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.

Dose 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The bottle should be well shaken before any vaccine is withdrawn.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 4.2 and 4.4).

Re-vaccination scheme:

A single dose should be administered every 6 to 12 months after the basic vaccination scheme (see also point 4.2).

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.

Adverse reactions

Sheep and cattle:

Very common

(>1 animal / 10 animals treated):

Injection site swelling^¹^,²,6, Injection site induration^2,6, Injection site reaction^2,6,

Hyperthermia

Common

(1 to 10 animals / 100 animals treated):

Injection site abscess⁶, Injection site skin discolouration^³^,6, Injection site pain^⁴,6

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Anaphylactic-type reaction^{^5,}^⁶

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.

⁵ If 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.