Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Trifarotene
GALDERMA SINGAPORE PRIVATE LIMITED
D10AD06
CREAM
Trifarotene 50 mcg/g
TOPICAL
Prescription Only
Laboratoires GALDERMA
ACTIVE
2022-08-17
1 SINGAPORE PRODUCT INFORMATION AKLIEF (TRIFAROTENE) CREAM 1 NAME OF THE MEDICINE Aklief Cream 50mcg/g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 50 micrograms of Trifarotene. EXCIPIENTS WITH KNOWN EFFECT Contains alcohol as 50 mg/g ethanol. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Cream White and homogenous cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aklief is indicated for the topical treatment of _Acne Vulgaris_ of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. It is recommended that the physician assesses the continued improvement of the patient after three months of treatment. The duration of treatment should be determined by the doctor based on the clinical response. _Special populations_ _Elderly patients _ The safety and efficacy of Aklief in geriatric patients aged 65 years and above have not been established. 2 RENAL IMPAIRMENT AND HEPATIC IMPAIRMENT Aklief has not been studied in patients with renal and hepatic impairment. _Paediatric population _ The safety and efficacy of Aklief in children below 12 years old have not been established. Method of administration For topical use only. Before using the pump for the first time, prime it by pressing down several times until a small amount of medicine is dispensed (up to 10 times maximum). The pump is now ready to use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin and right and left cheeks) and all affected areas of the trunk once a day, in the evening, on clean and dry skin: - One pump actuation should be enough to cover the face (i.e. forehead, cheeks, nose, and chin). - Two pump actuations should be enough to cover the upper trunk (i.e. reachable upper back, shoulders a Les hele dokumentet