Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Ciclesonide
Boehringer Ingelheim Vetmedica Gmbh
QR03BA08
Ciclesonide
POM-V - Prescription Only Medicine – Veterinarian
Horses
Respiratory
Authorized
2020-01-28
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 Citiți documentul complet