Enteroporc Coli AC

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

CLOSTRIDIUM PERFRINGENS TYPE C, BETA1 TOXOID / Clostridium perfringens, type A, alpha toxoid / Clostridium perfringens, type A, beta2 toxoid / Escherichia coli, fimbrial adhesin F4ab / Escherichia coli, fimbrial adhesin F4ac / Escherichia coli, fimbrial adhesin F5 / Escherichia coli, fimbrial adhesin F6

Fáanlegur frá:

CEVA Santé Animale

ATC númer:

QI09AB08

INN (Alþjóðlegt nafn):

Neonatal piglet colibacillosis (recombinant, inactivated), Clostridium perfringens vaccine (inactivated)

Meðferðarhópur:

Pigs

Lækningarsvæði:

Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium

Ábendingar:

For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:-           Clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6-           Clinical signs (diarrhoea during the first days of life) associated with Clostridium perfringens type A expressing alpha and beta 2 toxins-           Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by Clostridium perfringens type C expressing beta1 toxin

Vörulýsing:

Revision: 1

Leyfisstaða:

Authorised

Leyfisdagur:

2020-12-09

Upplýsingar fylgiseðill

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
ENTEROPORC COLI AC LYOPHILISATE AND SUSPENSION FOR 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:
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Szállás u. 5.
1107 Budapest
Hungary
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enteroporc COLI AC
lyophilisate and suspension for suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
LYOPHILISATE:
_Clostridium perfringens_
type A/C toxoids:
alpha toxoid
≥
125 rU/ml*
beta1 toxoid
≥
3354 rU/ml*
beta2 toxoid
≥
794 rU/ml*
_ _
SUSPENSION:_ _
Inactivated fimbrial adhesins of
_Escherichia coli_
:
F4ab
≥
23 rU/ml*
F4ac
≥
19 rU/ml*
F5
≥
13 rU/ml*
F6
≥
37 rU/ml*
* toxoid content and fimbrial adhesins content in relative units per
ml, determined in ELISA against an
internal standard
ADJUVANT:
Aluminium (as hydroxide)
2.0 mg/ml
17
Beige to brown lyophilisate.
Yellowish suspension.
4.
INDICATIONS
For the passive immunisation of progeny by active immunisation of
pregnant sows and gilts to
reduce:
-
Clinical signs (severe diarrhoea) and mortality caused by
_E. coli_
strains expressing the
adhesins F4ab, F4ac, F5 and F6,
-
Clinical signs (diarrhoea) during the first days of life associated
with
_Clostridium _
_perfringens_
type A expressing alpha and beta2 toxins.
-
Clinical signs and mortality associated with haemorrhagic and
necrotizing enteritis caused by
_Clostridium perfringens_
type C expressing beta1 toxin
Onset of immunity (after uptake of colostrum):
_E. coli_
F4ab, F4ac, F5, F6: within 12 hours after birth
_C. perfringens_
type A and C: First day of life
Duration of immunity:
_E coli_
F4ab, F4ac, F5

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enteroporc COLI AC lyophilisate and suspension for suspension for
injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
LYOPHILISATE:
_Clostridium perfringens_
type A/C toxoids:
alpha toxoid
≥ 125 rU/ml*
beta1 toxoid
≥ 3354 rU/ml*
beta2 toxoid
≥ 794 rU/ml*
SUSPENSION:
Inactivated fimbrial adhesins of
_Escherichia coli_
:
F4ab
≥ 23 rU/ml*
F4ac
≥ 19 rU/ml*
F5
≥ 13 rU/ml*
F6
≥ 37 rU/ml*
* toxoid and fimbrial adhesins content in relative units per ml,
determined by ELISA against an
internal standard
ADJUVANT:
Aluminium (as hydroxide)
2.0 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Beige to brown lyophilisate.
Yellowish suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pregnant sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of progeny by active immunisation of
pregnant sows and gilts to
reduce:
-
Clinical signs (severe diarrhoea) and mortality caused by
_Escherichia coli_
strains expressing
the fimbrial adhesins F4ab, F4ac, F5 and F6
-
Clinical signs (diarrhoea during the first days of life) associated
with
_Clostridium _
_perfringens_
type A expressing alpha and beta2 toxins
3
-
Clinical signs and mortality associated with haemorrhagic and
necrotising enteritis caused by
_Clostridium perfringens _
type C expressing beta1 toxin
Onset of immunity (after uptake of colostrum):
_E. coli_
F4ab, F4ac, F5, F6: within 12 hours after birth
_C. perfringens_
type A and C: First day of life
Duration of immunity (after uptake of colostrum):
_E. coli_
F4ab, F4ac, F5, F6:
first days of life
_C. perfringens_
type A:
14 days of life
_C. perfringens_
types C:
21 days of life
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precau