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Contra-indications, warnings, etc
Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
Special warnings for each target species
Special care should be taken when administering the veterinary medicinal product. To ensure an efficacious administration, the breath indicator in the chamber wall of the nostril adapter needs to be observed: when the horse inhales, the membrane of the breath indicator curves inwards. During exhalation, the membrane of the breath indicator curves outwards. The spray should be released at the beginning of inhalation, i.e. when the breath indicator starts curving into the chamber. If the movement of the breath indicator cannot be observed, assure the correct positioning of the nostril adapter. If movement of the breath indicator is still not visible or the movement is too rapid, the product should not be administered.
Efficacy of the product has not been established in horses with acute exacerbations (<14 days duration) of clinical signs.
Special precautions for use
Special precautions for use in animals
Safety of the veterinary medicinal product has not been established in horses weighing less than 200 kg body weight, or in foals.
The prescribing veterinarian should assess if the horse has a temperament suitable for a safe and efficacious administration of the Aservo EquiHaler in agreement with good veterinary practice.
Horses might not adapt to an easy and safe application of the Aservo EquiHaler within a couple of days. An alternative treatment should be considered if the horse does not adapt to the treatment with Aservo EquiHaler.
The onset of clinical improvement may take several days. The use of concomitant medication (such as bronchodilators) and environmental control may need to be considered in cases of severe clinical signs of respiratory obstruction, at the discretion of the attending veterinarian (see also "Interaction with other medicinal products and other forms of interaction").
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Follow closely the instructions for handling and use of the Aservo EquiHaler as provided in the package leaflet section “Other Information”.
Acclimatising the horse with a training device, available from the marketing authorisation holder, prior to treatment start has shown to ease the administration of the veterinary medicinal product. Surveillance has shown cases where the horses were non-cooperative and therefore could not be treated according to the product information. In case a horse has a tendency towards defensive behavioural reactions, additional safety precautions could be considered (e.g. employ a second person to handle the horse).
Administration of the product should take place in well ventilated surroundings.
People with known hypersensitivity to ciclesonide or any of the excipients should avoid contact with the veterinary medicinal product.
Inhalative or intranasal corticosteroids may cause rhinitis, nasal discomfort, nosebleed, upper respiratory tract infection and headache. An aerosol filtering mask must be worn during handling and administration. This prevents inadvertent inhalation in case of unintended release of actuations outside the nostril or without the nostril adapter.
The product can cause irritation to the eyes due to its ethanol content. Avoid contact with eyes. In case of accidental eye contact, rinse with large quantities of water.
In case of experiencing an adverse reaction due to accidental inhalation, and in case of eye irritation, seek medical advice and show the package leaflet or the label to the physician.
These precautions should be followed by the person administering the product and persons in close proximity to the horse’s head during administration.
The safety of ciclesonide after inhalatory exposure has not been established in pregnant women. In animal studies ciclesonide has been shown to induce malformations in foetuses (cleft palate, skeletal malformations). Pregnant women should therefore not administer the product.
If the Aservo EquiHaler is visually damaged it should not be used any more.
It is essential to keep the product out of reach for children.
Adverse reactions (frequency and seriousness)
Mild nasal discharge was commonly observed during safety and clinical studies. The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Use only according to the benefit/risk assessment by the responsible veterinarian.
The product was shown to be teratogenic following oral administration after high doses in rabbits but not in rats.
Interaction with other medicinal products and other forms of interaction
Concomitant use of clenbuterol in a field study in seven horses with severe equine asthma did not indicate any safety concerns.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of the veterinary medicinal product at up to the 3-fold recommended dose for 3 times the recommended treatment duration no relevant clinical signs were observed.
Withdrawal period
Meat and offal: 18 days
Not authorised for use in horses producing milk for human consumption.
Major incompatibilities
Not applicable.