Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Live myxoma vectored RHD virus strain 009, Live myxoma vectored RHD virus strain MK1899
Intervet International B.V.
QI08AD
myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant)
Rabbits
Immunologicals for leporidae
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
Authorised
2019-11-19
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: Nobivac Myxo-RHD PLUS 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 Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains: Live myxoma vectored RHD virus strain 009: 10 3.0 - 10 5.8 FFU * Live myxoma vectored RHD virus strain MK1899: 10 3.0 - 10 5.8 FFU* *Focus Forming Units Lyophilisate: off-white or cream-coloured pellet. Solvent: clear colourless solution. 4. INDICATION(S) For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2). 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 (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, 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. 19 The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases. Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent. The frequency of adverse reactions i Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live myxoma vectored RHD virus strain 009: 10 3.0 - 10 5.8 FFU* Live myxoma vectored RHD virus strain MK1899: 10 3.0 - 10 5.8 FFU* *Focus Forming Units 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. 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 rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2). Onset of immunity: 3 weeks. Duration of immunity: 1 year. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product. To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case. Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop an adequate immune response against rabbit haemorrhagic disease following vaccination. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 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 si Přečtěte si celý dokument