Patient leaflet - Rabigen SAG2
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
VIRBAC S.A.
1ere Avenue 2065m L.I.D.
06516 Carros
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
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3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance:
Live attenuated rabies virus, SAG2 strain 8 log10 CCID50*/dose
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* CCID50: Cell Culture Infective Dose 50%
Excipients:
Palatable matrix (bait) containing a tetracycline biomarker
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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.
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5. CONTRAINDICATIONS
None.
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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.
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7. TARGET SPECIES
Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides ).
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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:
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– 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.
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– 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.
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9. ADVICE ON CORRECT ADMINISTRATION
Baits shall not be distributed in inhabited areas, roads and watery areas.
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10. WITHDRAWAL PERIOD
Not applicable.
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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.
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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.
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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.
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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
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15. OTHER INFORMATION