Target species
Sheep and cattle.
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. 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: 2 weeks after the basic vaccination course (as demonstrated by serology only).
Duration of active immunity as demonstrated by serology only:
Sheep: 1 year 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: 1 year against C. tetani and C. perfringens type D
< 1 year against C. perfringens type A, B and C
< 6 months against C. novyi type B, C. septicum, C. sordellii, C. haemolyticum, C. chauvoei
Additionally, an anamnestic humoral immune response (immunological memory) to all components was demonstrated after antigen stimulation 1 year after the basic vaccination course.
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 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.
Calves:
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.
Contraindications
Do not use in sick or immunodeficient animals.
Special warnings for each target species
Vaccinate healthy animals only.
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, 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 basic vaccination should be delayed until the levels wane (which is after about 8-12 weeks of age, see section "Indications for use, specifying the target species").
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Sheep and cattle:
Very common (>1 animal / 10 animals treated): | Injection site swelling1,2,6, Injection site induration2,6, Injection site reaction2,6, Hyperthermia |
Common (1 to 10 animals / 100 animals treated): | Injection site abscess6, Injection site skin discolouration3,6, Injection site pain4,6 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction5 |
1Such a swelling may reach up to a mean value of 6 cm in diameter in sheep and 15 cm (sometimes up to 25 cm) in diameter in cattle.
2Most local reactions will resolve within 3-6 weeks in sheep and in less than 10 weeks in cattle but may persist longer.
3Returns to normal as the local reaction resolves.
4For 1 - 2 days post first vaccination.
5If such reaction occurs, appropriate treatment such as adrenaline should be administered without delay.
6The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Pregnancy:
No side effects other than those described under "Adverse reactions" were seen when the vaccine was used in sheep and cattle between 8 and 12 weeks prior to parturition. In the absence of specific data, no recommendation can be made for use of the vaccine during the first or second third of pregnancy.
Avoid stress in pregnant ewes and cows.
Interaction with other medicinal products and other forms of interaction
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.
Amount(s) 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.
The bottle should be well shaken before any vaccine is withdrawn.
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 scheme:
Two doses should be administered, 4-6 weeks apart (see section "Indications for use, specifying the target species" and "Special warnings for each target species").
Re-vaccination scheme:
A single dose should be administered every 6 to 12 months after the basic vaccination scheme (see also point "Indications for use, specifying the target species".
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 basic vaccination course before pregnancy.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (refer to section "Adverse reactions").
Withdrawal period(s)
Zero days.