Equilis Prequenza TE Suspension for injection for horses

Equilis Prequenza Te, Suspension for injection for horses.

Qualitative and quantitative composition

Per dose of 1 ml:

Active substances:

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

1 Antigenic units

2 Flocculation equivalents; corresponds with

= 30 IU/ml guinea pig serum in the Ph.Eur. potency test

Adjuvants:

Purified Saponin: 375 micrograms

Cholesterol: 125 micrograms

Phosphatidylcholine: 62.5 micrograms

For a full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Clear opalescent suspension for injection.

Clinical particulars

Target species

Horses

Indications for use

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.

Contra-indications

None.

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.

Special precautions for use

Only healthy animals should be vaccinated.

Special precautions for use in animals

Not applicable.

Operator warnings:

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

Adverse reactions

A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days. In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence may occur for 1 day, and up to 3 days in exceptional circumstances.

Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

Interactions

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Antitoxin Behring (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.

Amounts to be administered and administration route

Intramuscular use.

Vaccination schedule:

Primary vaccination course

Administer one dose (1 ml), by strict 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/equine-2/South Africa/4/03 and A/equine-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).

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 Antitoxin Behring 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 Antitoxin Behring 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 Antitoxin Behring may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin.

Overdose

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.

Withdrawal periods

Zero days.

Pharmacological particulars

Immunological properties

To stimulate active immunity against Equine influenza and tetanus.

ATC-vet code: QI05AL01

Pharmaceutical particulars

Excipients

Phosphate buffer, traces of thiomersal, traces of formaldehyde.

Major incompatibilities

Do not mix with any other veterinary medicinal product.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Special precautions for storage

Store at 2 °C - 8 °C, protected from light. Do not freeze.

Immediate packaging

Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.

Package size:

10 vials of 1 ml.

1, 5 or 10 pre-filled syringes with needles.