Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009
Intervet International BV
QI08AD
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009
Rabbits
Immunologicals
For active immunisation of rabbits from five weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease.Onset of immunity: 3 weeks.Duration of immunity: 1 year.
Revision: 4
Withdrawn
2011-09-07
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of reconstituted vaccine contains: Live myxoma vectored RHD virus strain 009: ≥ 10 3.0 and ≤ 10 6.1 FFU* *Focus Forming Units Lyophilisate: off-white or cream-coloured pellet. Solvent: clear colourless solution. Reconstituted product: off-pink or pink coloured suspension. 4. INDICATION(S) For active immunisation of rabbits to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains. Onset of immunity: 3 weeks. Duration of immunity: 1 year. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient temperature increase of 1 - 2° C can commonly occur. A small, non-painful swelling (max. 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination. In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur. In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination. In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination. Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent. 22 The frequency of adverse reactions is defined using the following convention: − very common (more than 1 in 10 animals treated displaying adverse reactions) − common (mo Lue koko asiakirja
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live myxoma vectored RHD virus strain 009: ≥ 10 3.0 and ≤ 10 6.1 FFU* *Focus Forming Units EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off-white or cream-coloured pellet. Solvent: clear colourless solution. Reconstituted product: off-pink or pink coloured suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rabbits. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains. Onset of immunity: 3 weeks. Duration of immunity: 1 year. 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 Vaccinate only healthy rabbits. 3 Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination. Special precautions to be taken by the person administering the veterinary medicinal product to animals None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A transient temperature increase of 1 - 2° C can commonly occur. A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination. In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur. In Lue koko asiakirja