Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
Testosterone 1%
PHARMED IMPORT & EXPORT PTE LTD
0.025g
GEL
Testosterone 1% 0.025g
CUTANEOUS
Prescription Only
Laboratoires Besins International
ACTIVE
2005-12-22
Package Insert ANDROGEL , GEL IN SACHET 1. NAME OF THE MEDICINAL PRODUCT ANDROGEL 25 mg, gel in sachet ANDROGEL 50 mg, gel in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Testosterone .................................. .............................0.025 g Testosterone ..................... .........................................0.050 g For excipients, see 6.1. For one 2.5 g sachet For one 5 g sachet 3. PHARMACEUTICAL FORM Gel in sachet. ANDROGEL is a transparent or slightly opalescent, colourless gel. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical signs and biochemical tests (see 4.4 Special warnings and precautions for use). 4 . 2 Posology and method of administration Cutaneous use. Adult and Elderly men The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, and both arms and abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing. Wash hands with soap and water after application. Do not apply to the genital areas as the high alcohol content may cause local irritation. Steady state plasma testosterone concentrations are reached approximately on the 2 nd day of treatment by ANDROGEL. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3 rd day on after start Lesen Sie das vollständige Dokument