Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
attenuated live rabies vaccine virus, strain SPBN GASGAS
CEVA Santé Animale
QI07BD
Rabies vaccine (live, oral) for foxes and raccoon dogs
Red foxes (Vulpes vulpes); Raccoon dogs (Nyctereutes procyonoides)
Immunologicals for canidae, Live viral vaccines
For the active immunisation of foxes and raccoon dogs against rabies to prevent infection and mortality.
Revision: 3
Authorised
2017-12-01
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 Baca dokumen lengkapnya
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 Baca dokumen lengkapnya