国: イギリス
言語: 英語
ソース: VMD (Veterinary Medicines Directorate)
Bovine coronavirus
MSD Animal Health UK Limited
QI02AD10
Bovine coronavirus
Nasal drops, lyophilisate and solvent for suspension
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Live Viral Vaccine
Authorized
2023-08-30
Issued August 2023 AN: 03016/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Nasalgen-C nasal spray, lyophilisate and solvent for suspension for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live attenuated bovine coronavirus, strain CA25: 5.4 – 7.8 log 10 TCID 50 * *Tissue culture infectious dose 50% For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate: white or off-white colour. Solvent: clear colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of cattle from the day of birth onwards to reduce clinical signs of upper respiratory tract disease and nasal viral shedding from infection with bovine coronavirus. Onset of immunity: 5 days. Duration of immunity: 12 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Animals should preferably be vaccinated at least 5–7 days before a period of stress or increased infection pressure. Issued August 2023 AN: 03016/2021 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Vaccinated cattle may excrete the vaccine strain nasally or orally following vaccination. Excretion has been observed for up to 9 days following vaccination but may persist longer. The vaccine strain can spread to other cattle. Spread to other species has not been investigated and cannot be excluded. It is recommended to vaccinate all calves of the herd. Appropriate biosecurity procedures to limit the risk of introduction and spread of bovine coronavirus infection in premises should be part of management tools. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals. Not applicable. Special precautions for the protection of the environment: Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOU 完全なドキュメントを読む