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Netvax

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Summary for the public


What is Netvax?

Netvax is a vaccine that contains a toxoid (a weakened toxin) from the bacterium Clostridium perfringens (C. perfringens) type A. The vaccine is an emulsion (a mixture of oil- and water-based liquids) for injection.


What is Netvax used for?

Netvax is used to vaccinate chickens against necrotic enteritis caused by C. perfringens type A, so that they pass their immunity against the disease on to their chicks. Necrotising enteritis is a disease that causes damage to the gut. Birds with the disease fail to thrive. Netvax is used to reduce the number of deaths, and the incidence and severity of the disease.

Netvax is given by injection into the breast muscle. The vaccination schedule consists of two doses: the first dose is given at 10 to 14 weeks of age, and then a second dose is given four to 10 weeks after the first. This second dose should be given at least six weeks before the hen will start to lay eggs. The hen can continue to pass on immunity to her chicks for almost a year after the end of vaccination.


How does Netvax work?

Netvax is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Netvax contains small amounts of a toxoid from C. perfringens type A. When it is given to a chicken, its immune system recognises the toxoid as ‘foreign’ and makes antibodies against it. The antibodies are transferred from the chicken to the chicks via the eggs. These antibodies help the chicks to fight necrotic enteritis caused by C. perfringens type A if they are exposed to the bacterium after they have hatched.

Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid. The vaccine also contains an ‘adjuvant’ (mineral oil) to stimulate a better response.


How has Netvax been studied?

The effectiveness of Netvax has been studied in several trials under laboratory and field conditions in chickens and their chicks. The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens’ blood and in their eggs. The studies compared chickens vaccinated with Netvax with birds that did not receive the vaccine. The studies also looked at death rates in the chicks hatched by vaccinated hens, and at the incidence and the severity of lesions caused by necrotic enteritis in the gut after the chicks were deliberately infected with the bacterium at three weeks of age.


What benefit has Netvax shown during the studies?

The studies showed that the vaccine is effective in stimulating the production of antibodies in chickens and in their eggs. The vaccine was well tolerated by the chickens, with no effect on the production of eggs or chicks.

In chicks hatched from vaccinated hens, the vaccine reduced the number of deaths, and the incidence and the severity of lesions caused by necrotic enteritis. The vaccine protected the chicks during the early period of life, when they are at greatest risk of the disease.


What is the risk associated with Netvax?

Vaccination causes swelling at the site of injection. Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.


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

This product contains mineral oil. Accidental injection of Netvax can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger. If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor. If pain persists for more than 12 hours after examination, seek medical advice again.


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

The withdrawal period is zero days.


Why has Netvax been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Netvax exceed the risks for the active immunisation of chickens, to provide passive immunisation against necrotic enteritis to their progeny, during the laying period, to reduce mortality and the incidence and severity of lesions caused by C. perfringens type A-induced necrotic enteritis. The CVMP recommended that Netvax should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Netvax

The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B.V. on 16 April 2009. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Netvax
EMEA Product number: EMEA/V/C/000134
Active substance: Clostridium perfringens Type A alpha toxoid
INN or common name: Adjuvanted vaccine against necrotic enteritis.of chickens due to C. perfringens
Species: Chicken
ATCvet Code: QI01AB08
Marketing Authorisation Holder: Intervet International BV
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 16/04/2009
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
    Netvax emulsion for injection for chickens
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    One dose (0.5ml) contains:
    Active substance:
    Clostridium perfringens Type A alpha toxoid Not less than 6.8 IU *
    Adjuvant
    Light Mineral Oil 0.31 ml
    Excipients
    Thiomersal 0.035-0.05 mg
    * International units per ml of rabbit serum determined by haemolysis inhibition assay
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    Off white oily emulsion.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Chickens
    4.2 Indications for use, specifying the target species
    For the active immunization of chickens to provide passive immunisation against necrotic enteritis to
    their progeny, during the laying period.
    To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type
    A induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three
    weeks after hatching.
    The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure
    The duration of passive transfer of immunity: 51 weeks following completion of the vaccination
    procedure
    4.3 Contraindications
    None
    2
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    None
    Special precautions for use in animals
    None
    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)
    No systemic reactions to vaccination were seen following intramuscular vaccination. Vaccination may
    result in moderate swelling of the breast tissue which will resolve within 30 days. Following the
    second vaccination swelling may persist for at least 35 days. Swelling was very common.
    4.7 Use during pregnancy, lactation or lay
    The vaccine is safe for use in laying and breeding birds.
    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
    Vaccinate chickens by the intramuscular route into the breast.
    One dose of 0.5 ml should be given at 10 to 14 weeks of age.
    A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination. The second
    dose should be administered no later than 6 weeks before the onset of lay.
    Shake well before use. Syringes and needles must be sterile before use. Follow usual aseptic
    procedures.
    3
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    After administration of a double dose, local reactions may increase slightly. (see section 4.6)..
    4.11 Withdrawalperiod(s)
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Immunologicals for aves, ATC vet code: QI01AB08
    To stimulate active immunity in chickens, in order to provide passive protection to the progeny against
    Clostridium perfringens Type A induced necrotic enteritis.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Light Mineral Oil
    Thiomersal
    Formaldehyde
    Sorbitan oleate
    Polysorbate 80
    Benzyl Alcohol
    Triethanolamine
    EDTA
    Sodium Chloride
    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: 18 months.
    Shelf-life after first opening the immediate packaging: Use Immediately
    6.4. Specialprecautionsforstorage
    Store and transport refrigerated (2ºC - 8°C). Do not freeze. Protect from light.
    6.5 Nature and composition of immediate packaging
    500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held
    in place with an aluminium seal with centre hole.
    Pack Sizes
    1 x 500ml
    6 x 500ml
    Not all pack sizes may be marketed
    4
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    5831AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/093/001
    EU/2/09/093/002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    16/04/2009
    10. DATE OF REVISION OF THE TEXT
    16/04/2009
    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)
    Schering-Plough Animal Health
    33 Whakatiki Street
    Upper Hutt
    New Zealand
    Name and address of the manufacturer responsible for batch release
    S-P Veterinary Ltd
    Breakspear Road South
    Harefield
    Uxbridge
    UB9 6LS
    United Kingdom
    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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    According to Article 71 of Directive 2001/82/EC 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 a national programme for the diagnosis, control and eradication of animal
    disease, 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.
    7
    D. STATEMENT OF THE MRLs
    Pharmacologically
    active substance(s)
    Animal species
    Other
    provisions
    Thiomersal
    All food producing species
    Annex II of Council Regulation (EEC)
    No. 2377/90
    EDTA
    All food producing species
    Annex II of Council Regulation (EEC)
    No. 2377/90
    Formaldehyde
    All food producing species
    Annex II of Council Regulation (EEC)
    No. 2377/90
    Mineral oil
    All food producing species
    Annex II of Council Regulation (EEC)
    No. 2377/90
    Benzyl alcohol
    All food producing species
    Annex II of Council Regulation (EEC)
    No. 2377/90
    Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council
    Regulation (EEC) No. 2377/90.
    8
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Netvax
    Emulsion for injection for chickens
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 0.5ml:
    Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU*
    Light mineral oil: 0.31 ml
    Thiomersal: 0.035-0.05 mg
    * International units per ml of rabbit serum determined by haemolysis inhibition assay
    3.
    PHARMACEUTICAL FORM
    4.
    PACKAGE SIZE
    1 x 500ml
    6 x 500ml
    5.
    TARGET SPECIES
    Chickens
    6.
    INDICATION(S)
    Vaccine against necrotic enteritis
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Intramuscular use.
    Shake well before use. Read the package leaflet before use
    8.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    11
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous – read package leaflet before use.
    10. EXPIRY DATE
    EXP month/year
    Once opened, use immediately
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2ºC- 8ºC). Do not freeze
    Protect from light
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Disposal: read 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.
    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.
    Wim de Körverstraat 35
    5831AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/093/001
    EU/2/09/093/002
    12
     
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    13
     
    MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
    Label
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Netvax
    Emulsion for injection for chickens
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 0.5ml:
    Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU*
    Light mineral oil: 0.31 ml
    Thiomersal: 0.035-0.05 mg
    * International units per ml of rabbit serum determined by haemolysis inhibition assay
    3.
    PHARMACEUTICAL FORM
    4.
    PACKAGE SIZE
    1 x 500ml
    6 x 500ml
    5.
    TARGET SPECIES
    Chickens
    6.
    INDICATION(S)
    Vaccine against necrotic enteritis
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Intramuscular use.
    Shake well before use. Read the package leaflet before use
    8.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days
    14
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous – read package leaflet before use.
    10. EXPIRY DATE
    EXP month/year
    Once opened, use immediately
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2ºC- 8ºC).
    Do not freeze
    Protect from light
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    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.
    Wim de Körverstraat 35
    5831AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/093/001
    EU/2/09/093/002
    15
     
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    16
     
    B. PACKAGE LEAFLET
    17
    PACKAGE LEAFLET FOR
    Netvax emulsion for injection for chickens
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder :
    Intervet International B.V.
    Wim de Körverstraat 35
    5831AN Boxmeer
    The Netherlands
    Manufacturer for the batch release :
    S-P Veterinary Ltd
    Breakspear Road South
    Harefield
    Uxbridge
    Middlesex, UB9 6LS
    United Kingdom
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Netvax emulsion for injection for chickens
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    One dose (0.5ml) contains:
    Active substance:
    Clostridium perfringens Type A alpha toxoid Not less than 6.8 IU *
    Adjuvant
    Light Mineral Oil
    0.31 ml
    Thiomersal
    0.035-0.05 mg
    * International units per ml of rabbit serum determined by haemolysis inhibition assay
    4.
    INDICATION(S)
    For the active immunization of chickens to provide passive immunisation against necrotic enteritis to
    their progeny, during the laying period.
    To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type
    A induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three
    weeks after hatching.
    18
    Excipients
    The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure
    The duration of passive transfer of immunity: 51 weeks following completion of the vaccination
    procedure
    5.
    CONTRAINDICATIONS
    None
    6.
    ADVERSE REACTIONS
    No systemic reactions to vaccination were seen following intramuscular vaccination. Vaccination may
    result in moderate swelling of the breast tissue which will resolve within 30 days. Following the
    second vaccination swelling may persist for at least 35 days. Swelling was very common.
    After administration of a double dose, local reactions may increase slightly.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Chickens
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Vaccinate chickens by the intramuscular route into the breast.
    One dose of 0.5 ml should be given at 10 to 14 weeks of age.
    A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination. The second
    dose should be administered no later than 6 weeks before the onset of lay.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Shake well before use.
    Syringes and needles must be sterile before use. Follow usual aseptic procedures.
    10. WITHDRAWAL PERIOD
    None
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2ºC- 8ºC). Do not freeze.
    Protect from light.
    Do not use after the expiry date stated on the carton.
    Shelf-life after first opening the immediate packaging:- Use immediately
    19
    12. SPECIAL WARNING(S)
    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.
    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.
    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 national requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    16/04/2009
    15. OTHER INFORMATION
    To stimulate active immunity in chickens, in order to provide passive protection to the progeny against
    Clostridium perfringens Type A induced necrotic enteritis.
    Pack sizes:
    1 x 500ml
    6 x 500ml
    Not all pack sizes may be marketed
    For any information about this veterinary medicinal product, please contact the local representative of
    the marketing authorisation holder.
    20


    Source: European Medicines Agency


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