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Rabigen SAG2
live vaccine against rabies


PACKAGE LEAFLET


Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE


    VIRBAC S.A.

    1ère Avenue 2065m L.I.D. 06516 Carros

    France


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Active substance:

    Live attenuated rabies virus, SAG2 strain 8 log10 CCID50*/dose


    * CCID50: Cell Culture Infective Dose 50%


    Excipients:

    Palatable matrix (bait) containing a tetracycline biomarker


  4. INDICATION


    For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus. The duration of protection is of at least 6 months.


  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS


    No adverse events have been reported in the target species.

    As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally

    ingested the bait.

    Vomiting due to gastric intolerance (potentially due to the aluminium/PVC sachet as part of the bait vaccine), in dogs which have accidentally ingested the bait, has been reported.


  7. TARGET SPECIES


    Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).

  8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION


    The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.


    The baits are distributed by land or by air within the framework of vaccination campaigns against rabies. They are intended to be eaten by foxes / raccoon dogs.

    The distribution rate depends on the topography and on the population of the target species. This minimum distribution rate is:

    • 13 baits per square km over the areas where fox / raccoon dog density indexes were equal or

      less than 3 foxes / raccoon dogs seen per 10 km.

    • 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3 foxes / raccoon dogs seen per 10 km.


  9. ADVICE ON CORRECT ADMINISTRATION


    Baits shall not be distributed in inhabited areas, roads and watery areas.


  10. WITHDRAWAL PERIOD


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the reach and sight of children Store in a freezer at -40°C to -20°C.

    Protect from light. Keep the boxes tightly closed.


  12. SPECIAL WARNINGS


    For animal treatment only.


    It is recommended to wear rubber gloves.


    People handling and distributing this vaccine should be vaccinated against rabies.


    The safety of the vaccine in pregnant and lactating animals has not been investigated. However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.


    Immunocompromised/immunosuppressed individuals must not be allowed to handle this vaccine.

    In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.


    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.


    Restricted to duly designated competent administrative authorities.

  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    Detailed information on this product is available on the website of the European Medicines Agency


  15. OTHER INFORMATION


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

VIRBAC BELGIUM N.V.

Esperantolaan 4 B-3001 Leuven

Tel: + 32 (0) 16 38 72 60

Република България

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Česká republika

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding Tel: + 45 7552 1244

Deutschland

VIRBAC Tierarzneimittel GmbH Rögen 20

D-23843 Bad Oldesloe Tel: 49 (4531) 805 111


Eesti

OÜ ZOOVETVARU

Uusaru 5

ET -76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006

E-mail: zoovet@zoovet.ee

Luxembourg/Luxemburg

VIRBAC BELGIUM N.V.

Esperantolaan 4 B-3001 Leuven

Tel: + 32 (0) 16 38 72 60

Magyarország

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Malta

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

NL-3771 ND-Barneveld Tel: 31 (0) 342 427 127

Norge

Virbac Norge

c/o Premium Pet Products Vollaveien 20 A

0614 Oslo

Tel: + 47 98 25 57 13

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27 A-1180 Wien

Tel: 43 (0) 1 21 834 260


Ελλάδα Polska

VIRBAC HELLAS A.E.

23 rd Klm National Road Athens-Lamia 145 65 Agios Stefanos

Athens - GREECE Tel: +30 210 6219520

E-mail: info@virbac.gr


España

VIRBAC ESPAÑA S.A.

Angel Guimera 179-181

ES-8950 Esplugues de Llobregat (Barcelona) Tél. : + 34 93 470 79 40


France VIRBAC France 13ème rue – L.I.D.

F-06517 Carros Cedex


Ireland

VIRBAC

1ère avenue 2065 m LID 06516 Carros

France

Tel: + 33 (0) 4 92 08 73 00

Ísland

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00


Italia

VIRBAC SRL

Via Ettore Bugatti 15 I-20142 Milano

Tel: + 39 02 40 92 47 1


Κύπρος

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca, Cyprus Tel: +357 24813333


Latvija

OÜ ZOOVETVARU

Uusaru 5

ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006

E-mail: zoovet@zoovet.ee


Lietuva

OÜ ZOOVETVARU

Uusaru 5

ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006

E-mail: zoovet@zoovet.ee

VIRBAC Sp. z o.o.

ul. Puławska 314

02-819 Warszawa


Portugal

VIRBAC DE Portugal

LABORATÓRIOS LDA

Ed13-Piso 1- Esc.3 Quinta da Beloura

2710-693 Sintra

+ 351 219 245 020


România

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00


Slovenija

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00


Slovenská republika

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00


Suomi/Finland

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00


Sverige

Virbac Danmark A/S Filial Sverige, c/o Incognito AB,

Box 1027,

171 21 Solna

Tel: + 45 7552 1244


United Kingdom

VIRBAC Ltd

UK-Suffolk IP30 9 UP Tel: 44 (0) 1359 243243


Република България

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

România

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: + 33 (0) 4 92 08 73 00

Hrvatska

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: + 33 (0) 4 92 08 73 00