COVEXIN10
Valsts: Spānija
Valoda: angļu
Klimata pārmaiņas: HMA (Heads of Medicines Agencies)
Produkta apraksts
(SPC)
21-08-2013
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Aktīvā sastāvdaļa:
C. chauvoei whole culture 0 , C. novyi Type B toxcid 0 , C. perfringens Type A Toxcid 0 ml, C. perfringens Type B & C toxcid 0 ml, C. perfringens Type D toxcid 0 ml, C. septicum toxcid 0 , C. sordellii toxcid 0 , C. tetani toxcid 0
Pieejams no:
Schering-Plough Limited
ATĶ kods:
QI02AB01
Zāļu forma:
Suspension for injection
Ārstniecības joma:
Cattle, Sheep
Autorizācija datums:
2011-03-11
Produkta apraksts
Revised: June 2013
AN: 00069/2013
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
Active Ingredients
Potency value/mL
_C. perfringens_ type A toxoid
0.5 U
#
_ _
_C. perfringens _type B & C (
β)
toxoid
18.2 IU*
_C. perfringens_ type D (
ε) 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
3.03
– 4.09 mg/mL Aluminium
Preservative
_ _
Thiomersal
0.05
– 0.18 mg/mL
Excipient to 1 ml
_ _
Formaldehyde
0.5mg/mL_ _
_ _
* ELISA According to Ph.Eur
** Challenge test according to Ph.Eur.
1
In House ELISA
#
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
Revised: June 2013
AN: 00069/2013
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. perfringe
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