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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1826412
Name of medicinal product: Bravoxin
Active substances:
Clostridium
Estonian, English, Latin
ATC code: QI02AB01; QI04AB01
Dosage form: suspension for injection
Route of administration: subcutaneous use
Strengh:  
Amount in package: 100ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For the active immunisation of sheep and cattle against disease 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: Sheep and Cattle: Two 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 C. septicum, C. haemolyticum, C. chauvoei Cattle: 12 months against C. tetani and C. perfringens type D < 12 months against C. perfringens type A, B and C < 6 months against C. novyi type B, C. septicum, C. sordellii, C. haemolyticum, C. chauvoei An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the basic course of vaccination. Duration of passive immunity: As demonstrated by serology only: Lambs: At least 2 weeks for C. septicum and C. chauvoei At least 8 weeks for C. perfringens type B and C. perfringens type C At least 12 weeks for C. perfringens type A, C. perfringens type D, C. novyi type B, C. tetani and C. sordellii No passive immunity was observed for C. haemolyticum. Calves: At least 2 weeks for C. sordellii and C. haemolyticum At least 8 weeks for C. septicum and C. chauvoei At least 12 weeks for C. perfringens type A, C. perfringens type B, C. perfringens type C, C. perfringens type D, C. novyi type B, and C. tetani
Safety features: No
Summary of product characteristics (SPC):  (last updated April 4, 2024)
Package information leaflet (PIL): EST  (last updated April 4, 2024)
Labelling:  (last updated April 4, 2024)
Withdrawal time: 0 päeva.
Species: veis, lammas
Last imported to Estonia: June 3, 2024
Marketing authorization holder: Intervet International B.V. 
Marketing authorization number: 2292 
Marketing authorization issued on: April 28, 2021 
Marketing authorization expires on: April 28, 2026 
Marketing authorization procedure type: Mutual recognition 
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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