Država: Tajvan
Jezik: kitajščina
Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
TESTOSTERONE UNDECANOATE
美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)
G03BA03
軟膠囊劑
TESTOSTERONE UNDECANOATE (6808501100) MG
鋁箔盒裝
製 劑
須由醫師處方使用
CATALENT FRANCE BEINHEIM S.A. 74, RUE PRINCIPALE F-67930 BEINHEIM, FRANCE FR
testosterone
經臨床徵象及實驗室檢驗確認因睪固酮缺乏之男性生殖腺功能不足症(hypogonadism)的替代治療。
註銷日期: 2021/03/11; 註銷理由: 自請註銷; 有效日期: 2024/05/26; 英文品名: ANDRIOL TESTOCAPS CAPSULES 40MG
已註銷
1986-11-08
S-CCDS-MK3033-CP-052017 MK-3033-TWN-2017-014576V1 ANDRIOL TESTOCAPS ® 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 Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism) has been confirmed by clinical symptoms and biochemical laboratory tests. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: In general, the dose should be adjusted according to the response of the individual patient. _Adults _The initial dosage required will usually be of 120–160 mg daily for 2–3 weeks. Subsequent dosage (40–120 mg daily) should be based on the clinical effect during the treatment. _Paediatric population: _ Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Andriol Testocaps should be treated with caution (see section 4.4). Method of administration: Andriol Testocaps must be taken with a meal, and can be taken with a little 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 carcinoma of the prostate or breast (see section 4.4). - Pregnancy. - Breast-feeding. - Hypersensitivity to the active substance or to any of the excipients (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medical examination: Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to e Preberite celoten dokument