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: 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.

An anamnestic humoral immune response (immunological memory) to all components was demonstrated 1 year 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

Cattle and sheep:

Very common

(>1 animal / 10 animals treated):

Injection site swelling^{^[1]}.

Common

(1 to 10 animals / 100 animals treated):

Injection site abscess, injection site skin discolouration^{^[2]}.

Hyperthermia^{^[3]}.

Uncommon

(1 to 10 animals / 1,000 animals treated):

Injection site pain^{^[4]}.

Very rare

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

Anaphylactic type reaction^{^[5]}.

¹ 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.

² Returns to normal as the local reaction resolves.

³ Mild.

⁴ For 1-2 days post first vaccination.

⁵In such cases appropriate treatment such as adrenaline should be administered without delay.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.