Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
live deletion-mutant Streptococcus equi strain TW928
Intervet International BV
QI05AE
live vaccine against Streptococcus equi
Horses
Immunologicals for equidae
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph-node abscesses.Onset of immunity: The onset of immunity is established as two weeks after basic vaccination.Duration of immunity: The duration of immunity is up to three months.The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows or competitions in such areas, or stables that obtain or have livery horses from such areas.
Revision: 10
Authorised
2004-05-07
19 _ _ MINIMUM PARTICULARS ON IMMEDIATE PACKAGING OF THE SOLVENT SOLVENT VIAL 1. NAME OF THE DILUENT Equilis StrepE – solvent 2. CONTENTS BY WEIGHT, BY VOLUME OR BYNUMBER OF DOSES 1 dose 3. ROUTE OF ADMINISTRATION See package leaflet. 4. STORAGE CONDITIONS 5. BATCH NUMBER Lot {number} 6. EXPIRY DATE Exp {month/year} 7. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Per dose of 0.2 ml vaccine: Live deletion mutant _Streptococcus equi_ strain TW928 10 9.0 to 10 9.4 cfu 1 1 colony forming units Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution 4. INDICATION(S) For immunisation of horses against _Streptococcus equi_ to reduce clinical signs and occurrence of lymph node abscesses. The onset of immunity is established as two weeks after vaccination. The duration of immunity is up to 3 months. The vaccine is intended for use in horses for which a risk of _Streptococcus equi_ infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours. The reaction is maximal at 2–3 days pos read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine: ACTIVE SUBSTANCE: Live deletion mutant _Streptococcus equi_ strain TW928 10 9.0 to 10 9.4 cfu 1 1 colony forming units EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For immunisation of horses against _Streptococcus equi_ to reduce clinical signs and occurrence of lymph node abscesses. Onset of immunity : 2 weeks after basic vaccination. Duration of immunity : up to 3 months. The vaccine is intended for use in horses for which a risk of _Streptococcus equi_ infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination. 3 From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection. Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE. As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely. In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose. Do not use antibiotics within one week after vaccination. The vaccine strain is sensitive to penicill read_full_document