Country: European Union
Language: English
Source: EMA (European Medicines Agency)
ciclesonide
Boehringer Ingelheim Vetmedica GmbH
QR03BA08
ciclesonide
Horses
Respiratory system, Other drugs for obstructive airway diseases, inhalants
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)).
Authorised
2020-01-28
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 Read the complete document
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 Read the complete document