ASERVO EQUIHALER- ciclesonide spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CICLESONIDE (UNII: S59502J185) (CICLESONIDE - UNII:S59502J185)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

NASAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

ASERVO EQUIHALER is supplied as one inhaler with a pre-inserted cartridge consisting of a plastic container crimped in an aluminum cylinder which contains inhalation solution for 140 treatment actuations (puffs).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ASERVO EQUIHALER- CICLESONIDE SPRAY, METERED
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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ASERVO EQUIHALER
(CICLESONIDE INHALATION SPRAY)
343 MCG/ACTUATION
GLUCOCORTICOID
FOR INTRANASAL INHALATION IN HORSES ONLY
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
ASERVO EQUIHALER (ciclesonide inhalation spray) is a non-pressurized
metered dose
inhaler and drug cartridge combination containing a solution of 30
mg/mL of the
prodrug ciclesonide, which is enzymatically converted to the
pharmacologically active
metabolite desisobutyrylciclesonide (des-ciclesonide) following
inhalation. Des-ciclesonide
is a glucocorticoid class of corticosteroid. Each actuation releases
343 mcg of
ciclesonide. Inactive carrier ingredients include alcohol, purified
water, and hydrochloric
acid. The structural formula for ciclesonide is:
INDICATION:
ASERVO EQUIHALER is indicated for the management of clinical signs
associated with
severe equine asthma in horses.
DOSAGE AND ADMINISTRATION:
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.
TOTAL TREATMENT DURATION IS 10 DAYS
TREATMENT DAYS
1 TO 5
8 actuations (puffs)
Twice daily
TREATMENT DAYS
6 TO 10
12 actuations (puffs)
Once daily
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.
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