Dermobacter

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

benzalkonium chloride, chlorhexidine (chlorhexidine digluconate)

Beschikbaar vanaf:

Innothera Chouzy

INN (Algemene Internationale Benaming):

benzalkonium chloride, chlorhexidine (chlorhexidine digluconate)

Dosering:

500mg/100ml+200mg/100ml

farmaceutische vorm:

solution for external application

Prescription-type:

OTC

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
DERMOBACTER, SOLUTION FOR CUTANEOUS APPLICATION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium chloride solution
……………………….....................………..
0.985 g
quantity corresponding to benzalkonium chloride
………………………......
0.500 g
Chlorhexidine digluconate solution
…………………………..............………
1.065 g
quantity corresponding to chlorhexidine digluconate
.............................
0.200 g
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
_ _
Solution for cutaneous application._ _
_ _
_ _
4. CLINICAL DATA
4.1.
Therapeutic indications
Cleansing and adjuvant treatment of disorders of the skin and mucous
affections, infected or suceptible to
become infected.
Note: antiseptic agents do not sterilise, they temporarily reduce the
number of micro-
organisms.
_ _
_ _
4.2. Posology and method of administration
_ _
The solution is used undiluted or diluted, once or twice a day for 7
to 10 days.

Use undiluted: apply to the skin.

Use diluted 1/10
th
: apply to the mucous membranes. The diluted solution must be prepared
immediately before use and should not be stored.
Application should ALWAYS BE FOLLOWED BY CAREFUL RINSING.
_ _
4.3. Contraindications
_ _
-
Hypersensitivity to one of the components, particularly chlorhexidine
(or compounds in its chemical
class) or benzalkonium chloride (quaternary ammonium compounds).
-
Do not apply to the eyes or ears.
-
This preparation must not be used to disinfect medical and surgical
equipment.
_ _
_ _
_ _
_ _
4.4. Special warnings and precautions for use
External use only.
Although cutaneous resorption is very slight, the risk of systemic
effects cannot be excluded. Such effects
are particularly likely if the antiseptic is applied to a large
surface area, under occlusive dressing
,
to damaged
skin (notably burns), mucous membranes or the skin of premature
infants or neonates (because of the surface
area/weight ratio and t