Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dexpanthenol, chlorhexidine (chlorhexidine dihydrochloride)
GP Grenzach Produktions GmbH
dexpanthenol, chlorhexidine (chlorhexidine dihydrochloride)
50mg/g+5mg/g
cream
OTC
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). _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 interference (antagonism or inactivation), Bepanthen Plus should not be used concurrently with other antiseptics. Page 2 of 4 Summary of Product Characteristics Bepanthen ® Plus, cream _4.6 _ _PREGNANCY AND LACTATION _ There is no evidence to suggest that the use of the cream should be restricted during pregnancy and lactation. _4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINERY _ No effects on the ability to drive and use machinery have been observed. _4.8 UNDESIRABLE EFFECTS _ The listed adverse drug reactions are based on spontaneous reports, thus an organization accordi Læs hele dokumentet