Hexvix 85 mg, powder and solvent for intravesical solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hexaminolevulinate hydrochloride

Available from:

Ipsen Pharmaceuticals Limited

ATC code:

V04CX

INN (International Name):

Hexaminolevulinate hydrochloride

Dosage:

85 milligram(s)

Pharmaceutical form:

Pdr+Solv/Soln/Intravesical Use

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other diagnostic agents

Authorization status:

Not marketed

Authorization date:

2007-02-23

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEXVIX
® 85 MG, POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION
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. See section 4.
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 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.
Page 2 of 7
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 medicin

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2019
CRN008RC5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hexvix 85 mg, powder and solvent for intravesical solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 85 mg hexaminolevulinate (as
hexaminolevulinate hydrochloride).
After reconstitution in 50 mL of solvent, 1 mL of the solution
contains 1.7 mg hexaminolevulinate which corresponds to a
8 mmol/L solution of hexaminolevulinate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for intravesical solution.
Powder: white to off-white or pale yellow
Solvent: clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Hexvix blue light fluorescence cystoscopy is indicated as adjunct to
standard white light cystoscopy to contribute to the
diagnosis and management of bladder cancer in patients with known or
high suspicion of bladder cancer. See section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hexvix cystoscopy should only be performed by health care
professionals trained specifically in Hexvix cystoscopy. The bladder
should be drained before the instillation.
_Adults (including the elderly)_
50 ml of 8 mmol/l reconstituted solution (see section 6.6) is
instilled into the bladder through a catheter. The patient should
retain the fluid for approximately 60 minutes.
Following evacuation of the bladder, the cystoscopic examination in
blue light should start within approximately 60 minutes.
The cystoscopic examination should not be performed more than 3 hours
after Hexvix is instilled in the bladder.
Also if the retention time in the bladder is considerable shorter than
one hour, examination should start no earlier than after 60
minutes. No minimum retention time has been identified making
examination non-informative.
For optimal visualisation it is recommended to examine and map the
entire bladder under both white and blue light before any
surg