Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
For the treatment of advanced hormone dependent prostatic carcinoma (stage C or stage D according to the classification of Murphy et al, in Cancer 45, p1889-95, 1980) in which suppression of testosterone is indicated; however, not after bilateral orchiectomy (no further reduction of testosterone level by buserelin to be expected).
Buserelin acts by blockade and subsequent down-regulation of pituitary LHRH receptor synthesis. Gonadotropin release is consequently inhibited. As a result of this inhibition there is reduced stimulation of testosterone secretion and serum testosterone levels fall to castration range. Before inhibition occurs there is a brief stimulatory phase during which testosterone levels may rise.
Initiation of therapy: is most conveniently carried out in hospital; 0.5ml Suprefact injection should be injected subcutaneously at 8 hourly intervals for 7 days.
Maintenance therapy: on the 8th day of treatment the patient is changed to intranasal administration of Suprefact. (see literature for dosage).
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedemas of the lower extremities, and mastodynia as well as to local reactions at the injection site such as pain, haemorrhage and induration (see section 4.8). Treatment should be symptomatic.
Unopened: 2 years.
Once opened use within 15 days.
Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.
Box of 1 × 5.5 ml multidose vial containing 1.05 mg buserelin acetate per 1ml, corresponding to 1.00mg buserelin per 1 ml.
Pack size: 2 individual cardboard boxes are wrapped together in a clear plastic outer.
No special instructions.
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