Bravoxin
Active substance
ATC code
Species
Cattle and sheep.
Indications
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 |
Dose to be administered and administration route
Subcutaneous use.
Dose:
- Sheep: 1 ml – from 2 weeks of age
- Cattle: 2 ml – from 2 weeks of age
Administration:
By subcutaneous injection preferably in the loose skin on the side of the neck, observing aseptic precautions. Shake the bottle thoroughly before use.
Syringes and needles should be sterile before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.
Basic vaccination: Two doses should be administered, 4-6 weeks apart (see section 4.2 and 4.4).
Re-vaccination: A single dose should be administered at 6 to 12 month intervals after the basic vaccination (see section 4.2.)
Use in pregnancy:
To provide passive protection of the offspring, via the colostrum, a single revaccination should be administered between 8 and 2 weeks before parturition, provided that animals have received a full basic vaccination course before pregnancy.
Adverse reactions
Swelling at the injection site was observed very commonly in clinical studies. This may reach up to a mean value of 6 cm in sheep and 15 cm diameter in cattle; sometimes reactions of up to 25 cm diameter may be seen in cattle.
Most local reactions resolve within 3-6 weeks in sheep and in less than 10 weeks in cattle. In a minority of animals they may persist longer.
An abscess may develop commonly.
Skin discolouration at the injection site (which returns to normal as the local reaction resolves) may occur commonly. Mild hyperthermia may occur commonly.
Localised pain at the injection site for 1-2 days post first vaccination may occur uncommonly.
Anaphylactic reactions were observed in very rare cases in spontaneous pharmacovigilance reports. In such cases appropriate treatment such as adrenaline should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
