Suiseng Coli /C Suspension for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

F4ab fimbrial adhesin of e.coli; F4ac fimbrial adhesin of e.coli; F5 fimbrial adhesin of e.coli; F6 fimbrial adhesin of e. coli; Lt enterotoxoid of e. coli; Clostridium perfringens, type C toxoid; Clostridium novyi, type B toxoid

Available from:

Laboratorios Hipra S.A.

ATC code:

QI09AB08

INN (International Name):

F4ab fimbrial adhesin of e.coli; F4ac fimbrial adhesin of e.coli; F5 fimbrial adhesin of e.coli; F6 fimbrial adhesin of e. coli; Lt enterotoxoid of e. coli; Clostridium perfringens, type C toxoid; Clostridium novyi, type B toxoid

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic area:

escherichia + clostridium

Authorization status:

Authorised

Authorization date:

2019-07-26

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suiseng Coli/C suspension for injection for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
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
RP > 1.05**
Toxoid
_Clostridium novyi_
type B
RP > 1.23
*% ERx: Percentage of immunized rabbits with a X serological EIA
response
**RP: Relative potency determined by ELISA.
ADJUVANTS:
Aluminium hydroxide gel
0.5 g (5.3 mg Al)
Ginseng extract (equivalent to ginsenosides)
4 mg (0.8 mg)
EXCIPIENT:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Simethicone
Disodium phosphate dodecahydrate
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Water for injections
White-yellowish suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (sows and gilts).
3.2
INDICATIONS FOR USE FOR EACH 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.
2
For the passive immunisation of neonatal piglets against Necrotic
Enteritis by means of the active
immunisation of breeding sows and gilts to induce seroneutralising
antibodies against the β-toxin of
_Clostridium perfringens_
type C.
The persistence of antibodies has not been established.
SOWS AND GILTS:
For active immunisation of breeding sows and gilts to induce
seroneutralising
antibodies against α-toxin of
_Clostridium novyi _
type B
_. _
The relevance of the seroneutralising
antibodies was not experimentally determined.
Antibodies have been det