Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
recombinant Verotoxin 2e of E. coli
Laboratorios Hipra, S.A.
QI09AB02
E. coli verotoxoid vaccine (inactivated recombinant)
Pigs
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium, Immunologicals for suidae
Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.
Revision: 3
Authorised
2017-08-17
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Cardboard box with vial of 10 x10 doses. Cardboard box with vials of 10, 50, 100 or 250 doses. Vial of 100 or 250 doses. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VEPURED suspension for injection for pigs recombinant verotoxin 2e of _E. coli_ 2. STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains: Recombinant verotoxin 2e of _E. coli_ ................................................................ RP ≥ 1.50. 3. PHARMACEUTICAL FORM Suspension for injection. 4. PACKAGE SIZE 10 doses (10 ml) 50 doses (50 ml) 100 doses (100 ml) 250 doses (250 ml) 10 x 10 doses (10 ml) 5. TARGET SPECIES Pigs. 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. 11 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} Once broached use within 10 hours. 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/2/17/214/001 (10 doses (10 ml)) EU/2/17/214/002 (50 doses (50 ml)) EU/2/17/214/003 (100 doses (100 ml)) EU/2/17/214/004 (250 doses (250 ml)) EU/2/17/214/005 (10 x 10 doses (10 ml)) 17. MANUFACTURER’S BATCH NUMBER Batch 12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of 10 or 50 doses 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VEPURED sus Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VEPURED suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Recombinant verotoxin 2e of _E. coli_ ................................................................ RP* ≥ 1.50 * RP – relative potency (ELISA) ADJUVANTS: Aluminium hydroxide (Al 3+ ) ........................................................................... 2.117 mg DEAE-dextran ...................................................................................................... 10 mg. 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 Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by _E. coli_ ) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing _E. coli _ until slaughter from 164 days of age. Onset of immunity: 21 days after vaccination. Duration of immunity: 112 days after vaccination. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, 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 animals Not applicable. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Very common adverse reactions: - Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment. - Mild depression during the day of vaccination. - Temperature rise of maximum 1.1 °C was observed. Temperatures returned to nor Olvassa el a teljes dokumentumot