<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold" >
Puregon
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
What you should know about Puregon
</HEAD>


<BLOCK>
Please read the following information carefully before using this medicine. The leaflet contains details about Puregon, as well as some general advice on using medicines. If you have any questions or other concerns, please ask your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Name of your medicine
</HEAD>


<BLOCK>
The medicine prescribed for you is called Puregon.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Composition and strength - what your medicine contains
</HEAD>


<BLOCK>
Puregon contains a hormone known as follicle-stimulating hormone (or FSH) in a strength of 100 I.U. per ampoule.
</BLOCK>


<BLOCK>
Besides FSH, the powder contains sucrose, sodium citrate, and polysorbate 20- the solvent contains sodium chloride (4.5 mg) and water for injections (1.0 ml).
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Pharmaceutical form - what your medicine consists of
</HEAD>


<BLOCK>
Puregon 100 I.U. is supplied in a glass ampoule as a dry powder, which should be dissolved with the solvent contained in a second glass ampoule. It is available in packs of 1, 3, 5 and 10 ampoules.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Therapeutic group - how your medicine works
</HEAD>


<BLOCK>
Gonadotropins (including FSH) play an important role in human fertility and reproduction. FSH is needed in women for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Marketing authorisation holder and manufacturer:
</HEAD>


<BLOCK>
Organon (Ireland) Limited P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Indications - when your medicine is used
</HEAD>


<BLOCK>
Puregon is used to treat infertility in either of the following situations:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
In women who are not ovulating Puregon can be used to cause ovulation in women who have not responded to treatment with clomiphene citrate.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
In women undergoing assisted reproduction techniques (ART), including in-vitro fertilisation (IVF) and other methods, Puregon can be used to bring about the development of multiple follicles.
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
Contraindications - when you should not use this medicine
</HEAD>


<BLOCK>
There are certain medical conditions in which Puregon should no be used. Do 
<EMPH weight="bold">
not
</EMPH>
 use Puregon if you:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
have a tumour of the ovary, breast, uterus, pituitary gland or hypothalamus.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
are pregnant or breast-feeding.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
are allergic to any of the substances of Puregon.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have heavy or irregular vaginal bleeding where the cause is not known.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD).
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
This medicine should not be used when a condition exists which makes a normal pregnancy impossible. This may occur with primary ovarian failure, when there are fibroids in the uterus or when certain malformations of the sexual organs are present.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Special warnings and precautions for use Caution
</HEAD>


<BLOCK>
Close supervision of patients by a doctor is very important. Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken. The results of these tests allow the doctor to choose the correct dose of Puregon from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated. This may be noticed as pain in the abdomen. Regular monitoring of the response to FSH-treatment helps the doctor to prevent ovarian overstimulation. So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Interactions - when you are taking other medicines
</HEAD>


<BLOCK>
If Puregon is used in combination with clomiphene citrate there may be an increased follicular response. If a GnRH agonist has been given, higher dose of Puregon may be needed to achieve a response.
</BLOCK>

<PB n=2>
<CB n=2>
<FIGURE></FIGURE>
<PB n=3>

<BLOCK>

<EMPH slant = "italic">
Women who are not ovulating:
</EMPH>
 Treatment usually starts with the administration of 75 I.U. FSH per day. The starting dose is continued for at least seven days. If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/ or plasma oestradiol levels indicate an adequate response. The daily dose is then maintained until a follicle of adequate size is present. Usually 7 to 14 days of treatment are sufficient. The administration of Puregon is then stopped and ovulation can be induced by administering human chorionic gonadotropin (hCG).
</BLOCK>

<PB n=4>
<CB n=1>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Step 5 - Checking the correct needle position
</HEAD>


<BLOCK>
If the needle position is correct the plunger should be quite difficult to draw back. Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery. If this happens pull out the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site will stop bleeding in a minute or two. Do not use this solution but flush it away. You should then start again with 
<EMPH slant = "italic">
Step 1
</EMPH>
 using a new needle and new ampoules of Puregon and sodium chloride solution.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Step - Injecting the solution
</HEAD>


<BLOCK>
Depress the plunger slowly and steadily, so the solution is correctly injected and the muscle or skin tissues are not damaged.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Step 7 - Removing the syringe
</HEAD>


<BLOCK>
Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant. A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
</BLOCK>


<BLOCK>
Any remaining solution should be discarded.
</BLOCK>


<BLOCK>
Do not mix the Puregon solution with any other medicines.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Overdose
</HEAD>


<BLOCK>
Too high a dose may cause overstimulation of the ovaries. See Section on Undesirable Effects below.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Undesirable effects - unwanted effects
</EMPH>
 A serious complication with FSH is unwanted overstimulation of the ovaries. This condition is rare, and the risk can be reduced by careful monitoring of follicle development during treatment. The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea. In more severe <CB n=2> cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots in the circulation. Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.
</BLOCK>


<BLOCK>
Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Shelf life and storage precautions - looking after your medicine
</HEAD>


<BLOCK>
Keep Puregon in the original box in a safe place out of the reach of children.
</BLOCK>


<BLOCK>
Puregon should be stored below 30°C and protected from light. Do not freeze. The expiry date is printed on the box and on the label after 'exp.'. Do not use Puregon after this date.
</BLOCK>


<BLOCK>
Any unused solution should be discarded.
</BLOCK>


<BLOCK>
This information was last updated in December 1995.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
General things to remember about medicines
</HEAD>


<LIST type="ordered">

<ITEM>

<BLOCK>
This medicine has been prescribed only for your current medical problem. It should not be used for other medical conditions.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Never give your medicine to anyone else and do not use medicines meant for other people.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Tell your doctor treating you, which medicines you are currently taking. Always carry a medical information card stating which medicines you are using. This can be very important in case you are involved in an accident.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Return unused medicines to the pharmacy for disposal.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Make sure that the people you live with or who look after you read this information.
</BLOCK>

</ITEM>

</LIST>


</DIV>

</DIV>

</DOCUMENT>
