Sheep and cattle.

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.

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 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").

Not applicable.

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

Not applicable.

Not applicable.

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.

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.

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.

Sheep - from 2 weeks of age:

Dose - 1 ml.

Cattle - from 2 weeks of age:

Dose - 2 ml.

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.

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").

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".

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.

In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (refer to section "Adverse reactions").

Zero days.