Testosterone Besins 1000 mg/4 ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TESTOSTERONE UNDECANOATE

Available from:

Besins Healthcare Ireland Limited

ATC code:

G03BA03

INN (International Name):

TESTOSTERONE UNDECANOATE

Pharmaceutical form:

Solution for injection

Therapeutic area:

testosterone

Authorization status:

Not marketed

Authorization date:

2024-03-01

Patient Information leaflet

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TESTOSTERONE BESINS 1000 MG/4 ML, SOLUTION FOR INJECTION
testosterone undecanoate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Testosterone Besins
is and what it is used for
2.
What you need to know before you use Testosterone Besins
3.
Possible side effects
4.
How to store Testosterone Besins
5.
Contents of the pack and other information
1.
WHAT TESTOSTERONE BESINS IS AND WHAT IT IS USED FOR
Testosterone Besins
contains testosterone, a male hormone, as the active ingredient.
Testosterone Besins
is injected into a muscle in your body. There it can be stored and
gradually
released over a period of time. Testosterone Besins
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
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 USE
TESTOSTERONE BESINS
DO NOT USE TESTOSTERONE BESINS
-
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
Testosterone Besins
is NOT
intended for use in women.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR
before tak

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2024
CRN00DC50
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Testosterone Besins 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, 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 vial of Testosterone Besins (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.