Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TESTOSTERONE UNDECANOATE
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
TESTOSTERONE UNDECANOATE
30Capsule Capsules; 120Capsule Capsules; 60Capsule Capsules
Catalent France Beinheim SA
LPC -MK3033 -CP -072015 b 052017 ANDRIOL TESTOCAPS Capsule 1. Name of the medicinal product Andriol ® Testocaps ® 40 mg capsules 2. Qualitative and quantitative composition Andriol Testocaps contain testoste rone undecanoate, a fatty acid ester of the natural hormone testosterone. Each capsule contains 40 mg testosterone undecanoate dissolved in a mixture of castor oil and propylene glycol laurate. For excipients, see 6.1. 3. Pharmaceutical form Capsules. Sof t oval glossy capsules, transparent, orange in colour, coded ORG DV3 containing a yellow oily fill. 4. Clinical particulars 4.1 Therapeutic indications Testosterone replacement therapy in male s, for conditions associated with primary or secondary hypogona dism (either congenital or acquired) when testosterone deficiency has been confirmed by clinical features and biochemical tests . 4.2 Posology and method of administration Posology In general, the dose should be adjusted according to the response of the in dividual patient. Adult s The initial dosage required will usually be 120 -160mg daily for 2 -3 weeks. Subsequent dosage (40 -120mg daily) should be based on the clinical effect obtained during the first weeks of therapy. Elderly Patients Citiți documentul complet