Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
ISOCONAZOLE NITRATE
DKSH SINGAPORE PTE. LTD.
D01AC05
10 mg/g
CREAM
ISOCONAZOLE NITRATE 10 mg/g
TOPICAL
Pharmacy Only
LEO Pharma Manufacturing Italy S.r.I
ACTIVE
1991-01-14
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: Manufactured by LEO Pharma Manufacturing Italy S.r.I. Important information, please read carefully QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Travogen Cream contains 10 mg Isoconazole nitrate (equivalent to 1% (w/w) isoconazole nitrate). PHARMACEUTICAL FORM White to slightly yellowish opaque cream. INDICATIONS Superficial fungal infections of the skin, e.g. in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions. DOSAGE AND ADMINISTRATION Cutaneous use. Travogen should be applied once daily to the affected areas of skin. A general rule for fungal infections is that topical therapy be continued for a period of two to three weeks, and for four weeks in refractory infections (particularly infections of the interdigital spaces). Longer period of treatment are also possible. To avoid recurrence, treatment should be continued for at least another two weeks after clinical healing. CONTRAINDICATIONS None so far known. INTERACTION WITH OTHER MEDICAMENT No interaction studies have been performed. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Travogen should not be allowed to come into contact with the eyes when being applied to the face. The physican should advise the patients on hygienic measures and skin care, if applicable, during the treatment. If Travogen cream is applied to the genital region, the excipients liquid paraffin and soft paraffin may cause damage of latex products for barrier methods such as condoms and diaphragms used concomitantly, thus impairing their effectiveness. FERTILITY, PREGNANCY AND LACTATION It has been shown in animal studies that there were no adverse effects on birth and lactation, and on the fertility and reproductive functions. Hence base Đọc toàn bộ tài liệu
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 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Travogen Cream contains 10 mg Isoconazole nitrate (equivalent to 1% (w/w) isoconazole nitrate). PHARMACEUTICAL FORM White to slightly yellowish opaque cream. INDICATIONS Superficial fungal infections of the skin, e.g. in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions. DOSAGE AND ADMINISTRATION Cutaneous use. Travogen should be applied once daily to the affected areas of skin. A general rule for fungal infections is that topical therapy be continued for a period of two to three weeks, and for four weeks in refractory infections (particularly infections of the interdigital spaces). Longer period of treatment are also possible. To avoid recurrence, treatment should be continued for at least another two weeks after clinical healing. CONTRAINDICATIONS None so far known. INTERACTION WITH OTHER MEDICAMENT No interaction studies have been performed. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Travogen should not be allowed to come into contact with the eyes when being applied to the face. The physican should advise the patients on hygienic measures and skin care, if applicable, during the treatment. If Travogen cream is applied to the genital region, the excipients liquid paraffin and soft paraffin may cause damage of latex products for barrier methods such as condoms and diaphragms used concomitantly, thus impairing their effectiveness. FERTILITY, PREGNANCY AND LACTATION It has been shown in animal studies that there were no adverse effects on birth and lactation, and on the fertility and reproductive functions. Hence base Đọc toàn bộ tài liệu