Rabigen SAG2 (live attenuated rabies virus, SAG2 strain) – Package leaflet - QI07AA02

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 http://www.ema.europa.eu/

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

Luxembourg/Luxemburg

VIRBAC BELGIUM N.V.

VIRBAC BELGIUM N.V.

Esperantolaan 4

Esperantolaan 4

B-3001 Leuven

B-3001 Leuven

Tel: + 32 (0) 16 38 72 60

Tel: + 32 (0) 16 38 72 60

Република България

Magyarország

VIRBAC S.A.

VIRBAC S.A.

1ère avenue 2065 m – L.I.D

1ère avenue 2065 m – L.I.D

F-06516 Carros

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Tel: 33 (0) 4 92 08 73 00

Česká republika

Malta

VIRBAC S.A.

VIRBAC S.A.

1ère avenue 2065 m – L.I.D

1ère avenue 2065 m – L.I.D

F-06516 Carros

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Tel: 33 (0) 4 92 08 73 00

Danmark

Nederland

VIRBAC Danmark A/S

VIRBAC NEDERLAND BV

Profilvej 1

Hermesweg 15

DK-6000 Kolding

NL-3771 ND-Barneveld

Tel: + 45 7552 1244

Tel: 31 (0) 342 427 127

Deutschland

Norge

VIRBAC Tierarzneimittel GmbH

Virbac Norge

Rögen 20

c/o Premium Pet Products

D-23843 Bad Oldesloe

Vollaveien 20 A

Tel: 49 (4531) 805 111

0614 Oslo

 

Tel: + 47 98 25 57 13

Eesti

Österreich

OÜ ZOOVETVARU

VIRBAC Österreich GmbH

Uusaru 5

Hildebrandgasse 27

ET -76505 Saue/Harjumaa, ESTONIA

A-1180 Wien

Tel: + 372 6 709 006

Tel: 43 (0) 1 21 834 260

E-mail: zoovet@zoovet.ee

 

Ελλάδα

Polska

 

VIRBAC HELLAS A.E.

VIRBAC Sp. z o.o.

23 rd Klm National Road Athens-Lamia

ul. Puławska 314

145 65 Agios Stefanos

02-819 Warszawa

Athens - GREECE

 

Tel: +30 210 6219520

 

E-mail: info@virbac.gr

Portugal

 

España

VIRBAC DE Portugal

VIRBAC ESPAÑA S.A.

LABORATÓRIOS LDA

Angel Guimera 179-181

Ed13-Piso 1- Esc.3

ES-8950 Esplugues de Llobregat (Barcelona)

Quinta da Beloura

Tél. : + 34 93 470 79 40

2710-693 Sintra

France

+ 351 219 245 020

 

VIRBAC France

România

13ème rue – L.I.D.

VIRBAC S.A.

F-06517 Carros Cedex

1ère avenue 2065 m – L.I.D

 

F-06516 Carros

Ireland

Tel: 33 (0) 4 92 08 73 00

 

VIRBAC Ltd

Slovenija

UK-Suffolk IP30 9 UP

VIRBAC S.A.

Tel: + 44 (0) 1359 243243

1ère avenue 2065 m – L.I.D

 

F-06516 Carros

Ísland

Tel: 33 (0) 4 92 08 73 00

 

VIRBAC S.A.

Slovenská republika

1ère avenue 2065 m – L.I.D

VIRBAC S.A.

F-06516 Carros

1ère avenue 2065 m – L.I.D

Tel: 33 (0) 4 92 08 73 00

F-06516 Carros

Italia

Tel: 33 (0) 4 92 08 73 00

 

VIRBAC SRL

Suomi/Finland

Via Ettore Bugatti 15

VIRBAC S.A.

I-20142 Milano

1ère avenue 2065 m – L.I.D

Tel: + 39 02 40 92 47 1

F-06516 Carros

Κύπρος

Tel: 33 (0) 4 92 08 73 00

 

Panchris Feeds (Veterinary) Ltd

Sverige

Industrial Area Aradippou, 7100, Larnaca, Cyprus

Virbac Danmark A/S Filial Sverige,

Tel: +357 24813333

c/o Incognito AB,

 

Box 1027,

 

171 21 Solna

Latvija

Tel: + 45 7552 1244

 

OÜ ZOOVETVARU

United Kingdom

Uusaru 5

VIRBAC Ltd

ET - 76505 Saue/Harjumaa, ESTONIA

UK-Suffolk IP30 9 UP

Tel: + 372 6 709 006

Tel: 44 (0) 1359 243243

E-mail: zoovet@zoovet.ee

Република България

 

Lietuva

VIRBAC S.A.

OÜ ZOOVETVARU

1ère avenue 2065 m – L.I.D

Uusaru 5

F-06516 Carros

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: 33 (0) 4 92 08 73 00

Tel: + 372 6 709 006

 

E-mail: zoovet@zoovet.ee

 

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

Athugasemdir