Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
OXYMETAZOLINE HYDROCHLORIDE
Seven Seas Ltd
0.05 %w/v
Nasal Drops Soln
1994-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Iliadin Mini 0.05% w/v Nasal Drops, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxymetazoline Hydrochloride 0.05% w/v. For excipients, see 6.1 3 PHARMACEUTICAL FORM Nasal drops, solution. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of nasal congestion associated with disorders of the upper respiratory tract including infective and allergic rhinitis, sinusitis, nasopharyngitis and coryza 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults and children over 6 years Instil half the contents of one mini unit into each nostril: repeat every 8-12 hours if necessary Intranasally 4.3 CONTRAINDICATIONS Use in patients with known hypersensitivity to sympathomimetics. Use in patients receiving monoamine oxidase inhibitors or within fourteen days of stopping such treatment. Use in acute coronary disease, cardiac asthma, thyrotoxicosis, hypertension, closed-angle glaucoma or urinary retention. Use in children under 6 years of age. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE This product should be given with care to patients with prostatic enlargement, as it may increase difficulty in micturition. Prolonged use may cause rebound congestion and drug induced rhinitis. Use with caution in diabetic patients as this product may cause an increase in blood sugar. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 10/08/2005_ _CRN 2013409_ _page number: 1_ The physician or pharmacist should reassure himself/herself that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye p Olvassa el a teljes dokumentumot