দেশ: সিঙ্গাপুর
ভাষা: ইংরেজি
সূত্র: HSA (Health Sciences Authority)
DIFLUCORTOLONE VALERATE; ISOCONAZOLE NITRATE
DKSH SINGAPORE PTE. LTD.
D01AC20
1 mg/g
CREAM
DIFLUCORTOLONE VALERATE 1 mg/g; ISOCONAZOLE NITRATE 10 mg/g
TOPICAL
Prescription Only
LEO Pharma Manufacturing Italy S.r.I
ACTIVE
1990-05-31
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: TRAVOCORT ® Cream Broad-spectrum antimycotic with a corticoid additive 063581 Manufactured by: LEO Pharma Manufacturing Italy S.r.l. Important information, please read carefully! COMPOSITION Travocort contains a white to slightly yellowish opaque cream. 1 g Travocort contains 10 mg (1%)isoconazole nitrate and 1 mg (0.1%) diflucortolone valerate in an easy- to-remove low fat base (o/w emulsion). PHARMACODYNAMICS Pharmacotherapeutic group:Imidazole and triazole derivatives, combinations ATC Code:D01AC20 Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It displays a very broad spectrum of antimicrobial action. It is effective against dermatophytes and yeasts, yeast-like fungi (including the causative organism of pityriasis versicolor) and molds, as well as against gram-positive bacteria in-vitro and against the causative organism of erythrasma. Diflucortolone valerate suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as pruritus, burning and pain. PHARMACOKINETICS R Isoconazole nitrate Isoconazole penetrates rapidly into human skin from Travocort cream and reaches maximum drug concentrations in the horny layer and in the living skin already 1 hour after application. High concentrations were maintained for at least 7 hours (horny layer: approx. 3500 μg/ml (corresponding to 7 mmol/l), living epidermis approx. 20 μg/ml (40 μmol/l), dermis approx. 3 μg/ml (6 μmol/l). Removal of the horny layer prior to the application increased isoconazole concentrations in the living skin approximately by a factor of 2, based on a study done on guinea pig skin. Drug concentrations in the horny layer and the epidermis exceeded সম্পূর্ণ নথি পড়ুন
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: Font updated to Univers Next 000000-YY TRAVOCORT® Cream Broad-spectrum antimycotic with a corticoid additive Manufactured by: LEO Pharma Manufacturing Italy S.r.l. Important information, please read carefully! COMPOSITION Travocort contains a white to slightly yellowish opaque cream. 1 g Travocort contains 10 mg (1%)isoconazole nitrate and 1 mg (0.1%) diflucortolone valerate in an easy-to-remove low fat base (o/w emulsion). PHARMACODYNAMICS Pharmacotherapeutic group:Imidazole and triazole derivatives, combinations ATC Code:D01AC20 Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It displays a very broad spectrum of antimicrobial action. It is effective against dermatophytes and yeasts, yeast-like fungi (including the causative organism of pityriasis versicolor) and molds, as well as against gram-positive bacteria in-vitro and against the causative organism of erythrasma. Diflucortolone valerate suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as pruritus, burning and pain. PHARMACOKINETICS • Isoconazole nitrate Isoconazole penetrates rapidly into human skin from Travocort cream and reaches maximum drug concentrations in the horny layer and in the living skin already 1 hour after application. High concentrations were maintained for at least 7 hours (horny layer: approx. 3500 μg/ml (corresponding to 7 mmol/l), living epidermis approx. 20 μg/ml (40 μmol/l), dermis approx. 3 μg/ml (6 μmol/l). Removal of the horny layer prior to the application increased isoconazole concentrations in the living skin approximately by a factor of 2, based on a study done on guinea pig skin. Drug concentrations in the horny l সম্পূর্ণ নথি পড়ুন