Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ivy leaf dry extract
KRKA d.d.
ivy leaf dry extract
7mg/ml
syrup
OTC
1.3.1 Ivy leaf dry extract SPC, Labeling and Package Leaflet AM SmPCPIL108689_4 – Updated: 04.04.2018 Page 1 of 4 1. NAME OF THE MEDICINAL PRODUCT Herbion ® ivy syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hederae helicis folium 1 ml of syrup contains 7 mg of ivy leaf dry extract (_Hedera helix _L., folium) (5–7.5 : 1). Extraction solvent: 30% (m/m) ethanol. Excipient(s) with known effect 5 ml of syrup (1 measuring spoon) contains 1750 mg sorbitol (E420) and 0.5 mg ethanol (a component of lemon balm flavour). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. The syrup is yellow-brown and has a specific odour and taste. A slight sediment can be noticed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbion ivy syrup is a herbal medicinal product that is used as an expectorant in complex therapy of acute respiratory disease, accompanied by productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE: 5 to 7.5 ml (one to one and a half measuring spoons) of syrup twice daily (corresponding to 70 to 105 mg of ivy leaf dry extract daily). CHILDREN 6 TO 12 YEARS OF AGE: 5 ml (one measuring spoon) of syrup twice daily (corresponding to 70 mg of ivy leaf dry extract daily). CHILDREN 2 TO 5 YEARS OF AGE: 2.5 ml (half a measuring spoon) of syrup twice daily (corresponding to 35 mg of ivy leaf dry extract daily). The use in children under 2 years of age is contraindicated (see section 4.3). This syrup is intended for oral use. It should be taken in the morning and in the early afternoon. Drinking plenty of warm beverages is recommended while taking Herbion ivy syrup. The drug may be taken regardless of meals. If the symptoms persist longer than one week during the use of the medicinal product, a doctor or a pharmacist should be consulted. Treatment duration is then determined by a doctor according to the disease course and individual efficacy and tolerability of therapy. 1.3.1 Ivy leaf dry extract SPC, Labeling and Package Leaflet AM SmPCP Läs hela dokumentet