Nebido 1000mg/4ml, Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Grünenthal Pharma Ltd 4045 Kingswood Road Citywest Business Park Citywest Co. Dublin, Ireland

ATC code:

G03BA03

INN (International Name):

TESTOSTERONE UNDECANOATE 250 mg/ml

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

1
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.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR
before using Nebido if you have or have ever had:
2
-
epilepsy
-
heart, kidney or liver problems
-
migraine
-
temporary interruptions in your breathing during slee

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nebido 1000 mg/4ml 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.
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
Clear, colorless to yellowish-brown 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.
3
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