SUSTANON 250 injection vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

testosterone propionate, Quantity: 30 mg; testosterone phenylpropionate, Quantity: 60 mg; testosterone isocaproate, Quantity: 60 mg; testosterone decanoate, Quantity: 100 mg

MAH:

Aspen Pharmacare Australia Pty Ltd

INN:

testosterone phenylpropionate,Testosterone decanoate,Testosterone isocaproate,Testosterone propionate

pharmaceutical_form:

Injection, solution

composition:

Excipient Ingredients: Arachis Oil; benzyl alcohol

administration_route:

Intramuscular

units_in_package:

3 vials of 1mL each, 1 vial

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

INDICATIONS AS AT 4 DECEMBER 1996: Androgen replacement therapy for confirmed testosterone deficiency in males.

leaflet_short:

Visual Identification: Clear oily liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

authorization_status:

Licence status A

authorization_date:

2011-12-23

PIL

SUSTANON '250'
1
SUSTANON '250'
_Testosterone propionate, phenylpropionate, isocaproate and decanoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sustanon. It does not
contain all the available information.
It does not take the place to talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Sustanon
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, 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.
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.
WHAT SUSTANON IS
USED FOR
Sustanon is used to treat confirmed
testosterone deficiency in males.
The active substances of Sustanon
are turned into testosterone by your
body.
Testosterone is the natural male
hormone known as an androgen. In
men, testosterone produced by the
testicles. It is necessary for the
growth, development and function of
the male sex organs and for
secondary male sex characteristics. It
is necessary for the growth of body
hair, the development of bones and
muscles, and it stimulates the
production of red blood cells. It also
makes men's voices deepen.
Preparations containing testosterone
are used to replace testosterone in a
person who has low or no natural
testosterone (a condition known as
hypogonadism).
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
A doctor's prescription is required to
obtain this medicine.
This medicine is not expected to
affect your ability to drive a car or
operate m

SPC

1
AUSTRALIAN PRODUCT INFORMATION
SUSTANON ‘250’ (TESTOSTERONE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
SUSTANON ‘250’ (250 MG/ML SOLUTION FOR INJECTION): Testosterone
propionate, testosterone
phenylpropionate, testosterone isocaproate, testosterone decanoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
ampoule
or
vial
of
Sustanon
250
contains
30
mg
testosterone
propionate,
60
mg
testosterone
phenylpropionate,
60
mg
testosterone
isocaproate
and
100
mg
testosterone
decanoate in 1 mL arachis oil. All 4 compounds are esters of the
natural hormone testosterone.
The total amount of testosterone per mL is 176 mg.
List of excipients with known effects: Arachis (peanut) oil.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sustanon ‘250’ is a clear, colourless glass ampoule or vial
containing 1 mL of pale yellow oily
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Androgen replacement therapy for confirmed testosterone deficiency in
males.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sustanon ‘250’ is an androgenic solution for intra-muscular
injection.
•
In general, dosage should be adjusted according to the response of the
individual patient.
•
ADULTS INCLUDING ELDERLY: Usually, one injection of 1mL per three
weeks is adequate for
Sustanon ‘250’.
•
Sustanon ‘250’ should be administered by deep intramuscular
injection.
•
Safety and efficacy have not been adequately determined in children
and adolescents. Pre-
pubertal children treated with Sustanon ‘250’ should be treated
with caution. Sustanon ‘250’
contains benzyl alcohol and should not be given to children under 3
years of age.
4.3
C
ONTRAINDICATIONS
•
Known or suspected carcinoma of the prostate or breast
•
Hypercalcaemia and/or hypercalciuria
•
Hypersensitivity to the active substances_ or _ any of the excipients,
including arachis oil.
Sustanon ‘250’ is therefore contraindicated in patients allergic
to peanuts or soya (see section
4.4 Special warnings and p