A suspension for injection ISCOM (Immune Stimulating Complex) Equine Influenza and Tetanus Vaccine:

Equine influenza virus inactivated strains:

Also contains the adjuvants Quil A and aluminium phosphate.

*HAI: Haemagglutination Inhibition titre.

**IU: International Units

For the active immunisation of horses aged 5 months of age or older against Equine Influenza of H7N7 and H3N8 types (European or American strains, including Florida sublineage Clade 1 and Clade 2 isolates) to reduce the clinical signs and virus excretion after infection, and against tetanus to prevent mortality.

Equip FT stimulates active immunity against equine influenza virus and tetanus by eliciting both a cell mediated immune response and a humoral response.

Onset of immunity is within 2 weeks of completion of the primary course, with duration of immunity of at least 15 months for the influenza and 36 months for the tetanus.

2 ml

Equip FT should be shaken thoroughly before use and administered by deep intramuscular injection.

For protection against equine influenza and tetanus, Equip FT should be used as follows:

Thereafter, booster doses of Equip FT or Equip F should be administered so that the interval between the vaccinations against influenza is not more than 15 months and the interval between vaccinations against tetanus is not more than 36 months.

The routine practice of administering booster doses annually may remain the most convenient, even though protection against equine influenza has been demonstrated by challenge studies 15 months following the third vaccination (first booster dose). No field challenge studies have been carried out prior to the third vaccination; instead efficacy was evaluated by serology which showed titres equivalent to those found in horses protected against challenge at 15 months.

It is recommended that a single booster dose should only be administered to horses that have already received a full primary course using vaccines that contain the same types of equine influenza virus included in this vaccine. A full primary course may be considered necessary in horses that have not been suitably primed.

The efficacy of active immunisation of young foals against equine influenza and tetanus will be influenced by the level of maternally derived antibodies. This will vary between individuals due to a number of factors, e.g. the immune status of the dam; adequacy of colostral intake by the foal, etc. The vaccine should not be used in foals below 5 months of age, and foals should not be vaccinated until maternally derived antibodies have fallen below protective levels.

The vaccine may be used in pregnant mares which have been vaccinated against both influenza and tetanus before pregnancy. Heavily pregnant mares should not be subjected to undue stress when vaccinated.

Do not use in unhealthy animals.

The product should be administered by respecting appropriate (aseptic) injection technique.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

Rarely (<1 in 1000), animals may exhibit a reaction to vaccination. This may be manifest by stiffness, a mild, transient rise in temperature, typically 9-12 hours post vaccination, or a small soft, non-painful local swelling (10-20 mm in diameter) at the injection site. These conditions normally resolve by the day following vaccination.

Injection site pain, anorexia and lethargy have been reported in very rare cases (<1 in 10,000).

Occasional hypersensitivity reactions may occur. In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously or adrenalin intramuscularly.

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

Zero days.

Store in a refrigerator (2°C to 8°C). Protect from light. Do not freeze.

Keep out of the sight and reach of children.

For animal treatment only.

Packs with 10 x 2 ml doses. Each pack contains ten sterile disposable 2 ml syringes and 10 sterile needles.

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.

Onset of immunity has been demonstrated by virulent challenge for Equine Influenza strains A/equine/Newmarket/1/93 (American lineage H3N8), A/equine/South Africa/4/03 (Florida sublineage Clade 1 of the American lineage H3N8), A/equine/Sydney/2888-8/07 (Florida sublineage Clade 1 of the American lineage H3N8) and A/equine/Richmond/1/07 (Florida sublineage Clade 2 of the American lineage H3N8).

Duration of immunity has been demonstrated by virulent challenge for Equine Influenza strains A/equine/Sussex/89 (Eurasian lineage H3N8) and A/equine/Newmarket/2/93 (Eurasian lineage H3N8).

Protection afforded by vaccination is additionally demonstrated by serology for Equine Influenza strains A/equine/Newmarket/77 (H7N7), A/equine/Brentwood/79 (Eurasian lineage H3N8), A/equine/Borlange/91 (Eurasian lineage H3N8), A/equine/Kentucky/98 (American lineage H3N8), A/equine/Newmarket/1/93 (American lineage H3N8), A/equine/Newmarket/2/93 (Eurasian lineage H3N8), A/equine/South Africa/4/03 (Florida sublineage Clade 1 of the American lineage H3N8), A/equine/Sydney/2888-8/07 (Florida sublineage Clade 1 of the American lineage H3N8) and A/equine/Richmond/1/07 (Florida sublineage Clade 2 of the American lineage H3N8).

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

Vm 42058/4062