Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: HMA (Heads of Medicines Agencies)
clostridium novyi 50 >=%ER120, clostridium perfringens Type C Toxoid 35 >=%ER25, escherichia coli 55 >=%ER70, escherichia coli 65 >=%ER60, escherichia coli 78 >=%ER70, escherichia coli 79 >=%ER50, escherichia coli 80 >=%ER25
Laboratorios Hipra S. A.
QI09AB08
Suspension for injection
Escherichia + Clostridium
Pigs Food
2010-12-16
Revised: December 2010 AN: 01077/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SUISENG Suspension for injection for swine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose (2 ml) : ACTIVE SUBSTANCES: F4ab fimbrial adhesin of _E. coli _ ≥65% ER 60 * F4ac fimbrial adhesin of _E. Coli _ ≥78% ER 70 F5 fimbrial adhesin of _E. coli _ ≥79% ER 50 F6_ _fimbrial adhesin of _E. coli _ ≥80% ER 25 LT Enterotoxoid of _E. coli _ ≥55% ER 70 Toxoid _Clostridium perfringens_, type C ≥35% ER 25 Toxoid _Clostridium novyi_ ≥50% ER 120 *% ERx: Percentage of immunized rabbits with a X serological EIA response ADJUVANTS: Aluminium hydroxide gel 0.5 g Ginseng extract (equivalent to ginsenosides) 4 mg (0.8 mg) EXCIPIENT: Benzyl alcohol 30 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White-yellowish suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Swine (sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES PIGLETS: For the passive protection of neonatal piglets by means of the active immunisation of breeding sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, such as diarrhoea caused by enterotoxigenic _Escherichia coli_, which express F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) adhesins. The persistence of these antibodies has not been established. Revised: December 2010 AN: 01077/2010 Page 2 of 5 For the passive immunisation of neonatal piglets against Necr Lue koko asiakirja