国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
nedocromil sodium
Sanofi-Aventis Australia Pty Ltd
Registered
TILADE ® CFC-FREE INHALER _nedocromil sodium_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tilade CFC-Free Inhaler. It does not contain all the information that is known about Tilade CFC-Free Inhaler. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Tilade CFC- Free Inhaler 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 TILADE CFC-FREE INHALER IS USED FOR Tilade CFC-Free Inhaler is inhaled into the lungs for the preventive treatment of mild to moderate asthma. Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, pollens, smoke, air-borne pollution or other irritants. Tilade CFC-Free Inhaler is used to prevent bronchial asthma due to allergy, exercise, cold air or irritants, in both adults and children over two years of age. Tilade CFC-Free Inhaler works by reducing the inflammation of the airways which occurs in asthma. With regular use, Tilade CFC-Free Inhaler will help prevent asthma symptoms from occurring. Tilade CFC-Free Inhaler will not relieve the symptoms of an asthma attack once the attack has started. YOU SHOULD FOLLOW YOUR DOCTOR'S ADVICE AND PRESCRIBED TREATMENT TO GET RELIEF FROM A SUDDEN ASTHMA ATTACK. Your doctor may have prescribed Tilade CFC-Free Inhaler for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TILADE CFC- FREE INHALER HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. There is no evidence that Tilade CFC-Free Inhaler is addictive. This product contains HFA-227, a non-ozone depleting propellant gas, which has been introduced as a replacement for the environmentally damaging chlorofluoro 完全なドキュメントを読む
tilade-ccdsv5-piv2-24jul20 Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION – TILADE CFC FREE (NEDOCROMIL SODIUM) 1 NAME OF THE MEDICINE Nedocromil sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation contains nedocromil sodium 2 mg. Menthol flavoured. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Pressurised inhalation. Tilade CFC-Free contains nedocromil sodium as a suspension in a non-CFC propellant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tilade CFC-Free is indicated for the prophylactic treatment of mild to moderate persistent asthma in adults and frequent episodic asthma in children aged over two years, and for the prevention of bronchospasm provoked by exercise, cold air, inhaled allergens, atmospheric pollutants and other irritants. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS (INCLUDING THE ELDERLY) AND CHILDREN OVER 2 YEARS OF AGE: The recommended initial dosage is two actuations (each yielding 2 mg of nedocromil sodium) four times daily. Some patients who have demonstrated a good response to therapy and whose asthma is stable may be able to reduce the dose to two actuations twice daily. This may take more than one week of regular use. The efficacy of Tilade CFC-Free in children under 2 years of age has not been established. Tilade CFC-Free, in a single dose of two actuations (4 mg) a few minutes before exposure, affords protection for several hours against bronchospasm provoked by exercise, cold air, inhaled allergens, atmospheric pollutants and other irritants. Most patients will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI or puffer), particularly those with poor inhaler technique. Use of a spacer will tilade-ccdsv5-piv2-24jul20 Page 2 of 9 also decrease the amount of drug deposited in the mouth and back of the throat, and therefore, reduce the incidence of local side effects such as mouth and throat irritation and hoarse voice. In those people using a spacer, a change in formulation of the drug 完全なドキュメントを読む