Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Cajuput oil; Eucalyptus oil; Methyl salicylate; LEVOMENTHOL; Mint oil, partly dementholised
GR Lane Health Products Ltd
R05X
Cajuput oil; Eucalyptus oil; Methyl salicylate; LEVOMENTHOL; Mint oil, partly dementholised
%w/w
Inhalation vapour, liquid
Product not subject to medical prescription
OTHER COLD PREPARATIONS
Not marketed
2012-08-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olbas for Children Inhalation Vapour, Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Inhalation vapour, liquid. Colourless to pale yellow transparent liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of bronchial and nasal congestion caused by colds, catarrh, influenza and hayfever, rhinitis and minor infections of the respiratory tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For inhalation use. Children aged 3 months to 2 years: Sprinkle 4 drops on to a tissue placed out of the child’s reach. Children aged 2 years and over: Sprinkle 8 to 12 drops on to a handkerchief, or add to hot water and inhale the vapours. Not recommended for babies under 3 months old. Do not use for topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not allow oil to remain in contact with skin for extended periods. If symptoms worsen or do not improve after 7 days, contact a doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. Ingredients % w/w Cajuput Oil 4.625 Mint Oil, Partly Dementholised 8.863 Eucalyptus Oil 8.863 Levomenthol 1.025 Methyl Salicylate 0.925 For a full list of excipients, see section 6.1. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _0_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _3_ _C_ _R_ _N_ _ _ _2_ _1_ _3_ _6_ _1_ _9_ Přečtěte si celý dokument