BioEquin FH, emulsion for injection for horses

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One vaccine dose (1 ml) contains:  

Virus influenzae equorum inactivatum, strain:

A/Equi 2/Brno 08 (American type line Florida 2) H3N8                Min. 6.0 log2 HIT¹

A/Equi 2/ Limerick 2010 (American type line Florida 1) H3N8      Min. 6.0 log2 HIT¹

Inactivated equine herpesvirus type 1, (EHV-1)                              Min. 2.1 log10 VNI²

1 The geometric mean of specific antibodies determined by hemagglutination inhibition test in the guinea pig serum

2 The virus neutralization index in the hamster serum

Adjuvant(s):

Oil adjuvant (Montanide ISA 35 VG)      0.25 ml

Excipient(s):

Thiomersal      0.1 mg

Emulsion for injection. The vaccine is a white, oily liquid with easily shakeable sediment.

Target species:

Horses.

Indications for use, specifying the target species:

For active immunization of horses to reduce the occurrence of respiratory infections and clinical signs caused by equine influenza virus and equine herpesvirus type 1(EHV-1).

For active immunization to reduce the occurrence of abortions in pregnant mares caused by equine herpesvirus type 1 (EHV-1) infection.

Onset of immunity has been demonstrated by virulent challenge for equine influenza strain A/Equi 2/Brno 08 and for strain A/Equi 2/ Limerick 2010.

Duration of immunity has been demonstrated by serology for both vaccine influenza strains.

Influenza

Onset of active immunity: 2 weeks after primary vaccination

Duration of active immunity: 6 months after revaccination

Herpesvirus type 1

Onset of active immunity: 2 weeks after primary vaccination

Duration of active immunity: 6 months after revaccination

Contraindications:

Not applicable.

Special warnings for each target species:

In order to reduce the infection pressure, all horses on a farm should be vaccinated. At least primary vaccination, with the following 14 days of rest necessary to create immunity, should be performed before transfers of horses to other herds or stables, or before races. Regular vaccination of all animals in a breeding facility, with observance of prescribed deadlines, is necessary to create and maintain immunity from equine herpesvirus and equine influenza virus infections. Primary vaccination, with the following 14 days of rest necessary to create immunity, is recommended during the quarantine period for all unvaccinated horses to be included in breeding. Sick horses with signs of a respiratory disease should be isolated from healthy animals.

Special precautions for use:

Special precautions for use in animals

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 the package leaflet or label to the physician. This product contains mineral oil. Accidental injection/self injection may result in severe pain. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.If pain persists for more than 12 hours after medical examination, seek medical advice again.

Adverse reactions (frequency and seriousness):

Temporary temperature increase can be observed after vaccination. Sporadic anaphylactic reactions may occur. Symptomatic treatment should be provided in such a case.

Use during pregnancy, lactation or lay:

Can be used during pregnancy.

The safety of the veterinary medicinal product has not been established during lactation.

Interaction with other medicinal products and other forms of interaction:

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

Vaccine dose - 1 ml.

The vaccine (1 ml) is applied deep intramuscularly.

Before use heat the contents of the vial to a temperature of 15-25°C and shake well.

Vaccination schedule:

Primary vaccination against equine influenza and herpesvirus:

The first vaccination at the age of 6 months; the second vaccination 4 weeks later.

Revaccination against equine influenza and herpesvirus:

The first revaccination (third dose) is administered 3 months after the primary vaccination and next revaccination is carried out every 6 months.

Vaccination of pregnant mares:

To reduce the incidence of abortions caused by equine herpesvirus infection one dose of the vaccine is administered to pregnant mares in the second month after mating and then in the fifth or sixth month and in the ninth month of pregnancy.

Overdose (symptoms, emergency procedures, antidotes), if necessary:

Not applicable.

Withdrawal periods:

Zero days.

Immunological properties:

For active immunization against equine influenza and equine herpesvirus.

Application of active substances into the body of an animal causes an active immune response that is manifested by induction of local and systemic humoral immunity and the activity of cytotoxic T-lymphocytes.

Active immunity starts no later than 14 days after the primary vaccination performed according to the recommended vaccination schedule.

The immunity of foals and adult horses against equine herpesvirus and equine influenza virus lasts at least 6 months after the third vaccination and next revaccinations. The recommended vaccination schedule must be observed to ensure a long-term immunity.

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months. Shelf-life after first opening the immediate packaging: 10 hours.

Special precautions for storage

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

Package:  

2 x 1 dose, 10 x 1 dose

Not all pack sizes may be marketed.