País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037
Laboratorios Hipra, S.A.
QI08AA
Rabbit haemorrhagic disease vaccine (inactivated)
Rabbits
Inactivated viral vaccines
For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2)
Revision: 6
Authorised
2016-09-22
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE CARTON 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERAVAC emulsion for injection for rabbits. 2. STATEMENT OF ACTIVE SUBSTANCES Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40. 3. PHARMACEUTICAL FORM Emulsion for injection. 4. PACKAGE SIZE 10 x 1 dose (0.5 ml) 1 x 10 doses (5 ml) 1 x 40 doses (20 ml) 1 x 200 doses (100 ml) _ _ _ _ 5. TARGET SPECIES Rabbits 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use. Shake well before administration. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. Accidental injection is dangerous. 12 10. EXPIRY DATE EXP {month/year} Once broached use immediately. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated. Do not freeze. _ _ Keep the vial(s) in the outer carton in order to protect from light. 12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read the package leaflet. 13. 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. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Laboratorios Hipra S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN 16. MARKETING AUTHORISATION NUMBER(S) EU/2/16/199/001 (5 ml) EU/2/16/199/002 (20 ml) EU/2/16/199/003 (0.5 ml) EU/2/16/199/004 (100 ml) 17. MANUFACTURER’S BATCH NUMBER Batch{number} 13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label (1, 10, 40 or 200 doses) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERAVAC emulsion for injection for rabbits 2. QUANTITY O Leia o documento completo
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERAVAC emulsion for injection for rabbits. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains: ACTIVE SUBSTANCE: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40. ADJUVANT: Mineral oil…………104.125 mg EXCIPIENTS: Thiomersal…………0.05 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Whitish emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2). Onset of immunity: 1 week. Duration of immunity: 12 months demonstrated by challenge _ _ _ _ 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated. Vaccinate healthy animals only. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant. Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for Leia o documento completo