Țară: Africa de Sud
Limbă: engleză
Sursă: South African Health Products Regulatory Authority (SAHPRA)
Galderma Laboratories S.A. (Pty) Ltd
50,0 μg
CREAM
EACH 1,0 g CREAM CONTAINS TRIFAROTENE 50,0 μg
Old Medicine
Applicant: Galderma Laboratories South Africa (Pty) Ltd Product name: Aklief Dosage form: Cream Strength:50 µg Trifarotene per 1 g of cream Registration number: 56/13.12/1007 Page 1 of 9 PATIENT INFORMATION LEAFLET SCHEDULING STATUS Aklief 50 microgram/g cream Trifarotene READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING AKLIEF BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist, nurse or other health care provider. • Aklief has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What Aklief is and what it is used for 2. What you need to know before you use Aklief 3. How to use Aklief 4. Possible side effects 5. How to store Aklief 6. Contents of the pack and other information 1. WHAT AKLIEF IS AND WHAT IT IS USED FOR Aklief contains the active substance trifarotene that belongs to a group of medicines called retinoids. S3 Applicant: Galderma Laboratories South Africa (Pty) Ltd Product name: Aklief Dosage form: Cream Strength:50 µg Trifarotene per 1 g of cream Registration number: 56/13.12/1007 Page 2 of 9 Aklief is used for the cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones (whiteheads and blackheads), papules and pustules (inflammatory pimples) are present. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AKLIEF DO NOT USE AKLIEF: - If you are allergic to trifarotene or any of the other ingredients of this medicine (listed in section 6) - If you are a woman planning pregnancy or if you are pregnant (see section “Pregnancy and breastfeeding”) WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH AKLIEF: Talk to your doctor or health care provider before using Aklief. • Redness, peeling, dryness, and stinging/burning may be experienced with the use of Aklief (see section 4 “Possi Citiți documentul complet
Applicant: Galderma Laboratories South Africa (Pty) Ltd Product name: Aklief Dosage form: Cream Strength:50 µg Trifarotene per 1 g of cream Registration number: 56/13.12/1007 Page 1 of 17 PROFESSIONAL INFORMATION SCHEDULING STATUS: S3 1. NAME OF THE MEDICINE Aklief 50 microgram/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 50 micrograms of trifarotene. _Excipients with known effect_ One gram of cream contains 300 milligrams of propylene glycol (E1520) and 50 milligrams of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White and homogenous cream 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Aklief is indicated for the cutaneous treatment of moderate _Acne Vulgaris_ of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Applicant: Galderma Laboratories South Africa (Pty) Ltd Product name: Aklief Dosage form: Cream Strength:50 µg Trifarotene per 1 g of cream Registration number: 56/13.12/1007 Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 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 medical practitioner assesses the continued improvement of the patient after three months of treatment. SPECIAL POPULATIONS _Renal and Hepatic impairment _ Aklief has not been studied in patients with renal and hepatic impairment. _Elderly patients _ The safety and efficacy of Aklief in elderly patients aged 65 years and above have not been established. PAEDIATRIC POPULATION The safety and efficacy of Aklief in children below 12 years old have not been established. METHOD OF ADMINISTRATION Cutaneous 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 fa Citiți documentul complet