INFORMATION FOR THE PATIENT

WHAT YOU SHOULD KNOW ABOUT HUMEGON

Before this medicine is given to you please read this page carefully. On the back of this leaflet you will find more information about Humegon as well as some general advice on using medicines.

If you have any questions or worries, ask your doctor or pharmacist.

What's in this medicine

Active substance: HMG, human menopausal gonadotrophins, 75 or 150 international units per ampoule.

How this medicine works and what it is used for

The action of Humegon is similar to that of two different, natural hormones, follicle-stimulating hormone {FSH) and luteinizing hormone (LH). In women these hormones are needed to ripen the egg cell: in men they are needed in the production of sperm. Humegon is used in fertility disorders that are caused by a shortage of these hormones. It is also used in in-vitro (test tube) fertilization. On the back of this leaflet you will find more information about the action and use of Humegon.

When not to use this medicine

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

Precautions and possible problems

There are no special precautions for use in men.

Close supervision of female patients is extremely important. Usually blood sampling and ultrasound are performed daily. The results of these tests allow the doctor to choose the proper dose from day to day. This is very important since too high a dose may lead to overstimulation of the ovaries. This may be noticed as pain in the abdomen. Should you be troubled with pain in the abdomen, contact your doctor without delay.

Pregnancy. If treatment with Humegon results in pregnancy, there is a high chance of having twins or multiplets. There is also more chance of a miscarriage.

Using this medicine properly

Humegon should only be given by a doctor or nurse

How much. The dose is chosen by the doctor.

In female patients injections are given daily or sometimes every second day for about 10 days.

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

How to administer 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).

Side effects this medicine may have

In rare cases skin rash may occur. No other side-effects are expected.

How to store this medicine

Keep the ampoules in the original package in a safe place where children cannot reach them. The storage conditions and the date that they should be used by are given on the pack. If not, consult your pharmacist or doctor.

 

MORE ABOUT HUMEGON

The action of Humegon is similar to that of two different, natural hormones, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). In both men and women these hormones are produced in the pituitary gland. Together FSH and LH control the action of the sexual glands (ovaries in women and testes in men).

In women FSH and LH ensure the monthly ripening of the follicle, a tiny cavity in which the egg cell develops. LH is also 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 Humegon 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 is 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 usually given as well as Humegon. 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 Humegon is used to cause a number of egg cells to develop.

IMPORTANT POINTS

  1. Humegon 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 who live with or who look after you read this information.

LEGAL CATEGORY POM

PACKAGING Humegon comes in ampoules of dry powder with ampoules of solvent

PRODUCT LICENCE NUMBERS

0065/0112 Humegon 75 I.U.

0065/0113 Humegon 150 I.U.

0065/0114 Solvent (0.9% saline)

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Manufactured by N.V. Organon, Oss, The Netherlands for

Organon Laboratories Limited,

Cambridge Science Park,

Milton Road, Cambridge, CB4 4FL. Telephone: Cambridge (0223) 423445

This information was last updated in July 1990.