Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
CLOSTRIDIUM PERFRINGENS TYPE C, BETA1 TOXOID / Clostridium perfringens, type A, alpha toxoid / Clostridium perfringens, type A, beta2 toxoid / Escherichia coli, fimbrial adhesin F4ab / Escherichia coli, fimbrial adhesin F4ac / Escherichia coli, fimbrial adhesin F5 / Escherichia coli, fimbrial adhesin F6
CEVA Santé Animale
QI09AB08
Neonatal piglet colibacillosis (recombinant, inactivated), Clostridium perfringens vaccine (inactivated)
Pigs
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium
For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:- Clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6- Clinical signs (diarrhoea during the first days of life) associated with Clostridium perfringens type A expressing alpha and beta 2 toxins- Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by Clostridium perfringens type C expressing beta1 toxin
Revision: 1
Authorised
2020-12-09
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: ENTEROPORC COLI AC LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France Manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany Ceva-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5. 1107 Budapest Hungary 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Enteroporc COLI AC lyophilisate and suspension for suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One dose (2 ml) contains: ACTIVE SUBSTANCES: LYOPHILISATE: _Clostridium perfringens_ type A/C toxoids: alpha toxoid ≥ 125 rU/ml* beta1 toxoid ≥ 3354 rU/ml* beta2 toxoid ≥ 794 rU/ml* _ _ SUSPENSION:_ _ Inactivated fimbrial adhesins of _Escherichia coli_ : F4ab ≥ 23 rU/ml* F4ac ≥ 19 rU/ml* F5 ≥ 13 rU/ml* F6 ≥ 37 rU/ml* * toxoid content and fimbrial adhesins content in relative units per ml, determined in ELISA against an internal standard ADJUVANT: Aluminium (as hydroxide) 2.0 mg/ml 17 Beige to brown lyophilisate. Yellowish suspension. 4. INDICATIONS For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce: - Clinical signs (severe diarrhoea) and mortality caused by _E. coli_ strains expressing the adhesins F4ab, F4ac, F5 and F6, - Clinical signs (diarrhoea) during the first days of life associated with _Clostridium _ _perfringens_ type A expressing alpha and beta2 toxins. - Clinical signs and mortality associated with haemorrhagic and necrotizing enteritis caused by _Clostridium perfringens_ type C expressing beta1 toxin Onset of immunity (after uptake of colostrum): _E. coli_ F4ab, F4ac, F5, F6: within 12 hours after birth _C. perfringens_ type A and C: First day of life Duration of immunity: _E coli_ F4ab, F4ac, F5 Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enteroporc COLI AC lyophilisate and suspension for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: ACTIVE SUBSTANCES: LYOPHILISATE: _Clostridium perfringens_ type A/C toxoids: alpha toxoid ≥ 125 rU/ml* beta1 toxoid ≥ 3354 rU/ml* beta2 toxoid ≥ 794 rU/ml* SUSPENSION: Inactivated fimbrial adhesins of _Escherichia coli_ : F4ab ≥ 23 rU/ml* F4ac ≥ 19 rU/ml* F5 ≥ 13 rU/ml* F6 ≥ 37 rU/ml* * toxoid and fimbrial adhesins content in relative units per ml, determined by ELISA against an internal standard ADJUVANT: Aluminium (as hydroxide) 2.0 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. Beige to brown lyophilisate. Yellowish suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (pregnant sows and gilts). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce: - Clinical signs (severe diarrhoea) and mortality caused by _Escherichia coli_ strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6 - Clinical signs (diarrhoea during the first days of life) associated with _Clostridium _ _perfringens_ type A expressing alpha and beta2 toxins 3 - Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by _Clostridium perfringens _ type C expressing beta1 toxin Onset of immunity (after uptake of colostrum): _E. coli_ F4ab, F4ac, F5, F6: within 12 hours after birth _C. perfringens_ type A and C: First day of life Duration of immunity (after uptake of colostrum): _E. coli_ F4ab, F4ac, F5, F6: first days of life _C. perfringens_ type A: 14 days of life _C. perfringens_ types C: 21 days of life 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precau Belgenin tamamını okuyun