Sustanon 250

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Testosterone decanoate 100 mg/mL;  ; Testosterone isocaproate 60 mg/mL;  ; Testosterone phenylpropionate 60 mg/mL;  ; Testosterone propionate 30 mg/mL;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Testosterone decanoate 100 mg/mL

Dosage:

250 mg

Pharmaceutical form:

Solution for injection

Composition:

Active: Testosterone decanoate 100 mg/mL   Testosterone isocaproate 60 mg/mL   Testosterone phenylpropionate 60 mg/mL   Testosterone propionate 30 mg/mL   Excipient: Arachis oil Benzyl alcohol

Units in package:

Ampoule, glass, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Testosterone replacement therapy in males for conditions associated with primary and secondary hypogonadism, either congenital or acquired.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, - 1 mL - 60 months from date of manufacture stored at or below 30°C - Vial, glass, Type I with rubber stopper, aluminium crimp cap and flip off seal - 1 mL - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

SUSTANON 250
_Testosterone propionate, phenylpropionate, isocaproate and decanoate_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using SUSTANON
250.
This leaflet answers some common questions about SUSTANON 250. 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 SUSTANON 250 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 SUSTANON 250 IS USED FOR
The active substances of SUSTANON 250 are turned into testosterone by
your
body. Testosterone is a natural male hormone known as an androgen.
In men, testosterone is produced by the testicles. It is necessary for
the normal
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). SUSTANON 250 is also used in men for the treatment
of
osteoporosis caused by androgen
deficiency.
SUSTANON 250 is used in female to male transsexuals for development of
male
sexual characteristics.
Your doctor may have prescribed SUSTANON 250 for another reason.
Ask your doctor if you have any questions about why SUSTANON 250 has
been
prescribed for you.
This medicine is available only with a doctor's prescription.
BEFORE YOU USE SUSTANON 250
_WHEN YOU MUST NOT USE IT_
Do not use SUSTANON 250 if:
•
you are pregnant or think you may be pregnant or by women who are
breastfeeding.
•
you have or have had a tumour of your prostate or breast, or are
suspected to
have one of these tumours.

Summary of Product characteristics

SUSTANON - Data Sheet
1/ 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SUSTANON 250 (250 mg testosterone esters solution for injection)
_PRESENTATIONS THAT ARE NOT CURRENTLY AVAILABLE_
The vials are currently not available.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substances -
testosterone proprionate 30 mg
testosterone phenylpropionate 60 mg
testosterone isocaproate 60 mg
testosterone decanoate 100 mg
All four compounds are esters of the natural hormone testosterone. The
total amount
of testosterone per 1 mL is 176 mg.
List of excipients -
1 mL arachis oil and the solution also contains 10 per cent benzyl
alcohol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Oily solution for intramuscular use. A clear, pale yellow solution.
Each clear glass
ampoule or vial contains 1 mL in arachis oil.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy in males for conditions associated
with primary and
secondary hypogonadism, either congenital or acquired.
In female to male transsexuals:
•
masculinization
Moreover, in men testosterone therapy may be indicated in osteoporosis
caused by
androgen deficiency.
4.2 DOSE AND METHOD OF ADMINISTRATION
In general, the dose should be adjusted according to the response of
the individual
patient.
_DOSE_
_Adults (incl. elderly):_
SUSTANON - Data Sheet
2/ 10
Usually, one injection of 1 ml per three weeks is adequate.
_Paediatric population_:
Safety and efficacy in children and adolescents, have not yet been
established. Pre-
pubertal children treated with SUSTANON should be treated with caution
(see Section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
SUSTANON contains benzyl alcohol and is contraindicated in children
under 3 years of
age.
_METHOD OF ADMINISTRATION _
SUSTANON should be administered by deep intramuscular injection.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1, including arachis oil. SUSTANON i