Cattle and sheep.
Indications for use
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).
The onset of immunity
Two weeks after the primary vaccination course.
Duration of active immunity:
An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the primary course of vaccination.
As demonstrated by serology/persistent antibody titre only:
12 months against C. perfringens types A, B, C and D; C. novyi type B; C. sordellii and C. tetani.
< 6 months against C. septicum; C. haemolyticum and C. chauvoei.
12 months against C. tetani and C. perfringens type D.
< 12 months against C. perfringens types A, B and C.
< 6 months against C. novyi type B; C. septicum; C. sordellii; C. haemolyticum and C. chauvoei.
Duration of passive immunity
As demonstrated by serology/persistent antibody titre only is:
At least 2 weeks for C. septicum and C. chauvoei.
At least 8 weeks for C. perfringens type B and C. perfringens type C, and
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.
At least 2 weeks for C. sordellii and C. haemolyticum.
At least 8 weeks for C. septicum and C. chauvoei and
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.
Do not vaccinate sick or immunodeficient animals.
Special warnings for each target species
The effectiveness of the vaccine in providing passive immunity to young lambs and calves depends on these animals ingesting adequate amounts of colostrum on the first day of life.
Clinical trials have demonstrated that the presence of maternal antibodies (MDA), particularly against C. tetani, C. novyi type B, C. perfringens type A (calves only), C. chauvoei (lambs only) and C. perfringens type D may reduce the antibody response to vaccination in young lambs and calves. Therefore, to ensure an optimal response in young animals with high levels of MDA, the primary vaccination should be delayed until the levels wane (which is after about 8-12 weeks of age, see section “Indications for use”).
Special precautions for use
In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.
In the case of accidental self-injection, encourage bleeding and wash the area immediately with water. If a local reaction develops, seek medical advice showing the package leaflet or the label to the physician.
75 - 100% of animals vaccinated with Bravoxin 10 may experience reactions to vaccination.
Most commonly reported adverse reactions are localised swelling or induration at the injection site but may also include mild hyperthermia, abscess or other reaction in the underlying tissues at the injection site.
Swelling at the injection site occurs in the majority of animals. This may reach up to a mean value of 6 cm in sheep and 15 cm diameter in cattle; occasionally 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, but may persist longer in a minority of animals. An abscess may develop in some animals. Vaccination may give rise to reactions in the underlying tissues at the injection site.
Skin discolouration at the injection site (which returns to normal as the local reaction resolved) may occur. Localised pain at the injection site for 1-2 days post first vaccination may occur.
The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.
Use during pregnancy or lactation
No side effects other than those described in section “Adverse Reactions” were seen when the vaccine was used in sheep and cattle between 8 and 2 weeks prior to parturition. In the absence of specific data, the use of the vaccine is not recommended during the first or second third of pregnancy. Avoid stress in pregnant ewes and cows.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Sheep – from 2 weeks of age: Dose - 1 ml.
Cattle – from 2 weeks of age: Dose – 2 ml.
Administration: By subcutaneous injection at a suitable site. The recommended site is the loose skin on the side of the neck.
Shake well 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.
Primary vaccination: Two doses should be administered, 4-6 weeks apart.
Booster vaccination: A single dose should be administered at 6 to 12 month intervals.
Use in pregnancy: To provide passive protection of the offspring, via the colostrum, a single booster dose should be administered between 8 and 2 weeks before parturition, provided that animals have received a full primary vaccination course before pregnancy.
In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (refer to section “Adverse Reactions”).