Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ARNICA MONTANA
Weleda (UK) Limited
Cutaneous Solution
1994-02-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combudoron Lotion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients per 100 ml: 2.5 g _Arnica montana_ L whole plant (tincture (1=2) in 30% w/w ethanol) and 47.5 g _Urtica urens_ L herb (tincture (1=2) in 30% w/w ethanol) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. A clear to slightly turbid, olive green to brown mobile liquid, with a characteristic odour of nettles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditionally used for the relief of sunburn, insect bites, minor burns and minor rashes including nettle rash. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Dilute 1 teaspoonful (5 ml) in a glassful (200ml) of cooled boiled water. Soak a piece of lint in the solution and apply as a compress. Keep moist. Apply the solution undiluted to insect bites. Children and the elderly: The adult dose is appropriate 4.3 CONTRAINDICATIONS Do not use in patients known to be sensitive to _Arnica montana L_ 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE In the rare case of sensitivity to _Arnica montana L _local irritation and redness may occur. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 03/08/2005_ _CRN 2013274_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies. Although no adverse reactions have been observed, the use of the product during pregnancy should be avoided unless under the guidance of a medical practitioner. Lactation: there is no evidence to suggest that the product should not be used during lactation. 4.7 EFFEC Prečítajte si celý dokument