COVEXIN 10 SUSPENSION FOR INJECTION FOR SHEEP AND CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOSTRIDIUM PERFRINGENS TYPE A TOXOID CLOSTRIDIUM PERFRINGENS TYP B CLOSTRIDIUM PERFRINGENS TYPE C TOXOID CLOSTRIDIUM PERFRINGENS TYPE D TOXOID CLOSTRIDIUM CHAUVOEI WHOLE CULTURE CLOSTRIDIUM NOVYI TYPE B TOXOID CLOSTRIDIUM SEPTICUM TOXOID CLOSTRIDIUM TETANI TOXOID CLOSTRIDIUM SORDELLII TOXOID CLOSTRIDIUM HAEMOLYTICUM TOXOID (STRAIN CN 3629)

Available from:

Pfizer Healthcare Ireland

ATC code:

QI02AB01

Pharmaceutical form:

Suspension for Injection

Therapeutic group:

Immunological - Inactivated vaccine

Therapeutic area:

Bovine

Authorization date:

2009-10-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Covexin 10 Suspension for injection for sheep and cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* ELISA According to Ph.Eur.
1
In House ELISA
** Challenge test according to Ph.Eur.
#
In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Light brown aqueous suspension that settles on storage.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and cattle.
Active ingredients
Potency value/mL
_C. perfringens _type A toxoid
0.5 U
#
_C. perfringens _type B & C ( ) toxoid
18.2 IU*
_C. perfringens _type D ( ) toxoid
5.3 IU*
_C. chauvoei _whole culture
meets Ph Eur.**
_C. novyi _toxoid
3.8 IU*
_C. septicum _toxoid
4.6 IU*
_C. tetani _toxoid
4.9 IU*
_C_. _sordellii _toxoid
4.4 U
1
_C. haemolyticum _toxoid
17.4 U
#
_Adjuvant_
Alum
3,026 – 4,094 ppm as aluminium
_Preserative_
Thiomersal
0.005-0.018 % w/v
Excipient to 1 ml
Formaldehyde
0.05% w/v
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/01/2012_
_CRN 7009761_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sheep and cattle against diseases associated with infections caused by _Clostridium_
_perfringens _type A, _C. perfringens _type B, _C. perfringens _type C, _C. perfringens _type D, _Clostridium chauvoei_,
_Clostridium novyi _type B, _Clostridium septicum_, _Clostridium sordellii _and _Clostridium haemolyticum _and against
tetanus caused by _Clostridium tetani_.
For the passive immunisation of lambs and calves against infections caused by the above mentioned clostridial species
(except _C. haemolyticum in sheep)_.