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

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

200 UNIT BOX

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

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

3.PHARMACEUTICAL FORM

Oral suspension.

4.PACKAGE SIZE

200 (4 x 50) vaccinal baits.

5.TARGET SPECIES

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

6.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.

7.METHOD AND ROUTE OF ADMINISTRATION

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

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. Read the package leaflet before use.

8.SPECIAL WARNINGS, IF NECESSARY

It is recommended to wear rubber gloves.

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

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 i or the label to the physician.

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.

9.EXPIRY DATE

EXP : {month/year}

10.SPECIAL STORAGE CONDITIONS

Store in a freezer at -40°C to -20°C.

Protect from light. Keep the boxes tightly closed.

11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.

12. 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. Restricted to duly designated competent administrative authorities.

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 insert for further information.

13.THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

14.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

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

15.MARKETING AUTHORISATION NUMBER

EU/2/00/021/001

16.MANUFACTURER’S BATCH NUMBER

BN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

400 UNIT BOX

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

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

3. PHARMACEUTICAL FORM

Oral suspension.

4. PACKAGE SIZE

400 (2 x 200) vaccinal baits.

5. TARGET SPECIES

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

6. 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.

7. METHOD AND ROUTE OF ADMINISTRATION

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

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. Read the package leaflet before use.

8. SPECIAL WARNINGS, IF NECESSARY

It is recommended to wear rubber gloves.

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

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.

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.

9. EXPIRY DATE

EXP: {month/year}

10. SPECIAL STORAGE CONDITIONS

Store in a freezer at -40°C to -20°C.

Protect from light. Keep the boxes tightly closed.

11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.

12. 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. Restricted to duly designated competent administrative authorities.

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 insert for further information.

13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

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

15. MARKETING AUTHORISATION NUMBER

EU/2/00/021/002

16. MANUFACTURER’S BATCH NUMBER

BN: {number}

MINIMUM PARTICULARS TO APPEAR ON SACHETS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2.BATCH NUMBER

BN: {number}

3.EXPIRY DATE

EXP: {month/year}

4.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

RABIES VACCINE DO NOT TOUCH

Informative phone number: + 33 4 92 08 73 04

PARTICULARS TO APPEAR ON BAITS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2.NAME OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

1ère Avenue 2065 M L.I.D

06516 Carros

France

3. EXPIRY DATE

EXP: {month/year}

4.BATCH NUMBER

BN: {number}

5.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

RABIES VACCINE DO NOT TOUCH

Informative phone number: + 33 4 92 08 73 04

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