PROP 100
Testosterone Propionate Injection BP 100 mg/ml

COMPOSITION:

Each ml contains

Testosterone Propionate BP 100mg

Ethyl Oleate BP q.s

PHARMACOLOGICAL CLASSIFICATIONS :

Male sex hormones

PHARMACOLOGICAL ACTION:

PROP 100 is an androgenic preparation for intramuscular administration containing 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. PROP 100 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

Contact your Doctor

STORAGE DIRECTIONS :

Store at room temperature below 25°C

eep out of reach of children! Do not freeze

PRESENTATIONS:

10 ml glass vial duly labeled & packed in a printed carton along with a leaflet.

OR

10 Ampoules of 1 ml vial duly labeled&packed in a printed carton along with a leaflet.

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