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HEXVIX 85 MG POWDER AND SOLVENT FOR SOLUTION FOR INTRAVESICAL USE

Active substance(s): HEXAMINOLEVULINATE HYDROCHLORIDE

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HEX85MGGBIELFLT_REV03_HEX85MGGBIELFLT_REV03 20/02/2013 11:04 Page 1

Dimensions:
Specification ref:

3001016003
3. Hexvix will be put into your bladder through
the tube.
4. Hexvix will be kept inside your bladder for about
60 minutes.
5. Your bladder will then be emptied through the tube.
6. The doctor will use a device (cystoscope) to look
inside of your bladder.
powder and solvent for
solution for intravesical use

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
HEXVIX® 85 MG
Powder and solvent for solution for intravesical use
Hexaminolevulinate
Read all of this leaflet carefully before you are given
this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your
doctor or nurse.
• If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet
1. What Hexvix is and what it is used for
2. What you need to know before you are given Hexvix
3. How to use Hexvix
4. Possible side effects
5. How to store Hexvix
6. Contents of the pack and other information

1. WHAT HEXVIX IS AND WHAT IT IS
USED FOR
This medicine is for diagnostic use only.
This medicine is used to help identify bladder cancers.
It is given before your doctor uses a special device
called a ‘cystoscope’ to look inside of your bladder. A
cystoscope helps to see possible tumours and thereby
removal of abnormal cells, which illuminate in blue
light after the administration of Hexvix.

2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN HEXVIX
Do not have Hexvix
• If you are allergic (hypersensitive) to the active
ingredient or any other ingredients of Hexvix,
including the liquid used to dissolve it (see Section 6
“Contents of the pack and other information”).
• If you have ‘porphyria’ (a rare inherited blood
disease).

Warnings and precautions
• Check with your doctor before having Hexvix:
• If you have a urinary infection or burning feeling
when you pass urine.
• If you have had BCG therapy on your bladder
recently.
• If you have had an operation on your bladder
recently.
These conditions may cause local reactions in your
bladder, which can make it more difficult for your
doctor to interpret what he sees during the
examination.

Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
become pregnant or are planning to have a baby, ask
your doctor for advice before having this medicine.

Driving and using machines
Talk to your doctor for advice about driving or using
machines after having Hexvix.

3. HOW TO USE HEXVIX
Hexvix will be prepared and given to you by a specially
trained and qualified person.
• Hexvix is usually given in a hospital or clinic.
Your doctor will give it to you in the way described
below:
1. A small tube called a ‘catheter’ will be placed into
your bladder.
2. Your bladder will be emptied through this tube.

If you are given more Hexvix than you should
If Hexvix is kept in your bladder for more than 60
minutes or more Hexvix than usual is used, no side
effects are expected. If you are concerned about this,
speak to your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Hexvix can cause side effects,
although not everybody gets them. There is a risk of
side effects related to the examination technique
(cystoscopy) used to look inside of your bladder. The
use of Hexvix as a supportive procedure to standard
cystoscopy for a more accurate diagnosis of your
bladder cancer is in general well tolerated. If side
effects happen, they are those typically associated with
the standard examination technique, they are not
usually serious and do not last very long. The following
side effects may happen after the examination
procedure using this medicine:
Common (affects 1 to 10 users in 100):
• Headache.
• Feeling sick (nausea), vomiting.
• Diarrhoea.
• Constipation.
• Muscle cramp or pain in and around your stomach
area (abdomen).
• Pain and difficulty passing urine.
• Feeling unable to empty your bladder fully (urinary
retention).
• Blood in your urine.
• Pain after the examination (procedure).
• Fever (high temperature).
Uncommon (affects 1 to 10 users in 1,000):
• Burning feeling when you pass urine (caused by
inflammation or infection of your bladder).
• Needing to pass urine more often.
• Blood poisoning (septicaemia).
• Not being able to sleep or difficulty going to sleep.
• Pain in the tube called the ‘urethra’ that urine passes
through.
• Feeling like you need to pass urine right away
(urgency).
• Higher levels of white blood cells, increased levels of
bilirubin (this is the yellowish pigment in your bile)
or increased liver enzymes, these would all be seen
in blood test results.
• Lower levels of red blood cells (anaemia).
• Inflammation of the head of the penis (balanitis)
• Back pain
• Gout
• Rash
Frequency not known
• Anaphylactoid shock (blood pressure drop,
increased heart rate, skin rash)
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.

5. HOW TO STORE HEXVIX
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the outer carton. The expiry date refers to the
last day of that month.
Powder and solvent: The product does not require any
special storage conditions.
Solution (after mixing): Store at 2°C - 8°C (in a
refrigerator) for not longer than 2 hours.
Hospital staff will ensure that the product is stored and
disposed of correctly and not used after the expiry date
stated on the outer carton.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Hexvix contains
• The active substance is hexaminolevulinate
hydrochloride.
• The other ingredients are disodium phosphate
dihydrate, potassium dihydrogen phosphate,
sodium chloride, hydrochloric acid, sodium
hydroxide and water for injections.

3001016003

powder and solvent for
solution for intravesical use

The following information is intended for
healthcare professionals only:

INSTRUCTIONS FOR HANDLING
Hexaminolevulinate may cause sensitisation by
skin contact.
All steps should be performed with sterile equipment
and under aseptic conditions.
1. Withdraw 50.0 ml of the solvent for Hexvix into a
sterile 50 ml syringe.
2. Inject about 10 ml of this solvent into the vial of
Hexvix powder.
3. Without withdrawing the needle from the vial, hold
the powder vial and the syringe in a firm grip and
shake gently to ensure complete dissolution.
4. Withdraw all of the dissolved solution from the
powder vial into the syringe. Gently mix the contents
of the syringe.
5. Hexvix is now reconstituted and ready for use. The
appearance of the reconstituted solution is clear to
slightly opalescent, and colourless to pale yellow.

The product is for single use only. Any unused product
should be discarded. No special requirements for
disposal.
Chemical and physical stability of the solution has been
demonstrated for 2 hours at 2°C - 8°C. From a
microbiological point of view, the product should be
used immediately. If not used immediately, in-use
storage times and conditions prior to use are the
responsibility of the user and would normally not be
longer than 2 hours at 2°C - 8°C.

Draft No.:
Artwork Amend Date:
Colours:
Barcode type:

420 x 160 mm Component code:
n/a
Presentation:
Component:
TWO Territory:
20/02/13 Language:
Black Ipsen Partner:
Pharma 114

3001016003 Document fonts:

Myriad Pro (family)

Hexvix 85mg
Pack insert Minimum font size:
UK/IE
English
Preliminary Artwork Approval
Photocure
Final Artwork Approval

7.5 pt

Front
Suggested Perforation:
Along dotted line

Global Packaging Development
Ipsen Biopharm Ltd., 190 Bath Road,
Slough, Berkshire, SL1 3XE, UK
Tel: +44 (0) 1753 627700
Fax: +44 (0) 1753 627886

For confirmation of Final Artwork
Approval refer to electronic
signature summary in PALM

HEX85MGGBIELFLT_REV03_HEX85MGGBIELFLT_REV03 20/02/2013 11:04 Page 2

Dimensions:
Specification ref:

What Hexvix looks like and contents of the pack
Draft No.:
Artwork Amend Date:

• Each pack consists of a vial of white to off-white or
pale yellow powder containing 85 mg of the active
substance, hexaminolevulinate, and a polypropylene
vial containing 50 ml clear, colorless liquid to
dissolve the powder.
• Hexvix powder is dissolved in the 50 ml solution
provided in the pack. Once the powder and the
solvent are mixed, a solution is made containing
1.7 mg/ml hexaminolevulinate, which corresponds
to a 8 mmol/l solution of hexaminolevulinate.

Colours:
Barcode type:

420 x 160 mm Component code:
n/a
Presentation:
Component:
TWO Territory:
20/02/13 Language:
Black Ipsen Partner:
See other side

3001016003 Document fonts:

Myriad Pro (family)

Hexvix 85mg
Pack insert Minimum font size:
UK/IE
English
Preliminary Artwork Approval
Photocure
Final Artwork Approval

7.5 pt

Back
Suggested Perforation:
Along dotted line

Global Packaging Development
Ipsen Biopharm Ltd., 190 Bath Road,
Slough, Berkshire, SL1 3XE, UK
Tel: +44 (0) 1753 627700
Fax: +44 (0) 1753 627886

For confirmation of Final Artwork
Approval refer to electronic
signature summary in PALM

Marketing Authorisation Holder
UK:
Ipsen Limited, 190 Bath Road, Slough, Berkshire,
SL1 3XE, UK.
Ireland:
Ipsen Pharmaceuticals Limited, Blanchardstown
Industrial Park, Blanchardstown, Dublin 15, Ireland.

Manufacturer
Photocure ASA
Hoffsveien 4
NO-0275 Oslo
Norway
For any information about this medicinal product,
please contact the local representative of the
Marketing Authorisation Holder.
UK:
Ipsen Limited
190 Bath Road
Slough
SL1 3XE
UK
Tel: +44 (0) 1753 627777
Ireland:
Ipsen Pharmaceuticals Limited
Blanchardstown Industrial Park
Blanchardstown
Dublin 15
Ireland
Tel: +353 (0) 1809 8200
This medicinal product is authorised under the trade
name Hexvix in the following member states of the
EEA: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Iceland, Italy, Latvia, Lithuania,
Luxembourg, Malta, The Netherlands, Norway,
Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
United Kingdom.
UK: This leaflet was last revised in 02/2013
Ireland: This leaflet was last revised in 02/2013
Licensed from: Photocure ASA.
Hexvix is a trademark of Photocure ASA.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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