Patient leaflet - Aservo EquiHaler
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Aservo EquiHaler 343 micrograms/actuation inhalation solution for horses
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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 Poce-sur-Cisse
FRANCE
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Aservo EquiHaler 343 micrograms/actuation inhalation solution for horses ciclesonide
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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.
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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)).
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5. CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
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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)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Horse
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Inhalation use.
The number of actuations to be administered is the same for all horses. The total treatment duration is 10 days:
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– Day 1 to 5:
8 actuations (corresponding to 2,744 ^g ciclesonide) administered twice daily approximately
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12 h apart
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– Day 6 to 10:
12 actuations (corresponding to 4,116 ^g ciclesonide) administered once daily approximately
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24 h apart.
The onset of clinical improvement may take several days. The 10 days treatment schedule should normally be completed. In case of any concerns related to the treatment the responsible veterinarian should be consulted.
The Aservo EquiHaler contains sufficient inhalation solution for one horse for the entire treatment duration of the 10 days and an additional amount covering priming and potential losses during administration.
Treatment schedule for use:
| Treatment days 1 to 5 | Treatment days 6 to 10 |
| 8 actuations morning and evening approximately 12 h apart | 12 actuations once daily approximately 24 h apart |
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9. ADVICE ON CORRECT ADMINISTRATION
The “Instructions for handling and use of the Aservo EquiHaler ” is provided in section “Other information” of this leaflet.
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10. WITHDRAWAL PERIOD(S)
Meat and offal: 18 days.
Not authorised for use in horses producing milk for human consumption.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf life after first activation: 12 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
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12. SPECIAL WARNING(S)
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 indicatior 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.
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 horse has a temperament suitable for a safe and efficacious administration of the Aservo EquiHaler in agreement with good veterinary practice. Horses might not adapt to an easy and safe application of the Aservo EquiHaler within a couple of days. In such cases, an alternative treatment should be considered.
The onset of clinical improvement may take several days. The use of concomitant medication (such as bronchodilators) and environmental control may need to be considered in cases of severe clinical signs of respiratory obstruction, at the discretion of the attending veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Follow closely the instructions for handling and use of the Aservo EquiHaler as provided in the package leaflet section “Other Information”.
Administration of the product should take place in well ventilated surroundings.
People with known hypersensitivity to ciclesonide or any of the excipients should avoid contact with the veterinary medicinal product.
Inhalative and intranasal corticosteroids may cause rhinitis, nasal discomfort, nosebleed, upper respiratory tract infection and headache. An aerosol filtering mask must be worn during handling and administration. This prevents inadvertent inhalation in case of unintended release of actuations outside the nostril or without the nostril adapter.
The product can cause irritation to the eyes due to its ethanol content. Avoid contact with eyes. In case of accidental eye contact, rinse with large quantities of water.
In case of experiencing an adverse reaction due to accidental inhalation, and in case of eye irritation, seek medical advice and show the package leaflet or the label to the physician.
These precautions should be followed by the person administering the product and persons in close proximity to the horse’s head during administration.
The safety of ciclesonide after inhalatory exposure has not been established in pregnant women. In animal studies ciclesonide has been shown to induce malformations in foetuses (cleft palate, skeletal malformations). Pregnant women should therefore not administer the product.
If the Aservo EquiHaler is visually damaged it should not be used any more.
It is essential to keep the product out of reach for children.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Use only according to the benefit/risk assessment by the responsible veterinarian.
The product was shown to be teratogenic following oral administration after high doses in rabbits but not in rats.
Interaction with other medicinal products and other forms of interaction:
Concomitant use of clenbuterol in a field study in seven horses with severe equine asthma did not indicate any safety concerns.
Overdose (symptoms, emergency procedures, antidotes) :
After administration of the veterinary medicinal product at up to the 3-fold recommended dose for 3 times the recommended treatment duration no relevant clinical signs could be observed.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
The cartridge contains residual amount of the product at the end of the course of administration. This should be taken into account at disposal of the used veterinary medicinal product.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION