País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ivy leaf dry extract
KRKA d.d.
R05CA12
ivy leaf dry extract
35mg
lozenges
(16/2x8/) in blister, (32/4x8/) in blister
OTC
Registered
2023-05-24
PI_Text042743_1 – Updated: Page 1 of 4 1. NAME OF THE MEDICINAL PRODUCT Herbion ivy lozenges 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 35 mg of extract (as dry extract) from _Hedera helix _L., folium (ivy leaf) (5– 7.5:1). Extraction solvent: Ethanol 30% (m/m). Excipients with known effect Each lozenge contains 2447.50 mg isomalt (E953) and 0.0006 mg butylhydroxyanisole (E320). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lozenge The lozenges are round with bevelled edges and a rough surface from light brown to brown colour. Allowed is presence of yellow to brown particles, lighter patches, air bubbles and small, jagged edges. _ _ _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbion ivy is a herbal medicinal product used as an expectorant in complex treatment of acute respiratory diseases accompanied by productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS, ELDERLY AND ADOLESCENTS 12 YEARS OF AGE AND OLDER: 1 lozenge three times daily (corresponding to 105 mg of ivy leaf dry extract daily). _Paediatric population _ CHILDREN 6 TO 11 YEARS OF AGE: 1 lozenge twice daily (corresponding to 70 mg of ivy leaf dry extract daily). For children 2 TO 5 YEARS OF AGE no adjusted dosage is possible with the lozenge formulation. The use of a syrup formulation is recommended in this age group. The use in CHILDREN UNDER 2 YEARS OF AGE is contraindicated (see section 4.3). If the symptoms persist longer than one week during the use of the medicinal product, a doctor or a pharmacist should be consulted. Further duration of treatment is determined by the doctor, taking into account the characteristics of the disease, the achieved effect and the tolerability of the medicinal product. Renal and/or hepatic impairment PI_Text042743_1 – Updated: Page 2 of 4 Patients with renal and/or hepatic impairment should seek medical advice before starting treatment. Method of administration Oromucosal use. Dissolve the lozenge in the mouth. Drinking plenty of Llegiu el document complet