Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
live attenuated rabies virus, SAG2 strain
Virbac S.A.
QI07AA02
live vaccine against rabies
Raccoon dogs (Nyctereutes procyonoides); Red foxes (Vulpes vulpes)
Live viral vaccines
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.
Revision: 9
Authorised
2000-04-06
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ