Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Bausch & Lomb UK Limited
CROMOGLICATE SODIUM
20 Micromol
Nasal Spray Solution
Product not subject to medical prescription
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vividrin Nasal Spray, Solution 2% w/v Against Hay Fever 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 20.0 mg of sodium cromoglicate. Each spray contains 2.8mg of sodium cromoglicate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution A colourless to slightly yellow, clear, aqueous nasal spray solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perennial allergic rhinitis, seasonal allergic rhinitis (hay fever). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise prescribed, the dose for adults and children is one squirt of the spray in each nostril four times a day. Treatment with Vividrin Nasal Spray Against Hay Fever should be continued even after the complaints have disappeared as long as the patient is exposed to the allergizing substances (pollen, house dust, fungus spores, etc.). 4.3 CONTRAINDICATIONS Vividrin Nasal Spray Against Hay Fever is contra-indicated in persons who have shown hypersensitivity to any component of this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known so far. 4.6 FERTILITY, PREGNANCY AND LACTATION Although there has been no evidence of any embryotoxic effect, Vividrin Nasal Spray should, if possible, not be used during the first three months of pregnancy. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/07/2012_ _CRN 2110843_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known so far. 4.8 UNDESIRABLE EFFECTS Mild transient irritation of the nasal mucosa may occur occasionally, rare cases of headache Leggi il documento completo