Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Inactivated Rabbit haemorrhagic Disease 5 PD90, myxomatosis virus attenuated 2.7 log10 CCID50
Merial
QI08AH01
Lyophilisate and Solvent
live myxomatosis virus + inactivated rabbit haemorrhagic disease virus
Rabbit
2012-02-24
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DERCUNIMIX Lyophilisate and suspension for suspension for injection for rabbits 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For one dose of vaccine (0.2 ml): _Lyophilisate _ Attenuated myxomatosis virus, SG33 strain, at least.............................................. 2.7 log 10 CCID50* * Cell Culture Infective Dose 50% _Suspension _ Inactivated Viral Haemorrhagic Disease (VHD) virus, AG88 strain .....................................5 PD90* Adjuvant: Al 3+ ions (in the form of aluminium hydroxide) ................................................................... 0.350 mg Excipient: Thiomersal....................................................................................................................... 0.010 mg * PD90 : q.s. to obtain the protection of at least 9 animals out of 10 vaccinated with 1/5 th of dose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rabbits. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In future breeders from the age of 10 weeks and in breeders: - For primary and booster immunisation to reduce mortality caused by Viral Haemorrhagic Disease of rabbits. - For booster immunisation to prevent mortality caused by myxomatosis. Immunity against VHD has been demonstrated 1 week after vaccination and persists during one year. Immunity against myxomatosis persists during 4 months. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGSNone. 3 4.5 SPECIAL PRECAU Read the complete document