Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TESTOSTERONE
SYDNA FARMA - Indonesia
TESTOSTERONE
0.050 G
GEL
DUS, 30 SACHET @ 5 GRAM
BESINS MANUFACTURING BELGIUM SA - Belgium
2020-04-06
Androgel SmPC – ID – Sep-20 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ANDROGEL 50 mg, gel in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of 5 g contains 50 mg of testosterone. Excipients with known effect: Ethanol. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel in sachet. Transparent or slightly opalescent, colourless gel in sachet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see 4.4 Special warnings and precautions for use). 4.2 Posology and method of administration Posology _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 physician 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. Steady state plasma testosterone concentrations are reached approximately on the 2 nd day of treatment by this medicine. 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 starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. _Paediatric population_ This medicine is not indicated for use in children and has not been evaluated clinically in males under 18 years of age. _Use in women _ This medicine is not indicated for use in women. DISETUJUI OLEH BPOM: 22/09/2020 EREG10021912000055 Androgel SmPC – ID – Sep-20 2 of 9 Method of administration Transdermal use. The application should be administered by the patient himself, onto clean, dry, h Izlasiet visu dokumentu