Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Betula pendula; Arnica montana; BIRCH LEAF
Weleda (UK) Limited
M02AX; M02AX10
Betula pendula; Arnica montana; BIRCH LEAF
52.0 percent weight/weight
Cutaneous solution
Product not subject to medical prescription
Other topical products for joint and muscular pain; various
Marketed
1992-10-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Massage Balm with Arnica 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of cutaneous liquid contains 480 mg of extract from_ Arnica montana_ L., flos, (equivalent to 22 mg of Arnica flower) and_ Betula pendula_ Roth and/or_ Betula pubescens_ Ehrh., folium, as well as hybrids of both species (equivalent to 22 mg of Birch leaf). Extraction solvents: ethanol 96 % v/v and refined sunflower oil For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Oil. A clear yellow-green oil with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal remedy for the symptomatic relief of rheumatic pain, muscular pain and stiffness, backache, fibrositis, bruising, cramp and sprains. Traditionally used topically as an anti-inflammatory agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Apply sparingly to the affected area with gentle massage three to four times daily. Elderly Patients: The normal adult application is appropriate. Children: The normal adult application is appropriate. Special Groups: None Known. 4.3 CONTRAINDICATIONS Hypersensitivity to any ingredient, particularly known sensitivity to_ Arnica montana L_. Hypersensitivity to members of the Compositae family of plants. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact sensitisation is a rare occurrence. Do not apply where the skin is broken. Cutaneous oil. For external use only. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P Прочитајте комплетан документ