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Duvaxyn WNV

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Summary for the public


What is Duvaxyn WNV?

Duvaxyn WNV is a vaccine containing an inactivated West Nile virus (inactivated means that the virus has been killed so that it cannot cause the disease any more).


What is Duvaxyn WNV used for?

Duvaxyn WNV is a vaccine used in horses to protect against West Nile virus disease. The vaccine reduces the number of viraemic horses (these are horses with virus circulating in their blood stream). The vaccine is injected intramuscularly (into a muscle) in the neck of the horse.


How does Duvaxyn WNV work?

Duvaxyn WNV is a vaccine. When it is given to horses, the animal’s immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. In the future, if the horses are exposed to the West Nile virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.


How has Duvaxyn WNV been studied?

The company carried out laboratory safety studies in both young foals (6 months of age) and pregnant mares using the vaccine. These showed the safety of the use of the vaccine in horses in general and in young (6 months of age or older) and pregnant animals in particular. They then performed a number of field trials which further confirmed the safety of Duvaxyn WNV and proved its efficacy in reducing the number of viraemic horses and thereby protecting against the disease.


What benefit has Duvaxyn WNV shown during the studies?
  • The results of the safety studies indicated that the product is safe for horses.
  • The vaccine has been shown to protect animals from the disease through a reduction of the number of viraemic horses.

What is the risk associated with Duvaxyn WNV?

A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days. It is sometimes associated with pain and mild depression. In some cases a higher temperature may occur for up to 2 days.


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

In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician. 


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

Zero days.


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

Zero days.


Why has Duvaxyn WNV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Duvaxyn WNV outweigh the risks for the treatment of West Nile virus disease in horses and recommended that Duvaxyn WNV be given a marketing authorisation.

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


Other information about Duvaxyn WNV

The European Commission granted a marketing authorisation valid throughout the European Union, for Duvaxyn WNV to MAH on 21.11.2008. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Duvaxyn WNV
EMEA Product number: EMEA/V/C/000137
Active substance: Inactivated West Nile Virus, strain VM-2
INN or common name: Adjuvanted vaccine against West Nile virus in horses
Species: Horses
ATCvet Code: QI05AA10
Marketing Authorisation Holder: Pfizer Limited
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 21/11/2008
Contact address:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Duvaxyn WNV emulsion for injection for horses
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 1 ml contains:
    Active substance:
    Inactivated West Nile Virus, strain VM-2
    RP* 1.0–2.2
    *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in
    horses.
    Adjuvant:
    MetaStim™ (SP Oil)
    0.05 ml
    For a full list of excipients, see section 6.1.
    3. PHARMACEUTICAL FORM
    Emulsion for injection.
    4. CLINICAL PARTICULARS
    4.1 TargetSpecies
    Horses
    4.2 Indications for use, specifying the target species
    For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by
    reducing the number of viraemic horses.
    Onset of immunity: 3 weeks after primary vaccination course.
    Duration of immunity: 12 months after primary vaccination course.
    4.3 Contraindications
    None
    4.4 Specialwarnings
    None
    4.5 Special precautions for use
    Special precautions for use in animals
    Only healthy animals should be vaccinated.
    2
    Vaccination may interfere with existing sero-epidemiological surveys. However, since the IgM
    response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of
    natural infection with West Nile Virus. If infection is suspected as a result of a positive IgM response,
    additional testing would need to be conducted to conclusively determine whether the animal was
    infected or vaccinated.
    No specific studies have been conducted to demonstrate absence of interferences from maternally
    derived antibodies on vaccine take. It is therefore recommended not to vaccinate foals of less than 6
    months of age.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately
    and show the package leaflet or label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    A small number of animals may show transient local reactions in the form of a mild, local swelling at
    the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to
    2 days. It is sometimes associated with pain and mild depression. In some cases hyperthermia may
    occur for up to 2 days.
    4.7 Use during pregnancy, lactation or lay
    Can be used during pregnancy and lactation.
    No specific efficacy studies were conducted in pregnant mares. As a consequence, it cannot be
    excluded that transient immunodepression that may be observed during pregnancy could interfere with
    vaccine uptake.
    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
    For intramuscular use.
    Administer one dose (1 ml), by deep intramuscular injection in the neck region, according to the
    following schedule:
    Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
    Revaccination: a sufficient degree of protection should be achieved after an annual
    booster injection with a single dose although this schedule has not been fully validated.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Following the administration of a double dose of vaccine, no adverse reactions other than those
    described under section 4.6 have been observed.
    4.11 Withdrawal period(s)
    Zero days.
    3
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Immunologicals for Equidae – Inactivated viral vaccines - West Nile
    Virus.
    ATCvet code: QI05AA10.
    The vaccine stimulates active immunity against West Nile Virus.
    6. PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Minimum Essential Medium (MEM)
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product.
    6.3 Shelflife
    Shelf life of the veterinary product as packaged for sale: 2 years.
    6.4 Special precautions for storage
    Store and transport refrigerated (+2°C to +8°C).
    Do not freeze.
    Protect from light.
    6.5 Nature and composition of immediate packaging
    Single-dose (1ml) polypropylene syringe closed with latex-free type I rubber tip.
    Box of 5 single-dose polypropylene syringes.
    Box of 10 single-dose polypropylene syringes.
    Box of 25 single-dose polypropylene syringes.
    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
    product should be disposed of in accordance with local requirements
    7. MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    4
    8. MARKETING AUTHORISATION NUMBERS
    EU/2/08/086/001
    EU/2/08/086/002
    EU/2/08/086/003
    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    21.11.2008
    10. DATE OF THE REVISION OF THE TEXT
    13.01.2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Duvaxyn WNV is or may be prohibited in certain Member
    States on the whole or part of their territory pursuant to national animal health policy. Any person
    intending to import, sell, supply and/or use Duvaxyn WNV must consult the relevant Member State’s
    competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
    5
    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
    6
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the active substance:
    Boehringer Ingelheim
    Vetmedica, Inc.
    141 East Riverside Drive
    Fort Dodge, Iowa 50501
    USA
    Name and address of the manufacturer responsible for batch release :
    Elanco Animal Health Ireland Limited
    Finisklin Industrial Estate
    Sligo
    Ireland
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETINGAUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
    amended, Member States prohibit or may prohibit the import, sale, supply and/or use of Duvaxyn
    WNV on the whole or part of their territory if it is established that:
    a) the administration of the veterinary medicinal product to animals will interfere with the
    implementation of national programmes for the diagnosis, control and elimination of animal diseases,
    or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or
    other products obtained from treated animals.
    b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
    absent from the territory.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    Not applicable.
    D. STATEMENT OF THE MRLs
    The following constituents of Duvaxyn WNV emulsion for injection for horses 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
    Pluronic L121
    (poloxamer)
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry No entry
    Polysorbate 80
    (Polyoxyethylene
    sorbitan
    monooleate)
    Not
    applicable
    All food
    producing
    species
    No MRL
    required
    Not
    applicable
    No entry No entry
    7
     
    In addition to the above constituents the product contains the following excipients: Squalane. These
    excipients are considered as not falling within the scope of Regulation (EC) No 470/2009 at the doses
    at which they will be administered.
    8
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Box of 5, 10, 25 single-dose polypropylene syringes
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Duvaxyn WVN emulsion for injection for horses
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each dose of 1 ml contains:
    Active substance:
    Inactivated West Nile Virus, strain VM-2 RP* 1.0–2.2
    *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in
    horses.
    Adjuvant:
    MetaStim™ (SP Oil)
    0.05 ml.
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    PACKAGE SIZE
    1x 5 single-dose syringes
    1x 10 single-dose syringes
    1x 25 single-dose syringes
    5.
    TARGET SPECIES
    Horses
    6.
    INDICATION(S)
    For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by
    reducing the number of viraemic horses.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use.
    Read the package leaflet before use.
    11
     
    8.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    10. EXPIRY DATE
    EXP {month/year}
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (+2 °C to +8 °C).
    Do not freeze.
    Protect from light.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Disposal: read the package leaflet.
    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.
    The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
    certain Member States on the whole or part of their territory, see package leaflet for further
    information.
    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
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    12
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/086/001
    EU/2/08/086/002
    EU/2/08/086/003
    17. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    13
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Single dose syringe
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Duvaxyn WVN emulsion for injection for horses
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Inactivated West Nile Virus, strain VM-2 (RP = 1.0–2.2).
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    For intramuscular use.
    5.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    14
     
    B. PACKAGE LEAFLET
    15
    PACKAGE LEAFLET FOR
    Duvaxyn WNV emulsion 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 :
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    Manufacturer for the batch release :
    Elanco Animal Health Ireland Limited
    Finisklin Industrial Estate
    Sligo, Ireland
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Duvaxyn WNV emulsion for injection for horses
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each dose of 1 ml contains:
    Active substance:
    Inactivated West Nile Virus, strain VM-2 RP* 1.0–2.2
    *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in
    horses.
    Adjuvant:
    MetaStim™ (SP Oil)
    0.05 ml.
    4. INDICATION(S)
    For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by
    reducing the number of viraemic horses.
    Onset of immunity: 3 weeks after primary vaccination course.
    Duration of immunity: 12 months after primary vaccination course.
    5. CONTRAINDICATIONS
    None.
    16
    6.
    ADVERSE REACTIONS
    A small number of animals may show transient local reactions in the form of a mild, local swelling at
    the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to
    2 days. It is sometimes associated with pain and mild depression. In some cases hyperthermia may
    occur for up to 2 days.
    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
    For intramuscular use.
    Administer one dose (1 ml), by deep intramuscular injection in the neck region, according to the
    following schedule:
    Primary vaccination course: first injection from 6 months of age, second injection 3–5 weeks later.
    Revaccination: a sufficient degree of protection should be achieved after an annual booster
    injection with a single dose although this schedule has not been fully validated.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Not applicable.
    10. WITHDRAWAL PERIOD
    Zero days.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (+2 °C to +8 °C).
    Do not freeze.
    Protect from light.
    12. SPECIAL WARNING(S)
    Only healthy animals should be vaccinated.
    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.
    The use of Duvaxyn WNV reduces the number of animals with viraemia after natural infection, but
    may not systematically prevent it.
    17
    Special precautions for use in animals
    Vaccination may interfere with existing sero-epidemiological surveys. However, since the IgM
    response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of
    natural infection with West Nile Virus. If infection is suspected as a result of a positive IgM response,
    additional testing would need to be conducted to conclusively determine whether the animal was
    infected or vaccinated.
    No specific studies have been conducted to demonstrate absence of interferences from maternally
    derived antibodies on vaccine take. It is therefore recommended not to vaccinate foals of less than 6
    months of age.
    The vaccine can be used during pregnancy and lactation. However, no specific efficacy studies were
    conducted in pregnant mares. As a consequence, it cannot be excluded that transient
    immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately
    and show the package leaflet or label to the physician.
    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
    product should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    13.01.2011
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    For animal treatment only – to be supplied only on veterinary prescription.
    Box of 5 single-dose polypropylene syringes.
    Box of 10 single-dose polypropylene syringes.
    Box of 25 single-dose polypropylene syringes.
    Not all pack sizes may be marketed.
    The import, sale, supply and/or use of Duvaxyn WNV is or may be prohibited in certain Member
    States on the whole or part of their territory pursuant to national animal health policy. Any person
    intending to import, sell, supply and/or use Duvaxyn WNV must consult the relevant Member State’s
    competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
    For any information about this veterinary medicinal product, please contact the local representative of
    the marketing authorisation holder.
    18
    België/Belgique/Belgien
    Pfizer Animal Health s.a.,
    Tél.: +32 (0)2 554 62 11
    Luxembourg
    Pfizer Animal Health s.a.,
    Tél.: + 32 (0)2 554 62 11
    Република България
    Pfizer Luxembourg SARL
    Tel: + 359 2 970 41 71
    Magyarország
    Pfizer Kft.
    Tel: +361 488 3695
    Česká Republika
    Pfizer Animal Health
    Tel: +420 283 004 111
    Malta
    Agrimed Limited
    Tel: +356 21 465 797
    Danmark
    Pfizer Oy Animal Health,
    Tlf: +358 (0)9 4300 40
    Nederland
    Pfizer Animal Health B.V.,
    Tel: +31 (0)10 4064 600
    Deutschland
    Pfizer GmbH
    Tel: +49 30-5500 5501
    Norge
    Pfizer Oy Animal Health,
    Tlf: +358 (0)9 4300 40
    Eesti
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    Österreich
    Pfizer Corporation Austria Ges.m.b.H.
    Tel: +43 (0)1 52 11 57 20
    Ελλάδα
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Polska
    Pfizer Trading Polska Sp. z.o.o.
    Tel: +48 22 335 62 00
    España
    Pfizer S.A.
    Tel: +34 91 4909900
    Portugal
    Laboratórios Pfizer, Lda.
    Tel: +351 21 423 55 00
    France
    Pfizer
    Tél: +33 (0)1 58 07 46 00
    Romania
    Pfizer Romania SRL
    Tel: + 0040 21 207 28 93
    Ireland
    Pfizer Healthcare Ireland, Trading As:
    Pfizer Animal Health
    Tel: +353 (0) 1 467 6500
    Slovenija
    Pfizer Luxembourg SARL
    Tel: +386 (0) 1 52 11 670
    Ìsland
    Pfizer Oy Animal Health,
    Tel: +358 (0)9 4300 40
    Slovenská Republika
    Pfizer Luxembourg SARL o.z.
    Tel: + 421 2 3355 5500
    Italia
    Pfizer Italia S.r.l.,
    Tel: +39 06 3318 2933
    Suomi/Finland
    Pfizer Oy Animal Health,
    Puh/Tel: +358 (0)9 4300 40
    Kύπρος
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Sverige
    Pfizer Oy Animal Health,
    Tel: +358 (0)9 4300 40
    Latvija
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    United Kingdom
    Pfizer Ltd
    Tel: +44 (0) 1304 616161
    Lietuva
    Pfizer Animal Health
    Tel.: +370 5 269 17 96
    19


    Source: European Medicines Agency


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