Summary of medicine characteristics - Rabitec
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
1. NAME OF THE VETERINARY MEDICINAL PRODUCTRabitec 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: 106.8 FFU* – 108.1 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 PARTICULARS4.1 Target species
4. CLINICAL PARTICULARS4.1 Target speciesFoxes, raccoon dogs
4.2 Indications for use, specifying the target species
4.2 Indications for use, specifying the target speciesFor 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
4.3 ContraindicationsNone.
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.
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 PostExposure 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 and other people that collaborate in the process, e.g. by wearing appropriate protective clothes.
4.6 Adverse reactions (frequency and seriousness)
No adverse reactions have been observed.
4.7 Use during pregnancy, lactation or lay
4.7 Use during pregnancy, lactation or layPregnancy and lactation:
Can be used during pregnancy.
The safety of the veterinary medicinal product has not been established during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Interaction with other medicinal products and other forms of interactionNone known.
4.9 Amounts to be administered and administration route
4.9 Amounts to be administered and administration routeOral 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 km2). 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 of the target species and on the epizootiological situation. Therefore the recommendations / request of the duly designated competent authority are followed concerning distribution rate, vaccination area, distribution/baiting method and other local/areal conditions as specified by the competent authority. A higher distribution density is recommended in areas with a high population density of foxes/raccoon dogs. Aerial distribution of the baits by any suitable flight devices (such as airplane, helicopter, drones or similar) is recommended for open or sparsely populated areas, and manual distribution in areas with a high human population.
Aerial baiting is not recommended in the vicinity of water (lakes, rivers, water reservoirs) neither in densely populated areas. The vaccination should be preferably carried out biannually (e.g. in spring and autumn), for a number of consecutive years, for at least two years after the last confirmed case of rabies in the region; however vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season. To protect regions which are free of rabies, baiting may be carried out to create a vaccination belt or in the form of spot vaccinations.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessaryThe administration of the vaccine at 10 times the recommended dose induced no undesirable effects.
4.11 Withdrawal period (s)
4.11 Withdrawal period (s)Not applicable.
5. IMMUNOLOGICAL PROPERTIES
5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
ATCvet code: QI07BD.
Rabitec is a live modified rabies vaccine for oral administration to foxes and raccoon dogs. Immunized animals are protected against field rabies virus infection and do not transmit rabies. In contrast to its parental strain SAD B19, the Rabitec vaccine’s active ingredient proved to be apathogenic for immunocompetent mice, the most sensitive species for rabies virus infection.
The active ingredient is a quadruple highly attenuated genetically modified rabies virus construct, derived from the SAD B19 vaccine strain. The genome carries mutations in the G-protein (glycoprotein) located at 2 independent loci of the genome (at amino acid positions 194 and 333 in G-protein), where all three nucleotides ‘codon’ were exchanged resulting in amino acid changes at both positions. In addition, the genome carries an exact duplicate of the modified immune-relevant G-protein (glycoprotein) gene, which results in the significant higher expression of the G protein gene. As each of these modifications on the genome were shown to further attenuate the SAD B19 virus strain, their multiple effect helps to avoid the reversion to the parental strain. Finally, the pseudogen located between the G – and L-gene has been deleted.
A differentiation of this vaccine virus from any other rabies virus strains is possible, including its parental strain, for example by PCR methods.
Rabitec is used for the induction of the protective immunity in foxes and raccoon dogs by the oral route characterised by the induction of rabies virus specific (neutralising) antibodies induced primarily by the G-protein (glycoprotein).
No field studies were conducted.
The efficacy of the vaccine was demonstrated in laboratory studies.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Vaccine:
Water for injections
Sucrose
Gelatin (porcine)
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Neomycin sulfate
Bait:
Fishmeal
Palm fat
Coconut fat
Paraffin
Oxytetracycline hydrochloride (may be added as biomarker if requested by authorities)
6.2 Major incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years at/below –15 °C.
Stability after distribution in the environment was shown for 7 days at temperatures up to 25 °C.
6.4 Special precautions for storage
6.4 Special precautions for storageStore and transport frozen, below –15 °C.
Do not refreeze.
Baits should be distributed immediately after thawing. The thawed vaccine bait may be stored for 7 days between 2 °C- 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
6.5 Nature and composition of immediate packaging
The vaccine suspension is filled in polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species. Baits are packed in plastic foil sleeves or bags in cardboard boxes of:
1 × 800 units
4 × 200 units
40 × 20 units
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such productsAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Ceva Santé Animale
-
10 av. de La Ballastière
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/17/219/001–003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 01/12/2017