Product Description

Aservo EquiHaler is indicated for use in horses to reduce clinical signs associated with severe respiratory airway disease. Ciclesonide acts as a glucocorticoid receptor agonist with potent anti-inflammatory properties, with its active metabolite demonstrating glucocorticoid-receptor affinity significantly greater than dexamethasone.

For Horses:

Alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction — RAO)

Alleviation of clinical signs of Summer Pasture Associated Recurrent Airway Obstruction (SPA-RAO)

Which Animals Can Use Aservo EquiHaler?

Aservo EquiHaler is licensed for use in horses only. It has not been established as safe for use in foals or horses weighing less than 200 kg. It must not be used in horses known to be hypersensitive to ciclesonide, corticosteroids, or any excipients. Always use under the direction of your vet, who will assess suitability before prescribing.

Available Strengths & Sizes

Please order the exact product as specified on your veterinary prescription.

Note: Each EquiHaler contains sufficient inhalation solution for one horse for the full 10-day treatment course, plus additional volume to cover priming and potential administration losses.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. The treatment schedule and number of actuations are standardised regardless of body weight, but the attending veterinarian will determine suitability based on the horse's condition and temperament. Refer to the dispensing label and package leaflet for full administration instructions.

Contraindications

Source: SPC Section 4.3

Do not use in horses with known hypersensitivity to the active substance ciclesonide

Do not use in horses with known hypersensitivity to corticosteroids

Do not use in horses with known hypersensitivity to any of the excipients (ethanol, hydrochloric acid, purified water)

Storage & Handling

This veterinary medicinal product does not require any special storage conditions. Shelf life after first activation is 12 days. Keep out of reach of children and animals at all times. If the Aservo EquiHaler is visually damaged, it must not be used. Dispose of used or unused product in accordance with local requirements, noting that the cartridge will contain residual product at end of course.

Withdrawal periods:

Meat and offal: 18 days

Not authorised for use in horses producing milk for human consumption

Important Warnings

Source: SPC Sections 4.4 & 4.5

Animal precautions:

Safety has not been established in horses weighing less than 200 kg or in foals — do not use in these animals

Efficacy has not been established in horses with acute exacerbations of clinical signs of less than 14 days' duration

The prescribing veterinarian should assess whether the horse's temperament is suitable for safe and effective administration

Some horses may not adapt to the EquiHaler device within a couple of days; an alternative treatment should be considered if the horse does not adapt

Onset of clinical improvement may take several days; the full 10-day treatment schedule should normally be completed

Concomitant medication such as bronchodilators and environmental management may need to be considered in cases of severe respiratory obstruction, at the veterinarian's discretion

The breath indicator in the nostril adapter chamber must be observed to confirm inhalation; if movement is not visible or is too rapid, do not administer

The product should not be used if the EquiHaler device is visually damaged

Human safety warnings:

An aerosol filtering mask must be worn during handling and administration to prevent inadvertent inhalation of ciclesonide in the event of unintended actuation

Persons with known hypersensitivity to ciclesonide or any excipient should avoid contact with this product

Inhalative or intranasal corticosteroids may cause rhinitis, nasal discomfort, nosebleed, upper respiratory tract infection, and headache in handlers

The product can cause irritation to the eyes due to ethanol content — avoid eye contact; in the event of accidental eye contact, rinse immediately with large quantities of water

Pregnant women must not administer this product. Ciclesonide has been shown to induce foetal malformations (cleft palate, skeletal malformations) in animal studies; its safety following inhalatory exposure in pregnant women has not been established

In the event of an adverse reaction due to accidental inhalation or eye irritation, seek medical advice immediately and show the package leaflet or label to the physician

Administration should take place in well-ventilated surroundings

These precautions apply to the person administering the product and to any person in close proximity to the horse's head during administration

It is essential to keep the product out of reach of children

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 04491/5003