Rabigen SAG2 (live attenuated rabies virus, SAG2 strain) – Summary of product characteristics - QI07AA02

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance :

Live attenuated rabies virus, SAG2 strain

minimum 8 log10 CCID50*/dose

* CCID50 : Cell Culture Infective Dose 50%

Excipients :

For a full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Oral suspension

4.CLINICAL PARTICULARS

4.1Target species

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

4.2Indications for use, specifying the target species

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.

4.3Contraindications

None.

4.4Special warnings for each target species

Not applicable.

4.5 Special precautions for use Special precautions for use in animals

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

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

4.6Adverse reactions (frequency and seriousness)

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.

4.7Use during pregnancy, lactation or lay

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.

4.8Interaction with other medicinal products and other forms of interaction

None known.

4.9Amounts to be administered and administration route

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.

The 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The administration of the vaccine at 10 times the recommended dosage induced no undesirable effects.

4.11 Withdrawal period

Not applicable.

5.IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Live viral vaccines

ATCvet code: QI07BD.

Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).

The active ingredient is a double low virulence mutant isolated from the SAD Bern strain of rabies virus by two successive selection steps in order to avoid natural reversion to the parental strain.

It is used for the active immunisation of foxes and raccoon dogs characterised by the induction of rabies specific antibodies.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Vaccine :

Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid – Saccharose – Gelatin – Tryptone - Lactalbumin hydrolysate - Sodium chloride - Water for injection

Appetent matrix (bait) :

Rhodor 7046R antifoam - Tetracycline (Hcl) HD - EVA (Ethyl Vinyl Acetate) - White soft paraffin - Paraffin 50/52° C - Seah Saur - Natural fish aroma

6.2Incompatibilities

Not applicable.

6.3Shelf life

2 years at -20°C and 2 days at +25°C.

6.4.Special precautions for storage

Store in a freezer at -40°C to -20°C.

Protect from light. Keep the boxes tightly closed.

6.5Nature and composition of immediate packaging

Liquid vaccine contained within an aluminium/PVC sachet coated with an appetising matrix. The baits are successively packed in boxes of:

-200 units (4x50)

-400 units (2x200)

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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.

7.MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

1ère Avenue 2065m L.I.D. 06516 Carros - France tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48

e-mail: darprocedure@virbac.com

8.MARKETING AUTHORISATION NUMBERS

EU/2/00/021/001

EU/2/00/021/002

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06/04/2000

Date of latest renewal: 16/03/2010

10 DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

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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