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Equilis Prequenza

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Summary for the public


What is Equilis Prequenza?

Equilis Prequenza is a vaccine for use in horses. It contains parts (subunits) of three equine influenza (flu) strains (‘A/equine-1/Prague/1/56’, ‘A/equine 2/Newmarket/1/93’ and ‘A/equine-2/Newmarket/2/93’). The vaccine is available as a suspension for injection.


What is Equilis Prequenza used for?

Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza. Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death. The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.

The vaccine is given as an injection into a muscle.

Horses should receive a primary vaccination, consisting of two injections given four weeks apart. This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.


How does Equilis Prequenza work?

Equilis Prequenza contains fragments (subunits) of the influenza virus against which the vaccine is indicated for. These fragments provoke a protective response of the immune system (the body’s natural defences) but cannot cause the disease.

Vaccines work by ‘teaching’ the immune system how to defend itself against diseases. When the product is given to horses, it helps the animals’ immune system to react more quickly when the animal is naturally exposed to the virus. This helps to protect against equine influenza. The vaccine also contains an ‘adjuvant’ to stimulate a better response.


How has Equilis Prequenza been studied?

The safety of Equilis Prequenza was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age. It was concluded that the product is well tolerated by horses of different ages. Equilis Prequenza was also studied in pregnant mares. No negative influence on gestation, foaling and offspring of mares was observed after vaccination at different times during pregnancy.

The effectiveness of Equilis Prequenza has been studied in several trials under laboratory and field conditions. Most of the studies used Equilis Prequenza Te, a vaccine that protects against the three equine influenza strains (the same as Equilis Prequenza), as well as tetanus. The main measure of effectiveness was the production of protective levels of antibodies against the influenza components. The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, i.e. which did not receive the vaccine.


What benefit has Equilis Prequenza shown during the studies?

The studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age. Horses developed protection two weeks after primary vaccination. The duration of protection was five months after primary vaccination and 12 months after the first revaccination.


What is the risk associated with Equilis Prequenza?

Swelling (max. diameter 5 cm) may occur, either as hard or soft swelling. The swelling is expected to decrease within two days. Pain at the injection site can occur occasionally. In some cases fever may occur for one day, and up to three days in exceptional circumstances.


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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period of the product is zero days.


What is the time to allow before milk can be taken from the animal for human consumption?

Zero days.


Why has Equilis Prequenza been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza exceeded the risks for the immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection. The Committee recommended that Equilis Prequenza should be given a marketing authorisation.

The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Equilis Prequenza

The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza to Intervet International BV on 8 July 2005. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Equilis Prequenza
EMEA Product number: EMEA/V/C/000094
Active substance: Purified haemagglutinin subunits from equine influenza viruses
INN or common name: Adjuvanted vaccine against equine influenza
Species: Horses
ATCvet Code: QI05AA01
Marketing Authorisation Holder: Intervet International BV
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 08/07/2005
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    Equilis Prequenza, suspension for injection, for horses
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of 1 ml:
    Active substances
    Purified haemagglutinin subunits from equine influenza viruses:
    A/equine-1/ Prague/1/ 56
    100 AU 1
    A/equine-2/ Newmarket/1/93
    50 AU
    A/equine-2/ Newmarket/2/93
    50 AU
    Adjuvant
    Purified Saponin
    375 micrograms
    Phosphatidylcholine
    62.5 micrograms
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Suspension for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Horses
    4.2 Indications for use, specifying the target species
    Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and
    virus excretion after infection.
    Influenza
    Onset of immunity: 2 weeks after the primary vaccination course
    Duration of immunity: 5 months after the primary vaccination course
    12 months after the first revaccination
    4.3 Contraindications
    None
    1 Antigenic units
    2
    Cholesterol
    125 micrograms
     
    4.4 Special warnings
    Foals should not be vaccinated before the age of 6 months, especially when born to mares that were
    revaccinated in the last two months of gestation, because of possible interference by maternally derived
    antibodies.
    4.5 Special precautions for use
    Only healthy animals should be vaccinated.
    Special precautions for use in animals
    Not applicable
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, seek medical advice immediately and show the package insert or the
    label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2
    days. Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort
    (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1
    day, and up to 3 days in exceptional circumstances.
    4.7 Use during pregnancy, lactation or lay
    Can be used during pregnancy and lactation.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the safety and efficacy of this vaccine when used with any other veterinary
    medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product
    therefore needs to be made on a case by case basis.
    4.9 Amounts to be administered and administration route
    Intramuscular use
    Vaccination schedule:
    Primary vaccination course
    Administer one dose (1ml), by intramuscular injection, according to the following schedule:
    •
    Revaccination
    The first revaccination (third dose) is given 5 months after the primary vaccination course. This
    revaccination results in immunity to equine influenza lasting at least 12 months.
    The second revaccination is given 12 months after the first revaccination.
    3
    Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
    The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains
    A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 and A/equi 2/Newmarket-2/93, is recommended to maintain
    immunity levels for the influenza component (see scheme).
    In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be
    given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6
    months of age and 4 weeks later).
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Following the administration of a double dose of vaccine, no side-effects other than those described under
    4.6 have been observed except for some depression at the day of vaccination
    4.11 Withdrawalperiod(s)
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    To stimulate active immunity against Equine influenza
    ATC-vet code: QI05AA01
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Lactose, phosphate buffer, chloride buffer, traces of thiomersal
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 2 years
    6.4 Special precautions for storage
    Store at 2-8
    °
    C, protected from light. Do not freeze.
    4
    6.5 Nature and composition of immediate packaging
    Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
    Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a
    halogenobutyl stopper.
    Package size:
    Cardboard box with 10 glass vials of 1 ml.
    Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/05/056/001-004
    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    08/07/2005 / 27/07/2010
    10. DATE OF REVISION OF THE TEXT
    27/07/2010
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5
    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
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance(s)
    Laboratorios Intervet, S.A.
    Poligono El Montalvo
    37080 Salamanca
    Spain
    Name and address of the manufacturer responsible for batch release
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    Not applicable
    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 Regulation (EC) 470/2009.
    The following constituents of Equilis Prequenza are included in Table 1 (Allowed substances) of the
    annex to Commission Regulation (EU) No 37/2010 as follows:
    Pharmaco-
    logically active
    substance
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other provisions Therapeutic
    classification
    Saponin
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry
    No entry
    Sodium
    phosphate
    (Na 2 HPO 4 ) –
    covered by entry
    for food
    additives with an
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    Only substances
    approved as
    additives in
    foodstuffs for
    human
    consumption, with
    No entry
    7
     
    Pharmaco-
    logically active
    substance
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other provisions Therapeutic
    classification
    E number
    (E339)
    the exception of
    preservatives listed
    in part C of Annex
    III to European
    Parliament and
    Council Directive
    95/2/EC
    Potassium
    phosphate
    (KH 2 PO 4 ) –
    covered by entry
    for food
    additives with an
    E number
    (E340)
    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
    Sodium chloride
    (NaCl)
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry
    No entry
    Magnesium
    chloride (MgCl 2 )
    Not
    applicble
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry
    No entry
    Calcium
    chloride (CaCl 2 )
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry
    No entry
    Thiomersal
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    For use only as
    preservative in
    multidose vaccines
    at a concentration
    not exceeding
    0,02%
    No entry
    In addition to the above constituents the product contains the following excipients: lactose, cholesterol and
    phosphatidylcholine. These excipients are considered as not falling within the scope of Regulation (EC)
    No 470/2009.
    8
     
    ANNEX III
    LABELLING AND PACKAGE INSERT
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    Equilis Prequenza
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 1 ml:
    A/equine-1/Prague 56 (100 AU), A/equine-2/Newmarket/1/93 (50 AU), A/equine 2/Newmarket/2/93 (50
    AU).
    3.
    PHARMACEUTICAL FORM
    Suspension for injection
    4.
    PACKAGE SIZE
    1, 5 or 10x 1 dose
    5.
    TARGET SPECIES
    Horses
    6.
    INDICATION(S)
    Active immunisation of horses against equine influenza.
    7. METHODS AND ROUTE OF ADMINISTRATION
    i.m. use
    8.
    WITHDRAWAL PERIOD
    Zero days
    9.
    SPECIAL WARNINGS
    Read the package leaflet before use
    11
     
    10. EXPIRY DATE
    EXP {month/year}
    11. SPECIAL STORAGE CONDITIONS
    Store at 2-8 °C, protected from light. Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
    MATERIALS, IF ANY
    Read the package insert before use
    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.
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/05/056/001-004
    17. MANUFACTURER'S BATCH NUMBER
    Lot {number}
    12
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    Equilis Prequenza
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose
    4.
    ROUTE OF ADMINISTRATION
    i.m.
    5.
    WITHDRAWAL PERIOD
    Zero days
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {number}
    8.
    THE WORDS ‘FOR ANIMAL TREATMENT ONLY’
    For animal treatment only
    13
     
    B. PACKAGE LEAFLET
    14
    PACKAGE LEAFLET FOR:
    Equilis Prequenza, suspension for injection, for horses
    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
    NL-5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    Equilis Prequenza, suspension for injection, for horses
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
    Per dose of 1 ml:
    Active substance
    Purified haemagglutinin subunits from equine influenza viruses:
    A/equine-1/ Prague/1/ 56
    100 AU 2
    A/equine-2/ Newmarket/1/93
    50 AU
    A/equine-2/ Newmarket/2/93
    50 AU
    Adjuvant
    Purified saponin
    375 micrograms
    Cholesterol
    125 micrograms
    Phosphatidylcholine
    62.5 micrograms
    4.
    INDICATION(S)
    Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and
    virus excretion after infection.
    Influenza
    Onset of immunity: 2 weeks after the primary vaccination course
    Duration of immunity: 5 months after the primary vaccination course
    12 months after the first revaccination
    5.
    CONTRAINDICATIONS
    None
    2 Antigenic units
    15
     
    6.
    ADVERSE REACTIONS
    A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2
    days. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort
    (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1
    day, for up to 3 days in exceptional circumstances.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary
    surgeon.
    7.
    TARGET SPECIES
    Horses
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    1 ml. Intramuscular use
    Vaccination schedule:
    Primary vaccination course
    Administer one dose (1ml), by intramuscular injection, according to the following schedule:
    •
    Revaccination
    The first revaccination (third dose) is given 5 months after the primary vaccination course. This
    revaccination results in immunity to equine influenza lasting at least 12 months.
    The second revaccination is given 12 months after the first revaccination.
    The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains
    A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 and A/equi 2/Newmarket-2/93, is recommended to maintain
    immunity levels for the influenza component (see scheme).
    In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be
    given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6
    months of age and 4 weeks later).
    16
    Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Allow the vaccine to reach a temperature of 15°C - 25°C.
    Administer 1 ml of vaccine IM.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children. Store at 2-8°C, protected from light. Do not freeze.
    Do not use after the expiry date stated on the label.
    12. SPECIAL WARNING(S)
    Foals should not be vaccinated before the age of 6 months, especially when born to mares that were
    revaccinated in the last two months of gestation, because of possible interference by maternally derived
    antibodies.
    Only healthy animals should be vaccinated. In case of accidental self-injection, seek medical advice
    immediately and show this package insert or the label to the physician.
    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.
    Do not mix with any other veterinary medicinal product.
    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
    27/07/2010
    15. OTHER INFORMATION
    Cardboard box with 10 glass vials of 1 ml.
    Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
    Not all pack sizes may be marketed.
    17


    Source: European Medicines Agency


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