Quốc gia: Indonesia
Ngôn ngữ: Tiếng Indonesia
Nguồn: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TESTOSTERONE UNDECANOATE
ORGANON PHARMA INDONESIA TBK - Indonesia
TESTOSTERONE UNDECANOATE
40 MG
KAPSUL LUNAK
DUS, 6 BLISTER @ 10 KAPSUL LUNAK
N.V. ORGANON - Netherlands
2020-02-18
ANDRIOL TESTOCAPS Testosterone undecanoate 40 mg Soft Capsule 1. NAME OF THE MEDICINAL PRODUCT Andriol® Testocaps® 40 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40.0 mg testosterone undecanoate, which is equivalent to 25.3 mg testosterone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule Soft oval glossy capsules, transparent, orange in color, coded ORG DV3 containing a yellow oily fill. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In males: testosterone replacement therapy for primary or secondary hypogonadal disorders when testosterone deficiency has been confirmed by clinical features and biochemical tests, for example: • After castration, • Eunuchoidism, • Hypopituitarism, • Endocrine impotence, • Certain types of infertility due to spermatogenic disorders, DISETUJUI OLEH BPOM: 25/06/2021 EREG100373VR12100082 • Male climacteric symptoms such as decreased libido and decreased feeling of general well-being and fitness. Moreover, in men testosterone therapy may be indicated in osteoporosis caused by androgen deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: In general, the dose should be adjusted according to the response of the individual patient. Adults (incl. elderly): Usually, an initial dosage of 120-160 mg testosterone undecanoate daily for 2-3 weeks is adequate, followed based on the clinical effect obtained, by a maintenance dosage of 40-120 mg testosterone undecanoate daily. Paediatric population: Safety and efficacy have not been adequately determined in children and adolescents (see section 4.4). Method of administration: Andriol Testocaps must be taken with a meal, with some fluid and swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an odd number of capsules is taken, the larger dose should be taken in the morning. 4.3 CONTRAINDICATIONS • Known or suspected prostatic carcinoma or breast carcinoma in t Đọc toàn bộ tài liệu