SUPREFACT Nasal spray Ref.[6712] Active ingredients: Buserelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  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

Therapeutic indications

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, p 1889-95, 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 the castration range. Before inhibition occurs there is a brief stimulatory phase during which testosterone levels may rise.

Posology and method of administration

Initiation of therapy: is most conveniently carried out in hospital; 0.5 ml 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. One spray dose is introduced into each nostril 6 times a day according to the following schedule:

1st dose before breakfast
2nd dose after breakfast
3rd and 4th doses before and after midday meal
5th and 6th doses before and after evening meal.

This dosage regimen is to ensure adequate absorption of the material and to distribute the dose throughout the day.

If used correctly, reliable absorption of the active ingredient takes place via nasal mucous membranes. Suprefact nasal spray is absorbed even if the patient has a cold.

If nasal decongestants are being used concurrently, they should be administered at least 30 minutes after buserelin.

Overdose

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. Treatment should be symptomatic.

Shelf life

Shelf life: 2½ years.

Special precautions for storage

Store below 25°C. The spray solution should last for 1 week of treatment. Any residual material after this time should be discarded.

Nature and contents of container

Box of 4 bottles each containing 10g solution and 4 spray pumps.

Special precautions for disposal and other handling

How to use the spray bottle.

  1. Remove spray cap from bottle.
  2. Remove metered dose nebulizer from transparent plastic container and take off both protective caps.
  3. Screw nebuliser on to bottle.
  4. Before first application only, pump 5-8 times, holding bottle vertical, until the solution has filled the system and a uniform spray is emitted. The preliminary pumping is for the purpose of filling the system and testing the spray. It must not be repeated after the first use, in order to avoid wasting the contents.
  5. Keeping the bottle vertical and bending head over it slightly, spray solution into nose. If necessary the nose should be cleaned before applying the solution.
  6. After use leave nebulizer on bottle. After replacing protective cap, spray bottle is best stored in its transparent container in an upright position.
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