Suspension for injection, for horses

Presentation

Inactivated vaccine containing per dose of 1 ml purified haemagglutinin subunits from equine influenza viruses: 100 AU[1]  A/equi-1/ Prague/1/ 56 ; 50 AU A/equi-2/ Newmarket/1/93 ; 50 AU A/equi-2/ Newmarket/2/93 and 40 Lf[2]  Tetanus toxoid, with an ISCOM-Matrix ( 375 µg purified Saponin; 125 µg Cholesterol; 62.5  µg Phosphatidylcholine).

Uses

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza

Onset of immunity:           2 weeks after completion of the primary vaccination course.

Duration of immunity:       5 months after completion of the primary vaccination course.

                                      12 months after the first revaccination.

Tetanus

Onset of immunity:           2 weeks after completion of the primary vaccination course.

Duration of immunity:       17 months after completion of the primary vaccination course.

                                      24 months after the first revaccination.

Dosage and administration

Dose: 1 ml by intramuscular administration in horses.

Vaccination schedule:

Primary vaccination course

Administer one dose (1ml) by intramuscular injection according to the following schedule:

Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later

Revaccination

Influenza

The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.

The second revaccination is given 12 months after the first revaccination.

The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equi 1/Prague 56, A/equi 2/Newmarket 1/93 and A/equi 2/Newmarket 2/93, is recommended to maintain immunity levels for the influenza component (see schedule).

Tetanus

The first revaccination is given not later than 17 months after the primary vaccination course.
Thereafter a maximum interval of two years is recommended (see schedule).

Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later.   A third vaccination with Equilis Prequenza Teshould be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared with horses vaccinated withEquilis Prequenza Te in the absence of tetanus antitoxin serum.

Allow the vaccine to reach room temperature (15-25°C) before use. 

Can be used during pregnancy and lactation.

Contra indications, warnings, etc.

A diffuse hard or soft swelling (max. diameter 5 cm) may occur, regressing within 2 days. Pain at the injection site can occur occasionally. In some cases fever may occur for 1 day, and up to 3 days in exceptional circumstances. 

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

Only healthy animals should be vaccinated.

Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies. However, if vaccination is given at 4 months of age owing to increased infection risk then the primary course should be given from 6 months of age.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other vaccine. Safety and efficacy of concurrent use with Tetanus-Serum from Intervet has been demonstrated. It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.

Do not mix with any other vaccine or immunological product.

Operator warning:

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

Withdrawal period:

Zero days

For animal treatment only.   Keep out of reach and sight of children.

Legal category

POM-V                         To be supplied only on veterinary prescription.

Pharmaceutical precautions

Store between 2°C and 8°C.   Protect from light. Do not freeze. 

Do not use after the expiry date stated on the label. 

Disposal advice:

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

Package quantities

Cardboard box with 10 glass vials of 1 ml.

Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.

Not all pack sizes may be marketed.

Further information

Nil.

Marketing Authorisation holder

Intervet International B.V. The Netherlands

Distributed in the UK by:

Intervet UK Ltd.

Walton

Milton Keynes, Bucks.

MK7 7AJ

Distributed in Ireland by:

Intervet Ireland Ltd

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Marketing Authorisation number

EU/2/05/057/001-004

Date of text preparation:

August 2006.

[1]Antigenic units

[2]Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test