Testosteron undecanoate-Depot 1000 mg EIFELFANGO

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

TESTOSTERONUNDECANOAAT 250 mg/ml

INN (Nama Internasional):

TESTOSTERONUNDECANOAAT 250 mg/ml

Bentuk farmasi:

Oplossing voor injectie

Komposisi:

BENZYLBENZOAAT ; CASTOROLIE, GEZUIVERD

Rute administrasi :

Intramusculair gebruik

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
TESTOSTERON UNDECANOATE-DEPOT 1000 MG EIFELFANGO
Testosterone undecanoate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally approved name] is and what it is used for
2.
What you need to know before you are given [Nationally approved name]
3.
How to use [Nationally approved name]
4.
Possible side effects
5.
How to store [Nationally approved name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY APPROVED NAME] IS AND WHAT IT IS USED FOR
[Nationally approved name] contains testosterone, a male hormone, as
the active ingredient.
[Nationally approved name] is injected into a muscle in your body.
There it can be stored and gradually released
over a period of time. [Nationally approved name] is used in adult men
for testosterone replacement to treat
various health problems caused by a lack of testosterone (male
hypogonadism). These should be confirmed by
two separate blood testosterone measurements and also include clinical
symptoms such as:
•
impotence
•
infertility
•
low sex drive
•
tiredness
•
depressive moods
•
bone loss caused by low hormone levels
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY APPROVED NAME]
DO NOT USE
[NATIONALLY APPROVED NAME]
-
if you are allergic to testosterone undecanoate or any of the other
ingredients of this medicine (listed
in section 6)
-
if you have androgen-dependent cancer or suspected cancer of the
prostate or of the breast
-
if you have or had a liver tumour
[Nationally approved name] IS NOT intended for

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Testosteron undecanoate-Depot 1000 mg EIFELFANGO
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for injection contains 250 mg testosterone
undecanoate corresponding to 157.9 mg
testosterone.
Each ampoule / vial with 4 ml solution for injection contains 1000 mg
testosterone undecanoate
corresponding to 631.5 mg testosterone.
Excipient with known effect:
2000 mg benzyl benzoate per ampoule / vial. For the full list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
Slightly yellow to yellow oily solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism, when
testosterone deficiency has been
confirmed by clinical features and biochemical tests (see section
4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY
One ampoule / vial of [Nationally approved name] (corresponding to
1000 mg testosterone
undecanoate) is injected every 10 to 14 weeks. Injections with this
frequency are capable of
maintaining sufficient testosterone levels and do not lead to
accumulation.
Start of treatment
Serum testosterone levels should be measured before start and during
initiation of treatment.
Depending on serum testosterone levels and clinical symptoms, the
first injection interval may be
reduced to a minimum of 6 weeks as compared to the recommended range
of 10 to 14 weeks for
maintenance. With this loading dose, sufficient steady state
testosterone levels may be achieved more
rapidly.
Maintenance and individualisation of treatment
The injection interval should be within the recommended range of 10 to
14 weeks. Careful monitoring
of serum testosterone levels is required during maintenance of
treatment. It is advisable to measure
testosterone serum levels regularly.
Measurements should be performed at the end of an injection interval
and clinical symptoms
considered. These serum levels should be within the lower third of the
normal range. Serum levels
below normal range wo