoli been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Porcoli, to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria, are greater than any risks. They recommended that Porcilis Porcoli should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Porcilis Porcoli:

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Porcoli to Intervet International B.V. on 29 February 1996. Information on the prescription status of this product may be found on the outer package.

Authorisation details
Name: Porcilis Porcoli
EMEA Product number: EMEA/V/C/000024
Active substance: F4ab (K88ab) fimbrial adhesin, F4ac (K88ac) fimbrial adhesin, F5 (K99) fimbrial adhesin, F6 (987P) fimbrial adhesin, LT toxoid
INN or common name: Adjuvanted vaccine against enterotoxicosis of piglets due to E. coli
Species: Pigs (gilts and sows)
ATCvet Code: QI09AB02
Marketing Authorisation Holder: Intervet International BV
Revision: 4
Date of issue of Market Authorisation valid throughout the European Union: 29/02/1996
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 Porcoli emulsion for injection
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of two ml:
    Active substances:
    F4ab (K88ab) fimbrial adhesin
    at least 100 SR 80 1
    F4ac (K88ac) fimbrial adhesin
    at least 100 SR 80
    F5 (K99) fimbrial adhesin
    at least 100 SR 80
    F6 (987P) fimbrial adhesin
    at least 100 SR 80
    LT toxoid
    at least 100 SR 80
    Adjuvant:
    Liquid paraffin
    941.4 mg
    For a full list of excipients, see section 6.1
    3. PHARMACEUTICAL FORM
    Emulsion for injection.
    4. CLINICAL PARTICULARS
    4.1 Target species
    Pigs (sows and gilts)
    4.2 Indications for use, specifying the target species
    For passive immunisation of piglets by active immunisation of sows and gilts to reduce mortality and
    clinical signs of neonatal enterotoxicosis, caused by those E. coli, which express the adhesins F4ab
    (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P), during the first days of life.
    4.3 Contraindications
    None.
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    Special precautions for use in animals
    Not applicable.
    1
    2
    SR 80 = sero-response in 80% of vaccinated rabbits
     
    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 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)
    Mild, transient clinical reactions (fever, lethargy) may occur in the first 24 hours after vaccination. For
    some weeks after vaccination a swelling may be present at the site of injection. Local tissue reactions
    in the form of abscesses may frequently occur. Six weeks after vaccination these local reactions are
    considerably decreased.
    4.7 Use during pregnancy and lactation
    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 concurrent use of this vaccine with any
    other. It is therefore recommended that no other vaccine should be administered concurrently with the
    product.
    4.9 Amounts to be administered and administration route
    Before using the vaccine allow it to reach room temperature (15-25C) and shake vigorously before
    use. Use sterile syringes and needles.
    Intramuscular injection in sows and gilts of 2 ml per animal in the neck in the area behind the ear.
    Vaccination scheme:
    Basic vaccination: Sows and gilts which have not been vaccinated with the product should be given
    two injections with an interval of six weeks.
    Revaccination: A single injection should be given prior to each farrowing. Generally speaking this
    means every 5 to 6 months.
    It is preferable to vaccinate sows and gilts during the second half of the pregnancy, but not within two
    weeks before the expected date of farrowing.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No other undesirable effects observed at double dose when compared with one dose of vaccine.
    3
    4.11 Withdrawal period
    Zero days
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: inactivated bacterial vaccine. ATC vet code: QI09AB02.
    Vaccine to stimulate active immunity in order to provide passive immunity to the progeny against
    E. coli fimbrial adhesins F4ab, F4ac, F5 and F6.
    The fimbrial adhesins F4ab, F4ac, F5, and F6 are responsible for the virulence of E. coli strains, which
    cause neonatal enterotoxicosis in piglets. The immunogens are incorporated in a water-in-oil emulsion
    in order to enhance a prolonged stimulation of immunity. Progeny of vaccinated sows and gilts derive
    a passive immunity via the colostrum.
    6. PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Liquid paraffin
    Polysorbate 80
    Sodium Chloride
    Sorbitan mono-oleate
    Water for injection
    6.2 Incompatibilities
    Do not mix with any other vaccine or immunological product.
    6.3 Shelf life
    2 years.
    Broached vials: 3 hours.
    6.4 Special precautions for storage
    Store in a refrigerator (+2°C to +8°C). Do not freeze. Protect from light.
    6.5 Nature and composition of immediate packaging
    Cardboard box with 1 PET or glass (hydrolytic Type II) vial of 20 or 50 ml with a nitryl rubber
    stopper and a coded 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, 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.
    4
    7. MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands.
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/96/001/001-002 & EU/2/96/001/009-010
    9. DATE OF RENEWAL OF THE AUTHORISATION
    10/04/2006
    10. DATE OF REVISION OF THE TEXT
    10/04/2006
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of two ml:
    Active substances:
    - F4ab (K88ab) fimbrial adhesin
     9.0 log 2 Ab titre 1
    - F4ac (K88ac) fimbrial adhesin
     5.4 log 2 Ab titre 1
    - F5 (K99) fimbrial adhesin
     6.8 log 2 Ab titre 1
    - F6 (987P) fimbrial adhesin
     7.1 log 2 Ab titre 1
    - LT toxoid
     6.8 log 2 Ab titre 1
    1
    Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
    Adjuvant:
    dl--tocopherol acetate
    150 mg
    For a full list of excipients, see section 6.1.
    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 passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and
    clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by
    those E.coli strains , which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6
    (987P).
    4.3 Contraindications
    None
    4.4 Special warnings
    None
    4.5 Special precautions for use
    Special precautions for use in animals
    Before using the vaccine allow it to reach room temperature (15-25 C) and shake well before use.
    Use sterile syringes and needles.
    6
    Avoid introduction of contamination.
    Vaccinate only healthy animals.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In the case of accidental self-injection, seek medical advice immediately and show the package leaflet
    or label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    A mean transient increase in body temperature of about 1°C, in some pigs up to 3°C, may occur in the
    first 24 hours after vaccination. Reduced feed intake and listlessness may occur in approximately 10%
    of the animals on the day of vaccination, but returns to normal within 1-3 days. A transient swelling
    and redness at the injection site may be observed in approximately 5% of the animals. The diameter of
    the swelling is in general below 5 cm, but in some cases a larger swelling may occur. Swelling and
    redness at the injection site may occasionally last for at least 14 days.
    4.7 Use during pregnancy, lactation or lay
    The vaccine 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 concurrent use of this vaccine with any
    other. It is therefore recommended that no other vaccine should be administered within 14 days before
    or after vaccination with this product.
    4.9 Amounts to be administered and administration route
    Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind
    the ear.
    Vaccination scheme:
    Basic vaccination: Sows/gilts which have not yet been vaccinated with the product shall be given an
    injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection
    4 weeks later.
    Revaccination: A single revaccination shall be carried out during the second half of each subsequent
    pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No undesirable effects other than those observed and mentioned in the “Adverse reactions” section
    have been observed.
    4.11 Withdrawal period(s)
    Zero days.
    7
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: inactivated bacterial vaccine. ATC vet code: QI09AB02.
    Vaccine to stimulate active immunity of sows/gilts in order to provide passive immunity to their
    progeny against E. coli strains that express the fimbrial adhesins F4ab, F4ac, F5 and F6.
    The fimbrial adhesins F4ab, F4ac, F5, and F6 are responsible for the adhesion and the virulence of
    E.coli strains, which cause neonatal enterotoxicosis in piglets. These immunogens are incorporated in
    an adjuvant in order to enhance a prolonged stimulation of immunity. Neonatal piglets derive passive
    immunity via ingestion of colostrum from vaccinated sows/gilts.
    6. PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Polysorbate 80
    Potassium Chloride
    Potassium Dihydrogen Phosphate
    Simethicone emulsion
    Sodium chloride
    Disodium Phosphate Dihydate
    DL-Alpha-Tocopherol Acetate
    Water for injection
    6.2 Incompatibilities
    Do not mix with any other vaccine or immunological product.
    6.3 Shelf life
    2 years.
    Shelf-life after first opening: 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
    Cardboard box with 1 glass (hydrolytic type I) or 1 PET vial of 20, 50 or 100 ml with a halogenobutyl
    rubber stopper and a coded aluminium cap. Not all pack sizes may be marketed.
    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
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/96/001/003-008
    9. DATE OF RENEWAL OF THE AUTHORISATION
    10/04/2006
    10. DATE OF REVISION OF THE TEXT
    10/04/2006
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    9
    ANNEX II
    A.
    MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER 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
    10
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substances
    Intervet International B.V.
    Wim de Körverstraat 35,
    P.O. Box 31,
    5830 AA Boxmeer,
    The Netherlands.
    Name and address of the manufacturer responsible for batch release
    Intervet International B.V.
    Wim de Körverstraat 35,
    P.O. Box 31,
    5830 AA Boxmeer,
    The Netherlands.
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Annex II of Council Regulation (EEC) No 2377/90
    Pharmacologically active substance
    Animal Species
    Other provisions
    dl- -tocopherol acetate a (Vitamin E) All food-producing species
    Potassium chloride b (E508) All food-producing species
    Potassium dihydrogen phosphate c (E340i) All food-producing species
    Sodium chloride d All food-producing species
    Disodium hydrogen phosphate e (E339ii) All food-producing species
    Polysorbate 80 f
    All food-producing species
    Sorbitan mono-oleate i
    All food-producing species
    a
    OJ No L122 of 12.05.99
    b
    OJ No L272 of 25.10.96
    c
    OJ No L272 of 25.10.96
    d
    OJ No L290 of 5.12.95
    e
    OJ No L272 of 25.10.96
    OJ No L290 of 5.12.95
    g
    OJ No L290 of 5.12.95
    h
    OJ No L291 of 5.12.95
    i
    OJ No L272 of 25.10.96
    11
    All food-producing species
    Simethicone g (Dimethicone) All food-producing species
    Mineral hydrocarbons h
    f
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    12
    A. LABELLING
    13
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli emulsion for injection
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of two ml:
    Active substances:
    F4ab (K88ab) fimbrial adhesin
    at least 100 SR 80 2
    F4ac (K88ac) fimbrial adhesin
    at least 100 SR 80
    F6 (987P) fimbrial adhesin
    at least 100 SR 80
    LT toxoid
    at least 100 SR 80
    Adjuvant:
    Liquid paraffin
    941.4 mg
    3. PHARMACEUTICAL FORM
    Emulsion for injection
    4. PACKAGE SIZE
    20 ml (10 doses)
    50 ml (25 doses)
    5. TARGET SPECIES
    Pigs (sows and gilts)
    6. METHOD AND ROUTE OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    7. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    1
    14
    F5 (K99) fimbrial adhesin
    at least 100 SR 80
    SR 80 = sero-response in 80% of vaccinated rabbits
     
     
    8. SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous.
    9. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    10. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator.
    Do not freeze.
    Protect from light.
    11.. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    14. NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/001 20 ml Glass
    EU/2/96/001/009 20 ml PET
    EU/2/96/001/002 50 ml Glass
    EU/2/96/001/010 50 ml PET
    15. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    16. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
    Veterinary medicinal product subject to prescription.
    15
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    20 ml vial labels (EU/2/96/001/001 & EU/2/96/001/009 only)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli emulsion for injection
    2. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    20 ml (10 doses)
    3. ROUTE(S) OF ADMINISTRATION
    IM injection
    4. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    5. BATCH NUMBER
    Batch: ......
    6. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    7. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    16
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    50 ml vial labels (EU/2/96/001/002 & EU/2/96/001/010 only)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli emulsion for injection
    2. PACKAGE SIZE
    50 ml (25 doses)
    3. TARGET SPECIES
    Pigs (sows and gilts)
    4. METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    5. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    6. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    7. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    8. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    9. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    17
     
    10. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/002 Glass
    EU/2/96/001/010 PET
    11. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    18
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of two ml:
    - F4ab (K88ab) fimbrial adhesin
     9.0 log 2 Ab titre 1
    - F4ac (K88ac) fimbrial adhesin
     5.4 log 2 Ab titre 1
    - F5 (K99) fimbrial adhesin
     6.8 log 2 Ab titre 1
    - F6 (987P) fimbrial adhesin
     7.1 log 2 Ab titre 1
    - LT toxoid
     6.8 log 2 Ab titre 1
    1
    Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
    dl--tocopherol acetate
    150 mg
    3. PHARMACEUTICAL FORM
    Suspension for injection.
    4. PACKAGE SIZE
    20 ml (10 doses)
    50 ml (25 doses)
    100 ml (50 doses)
    5. TARGET SPECIES
    Pigs (sows and gilts)
    6. METHOD AND ROUTE OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    7. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    19
     
    8. SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous.
    9. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    10. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator.
    Do not freeze.
    Protect from light.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    14. NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/003 20 ml Glass
    EU/2/96/001/006 20 ml PET
    EU/2/96/001/004 50 ml Glass
    EU/2/96/001/007 50 ml PET
    EU/2/96/001/005 100 ml Glass
    EU/2/96/001/008 100 ml PET
    15. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    16. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
    Veterinary medicinal product subject to prescription.
    20
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 & EU/2/96/001/007)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of two ml:
    - F4ab (K88ab) fimbrial adhesin
     9.0 log 2 Ab titre 1
    - F4ac (K88ac) fimbrial adhesin
     5.4 log 2 Ab titre 1
    - F5 (K99) fimbrial adhesin
     6.8 log 2 Ab titre 1
    - F6 (987P) fimbrial adhesin
     7.1 log 2 Ab titre 1
    - LT toxoid
     6.8 log 2 Ab titre 1
    1
    Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
    dl--tocopherol acetate
    150 mg
    3. PHARMACEUTICAL FORM
    Suspension for injection.
    4. PACKAGE SIZE
    20 ml (10 doses)
    50 ml (25 doses)
    5. TARGET SPECIES
    Pigs (sows and gilts)
    6. METHOD AND ROUTE OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    7. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    21
     
    8. SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous.
    9. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    10. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator.
    Do not freeze.
    Protect from light.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    14. NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/003 20 ml Glass
    EU/2/96/001/006 20 ml PET
    EU/2/96/001/004 50 ml Glass
    EU/2/96/001/007 50 ml PET
    15. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    16. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
    Veterinary medicinal product subject to prescription.
    22
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    100 ml (EU/2/96/001/005 & EU/2/96/001/008)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of two ml:
    - F4ab (K88ab) fimbrial adhesin
     9.0 log 2 Ab titre 1
    - F4ac (K88ac) fimbrial adhesin
     5.4 log 2 Ab titre 1
    - F5 (K99) fimbrial adhesin
     6.8 log 2 Ab titre 1
    - F6 (987P) fimbrial adhesin
     7.1 log 2 Ab titre 1
    - LT toxoid
     6.8 log 2 Ab titre 1
    1
    Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
    dl--tocopherol acetate
    150 mg
    3. PHARMACEUTICAL FORM
    Suspension for injection.
    4. PACKAGE SIZE
    100 ml (50 doses)
    5. TARGET SPECIES
    Pigs (sows and gilts)
    6. METHOD AND ROUTE OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    7. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    8. SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous.
    23
     
    9. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    10. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator.
    Do not freeze.
    Protect from light.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    14. NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/005 100 ml Glass
    EU/2/96/001/008 100 ml PET
    15. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    16. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
    Veterinary medicinal product subject to prescription.
    17. 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.
    24
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    20 ml vial labels (EU/2/96/001/003 & EU/2/96/001/006 only)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    20 ml (10 doses)
    3. ROUTE(S) OF ADMINISTRATION
    IM injection
    4. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    5. BATCH NUMBER
    Batch: ......
    6. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    7. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    25
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    50 ml & 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 &
    EU/2/96/001/008 only)
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte
    2. PACKAGE SIZE
    50 ml (25 doses)
    100 ml (50 doses)
    3. TARGET SPECIES
    Pigs (sows and gilts)
    4. METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    IM injection of 2 ml
    5. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    6. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 3 hours.
    7. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    8. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    9. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    NL-5831 AN Boxmeer
    26
     
    10. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
    EU/2/96/001/004 50 ml Glass
    EU/2/96/001/007 50 ml PET
    EU/2/96/001/005 100 ml Glass
    EU/2/96/001/008 100 ml PET
    11. MANUFACTURER’S BATCH NUMBER
    Batch: .......
    27
     
    B. PACKAGE LEAFLET
    28
    PACKAGE LEAFLET FOR
    PORCILIS PORCOLI
    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 Porcoli emulsion for injection
    3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each dose (2 ml) of Porcilis Porcoli vaccine contains at least 100 SR 80 3 e ach of the following
    components: the Escherichia coli LT toxoid and the Escherichia coli adhesins F4ab (K88ab), F4ac
    (K88ac), F5 (K99) and F6 (987P) in 941.4 mg liquid paraffin as adjuvant.
    4. INDICATION(S)
    For the passive immunisation of piglets by active immunisation of sows and gilts to reduce mortality
    and clinical signs of neonatal enterotoxicosis, caused by those E.coli, which express the adhesins
    F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P), during the first days of life.
    5. CONTRAINDICATIONS
    None.
    6. ADVERSE REACTIONS
    Mild, transient clinical reactions (fever, lethargy) may occur in the first 24 hours after vaccination. For
    some weeks after vaccination a swelling may be present at the site of injection. Local tissue reactions
    in the form of abscesses may frequently occur. Six weeks after vaccination these local reactions are
    considerably decreased.
    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)
    3
    29
    SR 80 = sero-response in 80% of vaccinated rabbits
     
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Intramuscular injection in sows and gilts of 2 ml per animal in the neck in the area behind the ear.
    Vaccination scheme:
    Basic vaccination : Sows and gilts which have not been vaccinated with the product should be given two
    injections with an interval of six weeks.
    Revaccination : A single revaccination should be carried out prior to each farrowing. Generally speaking
    this means every 5 to 6 months.
    It is preferable to vaccinate sows and gilts during the second half of the pregnancy, but not within two
    weeks before the expected date of farrowing.
    9. ADVICE ON CORRECT ADMINISTRATION
    Before using the vaccine allow it to reach room temperature (15-25C) and shake vigorously before use.
    Use sterile syringes and needles.
    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. Protect from light.
    Shelf-life after first opening: 3 hours.
    12. SPECIAL WARNING(S)
    No information is available on the safety and efficacy from concurrent use of this vaccine with any other.
    It is therefore recommended that no other vaccine should be administered concurrently with the product.
    Do not mix with any other product.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    label to the physician.
    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.
    30
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medical product or waste material derived from such veterinary medical products
    should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    10/04/2006
    15. OTHER INFORMATION
    Not all pack sizes may be marketed.
    The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E.
    coli strains, which cause neonatal enterotoxicosis in piglets. These immunogens are incorporated in an
    adjuvant in order to enhance a prolonged stimulation of immunity. Neonatal piglets derive passive
    immunity via ingestion of colostrum from vaccinated sows/gilts.
    For animal treatment only.
    31
    PACKAGE LEAFLET FOR
    PORCILIS PORCOLI DILUVAC FORTE
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis Porcoli Diluvac Forte suspension for injection
    3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
    Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin,
    the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean
    antibody titre of respectively  9.0 log 2 Ab titre,  5.4 log 2 Ab titre,  6.8 log 2 Ab titre,  7.1 log 2 Ab
    titre, and 6.8 log 2 Ab titre after vaccination of mice with a 1/20 sow dose. The antigens are adjuvanted
    with 150 mg dl--tocopherol acetate per dose.
    4. INDICATION(S)
    For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and
    clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by
    those E.coli strains , which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6
    (987P).
    5. CONTRA-INDICATIONS
    None
    6. ADVERSE REACTIONS
    A mean transient increase in body temperature of about 1°C, in some pigs up to 3 o C, may occur in the
    first 24 hours after vaccination. Reduced feed intake and listlessness may occur in approximately 10%
    of the animals on the day of vaccination, but returns to normal within 1-3 days. A transient swelling
    and redness at the injection site may be observed in approximately 5% of the animals. The diameter of
    the swelling is in general below 5 cm, but in some cases a larger size swelling may occur. Swelling
    and redness at the injection site may occasionally last for at least 14 days.
    If you notice any other side effects, please inform your veterinary surgeon.
    7. TARGET SPECIES
    Pigs (sows/gilts)
    32
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind the
    ear.
    Vaccination scheme:
    Basic vaccination : Sows/gilts which have not yet been vaccinated with the product shall be given an
    injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4
    weeks later.
    Revaccination : A single revaccination shall be carried out during the second half of each subsequent
    pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.
    9. ADVICE ON CORRECT ADMINISTRATION
    - Before using the vaccine allow it to reach room temperature.
    - Shake well before use.
    - Use sterile syringes and needles.
    - Avoid introduction of contamination.
    - Vaccinate only healthy animals.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Store in a refrigerator (+2°C to +8°C).
    Do not freeze.
    Shelf-life after first opening: 3 hours.
    12. SPECIAL WARNING(S)
    No information is available on the safety and efficacy from concurrent use of this vaccine with any other.
    It is therefore recommended that no other vaccine should be administered within 14 days before or after
    vaccination with this product.
    In the absence of incompatibility studies this vaccine must not be mixed with other veterinary medical
    products.
    In the case of accidental self-injection, seek medical advice immediately and show the package insert
    or label to the physician.
    Keep out of the reach and sight of children.
    33
    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
    10/04/2006
    15. OTHER INFORMATION
    Not all pack sizes may be marketed.
    The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E.
    coli strains, which cause neonatal enterotoxicosis in piglets. These immunogens are incorporated in an
    adjuvant in order to enhance a prolonged stimulation of immunity. Neonatal piglets derive passive
    immunity via ingestion of colostrum from vaccinated sows/gilts.
    For animal treatment only.
    34


    Source: European Medicines Agency


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