Nebido 1000mg/4ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Testosterone undecanoate

Available from:

Bayer Plc

ATC code:

G03BA03

INN (International Name):

Testosterone undecanoate

Dosage:

250mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200; GTIN: 5016703008705

Patient Information leaflet

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
_If you have any doubts or queries about your medication, please
contact _
_your doctor or pharmacist. _
_ _
_ _
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
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
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 thi

Summary of Product characteristics

OBJECT 1
NEBIDO 1000MG/4ML, SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 26-Sep-2017 | Bayer plc
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.
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 ne