<!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" >
Norditropin PenSet 24 IU
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
Somatropin (epr) 24 iu
</HEAD>


<BLOCK>
Please read this leaflet. It contains important information about your medicine.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is in the pack?
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Dry powder for injection
</HEAD>


<BLOCK>
The dry powder in the larger vial contains the active ingredient- biosynthetic human growth hormone [somatropin (epr)l 24 iu. Other ingredients are glycine, sodium hydrogen carbonate and mannitol.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Cartridge containing liquid
</HEAD>


<BLOCK>
The cartridge which fits into the pen contains a clear liquid. This is the solvent. The dry powder must be dissolved in this solvent before injecting. The solvent contains a preservative - benzyl alcohol 9 mg/ml in 2 ml Water for Injections.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is growth hormone
</HEAD>


<BLOCK>
Human growth hormone increases growth, mainly growth of bone. In the body, growth hormone is made by a small gland (pituitary gland) just below the brain. The scientific name for human growth hormone is somatropin.
</BLOCK>


<BLOCK>
Norditropin is human growth hormone produced by genetic engineering and is not made from human or animal material. Norditropin- is similar to naturally occurring human growth hormone.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Manufactured by
</EMPH>
 Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Supplied by
</EMPH>
 Novo Nordisk Pharmaceuticals Ltd, Novo Nordisk House, Broadfield Park, Brighton Road, Pease Pottage, Crawley, West Sussex RH11 9RT.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Uses Growth hormone insufficiency
</HEAD>


<BLOCK>
Growth hormone insufficiency means that the child's body cannot make enough growth hormone. Norditropin injections help to replace the natural growth hormone in these children and so speed up growth and height gain.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Turner syndrome
</HEAD>


<BLOCK>
Norditropin injections speed up growth and height gains in girls with Turner syndrome, but it is not yet known whether this will improve their adult height.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Chronic renal (kidney) disease
</HEAD>


<BLOCK>
Norditropin injections speed up growth and height gain in children with kidney disease who have not reached puberty. We do not yet know whether this treatment will improve the adult height in children with this condition.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Read before starting your medicine
</HEAD>


<BLOCK>
Do not use Norditropin if being treated for cancer or a tumour: if pregnant; or if allergic to any of the ingredients in Norditropin.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Regular check ups
</HEAD>


<BLOCK>
It is recommended that children being treated with Norditropin see their child or growth specialist for regular check ups. In patients with kidney disease, it is very important that they receive regular checks of kidney function.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Blood sugar
</HEAD>


<BLOCK>
Growth hormone may raise blood sugar levels- let your doctor know if anyone in your family has diabetes.
</BLOCK>


</DIV>
<DIV type=1>

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


<BLOCK>
Growth hormone may affect diabetic control and insulin doses may need to be altered.
</BLOCK>


</DIV>
<DIV type=1>

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


<BLOCK>
As it is not known if growth hormone injections are safe during pregnancy, if pregnancy occurs or is suspected stop treatment immediately.
</BLOCK>

<CB n=2>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Breast feeding
</HEAD>


<BLOCK>
Do not breast feed if being treated with Norditropin.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Interactions with other medicines
</HEAD>


<BLOCK>
Cortisone and related medicines may reduce the growth effect of Norditropin in children. Let your doctor know about other medicines that are being taken.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to take your medicine How much to use
</HEAD>


<BLOCK>
Your doctor will tell you how much Norditropin to use each day. Never take more than this amount.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to use
</HEAD>


<BLOCK>
Your doctor or nurse will show you how to inject Norditropin under the skin (subcutaneously) using Nordiject 24. Your cartridge must only be used with Nordiject 24.
</BLOCK>


<BLOCK>
Injections should be given in the evening 6-7 times a week. It is best to give each injection in a different place from the last one.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to prepare your growth hormone for injection
</HEAD>


<BLOCK>
The dry powder in the vial must be mixed with the liquid in the cartridge. Your doctor or nurse will show you how to do this. As a reminder, full instructions are included in the second part of this leaflet.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to use your Nordiject 24 Injection Device
</HEAD>


<BLOCK>
Remember to wash your hands well with soap and water and/or disinfectant before starting. The Norditropin PenSet 24 cartridge fits into the Nordiject 24 pen device. Your doctor or nurse will show you how to use Nordiject 24. As a reminder, full instructions are included in the box with your Nordiject 24.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
When to stop using Norditropin
</HEAD>


<BLOCK>
Norditropin has to be used over many years. Do not stop the treatment until your doctor tells you to. Treatment is usually stopped once adult height is reached. In children with kidney disease, treatment should stop at transplantation.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Important information Taking too much Norditropin
</HEAD>


<BLOCK>
If you take too much Norditropin you may disturb blood sugar levels. First blood sugar levels may fall leading to, e.g. sweating, shakiness, mood changes and/or paleness. Afterwards blood sugar levels may rise too high, leading to, e.g. thirst and frequent need to pass urine.
</BLOCK>


<BLOCK>
Too much growth hormone over a long period could result in a variety of effects, e.g. too rapid growth, thickening of skin, disproportionate growth and joint pains.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Forgetting to take your Norditropin
</HEAD>


<BLOCK>
If you forget to take your injection do not increase the dose. Carry on with the same dose and tell your doctor at the next visit.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Side effects
</HEAD>


<BLOCK>
If any of the side effects listed below occur you should tell your doctor as soon as possible. Also tell your doctor if you believe you might be suffering any other side effect to your treatment.
</BLOCK>


<BLOCK>
Skin reactions around the injection site are rare.
</BLOCK>


<BLOCK>
Very rarely, swelling of the extremities may occur. This is due to an excess of water in the body.
</BLOCK>


<BLOCK>
There have been a few reports of raised pressure within the brain in patients on human growth hormone. This may cause bad or frequent headaches, sight problems, nausea and/or vomiting. If any of these occur - see a doctor without delay.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Other possible problems
</HEAD>


<BLOCK>
Thyroid Hormone levels may drop while using growth hormone. Your doctor will check these from time to time and will let you know whether you need treatment with thyroid hormones.
</BLOCK>


<BLOCK>
Development of a limp or pain in the hip or knee may indicate a problem with growth of the thigh bone and you should consult your doctor if this occurs.
</BLOCK>

<PB n=2>

<BLOCK>
Take the mixing guide supplied with your Nordiject pen. Then take the vial of Norditropin and remove the plastic top. Now fit the vial onto the end of the mixing guide as shown in the drawing above.
</BLOCK>

<PB n=3>
<CB n=1>
<FIGURE></FIGURE>

<LIST type="ordered">

<ITEM>

<BLOCK>
Hold the vial upright - 
<EMPH weight="bold">
slowly
</EMPH>
 push the plunger rod down as far as it will go so that all the solvent is forced into the vial.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Dissolve the dry powder by gently turning the vial - 
<EMPH weight="bold">
Do not shake!
</EMPH>

</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Turn the mixing guide so that the vial is upside down. Slowly pull the plunger backwards so that the cartridge fills with the solution - 
<EMPH weight="bold">
make sure the vial is completely empty
</EMPH>
. Expel any air accidentally drawn into the cartridge.
</BLOCK>

</ITEM>


<CB n=2>
<FIGURE></FIGURE>
<ITEM>

<BLOCK>
Remove the cartridge and cartridge grip from the mixing guide by turning the cartridge grip anti clockwise one 1/4 turn and sliding it out.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>

<EMPH weight="bold">
Save the mixing guide for future use.
</EMPH>

</BLOCK>

<FIGURE></FIGURE>

<LIST type="ordered">

<ITEM>

<BLOCK>
Replace the green needle cover and unscrew the needle. Now replace the white needle cover and dispose of the needle safely as instructed by your doctor or pharmacist.
</BLOCK>

</ITEM>


<FIGURE></FIGURE>
<ITEM>

<BLOCK>
Unscrew the plunger rod from the cartridge.
</BLOCK>

</ITEM>


<FIGURE></FIGURE>
<ITEM>

<BLOCK>
Remove the cartridge from the cartridge grip. Peel off the outer label from the cartridge. Write in the date in the white space provided. Your cartridge is now ready for use.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You can now also discard the plunger rod and empty Norditropin vial. 
<EMPH weight="bold">
Remember to keep the mixing guide.
</EMPH>

</BLOCK>

</ITEM>

</LIST>


</DIV>

</DIV>

</DOCUMENT>
