恩賜特膠囊40公絲

Kraj: Tajwan

Język: chiński

Źródło: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Składnik aktywny:

TESTOSTERONE UNDECANOATE

Dostępny od:

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)

Kod ATC:

G03BA03

Forma farmaceutyczna:

軟膠囊劑

Skład:

TESTOSTERONE UNDECANOATE (6808501100) MG

Sztuk w opakowaniu:

鋁箔盒裝

Klasa:

製　劑

Typ recepty:

須由醫師處方使用

Wyprodukowano przez:

CATALENT FRANCE BEINHEIM S.A. 74, RUE PRINCIPALE F-67930 BEINHEIM, FRANCE FR

Dziedzina terapeutyczna:

testosterone

Wskazania:

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。

Podsumowanie produktu:

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

Status autoryzacji:

已註銷

Data autoryzacji:

1986-11-08

Ulotka dla pacjenta

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