INFORMATION FOR THE PATIENT

Mannitol, disodium hydrogen phosphate, sodium dihydrogen phosphate, water for injection.

Appearance: ORGAFOL comes in ampoules of dry white powder together with 1 millilitre ampoules of solvent. ORGAFOL comes in packs of 1 or 10 ampoules plus solvent.

The action of ORGAFOL is similar to that of the natural hormone, follicle-stimulating hormone (FSH).

In women this hormone is needed to ripen the egg cell; in men it is needed in the production of sperm.

Organon Laboratories Ltd., Science Park, Milton Road, Cambridge CB4 4FL. Manufactured by: N.V. Organon, Oss, The Netherlands.

ORGAFOL is used in fertility disorders that are caused by a shortage of FSH. It is also used in in-vitro (test tube) fertilization. At the end of this leaflet you will find more information about the action and use of ORGAFOL.

This medicine should not be given to patients with tumours of the ovaries, testes or pituitary gland.

There are no special precautions for use in men.

If treatment with ORGAFOL results in pregnancy, there is an increased chance of having twins or multiplets. There is also more chance of a miscarriage.

The dose is chosen by the doctor.

In female patients the dose is usually 75 or 150 units per day to start with, however the dose may vary according to the response. Injections are given daily or sometimes every second day for about 10 days.

In male patients injections of 75 units are given several times a week for at least 10-12 weeks.

The powder in one ampoule should first be dissolved in the fluid in the other ampoule. The injections should be given in muscle tissue (for instance in the buttock, upper leg or upper arm).

The toxicity of ORGAFOL has been shown to be very low. However too high a dose for more than one day may cause pain in the abdomen. if you have taken too much ORGAFOL or if you are troubled with pain in your abdomen consult your doctor immediately.

Sometimes allergic reactions like a rash, fever or pain at the injection site occur. If you suffer from any side-effects especially pain in your abdomen you should consult your doctor before taking this medicine again.

Keep the ampoules in the original package in a safe place where children cannot reach them. This medicine should be stored in the fridge or at room temperature in the dark.

There is a " Use by" date on this pack. The medicine should not be used after this date.

This information was last updated in February 1994

The action of ORGAFOL is similar to that of the natural hormone, follicle-stimulating hormone (FSH). In both men and women this hormone is produced in the pituitary gland. Together FSH and another hormone, luteinizing hormone (LH) control the action of the sexual glands (ovaries in women and testes in men).

In women FSH ensures the monthly ripening of the follicle, a tiny cavity in which the egg cell develops. LH is needed for ovulation, the release of the egg cell. If the body itself does not produce enough FSH and LH, infertility may be the result. In these cases ORGAFOL can be used to make up the shortage. To determine the right dosage a daily check is necessary. The amount of oestrogens (female hormones) in blood or urine is measured and the follicle size is determined by means of ultrasound. When the follicle is big enough, another hormone (for instance Pregnyl) is given. This is a strong LH preparation which causes ovulation. In spite of the careful monitoring more than one egg cell may be released. This increases the chance of twins or multiplets.

In men very high LH activity is necessary for the production of sperm cells. Therefore, extra Pregnyl injections are given as well as ORGAFOL. Because the development of sperm cells takes about 74 days, treatment should be continued for at least 10 to 12 weeks before any improvement can be expected.

Infertility can also be the result of causes other than a shortage of FSH and LH. In these cases artificial techniques are sometimes used, for instance test-tube fertilization (in-vitro fertilization). For this technique several egg cells are needed and ORGAFOL is used to cause a number of egg cells to develop.

1. Orgafol has been prescribed only for your current medical problem. Do not use it for other medical problems.
2. Do not allow other people to use your medicines and do not use medicines meant for other people.
3. Tell any doctor treating you what medicines you are taking. Always carry a medical information card stating which medicines you are using. This can be very important if you are involved in an accident.
4. Return unused medicines to the pharmacist.
5. Make sure that other people you live with or who look after you read this information.