Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HMA (Heads of Medicines Agencies)
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
Schering-Plough Limited
QI02AB01
Suspension for injection
Cattle, Sheep
2011-03-11
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 Soma hati kamili