Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616
Laboratorios Hipra, S.A.
QI02AB
Streptococcus uberis vaccine (inactivated)
Cattle
Immunologicals for bovidae
For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by Streptococcus uberis, to reduce the somatic cell count in Streptococcus uberis positive quarter milk samples and to reduce milk production losses caused by Streptococcus uberis intramammary infections.
Revision: 1
Authorised
2018-07-26
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Cardboard box with 20 glass vials of 1 dose. Cardboard box with 1 PET vial of 5, 25 and 50 doses. Vial of 25 and 50 doses. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UBAC emulsion for injection for cattle 2. STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of _Streptococcus uberis_ , strain 5616 ≥ 1 RPU* *Relative Potency Units (ELISA) 3. PHARMACEUTICAL FORM Emulsion for injection. 4. PACKAGE SIZE 20 x 1 dose (1 vial of 2 ml) 5 doses (1 vial of 10 ml) 25 doses (1 vial of 50 ml) 50 doses (1 vial of 100 ml) 25 doses (50 ml) 50 doses (100 ml) 5. TARGET SPECIES Cattle 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Withdrawal period: Zero days. 12 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} Once broached use immediately. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated. Protect from light. Do not freeze. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER LABORATORIOS HIPRA, S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN 16. MARKETING AUTHORISATION NUMBER(S) EU/2/18/227/001-004 17. MANUFACTURER’S BATCH NUMBER Batch {number} 13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1 dose and 5 doses 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UBAC emulsion for injection for cattle 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) LTA from BAC of _Streptococcus uberis_ , strain Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UBAC emulsion for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains: ACTIVE SUBSTANCES: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of _Streptococcus uberis_ , strain 5616 .................................................................................................................................. ≥ 1 RPU* *Relative Potency Units (ELISA) ADJUVANT: Montanide ISA ............................................................................................................................907.1 mg Monophosphoryl Lipid A (MPLA) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. White homogeneous emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by _Streptococcus uberis_ , to reduce the somatic cell count in _Streptococcus uberis_ positive quarter milk samples and to reduce milk production losses caused by _Streptococcus uberis_ intramammary infections. Onset of immunity: approximately 36 days after the second dose. Duration of immunity: approximately the first 5 months of lactation. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. The whole herd should be immunised. Immunisation has to be considered as one component in a complex intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only healthy animals. Special precautions to be taken by the person administering the veterinary medicinal p Aqra d-dokument sħiħ