CEVAC CLOSTRIDIUM OVINO
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
08-03-2012
Summary of Product characteristics
(SPC)
08-03-2012
Active ingredient:
clostridium chauvoei 90 %, Clostridium Novyi Alpha Toxoid 3.5 IU/ml, clostridium perfringens A 1.1 IU/ml, clostridium perfringens Type C Toxoid 10 IU/ml, clostridium perfringens Type D Toxoid 5 IU/ml, clostridium septicum 2.5 IU/ml, clostridium sordelli 100 %, clostridium tetani Toxoid 2.5 IU/ml
Available from:
CEVA SALUD ANIMAL
ATC code:
QI04AB01
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Clostridium vaccine
Therapeutic area:
Sheep Food
Authorization date:
2011-12-23
Patient Information leaflet
1
_[Version 7.3.1, 11/2010] _
_FINAL SPC, LABELLING AND PACKAGE LEAFLET _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC Clostridium Ovino suspension for injection (ES)
Coglavax S suspension for injection (IT)
Panclostil S suspension for injection (EL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Composition for a 2-ml dose _
ACTIVE SUBSTANCES:
Alpha toxoid of _Clostridium perfringens_ type A
2.2 IU *
Beta toxoid of _Clostridium perfringens_ type C
20.0 IU *
Epsilon toxoid of _Clostridium perfringens_ type D
10.0 IU *
Toxoid of _Clostridium novyi _type B
7.0 IU *_ _
Toxoid of _Clostridium septicum_
5.0 IU *
Toxoid of _Clostridium tetani_
5.0 IU *
Toxoid of _Clostridium sordellii_
100 % protection **
Anaculture of _Clostridium chauvoei_
90 % protection ***_ _
* International Units
** Level of protection in control animal (mice)
*** Level of protection in guinea-pigs (in line with Ph. Eur.)
ADJUVANT:
Aluminium hydroxide as Al(OH)3
5.19 mg
EXCIPIENTS:
Formaldehyde
0.05 % w/v
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Lacteal suspension more or less coloured in clear brown.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep, pregnant ewe and lamb
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation against enterotoxaemia due to _C. perfringens _type_ _A, B, C and D, and
_Clostridium sordellii _and clostridial infections due to _C. novyi _type_ _B_, septicum, chauvoei _and
_tetani_.
As primary or unique agents, these pathogens
Read the complete document
Summary of Product characteristics
1
_[Version 7.3.1, 11/2010] _
_FINAL SPC, LABELLING AND PACKAGE LEAFLET _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC Clostridium Ovino suspension for injection (ES)
Coglavax S suspension for injection (IT)
Panclostil S suspension for injection (EL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Composition for a 2-ml dose _
ACTIVE SUBSTANCES:
Alpha toxoid of _Clostridium perfringens_ type A
2.2 IU *
Beta toxoid of _Clostridium perfringens_ type C
20.0 IU *
Epsilon toxoid of _Clostridium perfringens_ type D
10.0 IU *
Toxoid of _Clostridium novyi _type B
7.0 IU *_ _
Toxoid of _Clostridium septicum_
5.0 IU *
Toxoid of _Clostridium tetani_
5.0 IU *
Toxoid of _Clostridium sordellii_
100 % protection **
Anaculture of _Clostridium chauvoei_
90 % protection ***_ _
* International Units
** Level of protection in control animal (mice)
*** Level of protection in guinea-pigs (in line with Ph. Eur.)
ADJUVANT:
Aluminium hydroxide as Al(OH)3
5.19 mg
EXCIPIENTS:
Formaldehyde
0.05 % w/v
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Lacteal suspension more or less coloured in clear brown.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep, pregnant ewe and lamb
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation against enterotoxaemia due to _C. perfringens _type_ _A, B, C and D, and
_Clostridium sordellii _and clostridial infections due to _C. novyi _type_ _B_, septicum, chauvoei _and
_tetani_.
As primary or unique agents, these pathogens
Read the complete document
