Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
ciclesonide, Quantity: 50 microgram/actuation
Chiesi Australia Pty Ltd
Ciclesonide
Spray, nasal
Excipient Ingredients: potassium sorbate; hypromellose; purified water; microcrystalline cellulose; disodium edetate; carmellose sodium; hydrochloric acid; nitrogen
Nasal
60 Actuation, 120 Actuation
(S4) Prescription Only Medicine
Omnaris Nasal Spray is indicated for: the treatment of seasonal allergic rhinitis in adults and children 6 years of age and older; and for the treatment of perennial allergic rhinitis in adults and adolescents 12 years of age and older.
Visual Identification: White to off-white suspension in brown glass bottle with a pump; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-12-16
OMNARIS AU CMI V2.0 1 OMNARIS ® NASAL SPRAY _ciclesonide _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OMNARIS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OMNARIS IS USED FOR The medicine is sprayed into the nose to help treat symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older, and perennial allergic rhinitis in adults and adolescents 12 years of age and older. Allergic rhinitis (hay fever) is an inflammation or swelling of the nose lining, which may cause blockage, runny nose, itching and/or sneezing. You may have symptoms only during spring or summer (seasonal). This type of allergy is generally due to various pollens. Some people may experience symptoms all year round (perennial). This is usually caused by house dust mites, pets or moulds. The medicine contains ciclesonide. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU USE OMNARIS _WHEN YOU MUST NOT USE IT _ DO N Perskaitykite visą dokumentą
OMNARIS PI v2.0 1 AUSTRALIAN PRODUCT INFORMATION OMNARIS ® (CICLESONIDE) NASAL SPRAY 1 NAME OF THE MEDICINE ciclesonide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OMNARIS Nasal Spray is a metered-dose, manual-pump spray. Once primed (see Section 4.2Dose and method of administration), each actuation of the pump delivers 50 µg ciclesonide in a volume of 70 µL from the nasal actuator. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Nasal spray presented as a white to off-white suspension in brown glass bottle with a pump. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OMNARIS Nasal Spray is indicated for: the treatment of seasonal allergic rhinitis in adults and children 6 years of age and older. the treatment of perennial allergic rhinitis in adults and adolescents 12 years of age and older. 4.2 DOSE AND METHOD OF ADMINISTRATION OMNARIS should only be administered by the intranasal route. DOSAGE CONSIDERATION The recommended dose of OMNARIS is 200 µg per day administered as 2 actuations (50 µg/actuation) in each nostril once daily. The maximum total daily dosage should not exceed 2 actuations in each nostril (200 µg/day). ADMINISTRATION Prior to initial use, OMNARIS must be shaken gently and then the pump must be primed by actuating 8 times. If not used for 4 or more consecutive days, it should be shaken gently and reprimed with 1 actuation or until a fine mist appears. During dosing, users are advised to tilt the head forward slightly and, while keeping the bottle upright, users are advised to press the pump quickly and firmly and inhale through the nose as they spray. 4.3 CONTRAINDICATIONS Patients with a hypersensitivity to ciclesonide or any of its ingredients. OMNARIS PI v2.0 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE IMMUNE SYSTEM Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of intranasal corticosteroids. Patients with a known hypersensitivity reaction to other corticosteroid preparations Perskaitykite visą dokumentą