BioEquin FT, injectable suspension for horses

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Content

One dose (1 ml) of vaccine contains:

Virus influenzae equorum inactivatum, strain:
A/Equi 2/Limerick 2010(American type, subline Florida 1), H3N8          min. 5 log₂ HIT¹
A/Equi 2/Brno 08 (American type, subline Florida 2), H3N8                   min. 5 log₂ HIT¹
Tetanus anatoxin, purified                                                                           min. 30 IU²

¹Geometric mean of specific antibodies determined by haemagglutination inhibition test in guinea pig serum
²International units; titre of anti-toxin antibodies, induced after repeated vaccination of guinea pigs according to Ph. Eur., as determined using the ELISA method

Injectable suspension.White or yellowish to grey-brown suspension. Sediment forms when left standing, which disperses after shaking.

Target species

Horses.

Indications for use, specifying the target species

For active immunisation of horses over six months of age against equine influenza to reduce clinical signs and viral excretion following infection with equine influenza virus and for active immunisation against tetanus.

The onset of immunity was demonstrated by challenge test for equine influenza strain A/Equi 2/Brno 08 and equine influenza strain A/Equi 2/Limerick 2010 .

The duration of immunity for vaccine strain A/Equi 2/Brno 08 of equine influenza was demonstrated by serology.

Influenza:

Onset of immunity: 2 weeks after basic vaccination

Duration of immunity: 6 months after basic vaccination and at least 12 months after first revaccination (third dose of the vaccine).

Tetanus:

Onset of immunity: 2 weeksafter basic vaccination

Duration of immunity: 6 months after basic vaccination and at least 12 months after first revaccination (third dose of the vaccine).

Contraindications

None.

Special warnings for each target species

In case of an increase in infection pressure, revaccination for equine influenza is recommended at an interval of 6 months, for all horses at stud.

All horses at stud should be vaccinated in order to reduce infection pressure.

Before moving horses to another stud farm or other stables, or before a race or meet, at least basic vaccination is recommended, allowing 14 days to acquire the necessary immunity. At least basic vaccination is also recommended as part of quarantine for all unvaccinated horses brought to stud, allowing 14 days to acquire the necessary immunity.

It is recommended that sick horses with symptoms of respiratory disease be stabled and kept in isolation from healthy animals.

Adverse reactions (frequency and seriousness)

Very often a slight increase in temperature of up to 1 °C may be observed in connection with vaccination for a period of 1-3 days.
In very rare cases, an anaphylactic reaction may occur. In such a case, symptomatic treatment is required.

Use during pregnancy, lactation or lay

Can be used during pregnancy. The safety of the veterinary medicinal product has not been determined during lactation.

Interactions with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when administered in conjunction with any other veterinary medicinal product. The decision to use this vaccine before or after any other veterinary medicinal product must be made on a case by case basis.

Amounts to be administered and administration route

Vaccination dose - 1 ml. The vaccine is administered by deep intramuscular injection.

The contents of the vial should be warmed to a temperature of 15 – 25 °C and shaken thoroughly before use.

Vaccination programme

Basic vaccination:
First vaccination from 6 months of age, second vaccination in 4 weeks.

Revaccination:
First revaccination 6 months after basic vaccination and further revaccination at intervals of 12 months.
Mares in foal are revaccinated in the last trimester of pregnancy, but no later than one month prior to scheduled delivery.
It is recommended that BioEquin FT not be used to revaccinate horses previously vaccinated with a vaccine from a different manufacturer or to revaccinate with a vaccine from a different manufacturer after using BioEquin FT. The exception is vaccines containing the same strains of equine influenza as BioEquin FT.

Withdrawal period

Zero days

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 33 months.
Shelf life after first opening of multi-dose package: 10 hours.

Special precautions for storage

Store in a refrigerator (2 – 8 °C). Protect from frost. Protect from light.  Store in a dry place.

Package sizes

2 x 1 dose, 10 x 1 dose

Not all pack sizes may be marketed.