Equilis Prequenza Te
vaccine against equine influenza and tetanus in horses
Equilis Prequenza Te suspension for injection for horses
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
The Netherlands
Equilis Prequenza Te suspension for injection for horses
Each dose of 1 ml contains:
Equine influenza virus strains:
A/equine-2/ South Africa/4/03 50 AU1
A/equine-2/ Newmarket/2/93 50 AU
Tetanus toxoid 40 Lf2
Antigenic ELISA units
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test
Iscom Matrix containing:
Purified saponin 375 micrograms
Cholesterol 125 micrograms
Phosphatidylcholine 62.5 micrograms Clear opalescent suspension.
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 the primary vaccination course Duration of immunity: 5 months after the primary vaccination course
12 months 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
24 months after the first revaccination
None.
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). A local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur in very rare cases. Fever, sometimes accompanied by lethargy and inappetence, may in very rare cases occur for 1 day, and up to 3 days in exceptional circumstances.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Horses 
1 ml. Intramuscular use. Vaccination schedule:
Primary vaccination course
Administer one dose (1 ml) strictly intramuscularly according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Revaccination
Influenza
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/4/03and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
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 scheme).
V1 V2 5 V3 12 V4 12 V5 12 V6
0 1 6 18 30
42 months
Prequenza Prequenza Prequenza
Prequenza Te
Prequenza
Prequenza Te
Te Te
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).
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 Te should 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 to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Allow the vaccine to reach room temperature before use.
Zero days.
Keep out of the sight and reach of children. Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month
Special warnings for each target species:
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.
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 this package insert or the label to the physician.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
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 Intervet (see section 8: Dosage for each species, route(s) and method of administration).
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.
Overdose (symptoms, emergency procedures, antidotes):
Following the administration of a double dose of vaccine, no side-effects other than those described under section 6. Adverse reactions, have been observed except for some depression at the day of vaccination.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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Cardboard box with 10 glass vials of 1 ml (1 dose).
Cardboard box with 1, 5 or 10 pre-filled syringes of 1 ml (1 dose) with needles.
Not all pack sizes may be marketed.