Herbion ivy syrup syrup

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Produkta apraksts Produkta apraksts (SPC)
18-01-2019

Aktīvā sastāvdaļa:

ivy leaf dry extract

Pieejams no:

KRKA d.d.

ATĶ kods:

R05CA12

SNN (starptautisko nepatentēto nosaukumu):

ivy leaf dry extract

Deva:

7mg/ml

Zāļu forma:

syrup

Vienības iepakojumā:

glass bottle 150ml and measuring spoon

Receptes veids:

OTC

Autorizācija statuss:

Registered

Autorizācija datums:

2019-01-18

Produkta apraksts

                                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
                                
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