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Suvaxyn Aujeszky 783 + O/W

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Summary for the public


What is Suvaxyn Aujeszky 783 + O/W?

Suvaxyn Aujeszky 783 + O/W is a vaccine that contains a live attenuated (weakened) form of Aujeszky’s disease virus strain NIA3-783. Suvaxyn Aujeszky 783 + O/W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.


What is Suvaxyn Aujeszky 783 + O/W used for?

Suvaxyn Aujeszky 783 + O/W is used to vaccinate pigs from the age of 10 weeks against Aujeszky’s disease, an illness similar to rabies that is caused by a herpesvirus. It prevents death and symptoms of the disease and reduces the shedding of the virus. Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/W can also result in immunity in the pig’s offspring.

Suvaxyn Aujeszky 783 + O/W is given as two 2-ml injections into the muscle of the neck behind the ear, three to four weeks apart. Immunity starts after three weeks and lasts for three months. Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth. Breeding boars (male pigs) should be revaccinated every six months. To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months.


How does Suvaxyn Aujeszky 783 + O/W work?

Suvaxyn Aujeszky 783 + O/W is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a diseases. Suvaxyn Aujeszky 783 + O/W contains small amounts of a weakened form of the virus that causes Aujeszky’s disease. The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker. The vaccine also contains ‘adjuvants’ (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.

When a pig is given the vaccine, the immune system recognises the weakened viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. This protects the pigs against the disease. The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk. This enables the piglets of vaccinated pigs to be protected against the disease.


How has Suvaxyn Aujeszky 783 + O/W been studied?

The effectiveness of Suvaxyn Aujeszky 783 + O/W has been studied in a large number of pigs in several farms in studies lasting around two years. The herds of pigs were monitored for signs of infection with the type of Aujeszky’s disease virus that is can be caught in the field.

The studies compared the levels of infection in vaccinated and unvaccinated pigs.


What benefit has Suvaxyn Aujeszky 783 + O/W shown during the studies?

Suvaxyn Aujeszky 783 + O/W was effective at preventing infection with the virus.

After vaccination, the number of pig herds with signs of infection fell significantly, as did the number of infected pigs within the herds. There was no change in the infection rates in the pigs that were not vaccinated.


What is the risk associated with Suvaxyn Aujeszky 783 + O/W?

In up to a half of pigs being vaccinated, a slight temporary reaction can occur at the site of injection. This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks. An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.


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

Wash and disinfect hands and equipment after use. Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger. In case of accidental injection, 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 Suvaxyn Aujeszky 783 + O/W been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/W exceed the risks for the active and passive immunisation of pigs to prevent or reduce the mortality and clinical signs of Aujeszky’s disease and to reduce the excretion of Aujeszky’s disease field virus, and recommended that Suvaxyn Aujeszky 783 O/W be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Suvaxyn Aujeszky 783 + O/W

The European Commission granted a marketing authorisation valid throughout the European Union for Suvaxyn Aujeszky 783 + O/W to Fort Dodge Animal Health Holland on 7 August 1998. The marketing authorisation was renewed on 7 August 2003. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Suvaxyn Aujeszky 783 + O/W
EMEA Product number: EMEA/V/C/000038
Active substance: Live attenuated Aujeszky's Disease Virus, strain NIA3-783
INN or common name: Adjuvanted live attenuated vaccine against aujeszky's disease in pigs
Species: Pigs
ATCvet Code: QI09AA01
Marketing Authorisation Holder: Fort Dodge Animal Health Holland
Revision: 8
Date of issue of Market Authorisation valid throughout the European Union: 07/08/1998
Contact address:
Fort Dodge Animal Health Holland
CJ van Houtenlaan 36
1381 CP Weesp
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Powder:
    Active substance(s)
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion
    *
    CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent:
    One dose of 2 ml contains
    Adjuvants :
    Aluminium hydroxide
    2.1 mg
    Mineral oil (Marcol 52)
    425
    µ
    l
    Mannide mono oleate (Arlacel A)
    46
    µ
    l
    Polysorbate 80 (Tween 80)
    17
    µ
    l
    Excipient
    Thiomersal
    0.15 mg
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Pigs
    4.2
    Indications for use, specifying the target species
    Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of
    Aujeszky’s Disease and to reduce the excretion of Aujeszky’s Disease field virus. Passive
    immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of
    Aujeszky’s Disease and to reduce the excretion of Aujeszky’s Disease field virus.
    - Active immunity: The onset of immunity is from 3 weeks after basic vaccination. The immunity lasts
    for 3 months after basic vaccination.
    4.3 Contraindications
    None
    4.4
    Special warnings for each target species
    None
    2
    4.5
    Special precautions for use
    Special precautions for use in animals
    Do not administer in conjunction with other medicinal products. Vaccinate only healthy animals. Each
    piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Wash and disinfect hands and equipment after use.
    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)
    Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after
    second vaccination may occur up to 50% of the pigs. In general these reactions disappear within 3
    weeks post primary vaccination. A transient increase in body temperature, up to about 40.5 o C and
    lasting for up to 2 days, may occur in a small number of pigs after vaccination.
    In very rare cases (<1/100000), hypersensitivity can be observed.
    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 compatibility of this vaccine with any other. Therefore the safety
    and efficacy of this product when used with any other (either used on the same day or at different
    times) has not been demonstrated.
    4.9
    Amounts to be administered and administration route
    For intramuscular use
    To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder. Shake gently to
    disolve the vaccine and transfer the disolved vaccine into the vial with the solvent.
    To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid
    component. Use sterile syringes and needles. Administer by intramuscular injection of 1 dose (2 ml)
    per pig in the neck in the area behind the ear.
    3
    Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
    •
    Inject one dose per fattening pig from the age of 10 weeks. A second dose may be injected 3 – 4
    weeks after the first injection. The presence of maternal antibodies against Aujeszky’s Disease
    Virus may have a negative influence on the result of vaccination.
    •
    Inject one dose per breeding pigs (gilts, sows and boars) from the age of 10 weeks followed by a
    second injection 3 – 4 weeks after the first injection.
    Re-vaccination of breeding pigs (gilts, sows and boars):
    •
    Inject one dose per gilt before the first mating, or
    •
    Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of
    farrowing.
    •
    Inject one dose per boar at least every 6 months.
    For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every
    4 months.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable
    effects have been observed.
    4.11 Withdrawal period
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    ATC vet code: QI 09 AD 01
    The active substance stimulates active immunity against Aujeszky’s Disease in pigs. By reconstitution
    of the immunogen in the oil emulsion, the stimulation of immunity after injection is prolonged.
    Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
    The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish
    between antibodies induced by vaccination with this product and those induced by field infection with
    Aujeszky’s Disease Virus, if the vaccine is used in association with an appropriate diagnostic test.
    Therefore, the product is suitable to be used in eradication programmes against Aujeszky’s Disease
    field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Aluminium hydroxide
    Mineral oil (Marcol 52)l
    Mannide mono oleate (Arlacel A)
    Polysorbate 80 (Tween 80)
    Thiomersal
    Disodiumhydrogenphosphate
    Sodiumhydrogenphosphate
    Mannitol
    Water for injections
    4
    6.2
    Incompatibilities
    Do not mix with any other vaccine or immunological product.
    6.3
    Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale (powder) : 2 years.
    Shelf-life of the veterinary medicinal product as packaged for sale (solvent) : 2 years.
    Shelf-life after reconstitution according to directions : 1 hour
    6.4
    Special precautions for storage
    Store and transport refrigerated (2°C – 8
    °
    C). Do not freeze.
    6.5
    Nature and composition of immediate packaging
    Cardboard box with 1 vial of powder and 1 bottle of solvent or 10 vials of powder and 10 bottles of
    solvent for injection
    Powder for emulsion for injection :
    7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder. The vials
    are closed with a butyl rubber stopper and sealed with an aluminium cap.
    Solvent for emulsion for injection :
    20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50-
    doses or 100-doses presentation. The bottles are closed with a butyl rubber stopper and sealed with an
    aluminium cap.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused medicinal product or waste materials, if
    any.
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved
    for use by the competent authorities.
    7. MARKETING AUTHORISATION HOLDER
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/001-006
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    07/08/1998
    22/08/2008
    5
    10
    DATE OF REVISION OF THE TEXT
    22.08.2008
    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 Suvaxyn Aujeszky 783 + OW 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 Suvaxyn Aujeszky 783 + OW 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
    7
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturers of the biological active substances
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    Name and address of the manufacturer(s) responsible for batch release
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    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
    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
    Annex II of Council Regulation (EEC) No 2377/90
    Pharmacologically active substance
    Animal Species
    Other provisions
    Aluminium hydroxide
    All food-producing
    species
    Disodiumhydrogenphosphate
    Mannitol
    Mineral oil
    Polysorbate 80
    Sodiumhydrogenphosphate
    Thiomersal
    8
    diseases, or will cause difficulties in certifying the absence of contamination in live animals or
     
    ANNEX III
    LABELLING AND PACKAGE INSERT
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 1 x 10 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent :
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    1 vial with powder for injection (10 doses) and 1 bottle of solvent for injection (20 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    11
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only
    Veterinary medicinal product subject to 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, see 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
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/001
    12
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    13
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 1 x 50 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder ::
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent:
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    1 vial with powder for injection (50 doses) and 1 bottle of solvent for injection (100 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    14
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    For animal treatment only
    Veterinary medicinal product subject to 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, see 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
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/002
    15
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    16
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 1 x 100 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent :
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    1 vial with powder for injection (100 doses) and 1 bottle of solvent for injection (200 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    17
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only
    Veterinary medicinal product subject to 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, see 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
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/003
    18
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    19
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 10 x 10 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent :
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection
    (each containing 20 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    20
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only
    Veterinary medicinal product subject to 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, see 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
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/004
    21
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    22
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 10 x 50 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent :
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection
    (each containing 100 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    23
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only
    Veterinary medicinal product subject to 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, see 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
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/005
    24
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    25
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (Carton label 10 x 100 doses)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent :
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    PACKAGE SIZE
    10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection
    (each containing 200 ml)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Active and passive immunisation of pigs against Aujeszky’s Disease.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use of 1 dose (2 ml) per pig
    8.
    WITHDRAWAL PERIOD
    Zero days
    26
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous - see package insert before use for further information and additional
    warnings.
    10.
    EXPIRY DATE
    EXP {month/year}
    Shelf life after reconstitution: Use within one hour
    11.
    SPECIAL STORAGE CONDITIONS
    Store (and transport) at 2ºC - 8ºC (in a refrigerator). Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS , IF ANY
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    13.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    Veterinary medicinal product subject to 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, see package leaflet for further
    information.
    14.
    THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” AND
    CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    Keep out of the reach and sight of children
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    16.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/98/009/006
    27
     
    17.
    MANUFACTURER’S BATCH NUMBER
    Batch: {number} for the powder:
    Batch: {number} for the solvent:
    28
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    (10 doses)
    A.
    Vials for the powder:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder for injection.
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Live attenuated Aujeszky’s Disease Virus
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    10 doses
    4.
    ROUTE(S) OF ADMINISTRATION
    For intramuscular use
    5.
    BATCH NUMBER
    Lot {number}
    6.
    EXPIRY DATE
    EXP {month/year}
    7.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    29
     
    B.
    Bottles for the solvent:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, solvent for injection.
    2.
    QUANTITY
    20 ml (10 doses)
    3.
    ROUTE OF ADMINISTRATION
    For intramuscular use
    4.
    BATCH NUMBER
    Lot {number}
    5.
    EXPIRY DATE
    EXP {month/year}
    Use within one hour after reconstitution
    6.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    7.
    SPECIAL WARNING(S)
    Accidental injection is dangerous – see package insert before use
    30
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    (50 doses)
    A.
    Vials for the powder:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder for injection
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Live attenuated Aujeszky’s Disease Virus
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    50 doses
    4.
    ROUTE(S) OF ADMINISTRATION
    For intramuscular use
    5.
    BATCH NUMBER
    Lot {number}
    6.
    EXPIRY DATE
    EXP {month/year}
    7.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    31
     
    B.
    Bottles for the solvent:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, solvent for injection
    2.
    QUANTITY
    100 ml (50 doses)
    3.
    ROUTE OF ADMINISTRATION
    For intramuscular use
    4.
    BATCH NUMBER
    Lot {number}
    5.
    EXPIRY DATE
    EXP {month/year}
    Use within one hour after reconstitution
    6.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    7.
    SPECIAL WARNING(S)
    Accidental injection is dangerous – see package insert before use
    32
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    (100 doses)
    A.
    Vials for the powder:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder for injection
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Live attenuated Aujeszky’s Disease Virus
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    100 doses
    4.
    ROUTE(S) OF ADMINISTRATION
    For intramuscular use
    5.
    BATCH NUMBER
    Lot {number}
    6.
    EXPIRY DATE
    EXP {month/year}
    7.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    33
     
    B.
    Bottles for the solvent:
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, solvent for injection
    2.
    QUANTITY
    200 ml (100 doses)
    3.
    ROUTE OF ADMINISTRATION
    For intramuscular use
    4.
    BATCH NUMBER
    Lot {number}
    5.
    EXPIRY DATE
    EXP {month/year}
    Use within one hour after reconstitution
    6.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    7.
    SPECIAL WARNING(S)
    Accidental injection is dangerous – see package insert before use
    34
     
    B. PACKAGE LEAFLET
    35
    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 :
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    Manufacturer for the batch release :
    Fort Dodge Animal Health Holland
    C.J. van Houtenlaan 36
    1381 CP Weesp
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection.
    3.
    STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
    Powder:
    Live attenuated Aujeszky’s Disease Virus, strain NIA 3 -783:
    ≥
    10 5.2 CCID 50 * per 2 ml dose of
    reconstituted emulsion.
    * CCID 50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
    Solvent:
    One dose of 2 ml contains:
    Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80
    (Tween 80), Thiomersal
    4.
    INDICATION(S)
    Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of
    Aujeszky’s Disease and to reduce the excretion of Aujeszky’s Disease field virus.
    Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs
    of Aujeszky’s Disease and to reduce the excretion of Aujeszky’s Disease field virus.
    - Active immunity: The onset of immunity is from 3 weeks after basic vaccination. The immunity lasts
    for 3 months after basic vaccination.
    5.
    CONTRAINDICATIONS
    None
    36
    6.
    ADVERSE REACTIONS
    Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after
    second vaccination may occur up to 50% of the pigs. In general these reactions disappear within 3
    weeks after the first vaccination. A transient increase in body temperature, up to about 40,5 o C and
    lasting for up to 2 days, may occur in a small number of pigs after vaccination.
    In very rare cases (<1/100000), hypersensitivity can be observed.
    If you notice any other side effects, please inform your veterinary surgeon.
    7.
    TARGET SPECIES
    Pigs
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    For intramuscular use
    One dose (2 ml) of reconstituted emulsion containing
    ≥
    10 5.2 CCID 50 of live attenuated Aujeszky’s
    Disease Virus strain NIA 3 -783 for each pig.
    Vaccination programme:
    Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
    •
    Inject one dose per fattening pig from the age of 10 weeks. A second dose may be injected 3 – 4
    weeks after the first injection. The presence of maternal antibodies against Aujeszky’s Disease
    Virus may have a negative influence on the result of vaccination.
    •
    Inject one dose per breeding pig (gilts, sows and boars) from the age of 10 weeks followed by a
    second injection 3 – 4 weeks after the first injection.
    Re-vaccination of breeding pigs (gilts, sows and boars):
    •
    Inject one dose per gilt before the first mating, or
    •
    Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of
    farrowing.
    •
    Inject one dose per boar at least every 6 months.
    For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every
    4 months.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder. Shake gently to
    disolve the vaccine and transfer the disolved vaccine into the vial with the solvent.
    To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid
    component. Use sterile syringes and needles. Administer by intramuscular injection of 1 dose (2 ml)
    per pig in the neck in the area behind the ear.
    Vaccinate only healthy animals. Each piglet of vaccinated gilts or sows should ingest a sufficient
    quantity of colostrum and milk.
    37
    10.
    WITHDRAWAL PERIOD
    Zero days
    11.
    SPECIAL STORAGE PRECAUTIONS
    C). Do not freeze.
    Do not use after the expiry date stated on the label.
    Shelf-life after reconstitution according to directions : 1 hour.
    °
    C – 8
    °
    12.
    SPECIAL WARNINGS
    The import, sale, supply and/or use of Suvaxyn Aujeszky 783 + OW 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 Suvaxyn Aujeszky 783 + OW has to consult the
    relevant Member States competent Authorities on the current vaccination policies prior to the import,
    sale, supply and/or use.
    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 used on the same day or at different
    times) has not been demonstrated.
    Wash and disinfect hands and equipment after use.
    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.
    13.
    SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
    WASTE MATERIALS , IF ANY
    Dispose of waste material 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
    22.08.2008
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.europa.eu /.
    38
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2
    15.
    OTHER INFORMATION
    For animal treatment only.
    The active substance stimulates active immunity against Aujeszky’s Disease in pigs. By reconstitution
    of the immunogen in the oil emulsion the stimulation of immunity after injection is prolonged.
    Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk. The
    presence of maternal antibodies against Aujeszky’s Disease Virus may have a negative influence on
    the result of vaccination.
    The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish
    between antibodies induced by vaccination with this product and those induced by field infection with
    Aujeszky’s Disease Virus, if the vaccine is used in association with an appropriate diagnostic test.
    Therefore, the product is suitable to be used in eradication programmes against Aujeszky’s Disease
    field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
    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.
    België/Belgique/Belgien
    Fort Dodge Animal Health Benelux B.V.
    Adenauerstrasse 20
    D-52146 Würselen
    Duitsland/Allemagne/Deutschland
    Tel/Tél: 0800 50327
    Luxemburg/Luxembourg
    Fort Dodge Animal Health Benelux B.V.
    Adenauerstrasse 20
    D-52146 Würselen
    Allemagne/Deutschland
    Tel: 0800 50327
    Република България
    ”СаниКо БЪЛГАРИЯ” ООД
    1408 – София, България
    бул. “Витоша” – 200, вх. “В”, ап. 51
    пощенски адрес: 1606 – София, България
    П.К. 237
    Teл: + 359 28514413
    Magyarország
    Cymedica Hungary Kft.
    Hr. Sz. 220/13
    H-2053 Herceghalom
    Tel.: + 36 305 652 187
    Česká republika
    Cymedica spol s.r.o.
    Pod Nádražím 853
    CZ-268 01 Hořovice
    Tel: + 420 311 545 011
    Malta
    Fort Dodge Animal Health
    Huizerstraatweg 117
    NL-1411 GM Naarden
    The Netherlands
    Tel: + 31 35 699 3365
    Danmark
    ScanVet Animal Health A/S
    66 Kongevejen
    DK 3480 - Fredensborg
    Tlf: + 45 48 48 43 17
    Nederland
    Fort Dodge Animal Health Benelux B.V.
    Adenauerstrasse 20
    D-52146 Würselen
    Duitsland
    Tel: 0800 4555554
    39
    Deutschland
    Fort Dodge Veterinär GmbH
    Adenauerstrasse 20
    D-52146 Würselen
    Tel: + 49 (0)2405 454 100
    Norge
    ScanVet informasjonskontor
    Kongsveien 91
    N-1177 Oslo
    Tlf: +47 22 76 72 50
    Eesti
    UAB Magnum Veterinarija
    Smelynes str. 2c
    LT-53143 Penevezys
    Leedu
    Tel: + 370 45 507 400
    Österreich
    Fort Dodge Veterinär GmbH
    Adenauerstr. 20
    D-52146 Würselen
    Tel: + 49 2405 454 100
    Ελλάδα
    ΛΑΠΑΦΑΡΜ Α.Ε.
    Μενάνδρου 73
    GR-10437 Αθήνα
    Τηλ: + 30 210 524.6011
    Polska
    ScanVet Poland Sp. z .o. o.
    Skiereszewo, ul. Kiszkowska 9
    62-200 Gniezno
    Tel.: +48 61 426 49 20
    España
    Fort Dodge Veterinaria S.A.
    Ctra. Camprodón s/n “La Riba”
    E -17813 Vall de Bianya – Girona
    Tel: + 34 91 598 1336
    Portugal
    Fort Dodge Veterinaria S.A.
    Ctra. Camprodón s/n “La Riba”
    E-17813 Vall de Bianya – Girona
    Espanha
    Tel: + 34 91 598 1336
    France
    Fort Dodge Santé Animale
    24, avenue Marcel Dassault – BP 440
    F-37204 Tours Cedex 3
    Tel: + 33 (0)2 47 74 89 89
    România
    Torox srl
    Otopeni, Str. Drumul Garii 30
    Judetul Ilfov, Romania
    Tel.: +40 21 300 17 80
    Ireland
    Fort Dodge Animal Health Limited
    Flanders Road
    Hedge End
    Southampton S030 4QH-UK
    Tel: + 44 1489 781 711
    Slovenija
    Vet4vet d.o.o.
    Gerbiceva 50a
    SI-1000 Ljubljana
    Tel: +386 1 2800672
    Ísland
    Vistor hf.
    Hörgatún 2
    210 Garðabær
    Sími: + 354 535 7000
    Slovenská republika
    Cymedica spol s.r.o.
    Pod Nádražím 853
    CZ-268 01 Hořovice
    Česká republika
    Tel: + 420 311 545 011
    Italia
    Fort Dodge Veterinaria S.p.A.
    Via Nettunense, 90
    I-04011 Aprilia (LT)
    Tel.: + 39 051 421 53 11
    Suomi/Finland
    ScanVet Eläinlääkkeet Oy
    Tyrvännöntie 769
    FIN-14610 Lepaa
    Puh/Tel: + 358 (0)3 630 3100
    40
    Κύπρος
    Premier Shukuroglou Ltd.
    Olympou str. 4
    CY-2234 Latsia
    Τηλ: + 357 22815353
    Sverige
    Ceva Vetpharma AB
    Annedalsvägen 9
    SE-227 64 Lund
    Tel: + 46 (0)46 12 81 00
    Latvija
    UAB Magnum Veterinarija
    Smelynes str. 2c
    LT-53143 Penevezys
    Lietuva
    Tel: + 370 45 507 400
    United Kingdom
    Fort Dodge Animal Health Limited
    Flanders Road
    Hedge End
    Southampton S030 4QH-UK
    Tel: + 44 (0)1489 781 711
    Lietuva
    UAB Magnum Veterinarija
    Smelynes str. 2c
    LT-53143 Penevezys
    Tel: + 370 45 507 400
    41


    Source: European Medicines Agency


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