[Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 [Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RABORAL V-RG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 1 dose: Active substance: - Vaccinia virus expressing the rabies glycoprotein CCID50 Excipient(s): - Gentamicin mg - Saline solution q.s ml For a full list of excipients, see section PHARMACEUTICAL FORM Bait (containing a polyethylene sachet filled with one dose of vaccine). 4. CLINICAL PARTICULARS 4.1 Target species Foxes (Vulpes vulpes). 4.2 Indications for use, specifying the target species Active immunization against rabies in foxes. 4.3 Contraindications None 4.4 Special warnings for each target species The bait matrix contains 0.6% of tetracycline chlorhydrate as tracer. 4.5 Special precautions for use Special precautions for use in animals - Vaccine shall only be used by duly designated competent administrative authorities or their authorized agents. - Baits shall be distributed manually or by low-altitude aerial drops, at approximately 15 vaccine-baits per square kilometer. - Baits shall not be distributed in inhabited areas, roads, rivers or other bodies of water. - The sachet and the bait are marked with the wording VACCINE DO NOT TOUCH. Special precautions to be taken by the person administering the veterinary medicinal product to animals No special precaution is to be taken during bait distribution campaigns. Persons involved in bait handling do not need to be vaccinated against rabies. 4.6 Adverse reactions (frequency and seriousness) None 4.7 Use during pregnancy, lactation or lay Not applicable. 2

3 4.8 Interaction with other medicinal products and other forms of interaction No data available. 4.9 Amounts to be administered and administration route One dose of vaccine (one bait) per fox. Baits are distributed at the density of approximately 15 vaccine-baits/km 2, and according to the legislation in force Overdose (symptoms, emergency procedures, antidotes), if ne cessary The ingestion of several baits does not cause any disorder Withdrawal period(s) Not applicable. 5. IMMUNOLOGICAL PROPERTIES Bait consumption is followed by the immunization of foxes against rabies, proven by the protection against challenges or by the onset of rabies-specific antibodies. ATCVet Code: QI07BD. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Gentamicin Sodium chloride Disodium phosphate dihydrate Postassium dihydrogen phosphate Water for injections 6.2 Incompatibilities Not applicable. 6.3 Shelf life 12 months 6.4. Special precautions for storage Store between +2 C and +8 C, protected from light. 6.5 Nature and composition of immediate packaging - Primary packaging consists of a polyethylene sachet inserted into a bait. - Secondary packaging consists of:. polystyrene box, packed in cardbox, containing 200 baits;. polyethylene bag, packed in cardbox, containing 200 baits. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Vaccine-baits shall be destroyed by MERIAL or the duly designated competent administrative authorities, by incineration. 3

4 7. MARKETING AUTHORISATION HOLDER France MERIAL 29 avenue Tony Garnier Lyon FRANCE Belgium and Luxembourg MERIAL Belgium 243 boulevard Sylvain Dupuis 1070 Bruxelles BELGIQUE 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT February PROHIBITION OF SALE, SUPPLY AND/OR USE 4

5 ANNEX III LABELLING AND PACKAGE LEAFLET 5

6 A. LABELLING 6

7 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Sticker on polystyrene box or polyethylene bag 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RABORAL V-RG 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 3. PHARMACEUTICAL FORM 4. PACKAGE SIZE 200 baits 5. TARGET SPECIES 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION 8. WITHDRAWAL PERIOD 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE 11. SPECIAL STORAGE CONDITIONS 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. 7

8 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER MERIAL 29, avenue Tony Garnier Lyon FRANCE 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Batch 8

9 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bait 1. NAME OF THE VETERINARY MEDICINAL PRODUCT 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 4. ROUTE(S) OF ADMINISTRATION 5. WITHDRAWAL PERIOD 6. BATCH NUMBER 7. EXPIRY DATE 8. THE WORDS FOR ANIMAL TREATMENT ONLY VACCINE DO NOT TOUCH 9

10 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Polyethylene sachet 1. NAME OF THE VETERINARY MEDICINAL PRODUCT 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 4. ROUTE(S) OF ADMINISTRATION 5. WITHDRAWAL PERIOD 6. BATCH NUMBER 7. EXPIRY DATE 8. THE WORDS FOR ANIMAL TREATMENT ONLY VACCINE DO NOT TOUCH Month Year (date of the campaign) 10

11 B. PACKAGE LEAFLET 11

12 PACKAGE LEAFLET RABORAL V-RG ORAL LIVE RABIES VACCINE FOR FOXES IN BAIT 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer MERIAL - 29 avenue Tony Garnier LYON, FRANCE MERIAL Laboratoire de Lyon Gerland - 254, rue Marcel Mérieux LYON CEDEX 07, FRANCE Manufacturer for the batch release: MERIAL Laboratoire de Porte des Alpes - 99 rue de l'aviation SAINT-PRIEST, FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT RABORAL V-RG ORAL LIVE RABIES VACCINE FOR FOXES IN BAIT 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each bait of one dose of vaccine contains:. Vaccinia virus expressing the rabies glycoprotein, at least CCID50. Gentamicin, at most... 0,125 mg. Saline solution... q.s. 2.5 ml 4. INDICATION(S) Prevention of rabies in foxes. 5. CONTRAINDICATIONS 6. ADVERSE REACTIONS 7. TARGET SPECIES Foxes 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION One dose of vaccine (one bait) per fox. Baits are distributed at the density of approximately 15 baits/km 2, and according to the legislation in force. 9. ADVICE ON CORRECT ADMINISTRATION No special precaution is to be taken during bait distribution campaigns. Persons involved in bait handling do not need to be vaccinated against rabies. 10. WITHDRAWAL PERIOD Not applicable 12

13 11. SPECIAL STORAGE PRECAUTIONS Store between 2 C and 8 C, protected from light 12. SPECIAL WARNING(S) The bait matrix contains 0.6% of tetracycline chlorhydrate as tracer. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY Vaccine-baits shall be destroyed by MERIAL or the duly designated competent administrative authorities, by incineration. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION Bait consumption is followed by the immunization of foxes against rabies, proven by the protection against challenges or by the onset of rabies-specific antibodies. Box containing 200 baits 13