Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Phenol; Chlorhexidine digluconate
Bayer Limited
D08AC; D08AC52
Phenol; Chlorhexidine digluconate
1.2 %w/w/0.25 percent weight/weight
Cream
Product not subject to medical prescription
Biguanides and amidines; chlorhexidine, combinations
Marketed
1987-01-02
Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bepantiseptic First Aid Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phenol 1.20 % w/w Chlorhexidine Digluconate Solution to give Chlorhexidine Digluconate 0.25 % w/w Also contains cetostearyl alcohol 10% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. A pink, viscous, homogeneous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of minor skin irritations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply as necessary after cleansing for up to 3 days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or the condition worsens, consult your doctor. 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Chlorhexidine is incompatible with anionic agents. 4.6 FERTILITY, PREGNANCY AND LACTATION Although use of this product is not contraindicated during pregnancy and lactation, as with all medicines during pregnancy, caution should be exercised. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 2 of 4 None known. 4.8 UNDESIRABLE EFFECTS Spontaneous reports of hypersensitivity reactions (hypersensitivity, anaphylactic reaction, anaphylactic shock) have been made; frequency of these reactions cannot be estimated from the available data. Rarely irritancy, rashes and other skin conditions may occur. REPORTING OF SUSPE সম্পূর্ণ নথি পড়ুন