Rabigen SAG2
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
06-11-2018
Produktets egenskaber
(SPC)
06-11-2018
Offentlige vurderingsrapport
(PAR)
21-07-2013
Aktiv bestanddel:
live attenuated rabies virus, SAG2 strain
Tilgængelig fra:
Virbac S.A.
ATC-kode:
QI07AA02
INN (International Name):
live vaccine against rabies
Terapeutisk gruppe:
Raccoon dogs (Nyctereutes procyonoides); Red foxes (Vulpes vulpes)
Terapeutisk område:
Live viral vaccines
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 9
Autorisation status:
Authorised
Autorisation dato:
2000-04-06
Indlægsseddel
11
-
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 a
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
4.1
TARGET SPECIES
Red foxes (_Vulpes vulpes_) and raccoon dogs (_Nyctereutes
procyonoides_).
4.2
INDICATIONS 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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL 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.
3
4.6
ADVERSE 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.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The safety of the vaccine in
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