Aservo^® EquiHaler^®

(ciclesonide inhalation spray)

ASERVO EQUIHALER is a novel glucocorticoid (ciclesonide) delivered via Soft Mist™ inhaler indicated for the management of clinical signs associated with severe equine asthma in horses.

For more information about Aservo EquiHaler please visit AservoEquihaler.com.

IMPORTANT SAFETY INFORMATION: ASERVO EQUIHALER has not been evaluated in pregnant or lactating mares. In a large clinical field study, the most common adverse reactions reported were coughing, nasal discharge, sneezing and nasal irritation/bleeding. Administration of glucocorticoids may worsen existing bacterial, fungal, or viral infection and may induce the first stage of parturition. Glucocorticoids should be used with caution in horses at a higher risk for laminitis. Not for use in humans. Keep this and all medications out of the reach of children. In case of accidental inhalation, seek medical advice immediately. INFORMATION FOR HORSE OWNERS: After veterinary consultation, please read and understand the entire contents of the user manual for instructions regarding proper handling and use of ASERVO EQUIHALER.

Severe equine asthma can only be diagnosed by a veterinarian. Therefore, ASERVO EQUIHALER can only be prescribed by a veterinarian. However, ASERVO EQUIHALER is made to be easily administered by an owner.

ASERVO EQUIHALER is an all-in-one product, so there is no need to purchase any additional equipment to administer it. The nostril adapter fits inside the horse’s left nostril and the lever is used to release each puff of medication. The product is administered with the left hand, leaving the right hand free to aid in handling the horse. ASERVO EQUIHALER contains enough medication to treat a horse for the labeled 10 days of administration (8 puffs twice a day for 5 days, then 12 puffs once a day for 5 days).

Before using the treatment, make sure to read the product leaflet inside the box carefully and follow the instructions on how to pierce, prime and administer the product safely. The User Manual is also available digitally on AservoEquihaler.com/how-to-use. The scannable QR code on the box and in the user manual provide an instructional video.

How to use ASERVO EQUIHALER

ASERVO EQUIHALER is not for human use. Keep this and all medications out of the reach of children. Do not use in horses with known hypersensitivity to ciclesonide or corticosteroids. Administration of corticosteroids may worsen existing bacterial, fungal, or viral infection and may induce the first stage of parturition. Glucocorticoids should be used with caution in horses at a higher risk for laminitis.

Find out more at AservoEquihaler.com

For the full Prescribing Information, click here.

ASERVO EQUIHALER has not been evaluated in pregnant or lactating mares. In a large clinical field study, the most common adverse reactions reported were coughing, nasal discharge, sneezing, and nasal irritation/bleeding. Not for use in humans. Keep this and all medications out of the reach of children. In case of accidental inhalation, seek medical advice immediately.

Information for horse owners: After veterinary consultation, please read and understand the entire contents of the user manual for instructions regarding proper handling and use of ASERVO EQUIHALER.

For full safety information visit: AservoEquihaler.com/important-safety-information

IMPORTANT SAFETY INFORMATION:

• Safe use of ASERVO EQUIHALER has not been evaluated in pregnant or lactating mares.

• In a large clinical field study, the most common adverse reactions reported were coughing, nasal discharge, sneezing, and nasal irritation/bleeding.

• Do not use in horses with known hypersensitivity to ciclesonide or corticosteroids.

• Corticosteroids may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition.

• Administration of corticosteroids may worsen existing bacterial, fungal, or viral infection.

• Inhaled corticosteroids should be used with caution, if at all, in horses with active infection of the respiratory tract.

• Glucocorticoids should be used with caution in horses with a history of laminitis.

• Concurrent use of other anti-inflammatory drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs) or other corticosteroids, should be approached with caution.

HUMAN WARNINGS:

• Not for use in humans.

• Keep this and all medications out of the reach of children.

• In case of accidental inhalation, seek medical advice immediately.

• People with known hypersensitivity to ciclesonide or any of the excipients should avoid contact with this veterinary medicinal product.