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Ibraxion

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Summary for the public


What is Ibraxion?

Ibraxion is an emulsion for injection. Each 2 ml dose of Ibraxion contains the active substance inactivated gene deleted Infectious Bovine Rhinotracheitis (IBR) virus. This deletion allows to differentiate vaccinated animals from infected animals allowing a better management of the disease.


What is Ibraxion used for?

Ibraxion is used to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion (virus that is passed out of the animal).

Ibraxion is shaken before use and injected subcutaneously (under the skin) into the neck at the front of the shoulder. Two injections are given 21 days apart in animals from the age of 2 weeks where there are no antibodies against IBR virus from the mother. If there are antibodies, the vaccine should be given from the age of 3 months. To revaccinate, a booster injection should be given at 6-month intervals. Immunity starts after 14 days and lasts for 6 months.


How does Ibraxion work?

Ibraxion contains a gene deleted IBR virus, which is inactivated. When injected, this exposure helps the calf’s immune system to recognise and fight the IBR virus. When exposed to IBR virus later in life, the calf will either not become infected or have a much less serious infection. Ibraxion is also intended to reduce the spread of the IBR virus by reducing the amount of virus excreted by the animals.


How has the effectiveness of Ibraxion been studied?

Ibraxion has been studied using the recommended dosing in all categories and age groups of animals.

The effect of antibodies passed on by the mother was also investigated. The protection given by Ibraxion was measured by the reduction of clinical signs of IBR after the virus was introduced to the cattle.


What benefit has Ibraxion shown during the studies?

The results of the trials showed that vaccination by Ibraxion of calves either not less than 3 to 4 months of age (if they have antibodies to IBR that have been passed on from their mother) or from 2-week of age (if they have no maternal antibodies). provided protection from IBR for six months. The studies also confirmed the effect of a booster injection at 15 months after the first vaccination (the booster for Ibrax is recommended every 6 months). Finally, it was shown that vaccination with Ibraxion did not induced antibodies against gE, allowing differentation between those animals and IBR infected ones.


What are the side effects of Ibraxion?

The injection of Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks. Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection. This does not affect the health or performance of the animal. Rarely, a hypersensitivity (allergic) reaction may occur, which requires treatment.


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

Ibraxion contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.


Why has Ibraxion been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Ibraxion are greater than any risks to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion. They recommended that Ibraxion should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Ibraxion:

The European Commission granted a marketing authorisation valid throughout the European Union, for Ibraxion to Merial on 9 March 2000. Information on the prescription status of this product may be found on the labelling.

Authorisation details
Name: Ibraxion
EMEA Product number: EMEA/V/C/000051
Active substance: inactivated IBR virus
INN or common name: Inactivated and adjuvanted vaccine against Bovine Rhinotracheitis
Species: Cattle
ATCvet Code: QI02AA03
Marketing Authorisation Holder: Merial
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 09/03/2000
Contact address:
Merial
29 avenue Tony Garnier
69007 Lyon
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibraxion emulsion for injection
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance
    Each dose of 2 ml contains:
    gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U*
    * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
    Adjuvant
    light paraffin oil .......................................................................................................... 449.6 to 488.2 mg
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cattle
    4.2 Indications for use, specifying the target species
    Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR)
    and field virus excretion.
    Onset of immunity: 14 days
    Duration of immunity : 6 months.
    4.3 Contraindications
    None
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate only healthy animals.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    2
    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)
    −
    The injection of the vaccine may cause a transient tissue reaction at the site of injection, which
    may persist for three weeks and rarely up to five weeks.
    −
    The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient
    period (less than 48 hours after injection) without any consequence to the health or
    performance of the animal.
    −
    A hypersensitivity reaction may occur. These are rare and an appropriate symptomatic
    treatment should be administered.
    4.7 Use during pregnancy, lactation or lay
    Ibraxion 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
    Shake well prior to use.
    Allow the vaccine to reach a temperature of 15°C-25°C.
    Use sterile syringes and needles
    Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder)
    according to the following regimen:
    The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may
    interfere with the vaccination and requires an appropriate vaccination regimen.
    Basic vaccination:
    two injections 21 days apart. For use in animals from the age of 2 weeks in
    the absence of maternally derived antibodies against IBR virus or from the
    age of 3 months in the presence of maternally derived antibodies.
    Revaccination:
    a booster injection should be administered at 6 month intervals.
    3
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No undesirable effects other than those mentioned in section 4.6 have been observed after the
    administration of an overdose.
    4.11 Withdrawalperiod(s)
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    ATCvet code: QI02AA03
    Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts
    by the active immunisation of cattle characterised by the production of Infectious Bovine
    Rhinotracheitis (IBR) vironeutralising antibodies.
    The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines
    (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals
    (positive to both IBR vironeutralising antibody and anti gE antibody). Ibraxion can therefore be used
    as a marker vaccine in association with an appropriate diagnostic test.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Light paraffin oil
    Benzyl alcohol
    Triethanolamine
    P olyoxyethylene oleate
    Polyoxyethylene oleic alcohol
    Potassium chloride,
    Sodium chloride,
    Potassium dihydrogen phosphate,
    Disodium phosphate dihydrate,
    Magnesium chloride,
    Calcium 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 broaching: 6 hours
    6.4. Special precautions for storage
    Store and transport refrigerated (2
    °
    C – 8
    °
    C),
    Protected from light.
    Do not freeze.
    4
    6.5 Nature and composition of immediate packaging
    Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap
    Cardboard box with 1 or 10 bottles of 5 doses
    Cardboard box with 1 or 10 bottles of 10 doses
    Cardboard box with 1 or 10 bottles of 25 doses
    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
    MERIAL
    29 avenue Tony Garnier
    F-69007 LYON
    FRANCE
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/99/017/001-006
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    Date of first authorisation: 09/03/2000
    Date of last renewal: 23/03/2010
    10. DATE OF REVISION OF THE TEXT
    23/03/2010
    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 the veterinary medicinal product 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
    Name and address of the manufacturer of the biological active substance(s)
    MERIAL
    Laboratoire Lyon Gerland
    254, Avenue Marcel Mérieux
    F-69007 LYON
    FRANCE
    Name and address of the manufacturer responsible for batch release
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l’Aviation
    F-69800 SAINT PRIEST
    FRANCE
    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 excipients listed in the table below are included in Annex II of Council Regulation (EC) No
    2377/90 in accordance with the information shown:
    Pharmacologically
    active substance
    Animal species
    Other provisions
    Light paraffin oil
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    Excludes aromatic and
    unsaturated compounds
    7
     
    Benzyl alcohol
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    For use as excipient
    Potassium chloride
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    Sodium chloride
    Annex II for all food producing
    species
    Potassium
    dihydrogen
    phosphate
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    Disodium phosphate
    dihydrate
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    Magnesium chloride
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    Calcium chloride
    Annex II of Council Regulation
    2377/90 for all food producing
    species
    At the doses used, triethanolamine, p olyoxyethylene oleate, p olyoxyethylene oleic alcohol and water
    for injections are all considered as not falling within the scope of Regulation (EC) No 470/2009.
    8
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    5 doses (10 ml)
    10 x 5 doses (10 x 10 ml)
    10 doses (20 ml)
    10 x 10 doses (10 x 20 ml)
    25 doses (50 ml)
    10 x 25 doses (10 x 50 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibraxion emulsion for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml:
    .gE deleted inactivated IBR virus, at least ............................................................................ 0.75 VN.U*
    .light paraffin oil ......................................................................................................... 449.6 to 488.2 mg
    * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4.
    PACKAGE SIZE
    5 doses (10 ml)
    10 x 5 doses (10 x 10 ml)
    10 doses (20 ml)
    10 x 10 doses (10 x 20 ml)
    25 doses (50 ml)
    10 x 25 doses (10 x 50 ml)
    5.
    TARGET SPECIES
    Cattle
    6.
    INDICATION(S)
    Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR)
    and field virus excretion.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    Subcutaneous use
    11
     
    8.
    WITHDRAWAL PERIOD
    Withdrawal period: zero days
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Accidental injection is dangerous – read package leaflet before use.
    10. EXPIRY DATE
    EXP {month/year}
    Once broached used by: 6 hours
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2
    °
    C – 8
    °
    C) ,
    Protected from light.
    Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use.
    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.
    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, read package leaflet for further
    information.
    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
    MERIAL
    29 avenue Tony Garnier
    F-69007 LYON
    France
    12
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/99/017/001 5 doses (10 ml)
    EU/2/99/017/004 10 x 5 doses (10 x 10 ml)
    EU/2/99/017/002 10 doses (20 ml)
    EU/2/99/017/005 10 x 10 doses (10 x 20 ml)
    EU/2/99/017/003 25 doses (50 ml)
    EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    13
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    5 doses (10 ml)
    10 doses (20 ml)
    25 doses (50 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibraxion emulsion for injection
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Per dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................. 0.75 VN.U*
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    5 doses (10 ml)
    10 doses (20 ml)
    25 doses (50 ml)
    4.
    ROUTE(S) OF ADMINISTRATION
    SC
    5.
    WITHDRAWAL PERIOD
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    Cattle
    Accidental injection is dangerous – see package leaflet before use.
    14
     
    B. PACKAGE LEAFLET
    15
    PACKAGE LEAFLET FOR
    Ibraxion emulsion for injection
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder
    MERIAL
    29 avenue Tony Garnier
    F-69007 LYON
    France
    Manufacturing for the batch release
    Merial
    Laboratoire Porte des Alpes
    Rue de l'Aviation
    F-69800 Saint Priest
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibraxion emulsion for injection
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
    Each dose (2 ml) contains:
    gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U*
    adjuvant: light paraffin oil ........................................................................................... 449.6 to 488.2 mg
    * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
    4.
    INDICATION(S)
    Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR)
    and field virus excretion.
    Onset of immunity: 14 days
    Duration of immunity: 6 months.
    5.
    CONTRAINDICATIONS
    None
    6.
    ADVERSE REACTIONS
    The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may
    persist for three weeks and rarely up to five weeks.
    The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient period (less
    than 48 hours after injection) without any consequence to the health or performance of the animal.
    16
    A hypersensitivity reaction may occur. These are rare and 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
    8.
    DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
    Shake well prior to use.
    Allow the vaccine to reach a temperature of 15 -25ºC.
    Use sterile syringes and needles.
    Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder),
    according to the following regimen:
    The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may
    interfere with the vaccination and requires an appropriate vaccination regimen.
    Basic vaccination:
    two injections 21 days apart. For use in animals from the age of 2 weeks in
    the absence of maternally derived antibodies against IBR virus or from the
    age of 3 months in the presence of maternally derived antibodies.
    Revaccination:
    a booster injection should be administered at 6 month intervals.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    See above.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children
    Store and transport refrigerated (2
    °
    C – 8
    °
    C),
    Protected from light.
    Do not freeze.
    Shelf life after first opening the container : 6 hours
    Do not use after the expiry date which is stated on the label.
    12. SPECIAL WARNING(S)
    Vaccinate only healthy 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.
    17
    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.
    Ibraxion can be used in during pregnancy and lactation.
    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 undesirable effects other than those mentioned in the “Adverse reactions” section have been
    observed after the administration of an overdose.
    Do not mix with any other 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
    23/03/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    http://www.ema.europa.eu/
    15. OTHER INFORMATION
    Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts
    by the active immunisation of cattle characterised by the production of Infectious Bovine
    Rhinotracheitis (IBR) vironeutralising antibodies.
    The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines
    (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals
    (positive to both IBR vironeutralising antibody and anti gE antibody). Ibraxion can therefore be used
    as a marker vaccine in association with an appropriate diagnostic test.
    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 the veterinary medicinal product must consult
    the relevant Member State’s Competent Authority on the current vaccination policies prior to the
    import, sale, supply and/or use.
    Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap
    18
    Cardboard box with 1 or 10 bottles of 5 doses
    Cardboard box with 1 or 10 bottles of 10 doses
    Cardboard box with 1 or 10 bottles of 25 doses
    Not all pack sizes may be marketed.
    19


    Source: European Medicines Agency


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