Herbion ivy lozenges lozenges

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

ivy leaf dry extract

제공처:

KRKA d.d.

ATC 코드:

R05CA12

INN (International Name):

ivy leaf dry extract

복용량:

35mg

약제 형태:

lozenges

패키지 단위:

(16/2x8/) in blister, (32/4x8/) in blister

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2020-12-30

제품 특성 요약

1.3.1
Ivy leaf dry extract
SPC, Labeling and Package Leaflet
AM
SmPCPIL141310_2
18.12.2019 – Updated: 08.05.2020
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
1.3.1
Ivy leaf dry extract
SPC, Labeling and Package Leaflet
AM
SmPCPIL141310_2
18.12.2019 – Updated: 08.05.2020
Page 2 of 4
Patients with renal an