国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Rabbit haemorrhagic disease virus, Rabbit haemorrhagic disease virus type 2
Filavie
QI08AA01
Rabbit haemorrhagic disease virus, Rabbit haemorrhagic disease virus type 2
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Rabbits
Inactivated Viral Vaccine
Authorized
2017-04-24
Revised: October 2020 AN: 00198/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FILAVAC VHD K C+V SUSPENSION FOR INJECTION FOR RABBITS. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.5 ml) of vaccine contains: Active substances: Rabbit haemorrhagic disease virus strain LP.SV.2012 (variant strain 2010, RHDV2), inactivated…………………….……………………………………………………….min 1 PD90% * Rabbit haemorrhagic disease virus strain IM507.SC.2011 (classical strain, RHDV1), inactivated……………………………………………………………………….…….min 1 PD90% * Adjuvant: Aluminium hydroxide …………………………………….…………..…………0.35 mg (*) Protective dose in at least 90% of the vaccinated animals. Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Reddish homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of rabbits from 10 weeks of age, to reduce mortality due to rabbit haemorrhagic disease caused by classical (RHDV1) and type 2 (RHDV2) virus strains. Onset of immunity: 1 week. Duration of immunity: 1 year. Revised: October 2020 AN: 00198/2020 Page 2 of 5 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. No information is available on the use of the vaccine in seropositive animals, including animals with maternally derived antibodies. Thus, in situations where a high level of antibodies is expected, the vaccination scheme must be adjusted accordingly. The efficacy of the vaccine in animals younger than 10 weeks of age has not been demonstrated. 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 In case of accidental self- 阅读完整的文件