Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
AZELAIC ACID
DKSH SINGAPORE PTE. LTD.
D10AX03
0.2 g/g
CREAM
AZELAIC ACID 20g/100g
TOPICAL
Prescription Only
LEO Pharma Manufacturing Italy S.r.I.
ACTIVE
1992-07-14
IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040 IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert 148 x 210 mm IIT004-00 29/01/2019 OMA 100% All products Used for: Segrate keyline DRA_90040 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040 IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert 148 x 210 mm IIT004-00 29/01/2019 OMA 100% All products Used for: Segrate keyline DRA_90040 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: Manufactured by: LEO Pharma Manufacturing Italy S.r.I Important information, please read carefully! COMPOSITION Skinoren contains a white, opaque cream. 1 g Skinoren cream contains 200 mg (20 %) azelaic acid. For the full list of excipients, see section _List of excipients._ PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: other anti-acne preparations for topical use, ATC code: D10AX03 The antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren in acne. Clinically, a significant reduction of the colonization density of Propionibacterium acnes and a significant reduction of the fraction of free fatty acids in the skin surface lipids is observed. In vitro and in vivo, azelaic acid inhibits the proliferation of keratinocytes and normalizes the disturbed terminal epidermal differentiation processes in acne. In the rabbit ear model, azelaic acid accelerates the comedolysis of tetradecane-induced comedones. Experimental results demonstrate that azelaic acid exerts a dose- and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes. The molecular mechanisms by which this is accomplished are not entirely clarified. Currently available data suggest that the main effects of azelaic acid in the treatment of melasma are brought about by an inhibition of the DNA synthesis and/or an inhibition of the cellular respi Lugege kogu dokumenti
IIT004-00 - Page 1 + 2 - 148 x 210 mm – DRA_90040 IIT004-00 - 29/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert 148 x 210 mm IIT004-00 29/01/2019 OMA 100% All products Used for: Segrate keyline DRA_90040 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: SKINOREN® Anti-acne agent Manufactured by: LEO Pharma Manufacturing Italy S.r.I Important information, please read carefully! COMPOSITION Skinoren contains a white, opaque cream. 1 g Skinoren cream contains 200 mg (20 %) azelaic acid. For the full list of excipients, see section List of excipients. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: other anti-acne preparations for topical use, ATC code: D10AX03 The antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren in acne. Clinically, a significant reduction of the colonization density of Propionibacterium acnes and a significant reduction of the fraction of free fatty acids in the skin surface lipids is observed. In vitro and in vivo, azelaic acid inhibits the proliferation of keratinocytes and normalizes the disturbed terminal epidermal differentiation processes in acne. In the rabbit ear model, azelaic acid accelerates the comedolysis of tetradecane-induced comedones. Experimental results demonstrate that azelaic acid exerts a dose- and time- dependent inhibitory effect on the growth and viability of abnormal melanocytes. The molecular mechanisms by which this is accomplished are not entirely clarified. Currently available data suggest that the main effects of azelaic acid in the treatment of melasma are brought about by an inhibition of the DNA synthesis and/or an inhibition of the cellular respiration of the abnormal melanocytes. PHARMACOKINETICS PROPERTIES Azelaic acid penetrates into all layers of human skin after topical application of the cream. Penetration is faster into damaged skin than into intact skin. A total of 3.6 % of the dose applied is absorbed percuta Lugege kogu dokumenti