Cattle and sheep.

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).

Sheep and Cattle: Sheep and Cattle: 2 weeks after the basic vaccination course (as demonstrated by serology only).

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 1year following the basic course of vaccination.

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.

Do not use in sick or immunodeficient animals.

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 derived 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 basic vaccination should be delayed until the levels wane (which is after about 8-12 weeks of age, see section ‘Indications for use’).

It is good practice to observe animals regularly for adverse reactions at the injection site following vaccination. It is recommended to seek medical advice from a veterinarian in case of a severe injection site reaction.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Cattle and Sheep:

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.

5 In 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.

No side effects other than those described under 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.

Subcutaneous use.

- Sheep: 1 ml – from 2 weeks of age

- Cattle: 2 ml – from 2 weeks of age

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 ‘Indications for use’ and ‘Special warnings for each target species’).

Re-vaccination: A single dose should be administered at 6 to 12 month intervals after the basic vaccination (see section ‘Indications for use’.)

Use in pregnancy:

To provide passive protection of the offspring, via the colostrum, a single re-vaccination should be administered between 8 and 2 weeks before parturition, provided that animals have received a full basic vaccination course before pregnancy.

In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (see section ‘Adverse reactions’).

Zero days.