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 * How to use
 * Important safety information
 * Prescribing information


BREATHE EASY


AN INNOVATION IN THE MANAGEMENT OF SEVERE EQUINE ASTHMA.

What Makes ASERVO EQUIHALER unique
 * Breathe Easy
 * Features
 * Ciclesonide
 * Soft Mist™
 * Designed for Horses


DESIGNED TO CONSISTENTLY DELIVER CICLESONIDE

 * Soft Mist™ Technology delivers medication in a slow-moving mist1

 * Prodrug activated in the airway epithelium2

 * Activated prodrug has 12 times greater glucocorticoid receptor affinity than
   dexamethasone2

 * No statistically significant decrease in serum cortisol3,4

 * Accepted by >93% of horses5

 * Proven safety and efficacy under controlled and field conditions in over 600
   horses*3,5,6

* Treated with ASERVO EQUIHALER or placebo.

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

THE QUESTIONNAIRE LINKED BELOW HELPS TO REVIEW A HORSE'S RESPIRATORY HEALTH
SIGNS, HEALTH HISTORY AND OTHER IMPORTANT TOPICS.

DOWNLOAD CHECKLIST


WHAT MAKES ASERVO EQUIHALER UNIQUE

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

Ciclesonide

A novel glucocorticoid that is activated in the lower airway into the potent
anti- inflammatory des-ciclesonide.

Soft MistTM Technology

The Soft Mist™ Inhaler provides high fine-particle fraction for deep peripheral
lung deposition, low velocity stream for easy inhalation and predetermined
dosing for accurate delivery.

Made for Horses

The nostril adapter fits inside the left nostril of the horse, while the
BreathView® indicator allows the user to time the generation of the mist with
the beginning of inhalation. The inhaler is ergonomically designed for left-hand
use, allowing the right hand to remain free to control the horse.

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.


THE ACTIVATED PRODRUG IS 12X AS POTENT COMPARED TO DEXAMETHASONE2

Ciclesonide is
an active prodrug Activated to
des-ciclesonide
in the airway Des-ciclesonide binds
to the glucocorticoid
receptors in the lungs


NO STATISTICALLY SIGNIFICANT EFFECT ON SERUM CORTISOL3,4

A decrease in serum cortisol level is a marker of systemic exposure to
administered glucocorticoids and this decrease may reflect the potential for an
increased risk of adverse consequences.7

Administration of glucocorticoids may worsen existing bacterial, fungal, or
viral infection. Secondary infections should be ruled out before prescribing
ASERVO EQUIHALER. Inhaled glucocorticoids should be used with caution, if at
all, in horses with active infection of the respiratory tract.

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THE SOFT MIST™ TECHNOLOGY ADVANTAGE


HIGH FINE- PARTICLE FRACTION

>90% of particles in ASERVO EQUIHALER are <5µm in diameter

Optimal size for deep peripheral lung deposition


LOW-VELOCITY STREAM

The mist in ASERVO EQUIHALER is released at low-velocity (0.8m/sec) for longer
duration (>1 sec) 8

Easy to inhale
Validated in horses with severe equine asthma 3


PROPELLANT- FREE

Mechanical energy of the compressed spring generates the Soft Mist™

Propellant-free inhaler has lower carbon footprint compared to pMDI 9


DOSING ACCURACY

Each actuation consistently delivers a predetermined dose

Consider appropriate wash out times prior to administering NSAIDs or additional
glucocorticoids.

SOFT MIST™ TECHNOLOGY = SMALL PARTICLE SIZE × LOW VELOCITY

Smaller, respirable particles (<5 microns) administered at low velocity travel
with inhaled air deep into peripheral lung.10

How the mist is made


DESIGNED FOR HORSES

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.


EASY TO USE

 * Nostril adapter

 * BreathView® breath indicator

 * Single use

 * Single-hand maneuver

 * Simple treatment protocol

 * Fill indicator


DESIGNED FOR HORSES

 * Snug fit in the left nostril serves as reservoir for the drug

 * Easy timing with beginning of inhalation

 * Minimizes risk for cross-contamination between horses

 * Second hand is free to aid in handling the horse

 * One dose fits all


ASERVO® EQUIHALER® (CICLESONIDE INHALATION SPRAY)

 * Soft Mist™ is easily inhaled into the lower airway1

 * Local drug activity deep within the lung2

 * Proven safe3,4



 * Prodrug reduces inflammation to decrease airway obstruction2

 * Accepted by >93% of horses5

 * Studied in over 600 horses under controlled and field conditions3,5,6
   
   *Treated with ASERVO EQUIHALER or placebo.

Inhaled glucocorticoids 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.

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.





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REFERENCES

 1.  Dalby, R., Spallek, M. and Voshaar, T., 2004. A review of the development
     of Respimat® Soft Mist™ Inhaler. International journal of pharmaceutics,
     283(1-2), pp.1-9.
 2.  Mukker, J.K., Singh, R.S.P. and Derendorf, H., 2016. Ciclesonide: a
     pro-soft drug approach for mitigation of side effects of inhaled
     corticosteroids. Journal of pharmaceutical sciences, 105(9), pp.2509-2514.
 3.  Lavoie, J.P., Bullone, M., Rodrigues, N., Germim, P., Albrecht, B. and von
     Salis‐Soglio, M., 2019. Effect of different doses of inhaled ciclesonide on
     lung function, clinical signs related to airflow limitation and serum
     cortisol levels in horses with experimentally induced mild to severe airway
     obstruction. Equine veterinary journal.
 4.  Derom, E., Van De Velde, V., Marissens, S., Engelstätter, R., Vincken, W.
     and Pauwels, R., 2005. Effects of inhaled ciclesonide and fluticasone
     propionate on cortisol secretion and airway responsiveness to adenosine 5′
     monophosphate in asthmatic patients. Pulmonary pharmacology & therapeutics,
     18(5), pp.328-336.
 5.  Prescribing Information. Aservo® EquiHaler® (ciclesonide inhalation spray),
     343 mcg/actuation, glucocorticoid
 6.  Freedom of Information Summary. 2020. Original New Drug Animal Application.
     Aservo® EquiHaler® (ciclesonide inhalation spray)
 7.  Capstick, T.G., Clifton, I.J., Lavorini, Crompton, Broeders, Horne, Horne,
     Menckeberg, Cochrane, Horne and Newman, 2012. Inhaler technique and
     training in people with chronic obstructive pulmonary disease and asthma.
     Expert review of respiratory medicine, 6(1), pp.91-103.
 8.  Tamura, G., 2015. Comparison of the aerosol velocity of Respimat® soft mist
     inhaler and seven pressurized metered dose inhalers. Allergology
     International, 64(4), pp.390-392.
 9.  Hänsel, M., Bambach, T. and Wachtel, H., 2019. Reduced Environmental Impact
     of the Reusable Respimat® Soft Mist™ Inhaler Compared with Pressurised
     Metered-Dose Inhalers. Advances in therapy, 36(9), pp.2487-2492.
 10. Cuming, R.S., Groover, E.S., Wooldridge, A.A. and Caldwell, F.J., 2018.
     Review of glucocorticoid therapy in horses. Part 1: Pharmacology. Equine
     Veterinary Education, 30(3), pp.141-150.

ASERVO®, BREATHVIEW® and EQUIHALER® are registered trademarks of Boehringer
Ingelheim Vetmedica GmbH, used under license. All other trademarks are property
of their respective owners. ©2023 Boehringer Ingelheim Animal Health USA Inc.,
Duluth, GA. All rights reserved. US-EQU-0026-2020-V4

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 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. Not for
use in humans. Keep this and all medications out of the reach of children.

Storage Information:
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.