Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
E. coli adhesin F4 (F4ab, F4ac, F4ad), E. coli adhesin F5, E. coli adhesin F6, E. coli adhesin F41
Boehringer Ingelheim Vetmedica GmbH
QI09AB02
Neonatal piglet colibacillosis vaccine (inactivated)
Sows; Sows (nullipar)
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Revision: 14
Authorised
1998-04-14
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: NEOCOLIPOR 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY MANUFACTURER FOR THE BATCH RELEASE Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes Rue de l’Aviation F-69800 SAINT PRIEST FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Neocolipor suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 2 ml: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U* E. coli adhesin F5, at least………………………1.7 SA.U* E. coli adhesin F6, at least………………………1.4 SA.U* E. coli adhesin F41, at least…………………….1.7 SA.U* *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log 10 in the guinea pig. Adjuvant: Aluminium (as hydroxide) ............................................................................................................. 1.4 mg 4. INDICATION(S) Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours). If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 17 7. TARGET SPECIES Pigs (sows and gilts) 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION One 2 ml dose according to the following schedule: Primary vaccination: First injection: 5 to 7 weeks before farrowing Second injection: 2 weeks before farrowing. Revaccination: 1 injection 2 weeks before each subsequent farrowing. 9. ADVICE ON CORRECT ADMINISTRATION Intramuscular injection in the neck in the area behind the ear. Shake the vial vigo Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Neocolipor suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Per dose of 2 ml: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U* *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig. Adjuvant: Aluminium (as hydroxide) ..................................................................................... 1.4 mg Excipients: Thiomersal .............................................................................................................. 0.2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts). 4.2 INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES _ _ Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth. - Vaccinate only healthy animals. - Do not administer in conjunction with other medicinal products. 3 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In the case of accidental self-injection, seek medical advice immediately and show the package insert or la Прочетете целия документ