Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
TRETINOIN
VALEANT CANADA LP / VALEANT CANADA S.E.C.
D10AD01
TRETINOIN
0.05%
CREAM
TRETINOIN 0.05%
TOPICAL
20G
Prescription
CELL STIMULANTS AND PROLIFERANTS
Active ingredient group (AIG) number: 0112395001; AHFS:
CANCELLED POST MARKET
2014-07-30
1 PRODUCT MONOGRAPH Pr RENOVA ® Tretinoin Emollient Cream 0.05%, House Std. Agent for the treatment of photodamaged skin Valeant Canada LP 4787 Levy Montreal, Canada H2R 2P9 DATE OF PREPARATION: March 21, 2012 Control # 153972 2 PRODUCT MONOGRAPH PR RENOVA* Tretinoin Emollient Cream 0.05%, House Std. PHARMACOLOGIC CLASSIFICATION Agent for the treatment of photodamaged skin CLINICAL PHARMACOLOGY RENOVA tretinoin emollient cream 0.05% significantly reduces clinical signs of photodamaged skin such as fine wrinkles, mottled hyperpigmentation, and roughness. While the exact mechanism of action of RENOVA emollient cream 0.05% is unknown, the clinical improvements are accompanied by the following histologic changes: increased epidermal and granular layer thickness, reduced melanin content, and stratum corneum alterations. INDICATIONS AND CLINICAL USE RENOVA tretinoin emollient cream 0.05% is indicated for the treatment of fine wrinkling, mottled hyperpigmentation, and roughness of the skin. These signs are usually associated with photodamaged (sun-damaged) skin and intrinsic aging, but may be associated with other conditions. The safety and efficacy of RENOVA emollient cream 0.05% for the prevention or treatment of actinic or solar keratoses have not been established. CONTRAINDICATIONS 3 RENOVA tretinoin emollient cream 0.05% is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS RENOVA tretinoin emollient cream 0.05% should be used under medical supervision as part of a comprehensive skin protection program, including use of sunscreen products and protective clothing. Excessive use of RENOVA emollient cream 0.05% should be avoided. RENOVA emollient cream 0.05% should be kept away from the eyes, mouth, angles of the nose, or mucous membranes. Topical use may induce severe local erythema, pruritus, burning or stinging, and peeling at the site of application. If the degree of local irrit Đọc toàn bộ tài liệu