REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

testosterone undecanoate, Quantity: 1000 mg

Available from:

Bayer Australia Ltd

INN (International Name):

testosterone undecanoate

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: benzyl benzoate; Castor Oil

Administration route:

Intramuscular

Units in package:

4 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Testosterone replacement in primary and secondary male hypogonadism.

Product summary:

Visual Identification: Clear, colourless to yellowish brown oily solution.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-10-26

Patient Information leaflet

REANDRON

1000 CMI VX1.0
REANDRON
® 1000
(REE·ANNE·DRON)
_testosterone undecanoate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Reandron. It does not contain all
the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Reandron against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT REANDRON IS
USED FOR
Male hypogonadism is the
condition where there are low
levels of testosterone in the body.
Reandron is used to replace the
body’s natural hormone
testosterone when not enough is
made by the body.
Testosterone is a natural male
hormone, known as an androgen,
which controls normal sexual
development in men.
Testosterone is essential for the
development and maintenance of
the male reproductive organs as
well as other male
characteristics, such as hair
growth, deep voice, sexual drive,
muscle mass and body fat
distribution.
Reandron contains testosterone
undecanoate, as the active
ingredient. Reandron is injected
into a location in your body
(buttock muscle) where it can be
stored and gradually released
over a period of time.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
BEFORE YOU ARE
GIVEN REANDRON
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE REANDRON IF YOU
HAVE OR ARE SUSPECTED TO HAVE:
•
prostate cancer
•
male breast cancer
•
high blood calcium levels
associated with tumours
•
past or present liver tumours
DO NOT USE REANDRON IF YOU ARE
A WOMAN.
DO NOT USE REANDRON IF YOU
HAVE AN ALLERGY TO:
•
testosterone undecanoate
•
any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath,

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION REANDRON
®
1000
(TESTOSTERONE UNDECANOATE)
SOLUTION FOR INJECTION
_ _
Reandron PI VX 2.0; CCDS10
Page 1 of 15
1 NAME OF THE MEDICINE
Testosterone undecanoate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Reandron 1000 is a hormonal preparation that contains 1000 mg
testosterone undecanoate in 4 mL
of oily solution.
Reandron contains benzyl benzoate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Reandron 1000 is a clear, colourless to yellowish brown oily solution
for injection.
Testosterone undecanoate is a white or off-white crystalline
substance.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement in primary and secondary male hypogonadism.
4.2 DOSE AND METHOD OF ADMINISTRATION
Reandron 1000 (1 ampoule/vial corresponding to 1000 mg testosterone
undecanoate) is
injected every 10 to 14 weeks for testosterone replacement, where
testosterone deficiency has
been confirmed by clinical features and biochemical tests. Injections
with this frequency are
capable of maintaining sufficient testosterone levels and do not lead
to accumulation.
The injections must be administered very slowly. Care should be taken
to inject Reandron 1000
deeply into the gluteal muscle (the only site for which clinical
experience has been obtained)
following the usual precautions for intramuscular administration.
Reandron 1000 is strictly for
intramuscular injection. Special care must be taken to avoid
intravenous injection and
injections must not be given subcutaneously. See Instructions for
use/handling to avoid injury
when opening.
START OF TREATMENT
Serum testosterone levels should be measured before start of treatment
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 rapi