Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.pfizerah.co.uk

Presentation

A suspension for injection containing Cl. perfringens Type B & C (β) toxoid (> 16.7 IU), Cl. perfringens Type D (ε) toxoid (> 5.3 IU), Cl. haemolyticum (> 17.4 IU), Cl. chauvoei whole culture (meets Ph. Eur.), Cl. novyi Type B toxoid (> 5.5 IU), Cl. septicum toxoid (> 4.6 IU) and Cl. tetani toxoid (> 3.5 IU). Also contains potash alum (as adjuvant) and thiomersal (as preservative).

Uses

For the active immunisation of sheep and cattle from 2 weeks of age against disease associated with infections caused by Cl. perfringens Type B, Cl. perfringens Type C, Cl. perfringens Type D, Cl. chauvoei, Cl. novyi Type B, Cl. septicum, Cl. haemolyticum and against tetanus caused by Cl. tetani.

For passive immunisation of lambs and calves against infections caused by the above mentioned clostridial species (except Cl. haemolyticum in sheep).

Duration of active immunity

An anamnestic humoral immune response (immunological memory) to all components has been demonstrated by serology 12 months following the primary course of vaccination.

Sheep:

12 months against Cl. perfringens Type B, C and D, Cl novyi Type B, Cl. tetani.

< 6 months against Cl. septicum, Cl. haemolyticum, Cl. chauvoei.

Cattle:

12 months against Cl. tetani and Cl. perfringens Type D.

< 12 months against Cl. perfringens Type B and C. < 6 months against Cl novyi Type B, Cl. septicum, Cl. haemolyticum, Cl. chauvoei.

Duration of passive immunity as demonstrated by serology/persistent antibody titre:

Lambs:

At least 2 weeks for Cl. septicum and Cl. chauvoei, at least 8 weeks for Cl. perfringens Type B and Cl. perfringens Type C and at least 12 weeks for Cl. perfringens Type D, Cl. novyi Type B and Cl. tetani. No passive immunity was observed for Cl.haemolyticum.

Calves:

At least 2 weeks for Cl. haemolyticum, at least 8 weeks for Cl. septicum and Cl. chauvoei and at least 12 weeks for Cl. perfringens Type B, Cl. perfringens Type C, Cl. perfringens Type D, Cl. novyi Type B, and Cl. tetani.

Dosage and administration

Dose

Sheep and lambs over 8 weeks of age: 5 ml initial dose followed by a 2 ml dose 6 weeks later.

Lambs 2–8 weeks of age, from unvaccinated ewes or ewes of unknown vaccination status: 2 ml initial dose followed by a second dose 4–6 weeks later.

Cattle of all ages: 5 ml initial dose followed by a second 5 ml dose 6 weeks later.

Revaccination

A single dose (2 ml for sheep, 5 ml for cattle) should be administered at 12 month intervals.

Administration

By subcutaneous injection preferably in the loose skin on the side of the neck, observing aseptic precautions. Shake thoroughly before use. Syringes and needles should be sterilised before use and the injection should be made through an area of clean, dry skin, taking aseptic precautions against contamination.

Vaccination programme

Sheep: The vaccine course should be completed at least two weeks before maximum immunity is required. This may be either a period of risk or in pregnant ewes during lambing.

Use during pregnancy: In lambing flocks, to ensure maximum protection of the lambs until 12 weeks of age, previously vaccinated ewes are best injected 2 weeks before lambing is due to commence. However, provided lambing in the group will not extend beyond a 6 week period, previously vaccinated pregnant ewes may be injected at any time from 6 to 2 weeks before the group is due to commence lambing.

Lambs: Lambs born from fully vaccinated ewes should not be given their first dose of Covexin 8 until 8 to 12 weeks of age, since the presence of maternally derived antibodies may interfere with the response to Cl. tetani and Cl. novyi type B. Lambs born from unvaccinated ewes may be given their first dose of Covexin 8 from 2 weeks of age.

Cattle: The vaccine course should be completed at least two weeks before maximum immunity is required. This may be either a period of risk or in pregnant cattle before calving.

Use during pregnancy: For passive protection of calves, previously vaccinated pregnant cattle should be vaccinated during the period 2-8 weeks before calving.

Calves: For an optimum immune response, calves from cows vaccinated during pregnancy should not be vaccinated until 8-12 weeks of age.

Contra-indications, warnings, etc

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.

No side effects other than those listed below are expected when the vaccine is used between 8 and 2 weeks prior to parturition. In the absence of specific data, the use of the vaccine during the first or second trimester of pregnancy should be avoided. Avoid stress in pregnant ewes and cows.

Clinical trials have demonstrated that the presence of maternal antibodies, particularly against Cl. tetani, Cl. novyi Type B, Cl. perfringens Type A (calves only), Cl. chauvoei (lambs only) and Cl. 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 primary vaccination should be delayed until the levels wane (which is after about 8-12 weeks of age).

75 - 100% of vaccinated animals may experience reactions to vaccination. These reactions are usually localised swelling or induration at the injection site but may also include mild hyperthermia, abscess or other reaction in the underlying tissues at the injection site.

Swelling at the injection site occurs in the majority of animals. This may reach up to 6 cm in sheep and 14 cm diameter in cattle. Most local reactions resolve within 3-6 weeks in sheep and in less then 10 weeks in cattle. In up to 17% of animals an abscess may develop. Vaccination may give rise to reactions in the underlying tissues at the injection site.

Skin discolouration (which returns to normal as the local reaction resolved) and localised pain for 1-2 days post first vaccination may occur at the injection site.

The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.

In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered.

In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.

Withdrawal periods

Cattle: zero days.

Sheep: zero days.

Operator warnings

In the case of accidental self-injection, encourage bleeding and wash the area immediately with water. If a local reaction develops, seek medical advice showing the package leaflet or the label to the physician.

Pharmaceutical precautions

Store and transport between +2°C and +8°C, protected from light. Do not freeze.

Do not mix with any other medicinal product. Part used containers should be discarded within 8 hours of first opening.

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 the product.

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

Keep out of reach and sight of children.

For animal treatment only.

Legal category

POM-VPS

Packaging Quantities

100 ml, 250 ml and 500 ml flexible bottles. Not all pack sizes may be marketed.

Further information

Should lambing extend over a period of more than six weeks, the duration of transferred colostral protection in the later-born lambs may be shortened. These lambs should be given their first dose of Covexin 8 from eight weeks of age.

In any animal population there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine together with the animal's ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, the presence of maternally-derived antibodies, nutritional status, concurrent drug therapy and stress.