Special precautions for safe use in the target species:
The efficacy of active immunisation of young foals against equine influenza 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 colostral 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 to be taken by the person administering the veterinary medicinal product to animals
The product should be administered by respecting appropriate (aseptic) injection technique
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Horses.
Rare
(1 to 10 animals / 10,000 animals treated):
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.
Pregnancy:
The vaccine may be used in pregnant mares which have been vaccinated against influenza before pregnancy.
Heavily pregnant mares should not be subject to undue stress when vaccinated.
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.
Withdrawal period
Zero days.