ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
2.
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.
Oral suspension
4.
Red foxes (
Vulpes vulpes
) and raccoon dogs (
Nyctereutes procyonoides
).
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.
None.
Not applicable.
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.
2/22
No undesirable effects have been shown for Rabigen SAG2.
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.
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.
None known.
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.
The administration of the vaccine at 10 times the recommended dosage induced no undesirable effects.
4.11 Withdrawalperiod
Not applicable.
5.
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.
3/22
6.
6.1 List 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
6.2 Incompatibilities
Not applicable.
6.3 Shelf 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.
6.5 Nature 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:
- 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.
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 :
dar@virbac.fr
8.
EU/2/00/021/001
EU/2/00/021/002
4/22
- 200 units (4x50)
9.
06/04/2000 / 16/03/2010
16/03/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
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.
5/22
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
6/22
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 Carros,
France
Manufacturing Authorisation issued on December 22
nd
1997 by the Ministère de la solidarité, de la
santé et de la protection sociale – Direction de la Pharmacie et du médicament – République
Française.
Name and address of the manufacturer responsible for batch release
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 Carros,
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
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.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLs
Not applicable.
7/22
ANNEX III
LABELLING AND PACKAGE LEAFLET
8/22
A. LABELLING
9/22
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
200 unit box
1.
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.
Oral suspension.
4.
PACKAGE SIZE
200 (4 x 50) vaccinal baits.
5.
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.
10/22
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.
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.
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.
11/22
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}
12/22
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
400 unit box
1.
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.
Oral suspension.
4.
PACKAGE SIZE
400 (2 x 200) vaccinal baits
5.
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.
13/22
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.
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.
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.
14/22
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}
15/22
MINIMUM PARTICULARS TO APPEAR ON SACHETS
1.
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
16/22
PARTICULARS TO APPEAR ON BAITS
1.
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
2.
VIRBAC S.A.
1
ère
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
17/22
B. PACKAGE LEAFLET
18/22
PACKAGE LEAFLET
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
VIRBAC S.A.
1ère Avenue 2065m L.I.D.
06516 Carros
France
2.
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.
None.
6.
No undesirable effects have been shown for Rabigen SAG2.
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.
7.
Red foxes
(Vulpes vulpes)
and raccoon dogs (
Nyctereutes procyonoides
).
19/22
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.
20/22
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
16/03/2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
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
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
Luxembourg/Luxemburg
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
Република България
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Magyarország
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Česká republika
VIRBAC S.A.
1
ère
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) 342 427 100
Deutschland
VIRBAC Tierarzneimittel GmbH
West Rögen 20
D-23843 Bad Oldesloe
Tel: 49 (4531) 805 555
Norge
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Eesti
OÜ ZOOVETVARU
Pärnasalu 31
ET -76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
Österreich
VIRBAC Österreich GmbH
Hildebrandgasse 27
A-1180 Wien
Tel: 43 (0) 1 21 834 260
21/22
Danmark
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Malta
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ελλάδα
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
Polska
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
España
VIRBAC ESPAÑA S.A.
ES-8950 Esplugues de Llobregat (Barcelona).
Tél. : + 34 93 470 79 40
Portugal
VIRBAC DE Portugal
LABORATÓRIOS LDA
P-2080 Almeirim
Tel: (351) 243 570 500
France
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
E-mail: dar@virbac.fr
România
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ireland
C&M Veterinary Distributors Limited
IE-Limerick
Tel: 353 61 314 933
Slovenija
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ísland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenská republika
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Κύπρος
PANCHRIS FEEDS VETERINARY LTD
Industrial Area Aradippou, 6302 Larnaca, Cyprus
Tel: +357 24813333
Fax: +357 24813377
E-Mail: markita@panchris.com
Suomi/Finland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Latvija
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
United Kingdom
VIRBAC Ltd
UK-Suffolk IP30 9 UP
Tel: 44 (0) 1359 243243
Lietuva
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
22/22
Italia
VIRBAC SRL
Via dei Gracchi 30
I-20146 Milano
Tel: 39 02 48 53 541
Sverige
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Source: European Medicines Agency
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