NEBIDO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TESTOSTERONE UNDECANOATE

Available from:

BAYER ISRAEL LTD

ATC code:

G03BA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TESTOSTERONE UNDECANOATE 250 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

BAYER AG, GERMANY

Therapeutic group:

TESTOSTERONE

Therapeutic area:

TESTOSTERONE

Therapeutic indications:

Testosterone replacement therpay in primary and secondary male hypogonadism.

Authorization date:

2021-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
NEBIDO
®
SOLUTION FOR INJECTION
One vial contains:
1000 mg testosterone undecanoate
(1
ml
solution
for
injection
contains
250
mg
testosterone
undecanoate,
corresponding to 157.9 mg testosterone).
Inactive ingredients and allergens in the preparation: see section 2
“Important
information regarding some of the ingredients of the medicine” and
section 6
“Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It
may harm them, even if it seems to you that their medical condition is
similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
Nebido is intended for use in adult men as a testosterone replacement
to treat
problems caused by a testosterone deficiency (male hypogonadism).
Testosterone deficiency will be confirmed by two separate blood
testosterone
measurements and will also include clinical symptoms, such as:
•
impotence
•
infertility
•
low sex drive
•
tiredness
•
depressive moods
•
loss of bone mass caused by low hormone levels
Nebido is slowly injected into the muscle, where it is stored and
gradually
released over a period of time.
THERAPEUTIC
GROUP:
Nebido
is
a
replacement
for
the
male
hormone
(androgen)
testosterone,
and
belongs
to
a
group
of
medicines
called
androgens.
2) BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to testosterone undecanoate or to any of
the
other ingredients contained in the medicine. For a list of the
inactive
ingredients, see section 6 “Further Information”.
•
You have an androgen-dependent cancer or suspected cancer of the
prostate or of the breast.
•
You have or had a liver tumor.
•
You are a woman.
SPECIAL WARNINGS REGARDING

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 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 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 in primary and secondary male
hypogonadism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One 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 need for a shorter injection
interval. In case of
high serum levels an extension of the injection interval may be
considered.
SPECIAL POPULATIONS