Nebido 1000mg/4ml, Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TESTOSTERONE UNDECANOATE

Available from:

Bayer PLC

ATC code:

G03BA03

INN (International Name):

TESTOSTERONE UNDECANOATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TESTOSTERONE UNDECANOATE 250 mg/ml

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2005-09-02

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIDO 1000 MG/4 ML, SOLUTION FOR INJECTION
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 Nebido is and what it is used for
2.
What you need to know before you are given Nebido
3.
How to use Nebido
4.
Possible side effects
5.
How to store Nebido
6.
Contents of the pack and other information
1.
WHAT NEBIDO IS AND WHAT IT IS USED FOR
Nebido contains testosterone, a male hormone, as the active
ingredient. Nebido is injected into a
muscle in your body. There it can be stored and gradually released
over a period of time. Nebido 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 NEBIDO
DO NOT USE NEBIDO
-
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
Nebido IS NOT intended for use in women.
Page 2 of 7
Nebido IS NOT for use in children and adolescents. There is no data
available on the use of Nebido in
males under 18 years of age.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR before usi

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebido 1000 mg/4 ml, solution for injection.
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish 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_ _ Nebido (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.
Page 2 of 12
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 would
indicate the need for a shorter
injection interval. In case o