País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
SODIUM PYRROLIDONE CARBOXYLATE LACTIC ACID
Stiefel Laboratories (U.K.) Ltd.
SODIUM PYRROLIDONE CARBOXYLATE LACTIC ACID
2.5/5.0 %w/w
Cutaneous Emulsion
Withdrawn
2008-08-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT LactiCare 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Cutaneous emulsion. A white viscous lotion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LactiCare is indicated for the symptomatic relief of hyperkeratotic and other chronic dry skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION LactiCare can be used as often as required. Apply to the affected skin and rub in gently. 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Keep away from the eyes and mucous membranes. Should contact with the eyes occur, remove with water. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION There are no restrictions on the use of LactiCare in pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. Sodium Pyrrolidone Carboxylate 2.5 % w/w Lactic Acid 5.0 % w/w For excipients, see 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 30/11/2005_ _CRN 2017329_ _page number: 1_ 4.8 UNDESIRABLE EFFECTS Occasionally a transient mild stinging sensation may occur. Should prolonged irritation develop when used on abraded or inflamed skin, discontinue use. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES LactiCare contains both the humectant sodium pyrrolidone carboxylate and lactic acid formulated in an oil in water emulsion base to promote hydration 5.2 PHARMACOKINETIC PROPERTIES Not applicable; the product is for cutaneous use and acts locally at the site of application. 5.3 PRECLINICAL SAFETY DATA Not applicable. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Carbomer 940 Imidurea Dehydroacetic Acid Sodium Llegiu el document complet