Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT
Intervet International BV
QI09AB08
vaccine to provide passive immunity to the progeny against Escherichia coli and Clostridium perfringens in pigs
Pigs
Immunologicals
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those Escherichia coli strains which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by Clostridium perfringens type C.,
Revision: 5
Authorised
2012-06-14
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: PORCILIS COLICLOS 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: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer(s) responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands MSD Animal Health UK Ltd Walton Manor, Walton, Milton Keynes Buckinghamshire, MK7 7AJ, UK 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis ColiClos suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 2 ml contains: ACTIVE SUBSTANCES: _Escherichia coli _ components: - F4ab fimbrial adhesin 9.7 log 2 Ab titre 1 - F4ac fimbrial adhesin 8.1 log 2 Ab titre 1 - F5 fimbrial adhesin 8.4 log 2 Ab titre 1 - F6 fimbrial adhesin 7.8 log 2 Ab titre 1 - LT toxoid 10.9 log 2 Ab titre 1 _Clostridium perfringens_ component: - Type C (strain 578) beta toxoid ≥20 IU 2 1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose 2 International units of beta antitoxin according to Ph. Eur. ADJUVANT: dl- -tocopheryl acetate 150 mg Aqueous, white to nearly white suspension for injection. 4. INDICATION(S) 18 For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those _E. coli_ strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by _C. perfringens_ type C. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS _In laboratory studies and field trials: _ An increase in body temperature up to 2°C was very commonly observed on the day of vaccination. Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis ColiClos suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: _Escherichia coli _ components: - F4ab fimbrial adhesin 9.7 log 2 Ab titre 1 - F4ac fimbrial adhesin 8.1 log 2 Ab titre 1 - F5 fimbrial adhesin 8.4 log 2 Ab titre 1 - F6 fimbrial adhesin 7.8 log 2 Ab titre 1 - LT toxoid 10.9 log 2 Ab titre 1 _Clostridium perfringens_ component: - Type C (strain 578) beta toxoid ≥20 IU 2 1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose 2 International units of beta antitoxin according to Ph. Eur. ADJUVANT: dl- -tocopheryl acetate 150 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. Aqueous, white to nearly white. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those _E. coli_ strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by _C. perfringens_ type C. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum. 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) _In laboratory studies and field trials: _ An increase in body temperature up to 2°C was very commo Belgenin tamamını okuyun