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Hiprabovis IBR Marker Live

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Summary for the public


What is Hiprabovis IBR Marker Live?

Hiprabovis IBR Marker Live is a vaccine. It is a powder for suspension for injection that contains a modified live infectious bovine rhinotracheitis (IBR) virus (also known as Bovine Herpes Virus type 1).


What is Hiprabovis IBR Marker Live used for?

Hiprabovis IBR Marker Live is used to vaccinate cattle (cows and calves) against the respiratory infections caused by IBR. The vaccine is used to reduce the clinical signs of IBR and the excretion (shedding) of the virus by the infected animals.
The vaccine is given to animals as two injections, three weeks apart, into the neck muscles. The first injection can be given to calves from three months of age. The injections should be preferably administered on the alternate sides of the neck. Afterward a single ‘booster’ can be given every six months to maintain the vaccine’s effect.


How does Hiprabovis IBR Marker Live work?

Hiprabovis IBR Marker Live is a vaccine that contains an IBR virus that has been genetically modified to delete two genes so that the virus is less ‘pathogenic’ (less able to cause a disease). The virus is alive, but it has also been attenuated (weakened) to further lower its ability to cause infection.

Hiprabovis IBR Marker Live is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Hiprabovis IBR Marker Live is given to cattle, the animals’ immune systems recognise the viruses as ‘foreign’ and make defences against it. In the future, if the animals are exposed to the IBR virus, the immune system will be able to respond more quickly. This will help to protect against the disease.


How has Hiprabovis IBR Marker Live been studied?

The safety of Hiprabovis IBR Marker Live was investigated in a number of laboratory studies and in one field trial that included dairy cows and fattening cattle. Studies also looked at the safety of the vaccine in pregnant animals.

The efficacy of the vaccine was studied in three laboratory studies including one study looking at the duration of immunity. A field study also looked at the efficacy of Hiprabovis IBR Marker Live, compared with a dummy vaccine, on reducing the clinical signs of the disease and virus excretion.


What benefit has Hiprabovis IBR Marker Live shown during the studies?

The studies showed that the vaccine is safe for cattle from three months of age and that it reduces the clinical signs of IBR and field virus excretion. The studies also showed that the vaccine can be used in pregnant cattle as well in the presence of maternally derived antibodies. This vaccine is a marker vaccine and can enable a differential testing of vaccinated and naturally infected cattle, which is a useful tool in eradication campaigns.


What is the risk associated with Hiprabovis IBR Marker Live?

After vaccination, animals may show a slight increase in body temperature up to 1° C, in the four days following vaccination. This increase can sometimes be higher (up to 1.6º C in adult cows and up to 2.2º C in calves). The rise in temperature is temporary and spontaneously resolved within two days without treatment. Animals can also show a temporary inflammation at the site of injection in the 72 hours after-vaccination. This slight swelling lasts for less than a day in most cases.


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

There are no specific risks for the user.


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.


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

Milk can be taken immediately.


Why has Hiprabovis IBR Marker Live been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Hiprabovis IBR Marker Live exceed the risks for the active immunisation of cattle from three months of age against Bovine Herpes Virus type 1 to reduce the clinical signs of infectious bovine IBR and field virus excretion and recommended that Hiprabovis IBR Marker Live be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.


Other information about Hiprabovis IBR Marker Live:

The European Commission granted a marketing authorisation valid throughout the European Union, for Hiprabovis IBR Marker Live to Laboratorios Hipra S.A. on 27 January 2011. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Hiprabovis IBR Marker Live
EMEA Product number: EMEA/V/C/000158
Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 106.3 – 107.3 CCID50.
INN or common name: A live gene-deleted vaccine for intramuscular use; active immunisation of cattle against IBR
Species: Cattle
ATCvet Code: QI02AD01
Marketing Authorisation Holder: Laboratorios HIPRA S.A
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 27/01/2011
Contact address:
Laboratorios HIPRA S.A
Avda. La Selva 135
17170 Amer (Girona)
Spain



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 2 ml contains:
    Lyophilisate:
    Active substance:
    Live gE - tk - double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 10 6.3 – 10 7.3
    CCID 50.
    Abbreviations:
    gE - : deleted glycoprotein E; tk - : deleted thymidine kinase; CCID: cell culture infectious dose
    Solvent:
    Phosphate buffer solution.
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    Lyophilisate: white to yellowish tablet.
    Solvent: transparent homogenous liquid.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cattle (calves and adult cows).
    4.2 Indications for use, specifying the target species
    For the active immunisation of cattle from 3 months of age against Bovine Herpes Virus type 1
    (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus
    excretion.
    Onset of immunity: 21 days after completion of the basic vaccination scheme.
    Duration of immunity: 6 months after completion of the basic vaccination scheme.
    4.3 Contraindications
    Do not use in case of hypersensitivity to the active substance or to any of the excipients.
    4.4 Special warnings
    None.
    2
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate healthy animals only.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    None.
    4.6 Adverse reactions (frequency and seriousness)
    A slight increase in body temperature up to 1° C is common within 4 days following vaccination.
    Occasionally, an increase in rectal temperature up to 1.63º C in adult cows and up to 2.18º C in calves
    may be observed. This transient rise in temperature is spontaneously resolved within 48 hours without
    treatment and it is not related to a febrile process.
    A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
    This slight swelling lasts for less than 24 hours in most cases.
    Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate
    symptomatic treatment should be administered.
    4.7 Use during pregnancy, lactation or lay
    Can be used during pregnancy and lactation.
    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
    Cattle: from the age of 3 months onwards.
    Reconstitute the lyophilised tablet with the entire contents of the enclosed solvent to obtain a
    suspension for injection.
    Recommended vaccination programme:
    The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. The
    animal should be revaccinated 3 weeks later with the same dose.
    Thereafter a single booster dose of 2 ml should be administered every six months.
    The method of administration is by intramuscular route, in the neck muscles. The injections should be
    preferably administered on the alternate sides of the neck. The solvent should be allowed to warm to a
    temperature between 15 ºC to 20ºC before reconstitution of the lyophilised tablet. Shake well before
    use. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles
    and syringes for administration.
    3
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No adverse reactions except those mentioned in section 4.6 were observed after the administration of a
    10-fold vaccine dose.
    4.11 Withdrawalperiod(s)
    Zero days.
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: live bovine vaccines against IBR, ATCvet code: QI02AD01.
    To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle. The vaccine
    contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE
    surface protein and the tk enzyme. The tk deletion is related to reduced viral neurotropism andreduced
    establishment of latency. The absence of the gene coding for the gE surface protein entails that the
    vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine). This enables
    discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus
    or vaccinated with conventional non-marker BoHV-1 vaccines. Diagnostic tools designed to detect gE
    antibodies should be suitable for this purpose. Animals exposed to gE surface protein will test positive
    (eg cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1
    vaccines) but unexposed animals will test negative (ie non-infected animals, including those
    vaccinated with Hiprabovis IBR Marker Live). Animals vaccinated with Hiprabovis IBR Marker live
    will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional
    non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of
    antibodies to any other BoHV-1 antigens.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Lyophilisate:
    Disodium phosphate dodecahydrate
    Potassium dihydrogen phosphate
    Gelatine
    Povidone
    Monosodium glutamate
    Sodium chloride
    Potassium chloride
    Sucrose
    Water for injections
    Solvent:
    Disodium phosphate dodecahydrate
    Potassium dihydrogen phosphate
    Sodium chloride
    Potassium chloride
    Water for injections
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the
    veterinary medicinal product.
    4
    6.3 Shelf life
    Shelf life of the lyophilisate as packaged for sale: 2 years.
    Shelf life of the solvent as packaged for sale: 2 years.
    Shelf life after reconstitution: 6 hours.
    6.4 Special precautions for storage
    Store and transport refrigerated (2° C - 8° C).
    Do not freeze.
    Keep the bottles in the outer carton in order to protect from light.
    6.5 Nature and composition of immediate packaging
    Lyophilisate: Colourless Type I glass bottle closed with a bromobutyl rubber closure and an
    aluminium cap.
    Solvent: Colourless Type I glass bottle (10 ml) or Type II glass bottle (50 ml) closed with a
    bromobutyl rubber closure and an aluminium cap.
    Package sizes:
    Cardboard box containing 1 bottle with 5 doses of lyophilised tablet and 1 bottle with 10 ml of solvent.
    Cardboard box containing 1 bottle with 25 doses lyophilised tablet and 1 bottle with 50 ml of solvent.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Laboratorios Hipra, S.A.
    Avda. La Selva, 135
    17170 Amer (Girona)
    SPAIN
    Tel. +34 972 43 06 60
    Fax. +34 972 43 06 61
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/114/001
    EU/2/10/114/002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    27/01/2011
    5
    10. DATE OF REVISION OF THE TEXT
    27/01/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu /.
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of this veterinary medicinal 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 of HIPRABOVIS ® IBR MARKER LIVE must
    consult the relevant Member State’s Competent Authority on the current vaccination policies prior to
    the import, sale, supply and/or use.
    6
    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
    7
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) of the biological active substance(s)
    Laboratorios Hipra, S.A.
    Avda. La Selva, 135
    17170 Amer (Girona)
    Spain
    Name and address of the manufacturer(s) responsible for batch release
    Laboratorios Hipra S.A.
    Avda. La Selva, 135
    17170 Amer (Girona)
    Spain
    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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    The active substance being a principle of biological origin intended to produce active immunity is not
    in the scope of Regulation (EC) 470/2009.
    The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the
    annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
    considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
    product.
    8
    E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
    AUTHORISATION HOLDER
    The applicant should perform a specific test on the Master Seed Virus (MSV) and on the Georgia
    Bovine Kidney (GBK) cell lines that would detect growth of Brucella abortus, within 6 to 9 months
    post-authorisation.
    9
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    10
    A. LABELLING
    11
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    CARDBOARD BOX
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each dose of 2 ml: Live gE - tk - double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain
    CEDDEL: 10 6.3 – 10 7.3 CCID 50.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    PACKAGE SIZE
    5 doses
    25 doses
    5.
    TARGET SPECIES
    Cattle (calves and adult cows).
    6.
    INDICATION(S)
    For the active immunisation of cattle from 3 months of age against Bovine Herpes Virus type 1
    (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus
    excretion.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Intramuscular use, in the neck muscles.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    12
     
    10. EXPIRY DATE
    EXP {month/year}
    Once reconstituted, use by 6 hours.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2 C- 8 C).
    Do not freeze.
    Keep the bottles in the outer carton in order to protect from light.
    12. SPECIAL 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 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
    Laboratorios Hipra, S.A.
    Avda. La Selva, 135
    17170 Amer (Girona)
    SPAIN
    Tel.+34 972 43 06 60
    Fax.+34 972 43 06 61
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/114/001
    EU/2/10/114/002
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    13
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    LABEL FOR THE LYOPHILISATE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection for cattle.
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Each dose of 2 ml: Live gE - tk - double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain
    CEDDEL: 10 6.3 – 10 7.3 CCID 50.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    5 doses
    25 doses
    4.
    ROUTE(S) OF ADMINISTRATION
    I.M.
    To be reconstituted with the enclosed solvent.
    5.
    WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    6.
    BATCH NUMBER
    Batch{number}
    7.
    EXPIRY DATE
    EXP {month/year}
    Once reconstituted, use by 6 hours.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    14
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    LABEL FOR THE SOLVENT
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Solvent for HIPRABOVIS IBR MARKER LIVE
    2.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    10 ml.
    50 ml
    3.
    ROUTE(S) OF ADMINISTRATION
    To be used for the reconstitution of the lyophilisate.
    4.
    WITHDRAWAL PERIOD
    Zero days
    5.
    BATCH NUMBER
    Batch {number}
    6.
    EXPIRY DATE
    EXP {month/year}
    Once reconstituted, use by 6 hours.
    7.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    15
     
    B. PACKAGE LEAFLET
    16
    PACKAGE LEAFLET
    HIPRABOVIS IBR MARKER LIVE
    Lyophilisate and solvent for suspension for injection for cattle.
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
    OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer :
    LABORATORIOS HIPRA, S.A.
    Avda. La Selva, 135
    17170 Amer (Girona)
    SPAIN
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Lyophilisate:
    Each dose of 2 ml contains: Live gE - tk - double-gene deleted Bovine Herpes Virus type 1 (BoHV-1),
    strain CEDDEL: 10 6.3 – 10 7.3 CCID 50.
    Abbreviations:
    gE - : deleted glycoprotein E; tk - : deleted thymidine kinase; CCID: cell culture
    infectious dose
    Solvent :
    Phosphate buffer solution.
    4.
    INDICATION(S)
    For the active immunisation of cattle from 3 months of age against Bovine Herpes Virus type 1
    (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus
    excretion.
    Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion
    (gE - ) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a
    conventional vaccine or infected with field virus.
    Onset of immunity: 21 days after completion of the basic vaccination scheme.
    Duration of immunity: 6 months after completion of the basic vaccination.
    5.
    CONTRAINDICATIONS
    Do not use in case of hypersensitivity to the active substance or to any of the excipients.
    17
    6.
    ADVERSE REACTIONS
    A slight increase in body temperature up to 1°C is common within 4 days following vaccination.
    Occasionally, an increase in rectal temperature up to 1.63ºC in adult cows and up to 2.18º C in calves
    may be observed. This transient rise in temperature is spontaneously resolved within 48 hours without
    treatment and it is not related to a febrile process.
    A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
    This slight swelling lasts for less than 24 hours in most cases.
    Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate
    symptomatic treatment should be administered.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Cattle (calves and adult cows).
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Cattle from the age of 3 months onwards: 2 ml/animal.
    Intramuscular use, in the neck muscles.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Reconstitute the lyophilised tablet with the entire contents of the enclosed solvent to obtain a
    suspension for injection.
    Recommended vaccination programme:
    The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. The
    animal should be revaccinated 3 weeks later with the same dose. Thereafter a single booster dose of
    2 ml should be administered every six months.
    The method of administration is by intramuscular route, in the neck muscles. The injections should be
    preferably administered on the alternate sides of the neck. The solvent should be allowed to warm to a
    temperature between 15 to 20 ºC before reconstitution of the lyophilised tablet. Shake well before use.
    Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and
    syringes for administration.
    10. WITHDRAWAL PERIOD
    Zero days.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (+2 C to +8 C). Do not freeze.
    Keep the bottles in the outer cartonin order to protect from light.
    18
    Do not use after the expiry date (EXP) stated on the carton and the label.
    Shelf-life after reconstitution according to directions: 6 hours.
    12. SPECIAL WARNING(S)
    - Can be used during pregnancy and lactation.
    - Vaccinate healthy animals only.
    - Apply the usual procedures for the handling of animals.
    - Apply the usual aseptic procedures.
    - 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.
    - No adverse reactions except those mentioned in section were observed after the administration of
    a 10-fold vaccine dose.
    - Do not mix with any other veterinary medicinal product, except the solvent supplied for use with
    the veterinary medicinal product.
    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 local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    27/01/2011
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    Pack sizes:
    5 doses (lyophilisate and solvent)
    25 doses (lyophilisate and solvent)
    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.
    Deutschland
    HIPRA DEUTSCHLAND GmbH
    Feldstrasse 21
    D-40479 Düsseldorf - DEUTSCHLAND
    Ελλάδα
    HIPRA EΛΛAΣ A.E.
    Ψuχάρη 3 / 184 53 Níκαια - ΕΛΛΑΣ
    Tηλ: 210 4978660 - Fax: 210 4978661
    19
     
    España
    LABORATORIOS HIPRA, S.A.
    Avda la Selva, 135
    17170 Amer (Girona)
    SPAIN
    Polska
    HIPRA POLSKA Sp.z.o.o.
    Ul. Królowej Marysienki, 9 - 1
    02-954 – WARSZAWA - POLSKA
    France
    HIPRA FRANCE
    1103 Avenue Jacques Cartier
    44800 - SAINT HERBLAIN - FRANCE
    Tél. - 02 51 80 77 91 Fax - 02 51 80 82 20
    Portugal
    ARBUSET, Produtos Farmacêuticos e Sanitários
    De Uso Animal, Lda
    Portela de Mafra e Fontaínha - Abrunheira
    2665 – 191 Malveira - PORTUGAL
    United Kingdom
    HIPRA UK, Ltd.
    Innovation Center, Office 503
    BioCity Nottingham
    Pennyfoot Street
    Nottingham
    NG1 1GF - UNITED KINGDOM
    e-mail: uk@hipra.com
    Italia
    HIPRA ITALIA, S.R.L.
    Via Franciacorta, 74
    25038, ROVATO (BS)
    ITALIA
    e-mail: italy@hipra.com
    20
     


    Source: European Medicines Agency


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