Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
porcine parvovirus, strain NADL-2 and Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)
Laboratorios Hipra, S.A.
QI09AL01
Porcine parvovirus and Erysipelothrix rhusiopathiae
Pigs
Immunologicals for suidae, Inactivated viral and inactivated bacterial vaccines
For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.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: 5
Authorised
2014-07-08
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE CARDBOARD BOX, (20 ML, 50 ML, 100ML, AND 250ML) BOTTLES (100 ML, 250 ML) AND VIALS (100 ML) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERYSENG PARVO suspension for injection for pigs 2. STATEMENT OF ACTIVE SUBSTANCES Inactivated porcine parvovirus, strain NADL-2, ....................................................... RP > 1.15, 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 12 10. EXPIRY DATE 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 the 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/2/14/167/001 EU/2/14/167/002 EU/2/14/167/003 EU/2/14/167/004 EU/2/14/167/005 EU/2/14/167/006 EU/2/14/167/007 17. MANUFACTURER’S BATCH NUMBER Batch 13 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 PARVO suspension for injection for pigs 2. QUANTITY OF THE Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERYSENG PARVO suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP > 1.15 * Inactivated _Erysipelothrix rhusiopathiae_ , strain R32E11, .............. ELISA > 3.34 log 2 IE 50% ** * RP – relative potency (ELISA). ** 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 female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus. 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: Porcine parvovirus: from the beginning of the gestation period. _E. rhusiopathiae_ : three weeks after completion of the basic vaccination scheme. Duration of immunity: Porcine parvovirus: vaccination provides foetal protection for the duration of gestation. Revaccination should be performed prior to each gestation, see section 4.9. _E. rhusiopathiae_ : vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), see section 4.9. 3 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animal Soma hati kamili