<!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" >
PATIENT INFORMATION LEAFLET
</HEAD>


<BLOCK>

<EMPH slant = "italic">
BiCNU&trade; INJECTION
</EMPH>
BiCNU&trade;  <CB n=2> &trade; <FIGURE></FIGURE>
</BLOCK>


<BLOCK>
Your doctor has prescribed BiCNU Injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.
</BLOCK>

<DIV type=1>

<HEAD weight="bold" >
Q. WHAT IS IN BiCNU INJECTION?
</HEAD>


<BLOCK>
A. The active ingredient in BiCNU Injection is called carmustine.  BiCNU Injection is packed in cartons of 10 units, each unit consists of one 30 ml vial which contains 100 mg carmustine powder and one 5 ml vial which contains 3 ml of sterile alcohol.  Carmustine belongs to a group of medicines called alkylating agents.  These agents interfere with the growth of cancer cells and eventually destroy them.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Q. WHO SUPPLIES BiCNU INJECTION?
</HEAD>

<PB n=2>
<CB n=1>

<BLOCK>

<EMPH weight="bold">
A.
</EMPH>

</BLOCK>

<CB n=2>
<DIV type=2>

<HEAD>
PRODUCT LICENCE
</HEAD>


<BLOCK>
HOLDER:
</BLOCK>


</DIV>
<DIV type=2>

<HEAD>
Bristol-MyersSquibb Holdings Ltd Hounslow, Middlesex PL No: 0125/0108
</HEAD>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
MANUFACTURER:
</HEAD>


<BLOCK>
Ben Venue Laboratories Inc.
</BLOCK>

<DIV type=2>

<HEAD>
Cleveland, Ohio, USA 
</HEAD>


<CB n=1>


</DIV>
<DIV type=2>

<HEAD>
PRODUCT AUTHORISATION
</HEAD>


<BLOCK>
HOLDER:
</BLOCK>


</DIV>
<DIV type=2>

<HEAD>
Bristol-Myers Squibb Holdings Ltd Dublin, Ireland PA No: 48 16 1
</HEAD>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Q. WHAT IS THIS MEDICINE FOR?
</HEAD>


<BLOCK>
A. BiCNU is used to treat certain types of cancer.  The precise reason why you are being given BiCNU is best discussed with your doctor.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
BEFORE YOUR MEDICINE IS ADMINISTERED
</HEAD>


<BLOCK>
Q.WHAT SHOULD YOUR DOCTOR KNOW BEFORE YOU RECEIVE BiCNU?
</BLOCK>


<BLOCK>
A.Tell your doctor if you have had any unusual or allergic reaction to BiCNU in the past.  Your doctor should have checked that the results of your last blood test mean that you can receive your course of treatment.
</BLOCK>


<BLOCK>
Q.WHAT IF YOU ARE PREGNANT OR THINKING OF BECOMING PREGNANT?
</BLOCK>


<BLOCK>
A.Make sure you tell your doctor as you should not receive BiCNU during pregnancy.
</BLOCK>


<BLOCK>
Q.IS IT ALL RIGHT TO BREAST-FEED WHILE YOU ARE BEING TREATED WITH BiCNU?
</BLOCK>


<BLOCK>
A.You should not breastfeed while you are being treated with BiCNU.  If you were breast-feeding before treatment, DO NOT restart breast-feeding until your doctor has told you that it is safe to do so.
</BLOCK>


<BLOCK>
Q.IS IT IMPORTANT THAT MALE PATIENTS USE CONTRACEPTIVES?
</BLOCK>


<BLOCK>
A.Yes, men receiving BiCNU should make sure that precautions are taken to prevent their partners becoming pregnant.
</BLOCK>


<BLOCK>
Q.CAN BiCNU BE USED TO TREAT CHILDREN?
</BLOCK>


<BLOCK>
A.The safety and usefulness of BiCNU in children has not been established.
</BLOCK>


<BLOCK>
Q.CAN YOU TAKE OTHER MEDICINES WHILST RECEIVING BiCNU?
</BLOCK>


<BLOCK>
A.Not unless these have been discussed with your doctor or pharmacist. This includes medicines bought at a pharmacy or elsewhere e.g. supermarket.
</BLOCK>


<BLOCK>
Q.IS IT ALL RIGHT TO DRIVE?
</BLOCK>


<BLOCK>
A.There is no reason why you cannot continue driving between courses of BiCNU but you should remember that this medicine contains alcohol and it may be unwise to drive immediately after a course of treatment.  As with all medicines, you should not drive if you feel dizzy or light headed.
</BLOCK>


<BLOCK>
Q.IS IT ALL RIGHT TO DRINK ALCOHOL?
</BLOCK>


<BLOCK>
A. There is no interaction between BiCNU and alcohol.  However, you should check with your doctor whether drinking is advisable for you.
</BLOCK>


<BLOCK>
Q. HAVE YOU HAD PROBLEMS WITH EITHER YOUR LUNGS, LIVER OR KIDNEYS IN THE PAST?
</BLOCK>


<BLOCK>
A. Make sure your doctor is aware of any problems that you have had, before you receive BiCNU.  Your doctor will probably monitor your liver, lungs and kidneys during treatment with BiCNU to check that they are working properly.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
ADMINISTRATION OF YOUR MEDICINE
</HEAD>


<BLOCK>
Q.HOW IS BiCNU GIVEN AND WHAT IS THE USUAL DOSE?
</BLOCK>


<BLOCK>
A.BiCNU is injected into a vein over a one to two hour period.  The dose of BiCNU that you received will be calculated according to your size. The usual dose is 200 mg/m2 body surface area every six weeks.  This may be given as a single dose or it can be divided into daily injections of 100 mg/m2 body surface area on two successive days.
</BLOCK>


<BLOCK>
Q.HOW OFTEN IS BiCNU GIVEN?
</BLOCK>


<BLOCK>
A.BiCNU can usually be given at 6 week intervals. This may vary depending on the results of regular blood tests.
</BLOCK>


<BLOCK>
Q.WILL YOU NEED TO HAVE ANY OTHER MEDICINES?
</BLOCK>


<BLOCK>
A.You may be given an anti-nausea medicine before you receive BiCNU, which should help to stop you feeling sick after you have been given BiCNU.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
UNDESIRABLE EFFECTS
</HEAD>


<BLOCK>
Q.ARE THERE ANY UNWANTED EFFECTS OF BiCNU?
</BLOCK>


<BLOCK>
A.All medicines may cause some unwanted or "side" effects.  BiCNU can lower the number of white blood cells found in the body, which may temporarily increase your chance of getting an infection, and it may also lower the number of blood platelets which are necessary for proper blood clotting.  These effects usually occur four to six weeks after a dose of BiCNU.  BiCNU may also lower your number of red blood cells. 
</BLOCK>


<BLOCK>
If you think you are getting an infection (fever, chills) or you notice any unusual bleeding or bruising (including blood in the urine or black tarry stools) tell your doctor immediately.
</BLOCK>


<BLOCK>
BiCNU can also damage your kidneys, although this tends to be more common in patients who have received a large amount over a long period.
</BLOCK>


<BLOCK>
Check with your doctor or nurse as soon as possible if you experience any of the following side effects:
</BLOCK>


<BLOCK>
Problem with your lungs (shortness of breath or cough), yellowing of the skin or eyes.
</BLOCK>


<BLOCK>
Blurring or worsening of vision, or pain in your eyes.
</BLOCK>


<BLOCK>
Nausea and vomiting may occur within two hours of receiving BiCNU.  This usually lasts no longer than 4-6 hours.  If this occurs tell your doctor as he/she may give you an anti-nauseant next time you receive BiCNU to help prevent this happening again.
</BLOCK>


<BLOCK>
Intense flushing of the skin and eyes has occasionally been reported within two hours of administration. A burning sensation at the site of the injection may also occur.
</BLOCK>


<BLOCK>
If you notice any other effects during or after treatment has finished tell your doctor.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
LOOKING AFTER YOUR MEDICINE
</HEAD>


<BLOCK>
This medicine will be stored in the refrigerator of the pharmacy and made up in a special area before the doctor or nurse gives it to you.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
DATE OF LAST REVISION
</EMPH>
 April 1995 
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
