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Poulvac Flufend H5N3 RG

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Summary for the public


What is Poulvac FluFend H5N3 RG?

Poulvac FluFend H5N3 RG is a vaccine containing an inactivated avian influenza virus H5N3 (inactivated means that the virus has been killed so that it cannot cause the disease anymore).


What is Poulvac FluFend H5N3 RG used for?

Poulvac FluFend H5N3 RG is a vaccine used in chickens and ducks to protect against avian influenza. The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds. The vaccine is injected intramuscularly (into the breast muscle) in chickens or subcutaneously (under the skin) in ducks, as two doses, 3 weeks apart.

The vaccine will only be used as part of an approved national disease control programme. This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.


How does Poulvac FluFend H5N3 RG work?

Poulvac FluFend H5N3 RG is a vaccine. When it is given to birds, the animals’ immune systems (their natural defences) learn how to make antibodies (a special type of protein) to fight the virus. In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease.

The virus used for the vaccine is a recombinant virus. It has been made using a ‘recombinant DNA technique’ (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens. This kind of ‘reassortment’ between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties. Birds vaccinated with this vaccine make antibodies against these two chosen antigens. This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. Vaccinated birds can be differentiated from infected birds by looking for antibodies against the N3 component. This differentiation is important for disease surveillance and control.


How has Poulvac FluFend H5N3 RG been studied?
  • In chickens: Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen. The results of studies of a similar vaccine on chickens free of any infection (containing the same ingredients, except for the virus) were also looked at. A field trial was also carried out.
  • In ducks: Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen. No field trial is available for this target species. This is acceptable because of the current political and epidemiological situation in Europe with regard to avian influenza.

The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed.


What benefit has Poulvac FluFend H5N3 RG shown during the studies?
  • The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus.
  • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks.
  • If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.

What is the risk associated with Poulvac FluFend H5N3 RG?

In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.


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

The vaccine contains a mineral oil. The person who gives the vaccine should be careful to avoid accidental self injection.


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

Zero days.
The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.


Why has Poulvac FluFend H5N3 RG been approved?

The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be safe and to be effective in preventing disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection. Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Poulvac FluFend H5N3 RG has been authorised under “Exceptional Circumstances”. This means that it has yet not been possible to obtain complete information about Poulvac FluFend H5N3 RG. The European Medicines Agency (EMA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.


Other information about Poulvac FluFend H5N3 RG

The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG to Fort Dodge Animal Health on 01.09.2006.

Authorisation details
Name: Poulvac Flufend H5N3 RG
EMEA Product number: EMEA/V/C/000117
Active substance: Recombinant inactivated avian influenza virus
INN or common name: Recombinant inactivated avian influenza virus
Species: ChickenDucks
ATCvet Code: QI01AA23
Accelerated procedure: Accelerated procedures are intended to speed up access to new medicines of major public-health interest. Eligible products must either responds to unmet medical needs or constitute a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.
Exceptional Circumstances: There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.
Marketing Authorisation Holder: Fort Dodge Animal Health Limited
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 01/09/2006
Contact address:
Fort Dodge Animal Health
Flanders Road
Hedge End
Southampton
SO30 4QH
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    One dose of 0.5 ml contains:
    Active substance :
    Inactivated recombinant avian influenza virus
    of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
    Adjuvants:
    White Oil
    Sorbitan sesquioleate
    Polysorbate 80
    Excipients:
    Thiomersal
    Phosphate Buffer Saline
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Chickens and ducks.
    4.2 Indications for use, specifying the target species
    For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
    Chickens: Reduction of mortality and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in chickens has not been established yet.
    Ducks: Reduction of clinical signs and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in ducks : 14 weeks after the second injection.
    4.3 Contraindications
    None
    2
    4.4 Special warnings for each target species
    The level of efficacy attained may vary depending on the degree of antigenic homology between the
    vaccine strain and circulating field strains.
    No information is available on the interference of maternally derived antibodies on vaccination for
    both target species.
    4.5 Special precautions for use
    Special precautions for use in animals
    Avoid stress in the birds around the time of vaccination.
    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)
    A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted
    vaccines.
    4.7 Use during pregnancy, lactation or lay
    No information is available on the safety of this vaccine for birds in lay.
    4.8 Interactions 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
    Chickens
    3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks.
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Ducks
    At one day old: 0.2 ml subcutaneously in the neck.
    Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    3
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Following the administration of a double dose in chickens and ducks, no adverse reactions other than
    those described in section 4.6 have been observed.
    4.11 Withdrawalperiod
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code: QI01AA23
    To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype.
    To induce serological response against N3 neuraminidase which can act as a marker to Differentiate
    Infected from Vaccinated Animals (DIVA strategy).
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    White Oil
    Sorbitan sesquioleate
    Polysorbate 80
    Thiomersal
    Sodium chloride
    Sodium phosphate dibasic
    Potassium phosphate monobasic
    6.2. Incompatibilities
    Do not mix with any other medicinal product.
    6.3 Shelf life
    1 year.
    The entire content of the bottle should be used within 2 hours after broaching the container.
    6.4 Special precautions for storage
    Store and transport refrigerated (2° to 8°C).
    Store in the original container in order to protect from light.
    Do not freeze.
    6.5 Nature and composition of immediate packaging
    500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and
    aluminium cap.
    The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
    4
    6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
    material 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 the local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    8.
    MARKETING AUTHORISATION NUMBER
    EU/2/06/060/001-002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    01/09/2006
    10. DATE OF REVISION OF THE TEXT
    13/12/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Poulvac FluFend H5N3 RG 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 Poulvac FluFend H5N3 RG must consult the
    relevant Member States competent authority on the current vaccination policies prior to the import,
    sale, supply and/or use.
    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
    E.
    SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
    AUTHORISATION HOLDER
    6
    A. MANUFACTURERS 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)
    Pfizer Global Manufacturing Weesp
    CJ van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    Pfizer Animal Health
    2000 Rockford Road
    Charles City, Iowa 50616
    USA
    Name and address of the manufacturer responsible for batch release
    Pfizer Global Manufacturing Weesp
    CJ van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    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 the veterinary
    medicinal product 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 eradication 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.
    The use of this veterinary medicinal product is only allowed under the particular conditions
    established by European Community legislation on the control of Avian Influenza.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    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
    within the scope of Regulation (EC) No 470/2009.
    7
    The following constituents of Poulvac FluFend H5N3 RG 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
    Sodium
    chloride
    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 a
    preservative in
    multidose
    vaccines at a
    concentration
    not exceeding
    0,02 %.
    No entry
    White oil is a mineral hydrocarbon, Arlacel 83V is sorbitan sesquioleate, Tween 80 is polyoxyethylene
    sorbitan monooleate, sodium phosphate dibasic (E339) and potassium phosphate monobasic (E340)
    are substances with E numbers. These constituents of Poulvac FluFend H5N3 RG 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
    Mineral
    hydrocarbons,
    low to high
    viscosity
    including
    microcrystalline
    waxes,
    approximately
    C10-C60,
    aliphatic,
    branched
    aliphatic and
    alicyclic
    compounds
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    Excludes
    aromatic and
    unsaturated
    compounds
    No entry
    Sorbitan
    sesquioleate
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    No entry
    No entry
    Polyoxyethylen
    e sorbitan
    monooleate and
    trioleate
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    No entry
    No entry
    Food additives
    (substances
    with a valid E
    number
    approved as
    additives in
    Not
    applicable
    All food
    producing
    species
    No
    MRL
    required
    Not
    applicable
    Only
    substances
    approved as
    additives in
    foodstuffs for
    human
    No entry
    8
     
    Pharmaco-
    logically active
    substance
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other
    provisions
    Therapeutic
    classification
    foodstuffs for
    human
    consumption)
    consumption,
    with the
    exception of
    preservatives
    listed in part C
    of Annex III to
    European
    Parliament and
    Council
    Directive
    95/2/EC
    E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
    AUTHORISATION HOLDER
    The Marketing Authorisation Holder shall complete the following programme of studies, the results of
    which shall form the basis of the annual reassessment of the benefit/risk profile. More detailed
    information on the specific obligations is set out in the CVMP assessment report.
    QUALITY ASPECTS
    1) There are important outstanding issues regarding the differences of production and control
    between the manufacturing sites (including the nature of the eggs used) and the lack of a
    validation study for the potency test on finished product (it appears that final product tests are
    only done at Weesp but in-process tests such as titration and HA quantification need to be
    equivalent too). With regard to the differences in production and control, harmonization of the
    production process and the controls between both manufacturing site is strongly suggested. An
    alternative solution could be to retain only one production site. In particular, a rationalization of
    the nature of eggs used (taking into consideration the problem of the possible presence of
    extraneous agents in conventional eggs and the possibility to inactivate them during the
    inactivation process of the Influenza virus, supported by a corresponding validation study). The
    Applicant is asked to commit to take appropriate measures to harmonise the productions and/or
    to provide the adequate demonstrations/data to solve the issues.
    9
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    10
    A. LABELLING
    11
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    CARTON LABEL
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Poulvac FluFend H5N3 RG
    Emulsion for injection for chickens and ducks
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    One dose of 0.5 ml contains:
    Inactivated recombinant avian influenza virus
    of H5N3 subtype (strain rg-A/ck/VN/C58/04)
    > 1:40 HI Units
    Water in oil adjuvant
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    PACKAGE SIZE
    1 x 500 ml
    10 x 500 ml
    5.
    TARGET SPECIES
    Chickens and ducks
    6.
    INDICATIONS
    For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
    Chickens:
    Reduction of mortality and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in chickens has not been established yet.
    Ducks:
    Reduction of clinical signs and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in ducks: 14 weeks after the second injection.
    12
     
    7.
    METHOD AND ROUTES OF ADMINISTRATION
    Chickens
    3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks.
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Ducks
    At one day old: 0.2 ml subcutaneously in the neck.
    Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Read the package leaflet before use
    8.
    WITHDRAWAL PERIOD
    Withdrawal period - Zero days
    9.
    SPECIAL WARNINGS, IF NECESSARY
    Accidental injection is dangerous.
    10. EXPIRY DATE
    EXP (month/year)
    Once broached, use within 2 hours.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2° to 8°C).
    Store in the original container in order to protect from light.
    Do not freeze.
    12. SPECIFIC 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 the local requirements.
    13. THE WORDS ‘FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only
    The use of this veterinary medicinal product is only allowed under the particular conditions
    established by European Community legislation on the control of Avian Influenza.
    13
     
    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
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/06/060/001-002
    17. MANUFACTURER’S BATCH NUMBER
    Lot (Number)
    14
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
    BOTTLE LABEL
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Poulvac FluFend H5N3 RG
    Emulsion for injection for chickens and ducks
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    One dose of 0.5 ml contains:
    Inactivated recombinant avian influenza virus
    of H5N3 subtype (strain rg-A/ck/VN/C58/04) ) > 1:40 HI Units
    Water in oil adjuvant
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    PACKAGE SIZE
    500 ml
    5.
    TARGET SPECIES
    Chickens and ducks
    6.
    INDICATION
    For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
    Chickens :
    Reduction of mortality and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in chickens has not been established yet.
    Ducks :
    Reduction of clinical signs and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in ducks : 14 weeks after the second injection.
    15
     
    7.
    METHOD AND ROUTES OF ADMINISTRATION
    Chickens
    3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks.
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Ducks
    At one day old: 0.2 ml subcutaneously in the neck.
    Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Read the package leaflet before use
    8.
    WITHDRAWAL PERIOD
    Withdrawal period - Zero days
    9.
    SPECIAL WARNINGS, IF NECESSARY
    Accidental injection is dangerous.
    10. EXPIRY DATE
    EXP (month/year)
    Once broached, use within 2 hours.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2ºC - 8ºC). Keep in the original container in order to protect from
    light. Do not freeze.
    12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    For disposal read the package leaflet.
    13. THE WORDS ‘FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF
    RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
    For animal treatment only
    14. THE WORDS ‘KEEP OUT OF THE REACH AND SIGHT OF CHILDREN’
    Keep out of the reach and sight of children
    16
     
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    16. MARKETING AUTHORISATION NUMBER
    EU/2/06/060/001-002
    17. MANUFACTURER’S BATCH NUMBER
    Lot (Number)
    17
     
    B. PACKAGE LEAFLET
    18
    PACKAGE LEAFLET FOR:
    Poulvac FluFend H5N3 RG
    Emulsion for injection for chickens and ducks
    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:
    Pfizer Global Manufacturing Weesp
    CJ van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Poulvac FluFend H5N3 RG
    Emulsion for injection for chickens and ducks
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
    One dose of 0.5 ml contains:
    Active substance :
    Inactivated recombinant avian influenza virus
    of H5N3 subtype (strain rg-A/ck/VN/C58/04)
    > 1:40 HI Units
    Adjuvants:
    White Oil
    Sorbitan sesquioleate
    Polysorbate 80
    Excipients:
    Thiomersal
    Phosphate Buffer Saline
    4.
    INDICATIONS
    For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
    Chickens :
    Reduction of mortality and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in chickens has not been established yet.
    19
    Ducks:
    Reduction of clinical signs and virus excretion after challenge.
    Onset of immunity: 3 weeks after the second injection.
    Duration of immunity in ducks : 14 weeks after the second injection.
    5.
    CONTRAINDICATIONS
    None
    6.
    ADVERSE REACTIONS
    A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted
    vaccines.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Chickens and ducks
    8.
    DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
    Chickens
    3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks.
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    Ducks
    At one day old: 0.2 ml subcutaneously in the neck.
    Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck
    The vaccination schedule should be completed at least 4 weeks before the start of laying.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Do not mix with any other medicinal product.
    10. WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    11. SPECIAL STORAGE CONDITIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2ºC - 8ºC). Keep in the original container in order to protect from
    light. Do not freeze.
    The entire content of the bottle should be used within 2 hours after broaching the container.
    20
    12. SPECIAL WARNINGS
    The level of efficacy attained may vary depending on the degree of antigenic homology between the
    vaccine strain and circulating field strains.
    No information is available on the interference of maternally derived antibodies on vaccination for
    both target species.
    No information is available on the safety of this vaccine for birds in lay.
    For animal treatment only
    Avoid stress in the birds around the time of vaccination.
    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.
    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
    Following the administration of a double dose in chickens and ducks, no adverse reactions other than
    those described in section 6 have been observed.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
    help to protect the environment.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    13/12/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
    The use of this veterinary medicinal product is only allowed under the particular conditions
    established by European Community legislation on the control of Avian Influenza.
    21
    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
    22
    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
    23


    Source: European Medicines Agency


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