Hexvix 85mg, powder and solvent for intravesical solution

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

HEXAMINOLEVULINATE

Tersedia dari:

IPSEN M.E.P.E Ag. Dimitriou 63 Alimos, 17456 Athens, Greece

Kode ATC:

V04CX

INN (Nama Internasional):

HEXAMINOLEVULINATE 85 mg

Bentuk farmasi:

POWDER AND SOLVENT FOR SOLUTION FOR INTRAVESICAL USE

Komposisi:

HEXAMINOLEVULINATE 85 mg

Jenis Resep:

POM

Area terapi:

DIAGNOSTIC AGENTS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2005-06-30

Selebaran informasi

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 of your bladder. A
cystoscope helps to see possible tumours
and thereby removing 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 Further
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
PAGE 2 OF 7
Please tell your doctor if you are taking or have recently taken any
other medicines, including
medicines obta

Karakteristik produk

PAGE 1 OF 8
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Hexvix 85 mg, powder and solvent for intravesical solution.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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
P
HARMACEUTICAL
F
ORM
Powder and solvent for intravesical solution.
Powder:
white to off-white or pale yellow
Solvent:
clear, colourless solution
4
C
LINICAL
P
ARTICULARS
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 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 surgical measures are initiated.
Biopsies of all mapped les