Presentation

Suspension for injection containing per ml 30-60 TCP units of each of Clostridium perfringens type B and type C, 80-160 TCP units of Clostridium perfringens type D, 3-6 TCP units of Clostridium septicum, 6-12 TCP units of Clostridium tetani, 8-16 TCP units of Clostridium novyi and five strains of Clostridium chauvoei, per strain 1.25 x 10⁸ cells and equivalent toxoid inactivated with formaldehyde.  Also contains aluminium hydroxide as an adjuvant and 0.13 mg/ml thiomersal as preservative.

Uses

Sheep 

For the active immunisation of sheep, not less than 3 weeks old, to:

-    reduce clinical signs and mortality due to the toxin of Clostridium tetani  (Tetanus);

-    reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney);

-    reduce mortality due to the toxin of Clostridium novyi (Black disease);

-    reduce mortality in sheep due to infections with Clostridium chauvoei (Blackleg); 

-   induce a serological response against the beta toxin of Clostridium perfringens (Struck, Lamb dysentery);

-   induce a serological response  against the toxin of Clostridium septicum (Braxy).

Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in lambs and sheep is expected to last one year.

The vaccine may be used in pregnant ewes to provide passive immunisation of lambs, provided that the lambs receive sufficient immune colostrum during the first 12 hours of life, to:

-    reduce clinical signs and mortality due to the toxin of Clostridium tetani  (Tetanus);

-    reduce mortality due to the epsilon toxin of Clostridium perfringens (Pulpy kidney);

-   induce a serological response  against the beta toxin of Clostridium perfringens (Lamb dysentery).

The duration of passive immunity is at least 4 - 6 weeks in lambs provided that lambs receive adequate quantities of colostrum in the first 12 hours after birth.

Pigs

For the active immunisation of pregnant sows, to:

-    reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus);

-    reduce clinical signs due to the toxin of Clostridium perfringens type C (enterotoxaemia);

-   induce a serological response  against the toxin of Clostridium novyi (sudden death), field data indicate that these antibodies reduce mortality due to Clostridium novyi infection.

Significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course. From experience from field use, the duration of active immunity in pigs is expected to last one year.

The vaccine may be used in pregnant sows to provide passive immunisation of piglets, provided that the piglets receive sufficient immune colostrum during the first 12 hours of life, to:

-    reduce clinical signs and mortality due to the toxin of Clostridium tetani (Tetanus); 

-    reduce mortality due to the toxin of Clostridium perfringens type C (enterotoxaemia).

Passive protection of piglets from immunised sows against Clostridium tetani will last for at least 14 days and against Clostridium perfringens type C for a shorter period.

Dosage and administration

The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions.

Sheep and lambs: 2 ml/dose.

Ewes and sows can be vaccinated during late pregnancy.

Pigs: 5 ml/dose.

Sheep

All sheep from 3 weeks of age onwards and not previously vaccinated with Heptavac must receive two injections separated by an interval of 4 - 6 weeks to be completed before onset of the period of risk. Thereafter they should receive booster injections 2 - 3 weeks prior to identified risk periods with intervals of not more than 12 months. In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4 - 6 weeks pre‑lambing, to allow passive protection of lambs via colostrum.  

Pigs

Two injections with an interval of at least 3 weeks between injections, the second dose to be administered at least 3 weeks before farrowing. The preferred schedule is vaccination at 6 and 3 weeks prior to the expected date of farrowing. Only a single booster dose is required in subsequent pregnancies at not less than 3 weeks pre-farrowing.

The vaccine bottle must be shaken well before use. 

Syringes and needles must be from gamma irradiated packs or freshly sterilised by boiling for at least 20 minutes. No alcohol or other disinfectants should be used for sterilisation.

The use of an automatic vaccinator is recommended. Since the bottle is non-collapsible, a vaccinator with a vented draw-off spike or similar device must be used.   The instructions supplied with such equipment should be noted and care should be taken to ensure the delivery of the full dose, particularly with the final few doses from the bottle.

Contra-indications, warnings, etc.

Occasional hypersensitivity may occur.

Vaccination may result in small (<10 cm) transient injection site reactions possibly lasting for up to 3 - 4 months after vaccination.

Local tissue irritating effects of alhydrogel-adjuvanted vaccines reveal granulomatous inflammatory reactions consisting mainly of activated macrophages containing foamy cytoplasm, epithelioid cells, small lymphocytes and multinuclear giant cells.

Reactions similar to those described above were observed following administration of a double dose.

The nutritional and metabolic status of pregnant ewes is extremely important at the time of vaccination. If in doubt, advice should be sought from a veterinary surgeon.

No information is available on the efficacy of the vaccine in young animals with maternally derived antibodies.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.  It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.

Do not mix with any other medicinal product.

In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence. Satisfactory immune responses will only be attained in healthy animals, thus it is important to avoid vaccination of animals which have an intercurrent infection or metabolic disorder. 

When handling animals, stress should be avoided, particularly during the later stages of pregnancy when there is a risk of inducing abortion and metabolic disorders.

Operator warning:

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

Withdrawal periods:

Zero days.

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store in a refrigerator (+2°C to +8°C).   Do not freeze.

Shelf-life after first opening the container: 10 hours

Disposal advice:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 

Legal category

POM-VPS         To be supplied only on veterinary prescription.

Package quantities

Cartons containing a 100ml, 250ml or 500ml polyethylene multidose bottle, closed with a combination seal.

Further information

Nil.

Marketing Authorisation number

Vm 01708/4508                UK Authorised veterinary medicinal product

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Bucks, MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation

26/07/06