SUPRECUR Nasal spray solution Ref.[28031] Active ingredients: Buserelin

Endometriosis

The total daily dose is 900 micrograms buserelin, administered as one spray dose in each nostril in the morning, at mid-day and in the evening. The product may be used before or after meals or at other times, provided that uniform intervals are maintained between doses.

The usual duration of treatment is six months and this should not be exceeded. Only a single course of treatment is recommended.

Repeated courses of treatment must only be administered after a careful review of the risk/benefit ratio by the attending physician since the possibility of additive effects on bone mass (reduction in bone mass) cannot be excluded (see also section 4.4).

Pituitary desensitisation prior to ovulation induction

The total daily intranasal dose for this indication is 600 micrograms buserelin, given in four divided dosages of 150 micrograms (one application in one nostril) spread over the waking hours. Treatment should start in the early follicular phase (day 1) or, provided the existence of an early pregnancy has been excluded in the midluteal phase (day 21). It should continue at least until down-regulation is achieved e.g. serum estradiol <50 ng/l and serum progesterone <1 microgram/l. This will usually take about 2-3 weeks. In some patients, dosages up to 4 × 300 micrograms may be required to achieve these levels.

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.

If used correctly, reliable absorption of the active ingredient takes place via nasal mucous membranes. The drug is absorbed even if the patient has a cold; however, in such cases the nose should be blown thoroughly before administration.

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

Children

Suprecur is not suitable for use in children.

Elderly

Suprecur is not suitable for use in post-menopausal women.

Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedema of the lower extremities and mastodynia. Treatment should be symptomatic.

3 years. 5 weeks after first opening.

Store between 2 and 25°C. Do not freeze

Cartons containing two bottles and two metered-dose pumps (nebulisers).

Each bottle contains l0g solution.

How to use the spray bottle:

1. Remove screw cap from bottle.
2. Remove metered-dose nebulizer from transparent plastic container and take off both protective caps.
3. Screw nebulizer 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 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.