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Date: Saturday, November 28, 2020 4:44

Description: Zoetis logo
Release 2.18
Blackleg Vaccine
 
Species: Sheep, Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle, For sheep
Active ingredient: Vaccine Antigens
Product:Blackleg Vaccine
Product index: Blackleg Vaccine (Zoetis)
Cattle - milk: Zero days
Cattle - meat: Zero days
Sheep - meat: Zero days
Presentation
A suspension for injection, containing whole culture of Clostridium chauvoei. Also contains potassium aluminium sulphate (as adjuvant) and thiomersal (as preservative).
Uses
For the active immunisation of cattle and sheep against disease associated with infections caused by Clostridium chauvoei (Blackleg and post-parturient gangrene). Onset and duration of immunity have not been determined for this vaccine.
Dosage and administration
Administration
By subcutaneous injection, preferably in the loose skin on the side of the neck, observing aseptic precautions.
Shake bottle 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 precautions against contamination.
Primary vaccination
Cattle: two doses of 2 ml administered six weeks apart, 2-3 weeks before the expected period of risk.
Sheep: two doses of 1 ml administered six weeks apart, 2-3 weeks before the expected period of risk.
Revaccination
Revaccination with a single dose is advised annually before the expected period of risk.
Contra-indications, warnings, etc
Do not vaccinate sick or immunodeficient animals.
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 against C. chauvoei may reduce the antibody response to vaccination in young lambs. 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).
In the event of an anaphylactic reaction appropriate treatment, such as adrenaline, should be administered without delay.
Most vaccinated animals may experience reactions to vaccination. These reactions are usually localised swelling (up to 14 cm in diameter, which resolves in less than 10 weeks) or induration at the injection site but may also include abscess (in up to 17% of animals) or other reaction in underlying tissues at the injection site.
Skin discolouration (which returns to normal as the local reaction resolves) 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.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. 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.
Do not mix with any other veterinary medicinal product.
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. Protect from light. Do not freeze.
Shelf-life after first opening the immediate packaging: 8 hours.
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
Legal category: POM-VPS
Packaging quantities
Cardboard box with a 50 ml high density polyethylene (HDPE) bottle. Not all pack sizes may be marketed.
Further information
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.
Marketing Authorisation Number
Vm 42058/4010
Significant changes
GTIN
GTIN:05013457085679