Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)
Laboratorios Hipra, S.A.
QI09AB03
Erysipelothrix rhusiopathiae
Pigs
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium
For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Revision: 4
Authorised
2014-07-04
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE CARDBOARD BOX, (20 ML, 50 ML, 100ML, AND 250ML) BOTTLES (100 ML AND 250 ML) AND VIALS (100 ML) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERYSENG suspension for injection for pigs 2. STATEMENT OF ACTIVE SUBSTANCES Inactivated _Erysipelothrix rhusiopathiae_ , strain R32E11, ....................... ELISA > 3.34 log 2 IE 50 % * * IE 50% – Inhibition ELISA 50%. 3. PHARMACEUTICAL FORM Suspension for injection. 4. PACKAGE SIZE 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml) 5. TARGET SPECIES Pigs 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Intramuscular use. 8. WITHDRAWAL PERIOD(S) Withdrawal period: Zero days. 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE 11 EXP {month/year} Once broached use immediately. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated Do not freeze. Protect from light. 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/2/14/166/001 EU/2/14/166/002 EU/2/14/166/003 EU/2/14/166/004 EU/2/14/166/005 EU/2/14/166/006 EU/2/14/166/007 17. MANUFACTURER’S BATCH NUMBER Batch 12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLES (20 ML, 50 ML) AND VIALS (20 ML, 50 ML) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERYSENG suspension for injection for pigs 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated _Erysipelothrix rhusiopathiae_ , strain R32E11, .................... ELISA > 3.34 log 2 IE Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERYSENG suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: Inactivated _Erysipelothrix rhusiopathiae_ , strain R32E11, ..................... ELISA > 3.34 log 2 IE 50% * * IE 50% – Inhibition ELISA 50%. ADJUVANTS: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran Ginseng. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Whitish suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by _Erysipelothrix rhusiopathiae_ , serotype 1 and serotype 2. Onset of immunity: three weeks after completion of the basic vaccination scheme. Duration of immunity: six months. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies. Common adverse reactions: - A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies. Very r Preberite celoten dokument