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Nobilis OR inac

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Summary for the public


What is Nobilis OR Inac?

Nobilis OR Inac is a vaccine that contains a suspension of the bacterium Ornithobacterium rhinotracheale serotype A, strain B3263/91. The bacterium has been inactivated (treated to make it unable to cause an illness). Nobilis OR Inac is an emulsion (a mixture of oil- and water-based liquids) for injection.


What is Nobilis OR Inac used for?

Nobilis OR Inac is used to vaccinate female chickens that are being used for breeding broilers (chickens bred for meat) against the bacterium O. rhinotracheale serotype A. This immunity is then passed on to the chickens’ offspring, so that the broilers are protected against infection with the same type of bacteria. Infection with O. rhinotracheale can cause respiratory diseases and death.

Nobilis OR Inac is given as two 0.25-ml injections, either under the skin in the neck or into the breast muscle. The first injection is given at an age of six to 12 weeks and the second at least six weeks later at an age of 14 to 18 weeks. Immunity is transferred to the chicken’s offspring for a period of 43 weeks after the last vaccination. In the broiler chicks, the immunity lasts until at least 14 days after hatching.


How does Nobilis OR Inac work?

Nobilis OR Inac is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Nobilis OR Inac contains small amounts of a killed bacterium called O. rhinotracheale serotype A, strain B3263/91. The vaccine also contains an ‘adjuvant’ (liquid paraffin) to stimulate a better response. When a breeder is given the vaccine, the immune system recognises the killed bacteria as ‘foreign’ and makes antibodies against them. These antibodies are then passed on to the breeder’s offspring through the eggs. The antibodies then protect the offspring against infection with this type of bacterium.


How has Nobilis OR Inac been studied?

The effectiveness of Nobilis OR Inac has been studied in two main studies that compared the effectiveness of Nobilis OR Inac with that of no vaccination. The studies looked at the levels of antibodies against O. rhinotracheale in the vaccinated breeders at four weeks after the second injection of the vaccine (22 weeks of age), and again at the end of the laying period (58 weeks of age). The studies also looked at the offspring (broilers).


What benefit has Nobilis OR Inac shown during the studies?

In the study, the levels of antibodies were higher in the vaccinated breeders than in those that did not receive the vaccine, both at 22 and at 58 weeks of age. The chicks of vaccinated breeders had lower death rates and produced more meat than those whose mothers had not been vaccinated.


What is the risk associated with Nobilis OR Inac?

Nobilis OR Inac can cause temporary swelling at the site of injection, as well as other sporadic reactions near the injection site and affecting the whole body.

Nobilis OR Inac should not be used in birds that are in lay (currently producing eggs).


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

Accidental injection of Nobilis OR Inac 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 Nobilis OR Inac been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis OR Inac exceed the risks for passive immunistaion of broilers induced by active immunisation of female broiler breeders to reduce infection with O. rhinotracheale serotype A when this agent is involved, and recommended that Nobilis OR Inac be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Nobilis OR Inac

The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis OR Inac to Intervet International on 24 January 2003. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Nobilis OR inac
EMEA Product number: EMEA/V/C/000062
Active substance: Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91
INN or common name: Adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A
Species: Chicken
ATCvet Code: QI01AB07
Marketing Authorisation Holder: Intervet International BV
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 24/01/2003
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
    Nobilis OR inac emulsion for injection for chickens
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of 0.25 ml:
    Active substance
    Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91 1 x
    10 7 cells *
    * inducing a mean titre in the chickens of the potency test of at least 11.2 (log 2 ).
    Adjuvant
    Light liquid paraffin:
    107.21 mg
    Excipients
    Traces of formaldehyde
    For a list of excipients, see section 6.1
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Chickens
    4.2 Indications for use, specifying the target species
    For passive immunisation of broilers induced by active immunisation of female broiler breeders to
    reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
    Under field conditions passive immunity is transferred during lay for 43 weeks after the last
    vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14
    days after hatching.
    4.3 Contraindications
    Do not use in birds in lay.
    4.4 Special warnings
    None
    2
    4.5 Special precautions for use
    Special precautions for use in animals
    Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
    Shake well before use.
    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 insert 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)
    In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of
    the birds for at least 14 days after subcutaneous vaccination. Under field conditions, sporadic local and
    systemic clinical reactions have been reported.
    4.7 Use during pregnancy, lactation or lay
    Do not use in birds in lay (see section 4.3).
    4.8 Interactions with other medicinal products and other forms of interaction
    No information is available on the compatibility of this vaccine with any other. Therefore the safety and
    efficacy of this product when used with any other (either when used on the same day or at different
    times) has not been demonstrated.
    4.9 Amounts to be administered and administration route
    The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in
    the neck or intramuscularly in the breast. The first injection can be administered at an age of 6 - 12 weeks.
    The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
    4.10 Overdose(symptoms,emergencyprocedures, antidotes), if necessary
    No other undesirable effects have been observed after administration of a double dose when compared
    with a single dose of vaccine.
    Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21
    days after vaccination.
    4.11 Withdrawalperiod
    Zero days.
    3
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Inactivated bacterial vaccine
    ATCvet code: QI 01AB07
    The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to
    the progeny against Ornithobacterium rhinotracheale serotype A .
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution
    6.2 Incompatibilities
    Do not mix with any other vaccine/immunological product.
    6.3 Shelf life
    15 months
    Shelf life after first opening: Use immediately after opening
    6.4 Special precautions for storage
    Store and transport at 2 - 8°C.
    Do not freeze.
    6.5 Nature and composition of immediate packaging
    Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000
    doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
    6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/02/036/001-002
    4
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    24/01/2003
    10.
    DATE OF REVISION OF THE TEXT
    10.01.2008
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of the product 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 the product 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
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    D.
    STATEMENT OF THE MRLs
    6
    REGARDING SUPPLY ORUSE
    WITH REGARD TO SAFE AND EFFECTIVE USE
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance
    Intervet International
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Name and address of the manufacturer responsible for batch release
    Intervet International
    Wim de Körverstraat 35
    5831 AN Boxmeer
    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.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    Not applicable
    D. STATEMENT OF THE MRLs
    •
    For the active principle of biological origin intended to produce immunity, Council Regulation
    (EEC) No 2377/90 does not apply.
    •
    The adjuvants and excipients listed are included in Annex II of Council Regulation (EEC) No
    2377/90.
    7
    Pharmacologically active substance Animal Species
    Other provisions
    Mineral hydrocarbons, low to high
    viscosity including microcristalline
    waxes, approximately C10-C60;
    aliphatic, branched aliphatic and
    alicyclic compounds.
    Excludes aromatic and
    unsaturated compounds
    All food producing species
    Polysorbate 80
    All food producing species
    Sodium chloride
    All food producing species
    •
    Sorbitan oleate (E 494), Potassium dihydrogen phosphate (E 340), Disodium hydrogen phosphate
    (E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human
    consumption and therefore covered by Annex II of Council Regulation (EEC) No. 2377/90 for
    substances with an E- number 1 (with the exception of preservatives listed in part C of Annex III
    to Council Directive 95/2/EC 2 .).
    1 OJ No L272 of 25.10.1996, p. 2
    2 OJ No L 61 of 18.3.1995, p. 1
    8
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobilis OR inac emulsion for injection for chickens
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 0.25 ml:
    Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91 1 x
    10 7 cells *
    * inducing a mean titre in the chickens of the potency test of at least 11.2 (log 2 ).
    Light liquid paraffin: 107.21 mg
    Traces of formaldehyde
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    PACKAGE SIZE
    1 PET vial with 250 ml (1000 doses)
    1 PET vial with 500 ml (2000 doses)
    5.
    TARGET SPECIES
    Chickens
    6.
    INDICATION(S)
    For passive immunisation of broilers induced by active immunisation of female broiler breeders to
    reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
    Under field conditions passive immunity is transferred during lay for 43 weeks after the last
    vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14
    days after hatching.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
    8.
    WITHDRAWAL PERIOD
    Zero days
    11
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Oil adjuvanted vaccine
    Do not use for birds in lay.
    Accidental injection is dangerous – see package insert before use.
    10. EXPIRY DATE
    EXP: (Month/Year) ……/…..
    Shelf life after first opening: Use immediately after opening
    11. SPECIAL STORAGE CONDITIONS
    Store and transport at 2 - 8°C. Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste material 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 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
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/02/036/001 (250 ml)
    EU/2/02/036/002 (500 ml)
    17. MANUFACTURER'S BATCH NUMBER
    Lot: ……
    12
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobilis OR inac emulsion for injection for chickens
    2.
    ACTIVE SUBSTANCE(S)
    Inactivated whole cell suspension of O. rhinotracheale
    Light liquid paraffin
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    250 ml (1000 doses)
    500 ml (2000 doses)
    4.
    TARGET SPECIES
    Chickens
    5.
    ROUTES OF ADMINISTRATION
    s.c. injection or i.m. injection of one dose of 0.25 ml.
    6.
    WITHDRAWAL PERIOD
    Withdrawal period: 0 days
    7.
    SPECIAL WARNINGS
    Do not use for birds in lay.
    Accidental self-injection is dangerous – see package insert
    8.
    EXPIRY DATE
    (Month/Year) ……/…..
    Once broached: Use immediately
    9.
    SPECIAL STORAGE CONDITIONS
    Store and transport at 2 - 8°C. Do not freeze.
    13
     
    10. THE WORDS "FOR ANIMAL TREATMENT ONLY"
    For animal treatment only.
    11. NAME OF THE MARKETING AUTHORISATION HOLDER AND OF THE
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA, IF DIFFERENT
    Intervet International
    12. MANUFACTURER'S BATCH NUMBER
    Batch: ……
    13. EU Number
    EU/2/02/036/001 (250 ml)
    EU/2/02/036/002 (500 ml)
    14
     
    B. PACKAGE LEAFLET
    15
    PACKAGE LEAFLET
    Nobilis OR inac emulsion for injection for chickens
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE IN THE EEA
    Marketing authorisation holder and manufacturer:
    Intervet International
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Nobilis OR inac emulsion for injection for chickens
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Per dose of 0.25 ml:
    Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91 1 x
    10 7 cells *
    * inducing a mean titre in the chickens of the potency test of at least 11.2 (log 2 ).
    Light liquid paraffin: 107.21 mg
    Traces of formaldehyde
    4.
    INDICATION(S)
    For passive immunisation of broilers induced by active immunisation of female broiler breeders to
    reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
    Under field conditions passive immunity is transferred during lay for 43 weeks after the last
    vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14
    days after hatching.
    5.
    CONTRAINDICATIONS
    Do not use for birds in lay
    6.
    ADVERSE REACTIONS
    In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of
    the birds for at least 14 days after subcutaneous vaccination. Under field conditions, sporadic local and
    systemic clinical reactions have been reported.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    16
    7.
    TARGET SPECIES
    Chickens
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Single dose of 0.25 ml.
    Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Allow the vaccine to reach room temperature (15-25°C) before using the vaccine. Shake well before use.
    Use sterile vaccination equipment.
    Vaccination scheme:
    The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in
    the neck or intramuscularly in the breast. The first injection can be administered at an age of 6 - 12
    weeks. The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport at 2 - 8°C.
    Do not freeze.
    Do not use after the expiry date stated on the label.
    12. SPECIAL WARNING(S)
    No information is available on the compatibility of this vaccine with any other. Therefore the safety and
    efficacy of this product when used with any other (either when used on the same day or at different times)
    has not been demonstrated.
    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 insert with you.
    If pain persists for more than 12 hours after medical examination, seek medical advice again.
    17
    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 other undesirable effects have been observed after administration of a double dose when compared
    with a single dose of vaccine.
    Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21
    days after vaccination.
    Do not mix with any other vaccine/immunological product.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
    product should be disposed of in accordance with the local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    10.01.2008
    15. OTHER INFORMATION
    For animal treatment only.
    The product contains the inactivated whole cells of Ornithobacterium rhinotracheale serotype A, strain
    B3263/91 mixed with an oil adjuvant. The vaccine is to stimulate active immunity in broiler breeders in
    order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A.
    18


    Source: European Medicines Agency


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