国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130
Intervet International BV
QI02AP01
Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130
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Lyophilisate and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
trichophyton
Immunological
Authorised
2017-04-21
Health Products Regulatory Authority 18 June 2019 CRN0094DC Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Ringvac lyophilisate and solvent for suspension for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 ml of vaccine: ACTIVE SUBSTANCE: Attenuated _Trichophyton verrucosum_, strain LTF - 130 ≥9 x 10 6 and ≤21 x 10 6 viable microconidia. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off white to light brown coloured pellet. Solvent: clear colourless solution. Reconstituted product: off white to grey homogenous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of calves and cattle at risk of infection, or calves and cattle suffering from dermatophytosisinduced by _Trichophyton verrucosum_. The prophylactic vaccination reduces clinical signs of _Trichophyton verrucosum_induced dermatophytosis while the therapeutic use results in a 2-foldfaster recovery of animals which already show clinical signs of disease. Onset of immunity: 3 weeks after vaccination. Duration of immunity: at least one year as demonstrated in a laboratory study. 4.3 CONTRAINDICATIONS Do not use in animals with fever and / or with dermatophytosis-independent symptoms of an infectious disease. Do not use in animals that are treated with corticosteroids. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES _Trichophyton verrucosum_can survive in the environment for 6 - 8 years. It is recommended to combine a vaccination program with a cleaning and disinfection protocol. Preparations with antifungal activity should not be given while immunization is ongoing until three weeks after completion of vaccination. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinated animals should not be housed among non-vaccinated animals showing clinical signs of _Trichophyton _ _verrucosum_infecti 完全なドキュメントを読む