Bepanthen cream

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

dexpanthenol

Commercializzato da:

GP Grenzach Produktions GmbH

INN (Nome Internazionale):

dexpanthenol

Dosaggio:

50mg/g

Forma farmaceutica:

cream

Tipo di ricetta:

OTC

Scheda tecnica

Page 1 of 3
Summary of Product Characteristics
Bepanthen
®
, cream
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BEPANTHEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains:
Dexpanthenol
50 mg
3.
PHARMACEUTICAL FORM
Cream
Route of application: topical.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
■
Care of dry, rough or chapped skin.
■
Promotion of healing and epithelialization in minor injuries (e.g.
minor burns
and scrapes), skin irritations (resulting e.g. from radiotherapy,
phototherapy or
exposure to ultraviolet light).
■
Off-day or follow-up medication for patients treated with
corticosteroids.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
For external use. Apply one or more times daily, as needed.
Breast care in nursing mothers: apply cream to nipples after each
breastfeeding.
Infant care: apply at each nappy (diaper) change.
_4.3 _
_CONTRAINDICATIONS _
Bepanthen Cream must not be used by persons known to be hypersensitive
to any
of its ingredients.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Avoid contact with the eyes.
_4.5 _
_INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS _
None known.
_4.6 _
_PREGNANCY AND LACTATION _
There is no evidence to suggest that use during pregnancy or while
breastfeeding
poses any risk.
_4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINERY _
Not applicable.
Page 2 of 3
Summary of Product Characteristics
Bepanthen
®
, cream
_4.8 UNDESIRABLE EFFECTS _
The listed adverse drug reactions are based on spontaneous reports,
thus an
organization according to CIOMS III categories of frequency is not
pertinent.
_Immune system disorders and skin and subcutaneous tissue disorders _
Allergic reactions and allergic skin reactions such as dermatitis
contact, dermatitis
allergic, pruritus, erythema, eczema, rash, urticaria, skin
irritation, and blisters
were reported.
_4.9 OVERDOSE _
Dexpanthenol is, even in high dosage, well tolerated and is therefore
considered
as nontoxic in the literature.
5.