Nebido 1000 mg/4 ml, solution for injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-11-2022
Summary of Product characteristics
(SPC)
24-11-2022
Active ingredient:
TESTOSTERONE UNDECANOATE
Available from:
Bayer Limited
ATC code:
G03BA; G03BA03
INN (International Name):
TESTOSTERONE UNDECANOATE
Dosage:
1000 milligram(s)
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
3-oxoandrosten (4) derivatives; testosterone
Authorization status:
Marketed
Authorization date:
2004-11-12
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:
BP21055 REC17464
2
-
epilepsy
-
heart, kidney or liver problems
-
migraine
-
temporary interruptions in your brea
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
24 November 2022
CRN00CMQP
Page 1 of 10
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.
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.
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
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