Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Sodium cromoglicate 5mg equivalent to 3.5211% w/w; ;
sanofi-aventis new zealand limited
Sodium cromoglicate 5 mg (equiv to 3.5211% w/w)
5 mg/dose
Aerosol inhaler, metered dose
Active: Sodium cromoglicate 5mg equivalent to 3.5211% w/w Excipient: Apaflurane Macrogol 600 Povidone
Inhaler, metered, 5mg/dose, 112 dose units
Prescription
Prescription
Aventis Pharma Manufacturing Pte Ltd
INTAL FORTE 5 mg CFC-free is indicated for the preventive treatment of bronchial asthma (which may be due to allergy, exercise, cold air or chemical irritants) in adults and children.
Package - Contents - Shelf Life: Inhaler, metered, 5mg/dose - 112 dose units - 24 months from date of manufacture stored at or below 30°C
1997-12-11
Intal ® Forte 1 INTAL ® FORTE _CFC-FREE INHALER _ _sodium cromoglycate _ CONSUMER MEDICINE INFORMATION CMI WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Intal Forte CFC- Free. It does not contain all the information that is known about Intal Forte CFC- Free. 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 Intal Forte CFC-Free 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 INTAL FORTE CFC- FREE IS USED FOR Intal Forte CFC-Free 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. This may be due to an allergy to house dust mites, smoke, air-borne pollution or other irritants. Intal Forte CFC-Free is used to prevent bronchial asthma due to allergy, exercise, cold air or irritants, in both adults and children. With regular use, Intal Forte CFC- Free will help prevent asthma symptoms from occurring. Intal Forte CFC-Free 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. Intal Forte CFC-Free can also be used before exercise or before exposure to dust or other known asthma triggers, such as pollens or dustmite. This should prevent the symptoms (wheeze, cough, breathlessness) these triggers can cause. Intal Forte CFC-Free works by reducing the inflammation of the airways which occurs in asthma. Your doctor may have prescribed Intal Forte CFC-Free for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY INTAL FORTE CFC-FREE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Intal Forte CFC-Free is addictive. BEFORE YOU USE INTAL FORTE CFC-FREE _WHEN YOU MUST NO Baca dokumen lengkap
New Zealand Data Sheet 19-Sep-2018 Intal Forte - sodium cromoglycate Property of the Sanofi group - strictly confidential Intal Forte-ccdsv4-dsv2-19sep18 Page 1 DATA SHEET 1 INTAL FORTE (5MG AEROSOL INHALER, METERED DOSE) Intal Forte 5 mg aerosol inhaler, metered dose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active component of INTAL FORTE 5 mg CFC-free is sodium cromoglycate 3.521% w/w. Each canister provides at least 112 actuations each containing 5 mg of sodium cromoglycate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM INTAL FORTE 5 mg CFC-free is presented as a metered dose inhaler containing sodium cromoglycate as a suspension in the non - CFC propellant HFA-227, for inhalation. Sodium cromoglycate is a white crystalline odourless powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INTAL FORTE 5 mg CFC-free is indicated for the preventive treatment of bronchial asthma (which may be due to allergy, exercise, cold air or chemical irritants) in adults and children. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE INTAL FORTE 5 mg CFC-free therapy is preventative, it is therefore important that regular dosing should be maintained. The patient should be advised that because several doses may be needed to establish benefit, relief may not be apparent immediately, but may take some weeks to develop. New Zealand Data Sheet 19-Sep-2018 Intal Forte - sodium cromoglycate Property of the Sanofi group - strictly confidential Intal Forte-ccdsv4-dsv2-19sep18 Page 2 ADULTS AND CHILDREN The recommended dosage is 10 mg of sodium cromoglycate (as two 5 mg inhalations of the aerosol) four times daily. (The suggested dosage regimen is two inhalations at bedtime, and on waking in the morning, and at regular intervals of 3 to 6 hours during the day). The dose may be increased to two inhalations six or eight times daily in more severe cases or during periods of high antigen challenge. When the asthmatic condition is stabilised, it is sometimes possible to reduce the dosage, but this must be careful Baca dokumen lengkap