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Nobivac Bb

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Summary for the public


What is Nobivac Bb?

Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.

Nobivac Bb is a dry substance and solvent that are made up into a suspension, which is given via the nose.


What is Nobivac Bb used for?

Nobivac Bb is used to vaccinate cats aged one month or older against the disease (a flu-like illness) caused by the bacterium B. bronchiseptica.

Cats are vaccinated by giving a 0.2-ml dose into one nostril. Immunity against infection is usually established after around three days and lasts for up to a year.


How does Nobivac Bb work?

Nobivac Bb is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2. When a cat is given the vaccine, the immune system recognises the bacteria as ‘foreign’ and makes a special type of antibodies against them. In the future, the immune system will be able to produce these antibodies more quickly when it is again exposed to the bacteria. The live bacterium strain included in Nobivac Bb differs from other types of B. bronchiseptica because it is missing certain molecules and is therefore less likely to cause disease. This makes it suitable for use in a vaccine. Vaccines against B. bronchiseptica that are administered through the nose are also used in dogs.


How has Nobivac Bb been studied?

The effectiveness of Nobivac Bb was investigated in three main studies involving cats of various breeds. The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica. Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.


What benefit has Nobivac Bb shown during the studies?

The main studies showed that Nobivac Bb was effective in reducing the symptoms caused by B. bronchiseptica.


What is the risk associated with Nobivac Bb?

Occasional side effects include sneezing, coughing and a mild and temporary discharge from the eyes or nose. In animals that show more severe signs, treatment with an antibiotic may be necessary.


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

The vaccine may be administered by veterinarians only. In case of accidental administration to people seek medical advice immediately and show the Package Leaflet or label to the doctor. Although the risk for people with weak immune systems becoming infected with B. bronchiseptica is extremely low, it is advised that cats which are in close contact with such people are not vaccinated with Nobivac Bb, since they can shed the bacteria intermittently for up to a year after vaccination.


Why has Nobivac Bb been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Bb exceed the risks of its use. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Nobivac Bb

The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B.V. on 10 September 2002. The marketing authorisation was renewed on 25 September 2007. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Nobivac Bb
EMEA Product number: EMEA/V/C/000068
Active substance: Live Bordetella bronchiseptica bacteria strain B-C2
INN or common name: Live vaccine against Bordetella bronchiseptica in cats
Species: Cats
ATCvet Code: QI06AE02
Marketing Authorisation Holder: Intervet International BV
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 10/09/2002
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
    Nobivac Bb for cats
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    10 8,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2, per 0.2 ml dose of
    reconstituted suspension.
    ≤
    Solvent
    Water for injections
    Excipients
    For a list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for nasal administration.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cats.
    4.2 Indications for use, specifying the target species
    For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella
    bronchiseptica associated upper respiratory tract disease.
    Onset of immunity : Onset of immunity was established in 8 week old cats as early as 72 hours after
    vaccination.
    Duration of immunity: The duration of immunity is up to 1 year.
    No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are
    available. From literature it is considered that this type of intranasal vaccine is able to induce an immune
    response without interference from maternally derived antibodies.
    4.3 Contra-indications
    None known.
    4.4 Special warnings for each target species
    If any antibiotic is administered within one week after vaccination, the vaccination should be repeated
    after the antibiotic treatment has been completed.
    Vaccinated animals can spread the Bordetella bronchispetica vaccine strain for six weeks; in individual
    cases for at least one year. Intermittent spreading is possible as well.
    2
    Active substance
    ≥
    10 6,3 and
    4.5 Special precaution(s) for use
    Special precautions for use in animals
    Only healthy cats should be vaccinated.
    Sneezing by cats after administration does not adversely affect the efficacy of the product.
    Do not administer during antibiotic treatment or in conjunction with any other intranasal products.
    Vaccinated animals can spread the vaccine strain of Bordetella bronchiseptica for six weeks, and there
    may be intermittent shedding for at least one year.
    Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica
    is extremely low, it is advised that cats, which are in close contact with immunocompromised humans
    are not vaccinated with this vaccine.
    Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory
    signs. Other animals, such as rabbits and small rodents, have not been tested.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-administration, seek medical advice immediately and show the package
    leaflet or the label to the physician.
    Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
    Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica
    is extremely low, such individuals should be aware that cats can shed the organism for up to 1 year
    after vaccination.
    4.6 Adverse reactions (frequency and seriousness)
    Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose. In animals,
    which show more severe signs, appropriate antibiotic treatment may be indicated.
    4.7 Use during pregnancy, lactation or lay
    Do not use in pregnant or lactating queens.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the safety and efficacy from the use of this vaccine with any other. It is
    therefore recommended that no other vaccine should be administered within 14 days before or after
    vaccination with the product.
    4.9 Amounts to be administered and administration route
    Vaccination scheme:
    One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
    C). Aseptically reconstitute the freeze-dried
    vaccine with 0.3 ml of the sterile solvent provided. Shake well after addition of the solvent. Withdraw
    0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole
    contents of the syringe into one of the cat’s nostrils.
    °
    3
    Allow the solvent to reach room temperature (15 - 25
    The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is
    forced to breathe through its nostrils. Place the syringe in front of one of the nostrils and carefully
    administer the whole contents of the syringe into the nasal cavity via this nostril. The vaccine is
    administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal
    cavity during inhalation.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose, particularly in very
    young susceptible kittens. In animals, which show more severe signs, appropriate antibiotic treatment
    may be indicated.
    4.11 Withdrawalperiod
    Not applicable.
    5.
    IMMUNOLOGICAL PROPERTIES
    To stimulate active immunity against Bordetella bronchiseptica.
    ATC vet code: QI 06AE02.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Gelatin, sorbitol, phosphate buffers.
    6.2 Incompatibilities
    In the absence of incompatibility studies, do not mix with any other product except the solvent
    supplied for use with the vaccine.
    6.3 Shelf-life
    5 years.
    After reconstitution the product should be used within 4 hours.
    6.4
    Special precautions for storage
    Store at 2 - 8
    °
    C. Protect from light.
    6.5 Nature and composition of immediate packaging
    One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and
    an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent.
    5 unit-dose vials of lyophilisate and 5 vials of solvent per carton.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Dispose of waste material that has had contact with the active substance by boiling, incineration or
    immersion in an appropriate disinfectant approved for use by the competent authorities.
    4
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    PO Box 31
    NL - 5830 AA Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/02/034/001
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    10-09-2002
    10. DATE OF REVISION OF THE TEXT
    25.09.2007
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA), http://www.emea.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Nobivac Bb for cats 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 Nobivac Bb for cats 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
    Manufacturer of the biological active substance
    Intervet Inc.
    21960 Intervet Lane,
    Delaware 19966, Millsboro
    U.S.A.
    Intervet Inc.
    275 South Lake Street,
    Minnesota 56187, Worthington
    U.S.A.
    Intervet International B.V.
    Wim de Körverstraat 35
    PO Box 31
    NL - 5830 AA Boxmeer
    The Netherlands
    Name and address of the manufacturer responsible for batch release
    Intervet International B.V.
    Wim de Körverstraat 35
    PO Box 31
    NL - 5830 AA Boxmeer
    The Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    According to Article 71 of Directive 2001/82/EEC 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
    b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
    absent from the territory.
    7
    in foodstuffs or other products obtained from treated animals.
    D. STATEMENT OF THE MRLs
    Not applicable
    8
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A.
    LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Carton label:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobivac Bb for cats
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per 0.2 ml dose of reconstituted suspension:
    ≥
    ≤
    10 8,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for nasal administration.
    4.
    PACKAGE SIZE
    5 unit-dose vials of lyophilisate and 5 vials of solvent.
    5.
    TARGET SPECIES
    Cats
    6.
    INDICATION
    Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica .
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    For nasal administration.
    Read the package leaflet before use for correct administration, disposal of waste materials and special
    warnings for immunecompromised humans.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use for correct administration, disposal of waste materials and special
    warnings for immunecompromised humans.
    11
    10 6,3 and
     
    10. EXPIRY DATE
    EXP {month/year}
    11. SPECIAL STORAGE CONDITIONS
    Store at 2 - 8°C. Protect from light.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use for correct administration, disposal of waste materials and special
    warnings for immunecompromised humans.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    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
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    PO Box 31
    NL - 5830 AA Boxmeer
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/02/034/001
    17. MANUFACTURER’S BATCH NUMBER
    Lot/Batch {number}
    12
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Label for the vaccine vial:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobivac Bb for cats
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    ≥
    10 6,3 and
    ≤
    10 8,3 CFU/dose B. bronchiseptica
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    1 dose.
    4.
    ROUTE(S) OF ADMINISTRATION
    Nasal administration.
    5.
    WITHDRAWAL PERIOD
    (not applicable - will not be mentioned)
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment
    13
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Label for the solvent vial:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Solvent for Nobivac Bb
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    1 dose
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    0.5 ml
    4.
    ROUTE OF ADMINISTRATION
    See package leaflet
    5.
    WITHDRAWAL PERIOD
    (not applicable - will not be mentioned)
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment
    14
     
    B.
    PACKAGE LEAFLET
    15
    PACKAGE LEAFLET
    Nobivac Bb for cats
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
    OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE, IF DIFFERENT
    Intervet International B.V.
    Wim de Körverstraat 35
    PO Box 31
    NL - 5830 AA Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobivac Bb for cats
    Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica .
    3.
    STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) AND OTHER
    INGREDIENT(S)
    10 8,3 CFU of live Bordetella bronchiseptica strain B-C2, per 0.2 ml dose of
    reconstituted suspension.
    ≥
    10 6,3 and
    ≤
    4.
    INDICATION(S)
    For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella
    bronchiseptica associated upper respiratory tract disease.
    The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
    The duration of immunity is up to 1 year.
    5.
    CONTRA-INDICATIONS
    Do not use in pregnant or lactating queens.
    6.
    ADVERSE REACTIONS
    Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose. After overdose,
    identical signs appear particularly in very young susceptible kittens. In animals, which show more
    severe signs, appropriate antibiotic treatment may be indicated.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    16
    Contains
    7.
    TARGET SPECIES
    Cats.
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
    For nasal administration.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    C). Aseptically reconstitute the freeze-dried
    vaccine with 0.3 ml of the sterile solvent provided. Shake well after addition of the solvent. Withdraw
    0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole
    contents of the syringe into one of the cat’s nostrils.
    °
    The head of the cat should be held with its nose pointing upward and its mouth closed, so that it is
    forced to breathe through its nostrils. Place the syringe in front of one of the nostrils and carefully
    administer the whole contents of the syringe into the nasal cavity via this nostril. The vaccine is
    administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal
    cavity during inhalation.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Store at 2 - 8
    °
    C. Protect from light.
    12. SPECIAL WARNINGS
    Only healthy cats should be vaccinated.
    Sneezing by cats after administration does not adversely affect the efficacy of the product.
    In the absence of incompatibility studies, do not mix with any other product except the solvent
    supplied for use with the vaccine.
    No information is available on the safety and efficacy from the use of this vaccine with any other. It is
    therefore recommended that no other vaccine should be administered within 14 days before or after
    vaccination with the product.
    Do not administer during antibiotic treatment, or in conjunction with any other intranasal product.
    If any antibiotic is administered within one week after vaccination, the vaccination should be repeated
    after the antibiotic treatment has been completed.
    Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks; in individual
    cases for at least one year. Intermittent spreading is possible as well.
    17
    Allow the solvent to reach room temperature (15 - 25
    Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica
    is extremely low, it is advised that cats that are in close contact with immunocompromised humans are
    not vaccinated with this vaccine. Such individuals should also be aware that cats can shed the
    organism for up to 1 year after vaccination.
    Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory
    signs. Other animals, such as rabbits and small rodents, have not been tested.
    Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
    In case of accidental self-administration seek medical advice immediately and show the package
    leaflet or the label to the physician.
    The import, sale, supply and/or use of Nobivac Bb for cats 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 Nobivac Bb for cats must consult the relevant Member
    State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or
    use.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material that has had contact with the active substance by boiling, incineration or
    immersion in an appropriate disinfectant approved for use by the competent authorities.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
    25.09.2007
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA), http://www.emea.europa.eu/ .
    15. OTHER INFORMATION
    For animal treatment only.
    Presentation:
    Carton box with 5 vials of freeze-dried vaccine and 5 vials of sterile solvent.
    18
    ANNEX IV
    GROUNDS FOR ONE ADDITIONAL RENEWAL
    The authorisation requires a further renewal for the following reasons:
    - Limited exposure due to limited marketing.
    19


    Source: European Medicines Agency


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