Bepanthen Plus cream for topical use

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

dexpanthenol, chlorhexidine (chlorhexidine dihydrochloride)

Prieinama:

GP Grenzach Produktions GmbH

ATC kodas:

D08AC52

INN (Tarptautinis Pavadinimas):

dexpanthenol, chlorhexidine (chlorhexidine dihydrochloride)

Dozė:

50mg/g+ 5mg/g

Vaisto forma:

cream for topical use

Vienetai pakuotėje:

30g aluminium tube

Recepto tipas:

OTC

Autorizacija statusas:

Registered

Leidimo data:

2018-05-02

Prekės savybės

Page 1 of 4
Summary of Product Characteristics
Bepanthen
®
Plus, cream
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bepanthen Plus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains:
Dexpanthenol
50 mg
Chlorhexidine dihydrochloride
5 mg
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
■
For the topical treatment of minor skin trauma such as superficial
wounds,
abrasions, cuts, scratches, burns, bites or stings, when there is a
risk of bacterial
infection.
■
As a topical antiseptic in minor surgery.
4.2
Posology and Method of Administration
Apply one or more times daily, as needed, to cleaned wounds or
inflamed skin areas.
Dressings may, but need not, be used.
4.3
Contraindications

Known hypersensitivity to dexpanthenol and/or chlorhexidine, or to any
other
components of the product;

must not be applied to a perforated eardrum.
4.4
Special Warnings and Precautions for Use
The product is intended for minor skin trauma; application over
extensive skin areas
should be avoided.
Avoid contact with the eyes, ears and mucous membranes.
Bepanthen Plus should not be used to treat skin irritations that are
unlikely to become
infected (e.g. sunburns).
Rare but serious allergic reactions including anaphylaxis have been
reported with use
of chlorhexidine containing antiseptic products. If symptoms of a
serious allergic
reaction appear (e.g. wheezing or difficulty breathing, swelling of
the face, hives that
can quickly progress to more serious symptoms, severe rash, or shock),
use must be
discontinued immediately, and doctor should be consulted.
Wool fat (lanolin), сetyl alcohol and stearyl alcohol excipients may
cause local
cutaneous adverse reactions (e.g. contact dermatitis).
Page 2 of 4
Summary of Product Characteristics
Bepanthen
®
Plus, cream
4.5
Interactions with Other Medicinal Products and Other Forms of
Interactions
Chlorhexidine
is
incompatible
with
soaps
and
other
anionic
compounds.
As
a
precaution
against
the
possibility
of
in