SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Equip FT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 2ml:

Active substances:

Equine influenza virus inactivated strains:

A/equine/Newmarket/77 (H7N7) ≥ 1.2 log₁₀HAI*

A/equine/Borlange/91 (H3N8) ≥ 2.1 log₁₀ HAI*

A/equine/Kentucky/98 (H3N8) ≥ 2.4 log₁₀HAI*

Immunopurified Tetanus Toxoid ≥ 70 IU/ml^$

* HAI: Haemagglutination Inhibition titre

^$IU: International units

Adjuvant(s):

Quil A

Aluminium phosphate

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Horses from 5 months of age

4.2 Indications for use, specifying the target species

For the active immunisation of horses of 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 clinical signs and virus excretion after infection, and against tetanus to prevent mortality.

Duration of immunity is at least 15 months for influenza and 36 months for tetanus.

Onset of immunity is within 2 weeks of completion of the primary course.

4.3 Contraindications

None

4.4 Special warnings

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.

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 and the ability of the animal to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, nutritional status, concurrent drug therapy and stress.

4.5 Special precautions for use

i. Special precautions for use in animals

Do not use in unhealthy animals.

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

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation or lay

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 subject to undue stress when vaccinated.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

Dose: 2 ml

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

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

Primary Course First dose EQUIP FT

6 week interval

Second dose EQUIP FT

5 month interval

Boosters 1st booster EQUIP F

12-15 month interval

2nd booster EQUIP F

12-15 month interval

3rd booster EQUIP FT

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

Note: 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Accidental overdosage is unlikely to cause any reactions other than those described in section 4.6.

4.11 Withdrawal period(s)

Zero days

5. IMMUNOLOGICAL PROPERTIES

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

Further information on the protection afforded by vaccination:

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).

ATC Vet Code:QI05AL01

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Quillaic Acid derivative (Quil A)

Aluminium phosphate

Phosphatidyl choline

Cholesterol

Ammonium acetate

Phosphate buffered saline

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

6.4. Special precautions for storage

Store in a refrigerator (2C to 8C).

Protect from light. Do not freeze.

Keep the container in the outer carton.

6.5 Nature and composition of immediate packaging

Type I glass vial with chlorobutyl rubber stopper and aluminium overseal.

Packaging: Box of 10 single-dose vials. Each box contains ten sterile disposable 2 ml syringes and 10 sterile needles.

Type I glass syringe closed with bromobutyl rubber plunger stopper and tip cap .

Packaging: Box of 10 single-dose prefilled syringes with needles

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm 42058/4062

17 October 2005

June 2016

27 June 2016