Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
F4ab (K88ab) fimbrial adhesin, F4ac (K88ac) fimbrial adhesin, F5 (K99) fimbrial adhesin, F6 (987P) fimbrial adhesin, LT toxoid
Intervet International BV
QI09AB02
vaccine to provide passive immunity to the progeny against E. coli in pigs
Pigs (gilts and sows)
Immunologicals
For the passive immunisation of piglets by active immunisation of sows / gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Revision: 7
Authorised
1996-02-29
B. PACKAGE LEAFLET 20/23 PACKAGE LEAFLET FOR PORCILIS PORCOLI DILUVAC FORTE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli Diluvac Forte suspension for injection 3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean antibody titre of respectively ≥ 9.0 log 2 Ab titre, ≥ 5.4 log 2 Ab titre, ≥ 6.8 log 2 Ab titre, ≥ 7.1 log 2 Ab titre, and 6.8 log 2 Ab titre after vaccination of mice with a 1/20 sow dose. The antigens are adjuvanted with 150 mg dl- α -tocopherol acetate per dose. 4. INDICATION(S) For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those _E.coli_ strains _,_ which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P). 5. CONTRA-INDICATIONS None 6. ADVERSE REACTIONS A mean transient increase in body temperature of about 1°C, in some pigs up to 3 o C, may occur in the first 24 hours after vaccination. Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days. A transient swelling and redness at the injection site may be observed in approximately 5% of the animals. The diameter of the swelling is in general below 5 cm, but in some cases a larger size swelling may occur. Swelling and redness at the injection site may occasionally last for at least 14 days. If you notice any other side effects, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs (sows/gilts) 21/23 8. DOSAGE FO Baca dokumen lengkap
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/23 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli DILUVAC FORTE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of two ml: ACTIVE SUBSTANCES: - F4ab (K88ab) fimbrial adhesin ≥ 9.0 log 2 Ab titre 1 - F4ac (K88ac) fimbrial adhesin ≥ 5.4 log 2 Ab titre 1 - F5 (K99) fimbrial adhesin ≥ 6.8 log 2 Ab titre 1 - F6 (987P) fimbrial adhesin ≥ 7.1 log 2 Ab titre 1 - LT toxoid ≥ 6.8 log 2 Ab titre 1 1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose. ADJUVANT: dl- α -tocopherol acetate 150 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 For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those _E.coli_ strains _,_ which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P). 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None 2/23 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Before using the vaccine allow it to reach room temperature (15-25 ° C) and shake well before use. Use sterile syringes and needles. Avoid introduction of contamination. Vaccinate only healthy animals. 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 leaflet or label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A mean transient increase in body temperature of about 1°C, in some pigs up to 3°C, may occur in the first 24 hours after vaccination. Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days. A transient swel Baca dokumen lengkap