Aservo EquiHaler

Страна: Австралія

мова: англійська

Джерело: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Активний інгредієнт:

CICLESONIDE

Доступна з:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Фармацевтична форма:

Inhalation solution

Склад:

CICLESONIDE Active 30.0 mg/ml

Одиниць в упаковці:

4.3 mL cartridge (140 actuations)

Клас:

VM - Veterinary Medicine

Терапевтична области:

ENDOCRINE SYSTEM

Огляд продуктів:

Poison schedule: 4; Withholding period: N/A N/A; Host/pest details: HORSE - ADULT: [ASTHMA]

Статус Авторизація:

Registered

Дата Авторизація:

2023-07-01

інформаційний буклет

Aservo EquiHaler
90307/128490
Product Name:
APVMA Approval No:
Label Name:
Aservo EquiHaler
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
30 mg/mL (343 µg/actuation) ciclesonide
Claims:
For use by or under direction of a veterinarian.
For the management of clinical signs associated with equine asthma in
horses.
Net Contents:
4.3 mL cartridge (140 actuations)
Directions for Use:
Use as directed by prescribing veterinarian.
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
This product is contraindicated for use in horses with known
hypersensitivity to ciclesonide
or corticosteroids.
Precautions:
The safety of this product has not been established in horses weighing
less than 200 kg
body weight, or in foals.
The safety of this product has not been established in pregnant or
lactating mares.
Due to the potential for exacerbation of clinical signs of laminitis,
glucocorticoids should be
used with caution in horses with a history of laminitis, or horses
otherwise at a higher risk
for laminitis.
Use with caution in horses with chronic nephritis, equine pituitary
pars intermedia
dysfunction (PPID), and congestive heart failure. RLP APPROVED
Concurrent use of other anti-inflammatory drugs, such as non-steroidal
anti-inflammatory
drugs (NSAIDs) or other corticosteroids, should be approached with
caution. Due to the
potential for systemic exposure, concomitant use of NSAIDs and
corticosteroids may
increase the risk of gastrointestinal, renal, and other toxicity.
Side Effects:
Mild nasal discharge.
In case of overdose, symptomatic treatment should be initiated.
Dosage and
Administration:
Use the contents within 12 days of first activating the cartridge.
Discard unused portion (including the inhaler).
For intranasal inhalation only.
The number of actuations administered is the same for all horses
independent of their
bodyweight.
The total treatment duration is 10 days:
Days 1 to 5
8