Kraj: Armenia
Język: angielski
Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dexpanthenol
GP Grenzach Produktions GmbH
dexpanthenol
50mg/g
cream
OTC
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. Przeczytaj cały dokument