Aservo EquiHaler 343 mcg/actuation

The Aservo Equihaler is designed specifically for use in horses with severe equine asthma. An ergonomic handle and dosing lever make it simple to administer. The anatomically designed nostril adaptor fits inside the nostril of the horse, making it easier for them to inhale the medicated mist. After veterinary consultation, please read and understand the entire contents of the user manual for instructions regarding proper handling and use of Aservo Equihaler. Do not use in horses with known hypersensitivity to ciclesonide or glucocorticoids.

Features

A combination of a novel glucocorticoid (ciclesonide) and advanced inhalation technology (Soft Mist Inhaler) designed specifically for horses with severe equine asthma.

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

Indications

Aservo Equihaler is indicated for the management of clinical signs associated with severe equine asthma in horses.

View Aservo Equihaler User Manual.

For intranasal inhalation use only. ASERVO EQUIHALER may be used as part of the overall management of severe equine asthma in addition to other appropriate strategies to control clinical signs, such as environmental changes and bronchodilator therapy, as needed.

The initial dose of ASERVO EQUIHALER is 8 actuations (2744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4116 mcg ciclesonide) once daily for 5 days.

Prior to use, please refer to the detailed instructions for the handling and use of ASERVO EQUIHALER provided in this "User Manual".

ASERVO EQUIHALER should only be administered in the left nostril of the horse. Following careful and proper insertion, the ASERVO EQUIHALER should have a snug fit in the left nostril. A snug fit is required to ensure the horse receives a complete dose of ASERVO EQUIHALER.

Instructions for handling and use of the Aservo Equihaler

Please read the following instructions carefully prior to first use of the ASERVO EQUIHALER (ciclesonide inhalation spray)

The ASERVO EQUIHALER is an inhaler for horses. It contains sufficient inhalation solution for the complete course of the 10-day treatment. The inhaler cannot be refilled and should be disposed of 12 days after activation.

Introduction to the Aservo Equihaler

The Aservo Equihaler is for left hand use only. While holding the Aservo Equihaler with your left hand, hold and control your horse with your right hand.

In the following chapters, activation, preparation, administration, cleaning, and storage of the ASERVO EQUIHALER are described in detail.

Activate the ASERVO EQUIHALER only once prior to first use.Use within 12 days of activation. Calculate 12 days from activation date and record this date on the device label on the "Use by ______" location provided.

Preparation

Preparation of the ASERVO EQUIHALER (ciclesonide inhalation spray) is required to ensure accurate initial dosing. Preparation is performed only once and consists of three (3) actuations (described below). The spray will be fully visible after the third actuation.

When pressing the lever (E) of the ASERVO EQUIHALER for the first time, the lower part of the piercing element with the fill indicator (F) will become visible again. Do not push the piercing element back up into the device.

Actuation

Each actuation is a two-step process that results in release of the drug (one puff).It consists of the following steps (pictures 5 to 8):

Please note: If the piercing element is accidently pushed completely into the handle again, it will automatically slide into the correct position the next time the ASERVO EQUIHALER is actuated.

Administration

Administration is intended for use in the left nostril only. The nostril adapter should remain in the nostril during the entire administration of the 8 or 12 actuations (puffs). If the nostril adapter slides out of the nostril during administration, please re-insert into the nostril again.

Fill Indicator

Manual recording of dosing is encouraged. In the event the fill indicator does not appear to be functioning, it is important to continue to treat the horse as prescribed. In addition, if the prescribed 10-day dosing has been completed do not continue to use if the fill indicator reads above 0%. If your horse continues to show clinical signs please contact your veterinarian.

Cleaning of the Aservo Equihaler

Cleaning is only required on an as-needed basis. Wipe the outside of the nostril adapter with a damp cloth to remove foreign material, if needed.

Cleaning of the inner surface of the nostril adapter is not required unless nasal discharge or other foreign material is adhered to the inner surface. If it is necessary to clean the inner surface, remove the nostril adapter and rinse as described below.

Before cleaning, check that the fill indicator is blue/white. If it is red, press the lever (E) until the click is heard. This will ensure you do not accidentally release any spray. To avoid inhalation, hold the inhaler away from your body.

Designed for horses with severe asthma

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.

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications:

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

Warnings/Precautions:

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 and show the package insert or the product label to the physician.

People with known hypersensitivity to ciclesonide or any of the excipients should avoid contact with ASERVO EQUIHALER.

Animal Safety Warnings and Precautions: Safe use of ASERVO EQUIHALER has not been evaluated in pregnant or lactating mares.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered during pregnancy can be teratogenic. Therefore, ASERVO EQUIHALER should only be used in pregnant mares if the potential benefit justifies the potential risk to the fetus.

Administration of corticosteroids may worsen existing bacterial, fungal, or viral infection. Secondary infections should be ruled out before prescribing ASERVO EQUIHALER. Inhaled corticosteroids should be used with caution, if at all, in horses with active infection of the respiratory tract. If clinical signs do not improve or worsen despite administration of ASERVO EQUIHALER, the prescriber should consider additional diagnostic evaluation.

Due to the potential for exacerbation of clinical signs of laminitis, glucocorticoids should be used with caution in horses with a history of laminitis, or horses otherwise at a higher risk for laminitis.

Use with caution in horses with chronic nephritis, equine pituitary pars intermedia dysfunction (PPID), and congestive heart failure.

Concurrent use of other anti-inflammatory drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs) or other corticosteroids, should be approached with caution. Due to the potential for systemic exposure, concomitant use of NSAIDs and corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity. Consider appropriate wash out times prior to administering NSAIDs or additional corticosteroids.

Other Warnings:

Do not use in horses intended for human consumption.

Information for Horse Owner:

Please review the User Manual with horse owners to ensure they understand the entire contents. The User Manual includes important instructions regarding the proper handling and use of ASERVO EQUIHALER. Demonstration of the activation, administration and storage of ASERVO EQUIHALER with the horse owner is highly recommended.

Storage:

Store at 15-30°C (59°-86°F), with excursions permitted up to 40°C (104°F). Protect from freezing.Use within 12 days of activation.