Rabitec
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
07-01-2021
Svojstava lijeka
(SPC)
07-01-2021
Izvješće o ocjeni javnog
(PAR)
03-04-2020
Aktivni sastojci:
attenuated live rabies vaccine virus, strain SPBN GASGAS
Dostupno od:
CEVA Santé Animale
ATC koda:
QI07BD
INN (International ime):
Rabies vaccine (live, oral) for foxes and raccoon dogs
Terapijska grupa:
Red foxes (Vulpes vulpes); Raccoon dogs (Nyctereutes procyonoides)
Područje terapije:
Immunologicals for canidae, Live viral vaccines
Terapijske indikacije:
For the active immunisation of foxes and raccoon dogs against rabies to prevent infection and mortality.
Proizvod sažetak:
Revision: 3
Status autorizacije:
Authorised
Datum autorizacije:
2017-12-01
Uputa o lijeku
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
RABITEC ORAL SUSPENSION, FOR FOXES AND RACCOON DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
Ceva Tiergesundheit (Riems) GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rabitec oral suspension for foxes and raccoon dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 dose (1.7 ml) embedded in bait contains:
ACTIVE SUBSTANCE:
Attenuated live rabies vaccine virus, strain SPBN GASGAS:
10
6.8
FFU* - 10
8.1
FFU*
(* Focus Forming Units)
The suspension has a yellow colour in a frozen state and a reddish
colour in the liquid state. The baits
are rectangular, brown coloured and have an intensive smell.
4.
INDICATION(S)
For the active immunization of foxes and raccoon dogs against rabies
to prevent infection and
mortality.
Duration of immunity: at least 12 months.
5.
CONTRAINDICATIONS
None.
16
6.
ADVERSE REACTIONS
Not known.
If you notice any side effects, even those not listed in this package
leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Foxes, raccoon dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
The intake of 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.
The vaccination area should be as large as possible (preferably larger
than 5,000 km
2
). The vaccination
campaigns in rabies-free areas should be designed in such a way that
the area covers a 50 km belt
ahead of the rabies front. The distribution rate depends on the
topography, on the population density
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Svojstava lijeka
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rabitec oral suspension for foxes and raccoon dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1.7 ml) contains:
ACTIVE SUBSTANCE:
Attenuated live rabies vaccine virus, strain SPBN GASGAS:
10
6.8
FFU* - 10
8.1
FFU*
(* Focus Forming Units)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
The suspension has a yellow colour in a frozen state and a reddish
colour in the liquid state. The baits
are rectangular, brownish coloured and have an intensive smell.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Foxes, raccoon dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of foxes and raccoon dogs against rabies
to prevent infection and
mortality.
Duration of immunity: at least 12 months.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Vaccine baits are not intended for vaccination of domestic animals.
Gastrointestinal signs (potentially due to the indigestible blister
material) have been reported in dogs
following accidental ingestion of the bait.
2
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Handle the baits with care. It is recommended to wear disposable
rubber gloves when handling and
distributing baits. In case of contact of the vaccine fluid,
immediately remove it by thoroughly rinsing
with water and soap. Seek medical advice immediately and show the
package leaflet or the label to the
physician.
Proposed first aid measures immediately after direct human exposure to
the vaccine fluid should
follow the recommendations of the WHO as outlined in the “WHO Guide
for Rabies Pre- and Post-
Exposure Prophylaxis (PEP) in Humans”.
Since this vaccine has been prepared with live, attenuated
microorganisms, appropriate measures
should be taken to prevent contamination of the handler a
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