Suiseng
Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-03-2012
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Active ingredient:
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
Available from:
Laboratorios Hipra S. A.
ATC code:
QI09AB08
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Escherichia + Clostridium
Therapeutic area:
Pigs Food
Authorization date:
2010-12-16
Summary of Product characteristics
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
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For the passive immunisation of neonatal piglets against Necr
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