Metrodin® High

Purity

What you should know about METRODIN High Purity (highly purified urofollitrophin (FSH) injection)

Please read this leaflet carefully before your treatment is started. This leaflet provides a summary of the information available on your medicine. If you have any questions, or are not sure about anything, ask your doctor.

The name of your medicine is Metrodin High Purity. It is a powder available in two strengths containing 75 or 150 IU of a very pure form of its active ingredient called human follicle stimulating hormone(urofollitrophin). Both strengths are available in packs of 1 or 10 ampoules.

What is in your medicine?

As well as follicle stimulating hormone (FSH), Metrodin High Purity also contains lactose, sodium hydroxide and hydrochloric acid. In addition to the ampoule(s) containing the Metrodin High Purity powder, each pack also contains 1 ml ampoule(s) of solvent to make up the powder.

The Product Licence/Authorisation holder is: Serono Laboratories (UK) Limited, 99 Bridge Road East, Welwyn Garden City, Hertfordshire AL7 1BG.

The product is manufactured by: Industria Farmaceutica Serono, Via Casilina 125, 00176 Rome, Italy or Laboratories Serono SA, Zone Industrielle de L'Ouriettaz, 1170 Aubonne, Switzerland.

Why Metrodin High Purity?

Metrodin High Purity is a hormone known as follicle stimulating hormone (FSH). It works in exactly the same way as FSH which is naturally found in the body. It is used to treat infertility in women. It is used in two situations as shown below:

  1. Metrodin High Purity is used in women who have a condition called hypothalamic pituitary dysfunction. If you have this condition, you may be having irregular periods or you may not be having periods at all. The medicine is used to bring about the development of a follicle. It is followed by treatment with another hormone which leads to ovulation (the release of the egg from the follicle).
  2. Metrodin High Purity is used to bring about the development of several follicles (and therefore several eggs) for women undergoing assisted conception techniques, e.g. in-vitro fertilisation (IVF) or gamete intrafallopian transfer (GIFT).

Who should not be given Metrodin High Purity?

Although the medicine can be used in most people with the conditions stated above, there are certain people who should not be given this medicine.

Please read the following questions. If the answer to any of them is "Yes" then tell your doctor before starting the treatment:

  • Are you pregnant?
  • Do you have an ovarian enlargement or cyst (not including polycystic ovaries)?
  • Do you have cancer of the ovary, womb or breast?
  • Do you have a brain tumour, or tumour of the pituitary gland?
  • Do you suffer from unexplained vaginal bleeding?
  • Have you ever had an allergic reaction to this or a similar medicine or its ingredients?

The medicine cannot be used when you have a condition which would make a normal pregnancy impossible, such as primary ovarian failure. Your doctor will be able to explain more about this.

Important information you should know about Metrodin High Purity

Before the treatment is started you and your partner's fertility will be tested. Several conditions will be looked for and you may have already been given treatment for these.

Sometimes multiple births occur when patients

have been treated with this medicine. When this happens it is usually twins. However, the number of babies produced depends on the number of embryos that are replaced.

How will Metrodin High Purity be given to you?

Metrodin High Purity is given by injection either under the skin or into the muscle. Different doses are given depending on your treatment.

Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injections at home. If you are injecting yourself, or your partner is giving you the injections, please carefully read the following instructions:

  • Wash your hands. It is important that your hands and the items you use be as clean as possible.
  • Assemble everything you need: Find a clean area and lay out everything (two alcohol swabs, one diluent ampoule, one ampoule containing the medication, one syringe, one needle for reconstitution and a fine bore needle for subcutaneous injection).

  • Open the ampoule: You should have one ampoule containing clear liquid (the diluent) and a set number of ampoules containing Metrodin High Purity (the white powder). On the head of the diluent ampoule you will see a small coloured dot. Directly below ii is where the neck of the ampoule has been treated to make it easier to break. Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber. Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot. Carefully place the open ampoule upright on the work surface.

  • Draw up the diluent: Attach the needle for reconstitution to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the diluent. Carefully set the syringe down on the work surface, taking care not to touch the needle.

Your doctor will have explained exactly what dose