Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Purified Tetanus toxoid, ≥30 IU* per 1ml dose.

*Mean potency determined by enzyme linked immunosorbant assay (ELISA) compared to a reference antiserum. Ph Eur. 0697

Uses

For the active immunisation of horses and ponies against tetanus. Protective antitoxin antibody titres are detected within two weeks of the second vaccination and last for 1 year. After the third vaccination and subsequent biannual booster vaccinations, protective titres last two years.

Dosage and administration

One 1.0ml dose per horse to be administered by deep intramuscular injection.

Vaccination Schedule

Primary Course:

A single dose of Duvaxyn T should be administered from 3 months of age followed by a second injection of Duvaxyn T after an interval of 4-6 weeks and a third injection one year after that.

Primary vaccination of foals born to mares highly immunised against tetanus (i.e. vaccinated two or more times a year or within the last trimester of pregnancy) should be delayed until the age of 6 months, as such foals may have high levels of maternally derived antibody against tetanus toxoid that could interfere with successful immunisation.

Booster Immunity:

Booster vaccinations should be administered at two year intervals.

Correct Administration:

Syringes and needles should not have been sterilised chemically or be above ambient temperature.

Contra-indications, warnings, etc

Do not use in unhealthy animals.

Duvaxyn T may only be used in pregnant or lactating mares which have been given a primary vaccination course prior to pregnancy. However, the risks connected with any treatment of a pregnant animal are undiminished.

No information is available on the safety and efficacy of the concurrent use of this vaccine with any other except Duvaxyn IE Plus or Duvaxyn EHV 1,4. It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with this product.

Do not mix with any other vaccine or immunological product.

Adverse reactions:

Following administration of Duvaxyn T, a small, palpable injection-site reaction may result in approximately 2% of vaccinated animals. No information on microscopic features of the injection site reaction is available. Transient elevation of body temperature may be seen within a few days of vaccination in approximately 2% of vaccinated animals. While extremely rare, hypersensitivity reactions to the vaccine may occur. In the event of an allergic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously (e.g. dexamethasone sodium phosphate), adrenaline intramuscularly or antihistamine intramuscularly.

Special warnings:

The skin at the site chosen for injection should not be disinfected prior to vaccination using chemical disinfectants.

Maternally derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the dam has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly.

In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal's ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc.

Animals that have received the corresponding antiserum at a therapeutic dosage, or immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.

Special precautions for use in animals:

Avoid stress in the animals around the time of vaccination.

Special precautions to be taken by the person administering the veterinary medicinal product to the animal:

In the case of accidental self-injection/ingestion/spillage onto skin, seek medical advice immediately and show the package insert or label to the physician.

Withdrawal Period: Zero days

Pharmaceutical precautions

Store and transport at +2°C to +8°C. Do not freeze. Protect from light.

Keep out of reach and sight of children.

Use entire contents when first opened.

Legal category

POM-V

Packaging Quantities

Packs of 2 and 10 single dose vials.

Not all pack sizes may be marketed.

Further information

For Animal Treatment Only

Disposal:

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

Marketing authorisation number

Vm 01596/4204.