Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NEDOCROMIL SODIUM
Sanofi-Aventis Ireland Limited
2 Mg/Dose
Pressurised Inhalation Suspension
2001-12-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tilade Aerosol 2 mg per metered dose Pressurised Inhalation, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 2 mg of nedocromil sodium. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. Yellow, mint flavoured suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of reversible obstructive airways disease such as bronchial asthma, asthmatic bronchitis, exercise- induced asthma, late onset asthma and bronchospasm from external causes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For respiratory use. Adults (including the elderly) and children over 2 years of age: Initially two actuations (4mg of nedocromil sodium) four times daily. Once symptomatic control has been achieved, the usual maintenance dose is two actuations twice daily. Tilade is intended for regular usage and should not be used for the relief of symptoms in an acute attack. 4.3 CONTRAINDICATIONS Tilade is contra-indicated in patients with known hypersensitvity to any of the constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tilade should not be used for the relief of an acute attack of bronchospasm. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/02/2008_ _CRN 2046293_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Studies with nedocromil sodium in pregnant and lactating animals have failed to reveal a hazard. However as with all new medicines caution should be exercised especially during the first trimester of pregnancy. On the basis of animal studies and its Read the complete document