Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Fisons Limited
CROMOGLICATE SODIUM
4 %w/v
Nasal Spray Solution
Withdrawn
2007-04-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rynacrom 4% w/v Nasal Spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 40 mg sodium cromoglicate delivering 5.2mg sodium cromoglicate per metered dose. Excipients: Benzalkonium Chloride 0.01% w/v. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution Colourless or pale yellow, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rynacrom 4% Nasal Spray is indicated for the preventative treatment of allergic rhinitis (seasonal and perennial). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children: One spray into each nostril two to four times daily. Since Rynacrom 4% Nasal Spray is essentially preventative, it is important to maintain regular dosage, as distinct from using the drug intermittently to relieve symptoms. 4.3 CONTRAINDICATIONS Rynacrom is contraindicated in patients with known sensitivity to sodium cromoglicate or any of the other ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. The product is for intranasal use only. 2. Use of medication should be continued even in the absence of symptoms during exposure to the allergen. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should only be used in pregnancy where there is a clear need. On the basis of animal studies and its physiochemical properties, sodium cromoglicate is considered unlikely to pass into human breast milk. There is no information to suggest that use of sodium cromoglicate by nursing mothers has any IRISH MEDICINES BOARD _____________________________________________ Baca dokumen lengkap