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Equilis Te

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Summary for the public


What is Equilis Te?

Equilis Te is a vaccine for use in horses. It contains the toxoid (chemically inactivated toxin) from the tetanus bacterium.

It is available as a suspension for injection.


What is Equilis Te used for?

Equilis Te is used to vaccinate horses from six months of age against tetanus to prevent mortality. Tetanus is an acute, often fatal disease caused by a neurotoxin produced by the bacterium Clostridium tetani. The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles. Horses belong to the most susceptible species to tetanus.

The vaccine is given as an injection into a muscle.

Horses should receive a primary vaccination, consisting of two injections given four weeks apart. To retain protection against tetanus, horses need to be revaccinated. The first revaccination should be no later than 17 months after primary vaccination. Afterwards, a maximum interval of two years is recommended.


How does Equilis Te work?

Equilis Te is a vaccine containing purified tetanus toxoid. The toxoid is a toxin processed in order to remove its toxic effect, but retain its antigenic properties.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. When the product is given to horses, it helps the animals’ immune system to react quicker when the animal is naturally exposed to the Clostridium tetani bacterium. This helps to protect against tetanus.

The vaccine also contains an ‘adjuvant’ to stimulate a better immune response.


How has Equilis Te been studied?

The safety of Equilis Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age. All studies were performed with Equilis Prequenza Te (comment: double; mentioned in next paragraph).

It was concluded that the product is well tolerated by horses of different age. Studies in pregnant mares were also performed. No negative influence on gestation, foaling and offspring of mares was observed after vaccination at different times during pregnancy.

The effectiveness of Equilis Te has been studied in several trials under laboratory and field conditions. Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus. For ethical reasons no challenge (infection) experiment was performed against tetanus. The main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.


What benefit has Equilis Te shown during the studies?

The studies showed that Equilis Te is an effective vaccine against tetanus to prevent mortality in horses from 6 months of age. Horses developed protection two weeks after primary vaccination. The duration of protection against tetanus was 17 months after primary vaccination and 24 months after the first revaccination.


What is the risk associated with Equilis Te?

Swelling (max. diameter 5 cm) may occur at the injection site, either as diffuse 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 Te been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Te exceeded the risks for the immunisation of horses from six months of age against tetanus to prevent mortality. The Committee recommended that Equilis Te should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Equilis Te

The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Te 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 Te
EMEA Product number: EMEA/V/C/000093
Active substance: tetanus toxoid
INN or common name: Adjuvanted vaccine against tetanus
Species: Horses
ATCvet Code: QI05AB03
Marketing Authorisation Holder: Intervet International BV
Revision: 4
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 VETERINARY THE MEDICINAL PRODUCT
    Equilis Te, suspension for injection, for horses
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of 1 ml:
    Active substance:
    Tetanus toxoid
    40 Lf 1
    Adjuvants:
    Purified Saponin
    375 µg
    Cholesterol
    125 µg
    Phosphatidylcholine
    62.5 µg
    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 tetanus to prevent mortality.
    Duration of immunity:
    17 months after the primary vaccination course
    24 months after the first revaccination
    4.3 Contraindications
    None
    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
    Special precautions for use in animals
    Only healthy animals should be vaccinated.
    1 Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur. potency test
    2
    Onset of immunity:
    2 weeks after the primary vaccination course
    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 leaflet 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, regressing within 2 days. Pain at the
    injection site can occur occasionally. In some cases fever 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
    Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
    same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
    No information is available on the safety and efficacy of this vaccine when used with any other
    veterinary medicinal product except the product mentioned above. 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
    Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
    Revaccination
    The first revaccination is given not later than 17 months after the primary vaccination course.
    Thereafter a maximum interval of two years is recommended (see scheme).
    V1
    V2
    5
    12
    V3
    24
    V4
    0
    1
    6
    18
    42 months
    Equilis Te Equilis Te
    Equilis Te
    Equilis Te
    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)
    Concurrent active and passive immunisation (emergency vaccination)
    The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that
    have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given
    concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate
    injection site, using separate syringes and needles. This will lead to a passive protection against tetanus
    3
    Administer one dose (1ml), by intramuscular injection, according to the following schedule:
    •
    V1
    V2
    V3
    V4
    5
    12
    24
    0
    1
    6
    18
    42 months
    Equilis Te Equilis Te
    Equilis Te
    Equilis Te
    for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be
    administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks
    later. Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against
    tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
    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 Withdrawal period
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    To stimulate active immunity against tetanus
    ATC-vet code: QI05AB03
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Lactose, phosphate buffer, chloride buffer, traces of formaldehyde
    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.
    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 with 10 pre-filled syringes with needles.
    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.
    4
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/05/055/001-002
    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)
    CSL Ltd.
    45 Poplar Road
    Parkville
    3052 Victoria
    Australia
    Novartis Vaccines and DIagnostics GmbH and Co.
    Emil-von-Behring-Str. 76
    35 041 Marburg
    Germany
    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 Te 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
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    Only substances
    approved as
    additives in
    foodstuffs for
    human
    No entry
    7
     
    Pharmaco-
    logically active
    substance
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other provisions Therapeutic
    classification
    additives with
    an E number
    (E339)
    consumption, with
    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
    Formaldehyde
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    No entry
    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 LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Equilis Te suspension for injection for horses
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tetanus toxoid 40 Lf/ml
    3.
    PHARMACEUTICAL FORM
    Suspension for injection.
    4.
    PACKAGE SIZE
    10 x 1 dose
    5.
    TARGET SPECIES
    Horses
    6.
    INDICATION(S)
    Active immunisation of horses against tetanus.
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    i.m. use
    8.
    WITHDRAWAL PERIOD
    Zero days
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read package leaflet before use.
    10. EXPIRY DATE
    EXP
    11
     
    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 package leaflet 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/2/05/055/001-002
    17. MANUFACTURER'S BATCH NUMBER
    Lot
    12
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Equilis Te
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    1 dose
    4.
    ROUTE(S) OF ADMINISTRATION
    i.m. injection
    5.
    WITHDRAWAL PERIOD
    Zero days
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    13
     
    B. PACKAGE LEAFLET
    14
    PACKAGE LEAFLET FOR
    Equilis Te, suspension for injection, for horses
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer:
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Equilis Te, suspension for injection, for horses
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Per dose of 1 ml:
    Active substance
    Tetanus toxoid
    40 Lf 1
    Adjuvant
    Purified Saponin
    375 µg
    Phosphatidylcholine
    62.5 µg
    4.
    INDICATION(S)
    Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
    Onset of immunity:
    2 weeks after the primary vaccination course
    Duration of immunity:
    17 months after the primary vaccination course
    24 months after the first revaccination
    5.
    CONTRAINDICATIONS
    None
    6.
    ADVERSE REACTIONS
    A diffuse hard or soft swelling (max. diameter 5 cm) may occur, regressing within 2 days. Pain at the
    injection site can occur occasionally. In some cases fever may occur for 1 day, and up to 3 days in
    exceptional circumstances.
    1 Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test
    15
    Cholesterol
    125 µg
    If you notice any other side effects, please inform your veterinary surgeon.
    7.
    TARGET SPECIES
    Horses
    8.
    DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
    1 ml
    Intramuscular use
    Vaccination schedule:
    Primary vaccination course
    Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
    Revaccination
    The first revaccination is given not later than 17 months after the primary vaccination course.
    Thereafter a maximum interval of two years is recommended (see scheme).
    V1
    V2
    5
    12
    V3
    24
    V4
    0
    1
    6
    18
    42 months
    Equilis Te Equilis Te
    Equilis Te
    Equilis Te
    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)
    Concurrent active and passive immunisation (emergency vaccination)
    The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that
    have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given
    concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate
    injection site, using separate syringes and needles. This will lead to a passive protection against tetanus
    for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be
    administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks
    later. Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity
    against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Allow the vaccine to reach room temperature of.
    Administer 1 ml of vaccine intramuscularly.
    10. WITHDRAWAL PERIOD
    Zero days
    16
    Administer one dose (1ml), by intramuscular injection, according to the following schedule:
    •
    V1
    V2
    V3
    V4
    5
    12
    24
    0
    1
    6
    18
    42 months
    Equilis Te Equilis Te
    Equilis Te
    Equilis Te
    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.
    Can be used during pregnancy and lactation.
    Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
    same day but not mixed with Tetanus Serum from Intervet (see section 8).
    No information is available on the safety and efficacy of this vaccine when used with any other
    veterinary medicinal product except the product mentioned above. 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
    Package sizes:
    Cardboard box with 10 glass vials of 1 ml.
    Cardboard box with 10 pre-filled syringes with needles.
    Not all pack sizes may be marketed.
    17


    Source: European Medicines Agency


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