Suspension for injection, for horses

Presentation

Inactivated vaccine containing per dose of 1 ml:

Purified haemagglutinin subunits from equine influenza viruses:   100   AU¹ A/equi-1/ Prague/1/ 56; 

50 AU A/equi-2/ Newmarket/1/93; 50 AU A/equi-2/ Newmarket/2/93 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.

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.

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

The first revaccination (third dose) 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 tetanus and 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).

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).

Allow the vaccine to reach a temperature of 15°C - 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.

Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression on the day of vaccination.

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

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.

Only healthy animals should be vaccinated.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other vaccine. 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.

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.

Legal category

POM-V                        To be supplied only on veterinary prescription.

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/2/05/056/001-002

Date of text preparation:

October 2006.

^{1  Antigenic units}