Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom
Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
The total daily dose is usually in the range 200-500 microgram (μg) given as a single injection by the subcutaneous route. Treatment should start in the early follicular phase (day 1) or, provided the existence of an early pregnancy has been excluded, in the mid-luteal phase (day 21). It should continue at least until down regulation is achieved e.g. serum oestradiol <180 pmol/l and serum progesterone <3 nmol/l. This will usually take about 1-3 weeks. Doses may have to be adjusted for individuals. Occasionally, patients may require up to 500 μg twice daily in order to achieve down-regulation. When down-regulation is achieved, stimulation with gonadotropin is commenced while the dosage of buserelin is maintained. At the appropriate stage of follicular development, gonadotropin and buserelin are stopped and hCG is given to induce ovulation.
Treatment monitoring, oocyte transfer and fertilisation techniques are performed according to the normal practice of the individual clinic.
Luteal support with hCG or progesterone should be given as appropriate.
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 (see section 6.6).
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 2 × 5.5 ml multidose vials each containing 1.05 mg buserelin acetate per 1 ml, corresponding to 1.00 mg buserelin per 1 ml.
Each vial contains enough material for 10 doses. After finishing the course of treatment the vial should be disposed of and a new vial started for the next treatment. Do not use if the contents of the vial are cloudy or discoloured.
Patients should be instructed on the correct handling of the vial (aseptic technique) by a doctor or nurse.
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