Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Adjuvanted equine influenza and tetanus vaccine (inactivated).

Each 1.5ml dose contains A/equi-1/Prague/56, 15 - 18 μg HA*; A/equi-2/Suffolk/89 (European type), 15 - 18 μg HA* and A/equi-2/Newmarket/1/93 (American type), 15 - 18 μg HA*; concentrated tetanus toxoid 18 Lf (RP≥1,0)**; adjuvants: hydroxide and Carbopol 934P.

*Haemagglutinin

**Mean potency relative to a reference vaccine of known potency: ≥150 IU/dose

Uses

For the active immunisation of horses and ponies to reduce clinical signs of respiratory disease and viral shedding caused by equine influenza viruses of H7N7 and H3N8 types (European and American strains) as demonstrated by serology and challenge infection using the A/equi-2/Sussex 89 and A/equi-2/South Africa/4/03 strains. For the active immunisation of horses and ponies to prevent tetanus infection.

Protective antibody titres against the listed equine influenza virus strains and protective antitoxin antibody titres have been shown to be present within two weeks of completion of the second dose of the primary vaccination course and protection has been demonstrated against challenge with virulent isolates of the listed equine influenza virus strains.

Following administration of the second dose of the primary vaccination course, protective antibody titres against the listed equine influenza strains and protective antitoxin antibody titres last at least 6 months. After completion of the 3 dose primary vaccination course and for subsequent booster vaccinations, protective antibody titres against the listed equine influenza strains last at least 1 year and against tetanus last at least 2 years.

Dosage and administration

One 1.5ml dose per horse to be administered by deep intramuscular injection. Shake well before use.

Vaccination Schedule:

Primary vaccination

A single dose of Duvaxyn IE‑T Plus should be administered from the age of 5 months followed by a second dose of Duvaxyn IE‑T Plus after an interval of 4–6 weeks and a third dose 6 months later.

Primary vaccination of foals born to mares highly immunised against equine influenza or 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 equine influenza virus and tetanus toxoid that could interfere with successful immunisation.

In cases of increased risk of equine influenza or tetanus in the young foal, especially when colostrum intake has been inadequate, an additional vaccination may be given from three months of age. Such foals should be shown to have no or very low titres of IgG using a suitable test before proceeding with early vaccination.

The full primary course of vaccination should still be given from five months of age.

Booster vaccination

Administer a single dose of vaccine annually, beginning with Duvaxyn IE Plus and alternating thereafter with Duvaxyn IE-T Plus.

In enzootic or epizootic situations, especially where the causative strain of equine influenza has not been identified, young horses in a yard or crowded situation may be particularly at risk and an additional 6 month booster with Duvaxyn IE Plus may be given in order to further enhance the immune response prior to the commencement of the annual booster programme.

It is recommended that Duvaxyn IE-T Plus should not be used as a booster vaccine in horses previously vaccinated with another manufacturer's vaccine nor should another manufacturer's vaccine be used as a booster vaccine in horses previously vaccinated with Duvaxyn IE-T Plus unless the other manufacturer's vaccine comprises the same equine influenza strains as Duvaxyn IE-T Plus.

Contra-indications, warnings, etc

For Animal Treatment Only.

Do not vaccinate unhealthy animals.

It is recommended to vaccinate all horses on the premises according to the recommended schedule.

Maternally derived antibodies (MDA) can interfere with the development of active immunity. Please refer to section 8 for advice on vaccination in the presence of MDA.

Animals that have received tetanus antiserum at a therapeutic dosage should not be vaccinated until an interval of at least 4 weeks has elapsed.

Safe for use in pregnant mares in second to third trimester which have been vaccinated against both influenza and tetanus before pregnancy.

Avoid stress in the animals around the time of vaccination.

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

Do not mix with any other medicinal product.

Withdrawal period: Zero days.

Adverse reactions:

The occurrence of adverse reactions after the first and second doses is low. After the third and subsequent doses, the incidence of adverse reactions, particularly local reactions, increases. Very commonly these reactions include visible swellings measuring less than 5 cm in diameter lasting for up to 1 day and mild, transient hyperthermia lasting up to 4 days. Common reactions include palpable, transient swellings and visible swellings measuring more than 5cm in diameter which resolve within weeks and stiffness of the neck evident at between 2 to 4 days after vaccination. In rare occasions, abscessation may be observed. No information on microscopic features of the injection site reactions is available.

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.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary practitioner.

Operator Warning:

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.

Pharmaceutical precautions

Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light. Keep out of the reach and sight of children. Do not use after the expiry date stated on the label.

Legal category

POM-V

Packaging Quantities

2, 10, 50 x 1 dose vials.

Not all pack sizes may be marketed.

Further information

Disposal

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

Marketing authorisation number

Vm 01596/4205