Χώρα: Ισπανία
Γλώσσα: Αγγλικά
Πηγή: HMA (Heads of Medicines Agencies)
Equine Rotavirus 1 IU
Fort Dodge Animal Health
QI05AA09
Suspension for injection
Equine rotavirus vaccine
Horses Females
2011-12-21
Revised: April 2012 AN: 01961/2011 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equip Rotavirus emulsion for injection for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION Equine Rotavirus vaccine (inactivated). QUANTITATIVE COMPOSITION Active Substances: Per 1 ml dose Inactivated Equine Rotavirus H2 strain RP>1.0* (7.4 x 10 6 to 7.4 x 10 7 FAID 50 ) *Product is blended based on pre-inactivation titre but the blended and finished product must have a relative potency of at least 1.0. Adjuvants: Per 1 ml dose SP Oil Adjuvant: Pluronic L121 1mg Squalane 2mg Tween 80 (Polysorbate 80) 0.16mg Phosphate Buffered Saline to 0.05ml Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses (pregnant mares) 4.2 INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES For vaccination of pregnant mares to provide passive transfer of antibodies to foals to reduce the risk of diarrhoea caused by Equine Rotavirus H2 serotype. Mares are able to transfer the passive immunity to the foals 4 weeks after the third vaccination. Foals of the vaccinated mares show an increase in antibodies against Equine Διαβάστε το πλήρες έγγραφο