Aservo EquiHaler 343 micrograms/actuation Inhalation Solution for Horses

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Ciclesonide

Verfügbar ab:

Boehringer Ingelheim Vetmedica Gmbh

ATC-Code:

QR03BA08

INN (Internationale Bezeichnung):

Ciclesonide

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Horses

Therapiebereich:

Respiratory

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2020-01-28

Fachinformation

Revised: January 2023
AN: 02497/2022
Page 1 of 7
SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aservo EquiHaler 343 micrograms/actuation inhalation solution for
horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation (ex nostril adapter) contains:
ACTIVE SUBSTANCE:
Ciclesonide
343 micrograms
EXCIPIENTS:
Ethanol:
7.9 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation solution.
Clear, colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the alleviation of clinical signs of severe equine asthma
(formerly known as
Recurrent Airway Obstruction– (RAO), Summer Pasture Associated
Recurrent
Airway Obstruction – (SPA-RAO)).
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to
corticosteroids or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Special care should be taken when administering the veterinary
medicinal product.
To ensure an efficacious administration, the breath indicator in the
chamber wall of
the nostril adapter needs to be observed: when the horse inhales, the
membrane of
the breath indicator curves inwards. During exhalation, the membrane
of the breath
Revised: January 2023
AN: 02497/2022
Page 2 of 7
indicator curves outwards. The spray should be released at the
beginning of
inhalation, i.e. when the breath indicator starts curving into the
chamber. If the
movement of the breath indicator cannot be observed, assure the
correct positioning
of the nostril adapter. If movement of the breath indicator is still
not visible or the
movement is too rapid, the product should not be administered.
Efficacy of the product has not been established in horses with acute
exacerbations
(<14 days duration) of clinical signs.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Safety of the veterinary medicinal product has not been established in
horses
weighing less than 200 k