INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SUSTANON ‘250’ampoules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form)

SUSTANON ‘250’ampoules

COMPOSITION
Each mL of the oily solution contains:

	testosterone propionate	30 mg
	testosterone phenylpropionate	60 mg
	testosterone isocaproate	60 mg
	testosterone decanoate	100 mg
	benzyl alcohol	10% v/v

PHARMACOLOGICAL CLASSIFICATION
A/21.7/Male sex hormones.

PHARMACOLOGICAL ACTION
Sustanon ‘250’is an androgenic preparation for intramuscular administration containing four different ester of the natural hormone testosterone.

INDICATIONS
Testosterone replacement therapy in male hypogonadal disorders, for example:

–	after castration
–	eunuchoidism
–	hypopituitarism

Moreover, testosterone therapy may be indicated in osteoporosis due to hypogonadal male androgen deficiency.

CONTRA-INDICATIONS
Known or suspected mammary or prostatic carcinoma in the male. This medicine is not intended for use in female patients.

WARNINGS
Middle-aged and elderly males with angina pectoris or other severe circulatory disease should receive androgen treatment only under very careful supervision.

DOSAGE AND DIRECTIONS FOR USE
In general, dosage should be adjusted according to the response of the individual patient.
Usually, one injection of 1 mL per four weeks is adequate.
SUSTANON ‘250’should be administered by deep intramuscular injection.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following adverse reactions have been associated with androgen therapy:

–	Priapism and other signs of excessive sexual stimulation.
–	In prepubertal boys: precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.
–	Oligospermia and decreased ejaculatory volume.
–	Water and salt retention.

Precautions
If androgen-associated adverse reactions occur, treatment should be interrupted and, after disappearance of the symptoms, be resumed at a lower dosage. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be monitored, since androgens may occasionally induce salt and fluid retention.
Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. A decrease in protein bound iodine (PBI) may occur, but this has no clinical significance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side-effects and Special Precautions”.
Treat symptomatically.

CONDITIONS OF REGISTRATION
Advertising to the professions only.

IDENTIFICATION
An ampoule marked with a red and yellow stripe on the neck, containing a clear oily solution.

PRESENTATION
SUSTANON ‘250’1 mL ampoules –boxes of 3

STORAGE DIRECTIONS
The ampoules and syringes should be kept between 15°C and 25°C and protected from light.
Keep out of reach of children.

REFERENCE NUMBER
G 3208 (Act 101/1965)

NAME AND ADDRESS OF THE APPLICANT
Donmed Pharmaceuticals (Pty) Ltd
Cambridge Place
cnr. Kirkby and Oxford Roads
Bedfordview
2007

DATE OF PUBLICATION OF THIS PACKAGE INSERT
1986.11.25

DONMED
Pharmaceuticals

Under licence of NV Organon The Netherlands
        252995
        Britepak 01/97

RU 1440.020.002

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