ANDRIOL TESTOCAPS

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

सक्रिय संघटक:

TESTOSTERONE UNDECANOATE

थमां उपलब्ध:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (इंटरनेशनल नाम):

TESTOSTERONE UNDECANOATE

डोज़:

40 MG

फार्मास्यूटिकल फॉर्म:

KAPSUL LUNAK

पैकेज में यूनिट:

DUS, 6 BLISTER @ 10 KAPSUL LUNAK

द्वारा बनाया गया:

N.V. ORGANON - Netherlands

प्राधिकरण की तारीख:

2020-02-18

उत्पाद विशेषताएं

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