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.

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

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

1 year after the first revaccination. Tetanus

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

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

2 years after the first revaccination.

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.

Vaccinate healthy animals only.

Horses:

1 A diffuse hard or soft swelling (max. diameter 5 cm), regressing within 2 days. A local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur in very rare cases.

2 Pain at the injection site may result in temporary functional discomfort (stiffness).

3 Fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.

4 Including anaphylaxis (sometimes fatal). If such a reaction occurs, appropriate treatment should be administered without delay.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from MSD Animal Health (see section "Amounts to be administered and administration route").

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

Allow the vaccine to reach room temperature before use.

Vaccination schedule:

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

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

It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine. A primary vaccination course may be considered necessary in horses that have not been suitably primed. 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/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).

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 scheme).

The vaccine can be used together with Tetanus Serum from MSD Animal Health 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 MSD Animal Health 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 Te should be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus Serum from MSD Animal Health may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.

Following the administration of a double dose of vaccine, no side-effects other than those described in section “Adverse Reactions” have been observed except for some depression at the day of vaccination.