Aservo EquiHaler

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

ciclesonide

Tilgjengelig fra:

Boehringer Ingelheim Vetmedica GmbH

ATC-kode:

QR03BA08

INN (International Name):

ciclesonide

Terapeutisk gruppe:

Horses

Terapeutisk område:

Respiratory system, Other drugs for obstructive airway diseases, inhalants

Indikasjoner:

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)).

Autorisasjon status:

Authorised

Autorisasjon dato:

2020-01-28

Informasjon til brukeren

16
B.
PACKAGE LEAFLET
17
PACKAGE LEAFLET:
ASERVO EQUIHALER 343 MICROGRAMS/ACTUATION INHALATION SOLUTION FOR
HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Fareva Amboise
Zone Industrielle
29 Route des Industries
37530 Pocé-sur-Cisse
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aservo EquiHaler 343 micrograms/actuation inhalation solution for
horses
ciclesonide
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each actuation (ex nostril adapter) contains:
ACTIVE SUBSTANCE:
Ciclesonide
343 micrograms
EXCIPIENTS:
Ethanol
8.4 mg
Clear, colourless to yellowish solution.
4.
INDICATION
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)).
5.
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to corticosteroids or to any of
the excipients.
6.
ADVERSE REACTIONS
Mild nasal discharge was commonly observed during safety and clinical
studies.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reactions)
18
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Horse
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Inhalation use.
The number of actu

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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:
8.4 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 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.
3
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 kg body weight, or in foals.
The prescribing veterinarian should assess if the hor