Covexin 10 Suspension for Injection for Sheep and Cattle

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Clostridium chauvoei, Clostridium haemolyticum, Clostridium novyi, Clostridium perfringens, Clostridium septicum, Clostridium sordellii, Clostridium tetani

Beschikbaar vanaf:

Zoetis UK Limited

INN (Algemene Internationale Benaming):

Clostridium chauvoei, Clostridium haemolyticum, Clostridium novyi, Clostridium perfringens, Clostridium septicum, Clostridium sordellii, Clostridium tetani

farmaceutische vorm:

Suspension for injection

Prescription-type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutische categorie:

Cattle, Sheep

Therapeutisch gebied:

Inactivated Bacterial Vaccine

Autorisatie-status:

Authorized

Autorisatie datum:

2003-03-11

Productkenmerken

Revised: January 2021
AN: 02128/2019
Page 1 of 6
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
Each 1 ml of vaccine contains:
ACTIVE SUBSTANCES:
_C._ _perfringens_ type A toxoid
≥ 0.9 U
3
_C._ _perfringens_ type B & C (β) toxoid
≥ 12.4 U
1
_C._ _perfringens_ type D (ε) toxoid
≥ 5.1 U
1
_C._ _chauvoei_ whole culture, inactivated
meets Ph. Eur.
2
_C._ _novyi_ toxoid
≥ 1.2 U
1
_C._ _septicum_ toxoid
≥ 3.6 U
1
_C._ _tetani_ toxoid
≥ 2.5 U
1
_C._ _sordellii_ toxoid
≥ 0.8 U
1
_C._ _haemolyticum_ toxoid
≥ 16.5 U
3
ADJUVANT:
Alum
3.03 – 4.09 mg Aluminium
EXCIPIENT:
thiomersal
0.05 – 0.18 mg
1
In-house ELISA
2
Challenge test according to Ph. Eur.
3
In vitro toxin neutralisation test based on haemolysis of sheep
erythrocytes.
For the 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.
Revised: January 2021
AN: 02128/2019
Page 2 of 6
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).
Onset of immunity: 2 weeks after the basic vaccination course (as
demonstrated by
serology only).
Duration of active immunity as demonstrated by serology only:
Sheep: 12 months against _C. perfringens_ type A, B, C and D, _C._
_novyi_ type B, _C._ _sordellii_,
_C. tetani_
< 6 months against