Choragon 5000 U And Choragon Solvent

2009052656_Choragon_2009052656 14.02.13 12:20 Seite 1

FERRING

CHORAGON 5.000U and CHORAGON SOLVENT PL 03194/0065 This leaflet was last revised in June 2011. CHORAGON is a registered trade mark.

IchORAGON® 5,000u

and CHORAGON SOLVENT (chorionic gonadotrophin)

Patient Information

Remember

Only a doctor can prescribe this medicine. It should never be given to anyone except the person it has been prescribed for. It may harm them even if they have the same symptoms.

Please read this information leaflet carefully before starting treatment with the medicine.

This leaflet does not contain the complete information, so if you have any questions or there is anything you are unsure about, ask your doctor or pharmacist.

• The doctor will decide how much the child needs and how often they need it.

• The usual starting dose is 500 units three times a week. However, this may be increased up to 4000 units three times a week if necessary.

• Treatment normally lasts for 6 to 10 weeks.

• In males over 17 years of age, a starting dose of 1000 units twice a week can be given. Treatment is normally continued for 1 to 2 months after the testicles have dropped.

For low sperm count

• The starting dose is 500 units two or three times a week.

• During your treatment, your doctor will check

semen samples to see how well the treatment is working. Your doctor may then adjust your dose.

• Treatment normally lasts for 16 weeks.

If you are given too much Choragon

If you think you have been given too much Choragon, tell your doctor, nurse or pharmacist.

If you forget to have Choragon

If you think that you have missed a dose, tell your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, Choragon can cause side

effects, although not everybody gets them.

The following side effects may happen in women or men:

• Allergic reactions.

• Headaches.

• Feeling tired.

• Mood changes.

The following side effects may happen in women:

• An increase in the size of the ovaries.

• Cysts in the ovary.

• Sudden tummy pain (acute abdominal pain).

• The production of more than one egg at a time by the ovaries (superovulation).

• Being pregnant with two or more babies at one time (multiple pregnancies).

The following side effects may happen in men:

• An increase in breast size.

• A growth spurt.

Read all of this leaflet carefully before you

are given this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, nurse or pharmacist.

• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1. What Choragon is and what it is used for

2. Before Choragon is given to you

3. How Choragon is given to you

4. Possible side effects

5. How to store Choragon

6. Further information

1. What Choragon is and what it is used for What Choragon is

Choragon contains a hormone produced in women called chorionic gonadotrophin. It works by helping reproductive organs to work normally in both women and men.

What Choragon is used for

In women, Choragon is used for infertility caused by eggs not being produced or released properly (anovulatory infertility).

In men, Choragon is used for:

• Delayed puberty.

• Testicles which have not dropped (cryptorchidism).

• Low sperm count (oligospermia).

Choragon should only be given by a specialist doctor who has the facilities needed to monitor you.

2. Before Choragon is given to you You must not be given Choragon if:

• You have a condition that is made worse by increasing levels of male sex hormones (such as testosterone).

If you are not sure if this applies to you, talk to your doctor, nurse or pharmacist before you are given this medicine.

Take special care with Choragon

Check with your doctor, nurse or pharmacist before you are given your medicine if:

• You have asthma.

• You have epilepsy.

• You get migraines.

• You have heart or kidney problems.

• You are allergic to any of the ingredients of the medicine (listed in Section 6). You may be given a skin test first if your doctor thinks that you might have an allergic reaction to Choragon.

If any of the above apply to you (or if you are not sure), talk to your doctor, nurse or pharmacist before you are given Choragon.

3. How Choragon is given to you

Choragon will be given to you by a doctor.

• It will be given to you as an injection into a muscle.

• The dose depends on what you are being treated for. The usual doses are given below.

Women For infertility

• Before you have Choragon, your doctor will take blood samples to check the level of oestrogen (a hormone) in your blood.

• If your oestrogen is at the right level, you will be given 10,000 units of Choragon.

• It will be given to you in the middle of your menstrual cycle.

Men

For delayed puberty

• The usual starting dose is 500 units twice a week.

• During your treatment, your doctor will take blood samples. This is to check the levels of testosterone (a hormone) in your blood. Your doctor may then adjust your dose.

• Treatment normally lasts for 4 to 6 weeks.

For testicles which have not dropped

• Treatment should begin before the child reaches puberty. The best age to start treatment is between 7 and 10 years.

• When Choragon is used to for testicles which have not dropped, it may cause early puberty.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Choragon

• Keep out of the reach and sight of children.

• Do not use Choragon after the expiry date which is stated on the carton and ampoules (glass bottles). The expiry date refers to the last day of that month.

• Store Choragon below 25 °C and protect it from light.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. Futher information What Choragon contains

• The active substance is chorionic gonadotrophin. Each ampoule contains 5000 units of chorionic gonadotrophin. The other ingredients are mannitol and sodium hydroxide.

• Choragon Solvent contains water for injection, sodium chloride and hydrochloric acid.

What Choragon looks like and contents of the pack

Choragon is a white, sterile, freeze-dried powder for injection. It is supplied in boxes of 3 brown glass ampoules. These come with 3 ampoules of Choragon Solvent 1ml. The solvent is used to dissolve the powder before it is injected.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton,

UB7 7PS, UK.

Manufacturer of Choragon 5000U and Choragon Solvent:

Ferring GmbH, Wittland 11,

D-24109 Kiel, Germany.