Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Fisons Limited
2 %w/v
Nasal Drops Soln
1976-03-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rynacrom Nasal Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Cromoglicate 1.6 mg per dose (2 drops). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Nasal drops, solution Clear colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rynacrom Nasal Drops are indicated for the prevention of allergic rhinitis (seasonal and perennial). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children: Two drops (1.6 mg of sodium cromoglicate) into each nostril 6 times daily. Rynacrom should be used regularly to ensure optimal control of symptoms. It is recommended that treatment is continued during the period of exposure to the allergen, even when free of 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 nasal 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. However, it should be used in pregnancy only if there is a clear need. On the basis of animal studies it physiochemical properties, sodium cromoglicate is considered unlikely to pass into human breast milk. There is not information to suggest that use of sodium cromoglicate by nursing mothers has any undesirable effects on the baby. IRISH MEDICINES BOARD ____________________________________________________________________________________________________________________ Lugege kogu dokumenti