Target species
Horses.
Indications for use for each target species
For the active immunisation of horses of 5 months of age or older against Equine Influenza of H7N7 and H3N8 types (European or American strains, including Florida sublineage Clade 1 and Clade 2 isolates) to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Onset of immunity: within 2 weeks of completion of the primary course.
Duration of immunity: 1 year and 3 months for influenza and 3 years for tetanus.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
The efficacy of active immunisation of young foals against equine influenza and tetanus will be influenced by the level of maternally derived antibodies. This will vary between individuals due to a number of factors, e.g. the immune status of the dam, adequacy of colostrum intake by the foal, etc. The vaccine should not be used in foals below 5 months of age, and foals should not be vaccinated until maternally derived antibodies have fallen below protective levels.
In any animal population, there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the ability of the animal to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, nutritional status, concurrent drug therapy and stress.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
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 the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses:
Rare (1 to 10 animals / 10,000 animals): | Injection site swelling1,3 Stiffness1 Elevated temperature1,2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site pain Hypersensitivity reaction4 Anorexia, Lethargy |
1 This condition normally resolves by the day following vaccination.
2 Mild, transient, typically 9-12 hours post vaccination.
3 Local, small (10-20 mm in diameter), soft, non-painful.
4 In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously or adrenalin intramuscularly.
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.
Use during pregnancy, lactation or lay
Pregnancy:
The vaccine may be used in pregnant mares which have been vaccinated against both influenza and tetanus before pregnancy.
Heavily pregnant mares should not be subject to undue stress when vaccinated.
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.
Administration routes and dosage
Dose: 2 ml
Administration: The veterinary medicinal product should be shaken thoroughly before use and administered by deep intramuscular injection.
Vaccination schedule: For protection against equine influenza and tetanus, the veterinary medicinal product should be used as follows:
Primary course | First dose | EQUIP FT |
| | 6 week interval |
| Second dose | EQUIP FT |
| | 5 month interval |
Boosters | 1st booster | EQUIP F |
| | 12-15 month interval |
| 2nd booster | EQUIP F |
| | 12-15 month interval |
| 3rd booster | EQUIP FT |
Thereafter, booster doses of Equip FT or Equip F should be administered so that the interval between vaccinations against influenza is not more than 15 months and the interval between vaccinations against tetanus is not more than 36 months.
Note: The routine practice of administering booster doses annually may remain the most convenient, even though protection against equine influenza has been demonstrated by challenge studies 15 months following the third vaccination (first booster dose). No field challenge studies have been carried out prior to the third vaccination; instead, efficacy was evaluated by serology which showed titres equivalent to those found in horses protected against challenge at 15 months.
It is recommended that a single booster dose should only be administered to horses that have already received a full primary course using vaccines that contain the same types of equine influenza virus included in this vaccine. A full primary course may be considered necessary in horses that have not been suitably primed.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Accidental overdosage is unlikely to cause any reactions other than those described in section "Adverse events".
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Zero days.