מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
White soft paraffin; Light liquid paraffin; Lanolin anhydrous
KARO PHARMA AB
D02AX
White soft paraffin; Light liquid paraffin; Lanolin anhydrous
Cream
Other emollients and protectives
Marketed
1977-04-01
Health Products Regulatory Authority 30 September 2022 CRN00CVF9 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6% w/w Anhydrous Lanolin 1.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION White soft paraffin 14.5 % w/w Light liquid paraffin 12.6 % w/w Anhydrous lanolin 1.0 % w/w Also contains: Cetyl alcohol 0.5% w/w Methyl Hydroxybenzoate (E218) 0.15% w/w Proryl Hydroxybenzoate (E216) 0.04% w/w 3 PHARMACEUTICAL FORM Cream Smooth white or practically white cream with not more than a slight odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, dermatitis, sunburn, the dry stage of eczema and for the use as emollient adjunctive therapy in the treatment of dry cases of psoriasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily. METHOD OF ADMINISTRATION For topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to white soft paraffin, light liquid paraffin and anhydrous lanolin or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. If hypersensitivity occurs, such as a rash, use of the product should be discontinued. May cause allergic reactions (possibly delayed), such as local skin reactions. If rash develops, use of the product should be discontinued. Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard, and as such should avoid smoking. The product should not be applied to the mucous membranes or to broken skin. Health Products Regulatory Authority 30 September 2022 CRN00CVF9 Page 2 of 4 4.5 INTERACTION WITH OTHER MEDIC קרא את המסמך השלם