देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
ciclesonide, Quantity: 100 microgram
Chiesi Australia Pty Ltd
Inhalation, pressurised
Excipient Ingredients: norflurane; ethanol
Inhalation
60 metered doses, 120 metered doses
(S4) Prescription Only Medicine
Alvesco is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older.
Visual Identification: A colourless solution in an aluminium canister with a metering valve.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2004-02-24
ALVESCO AU CMI v2.0 1 ALVESCO ® _ciclesonide _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALVESCO. 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 he/she expects 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 ALVESCO IS USED FOR ALVESCO is inhaled into the lungs for the treatment of asthma. Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. ALVESCO contains a medicine called ciclesonide, which belongs to a family of medicines called corticosteroids. ALVESCO metered dose inhalers deliver a measured amount of ciclesonide, which acts directly on your air passages to reduce inflammation and help keep the air passages open. In doing so, this medication helps to improve your condition and to prevent asthma attacks from occurring. It is a preventer and needs to be taken regularly. ALVESCO will NOT give you immediate relief of wheezing or breathlessness during sudden, severe or continuous asthma attacks. In this situation you should use a quick acting reliever inhaler, which contains a different medicine, a so- called bronchodilator. Your doctor may prescribe ALVESCO to replace corticosteroid tablets, which will mean that you need to take both medicines for a short period of time. It is important to foll पूरा दस्तावेज़ पढ़ें
ALVESCO AU PI v 2.0 1 of 16 AUSTRALIAN PRODUCT INFORMATION ALVESCO ® (CICLESONIDE) PRESSURISED METERED DOSE INHALER (PMDI) 1 NAME OF THE MEDICINE ciclesonide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALVESCO is available in the following strengths: ALVESCO 80: 80 micrograms ciclesonide per actuation ALVESCO 160: 160 micrograms ciclesonide per actuation _Excipient(s) with known effect:_ ethanol For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Inhalation, pressurised. The drug is dissolved in a non-halogenated solution and delivered via a pMDI, resulting in an extra fine aerosol. The main particle fraction ranges from 1.1 microns to 2.1 microns, which ensures high lung deposition (>50% of the ex-actuator dose), and less deposition in the oropharynx than marketed suspension formulations of other ICS. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALVESCO is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older. 4.2 DOSE AND METHOD OF ADMINISTRATION ALVESCO is for oral inhalation use only. Symptoms start to improve with ALVESCO within 24 hours of treatment. However, due to its prophylactic nature, ALVESCO should be taken regularly even when patients are asymptomatic. DOSING RECOMMENDATION FOR CHILDREN (6-11 YEARS) The recommended dose of ALVESCO for children is 80 micrograms or 160 micrograms once daily. ALVESCO can be administered as 1 or 2 puffs once daily either in the morning or evening. The use of a spacer is recommended for children 6-11 years (see _Method of administration_ ). The dose should be adjusted to the lowest dose at which effective control of asthma is maintained. ALVESCO AU PI v 2.0 2 of 16 DOSING RECOMMENDATION FOR ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER The recommended dose range is 80 to 320 micrograms per day in adult and adolescent patients. In certain circumstances the dosage may be increased in adults (see _Adult Patients - Higher doses in _ _certain circumstances_ below). Pa पूरा दस्तावेज़ पढ़ें