HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

hexaminolevulinate hydrochloride

可用日期:

Juno Pharmaceuticals Pty Ltd

INN（国际名称）:

hexaminolevulinate hydrochloride

授权状态:

Registered

资料单张

_Hexvix Consumer Medicines Information Juno Pharmaceuticals Pty Ltd _
39.HX.M.1.4
1
HEXVIX
_Hexaminolevulinate (as hydrochloride) _
_Powder for intravesical solution and diluent 85 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about Hexvix
powder for intravesical solution
and diluent.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. In deciding to give you.
Hexvix, your doctor has weighed
the risks of you taking Hexvix
against the benefits it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT HEXVIX IS
USED FOR
Hexvix is for diagnostic use
only.
Hexvix blue light fluorescence
cystoscopy is used as an 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.
Hexvix is not recommended for
use in children.
Your doctor may have
prescribed this medicine for
another reason.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE _
_HEXVIX _
1.
DO NOT USE HEXVIX IF YOU
ARE ALLERGIC TO
HEXAMINOLEVULINATE
HYDROCHLORIDE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
2.
DO NOT USE HEXVIX IF YOU
HAVE BEEN DIAGNOSED WITH
PORPHYRIA.
3.
DO NOT USE HEXVIX IF YOU
ARE SUFFERING FROM
HAEMATURIA OR BLOOD IN THE
URINE.
4.
DO NOT USE HEXVIX IF YOU
HAVE BLADDER INFLAMMATION,
A RECENT URINARY TRACT
INFECTION OR BCG
TREATMENT.
5.
DO NOT USE HEXVIX IF YOU
ARE PREGNANT OR INTENDING
TO GET PREGNANT.
6.
DO NOT BREASTFEED IF YOU ARE
USING HEXVIX AS THE DRUG
MAY BE FOUND IN BREAST
MILK.
TALK TO YOUR DOCTOR IF YOU ARE
UNSURE WHETHER YOU HAVE ANY
OF THE CONDITIONS LISTED ABOVE.
DO NOT USE HEXVIX AFTER THE
EXPIRY (EXP) PRINTED ON THE
PACK.
It you

产品特点

Hexvix PI Juno Pharmaceuticals Pty Ltd
Doc ID: 39.HX.P.1.10
Page 1 of 11
_HEXVIX _
_HEXAMINOLEVULINATE (AS HYDROCHLORIDE) 85 MG _
POWDER FOR INTRAVESICAL SOLUTION AND DILUENT
PRODUCT INFORMATION
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Hexaminolevulinate hydrochloride
CHEMICAL STRUCTURE
Molecular Formula: C
11
H
21
NO
3
.HCl
Molecular Weight. 251.76
CAS NUMBER
140898-91-5
DESCRIPTION
Hexaminolevulinate hydrochloride is a blue light cystoscopy imaging
agent. It is a white to
slightly yellow powder which has been shown to add water at relative
humidities higher than
approximately 62% RH at room temperature. Hexaminolevulinate is freely
soluble in water and
sparingly soluble in hexanol and acetone.
Hexvix Solution for intravesical use is available as a kit containing
Hexvix powder and a diluent
for reconstitution.
Hexvix powder is a sterile, freeze-dried white to off-white or pale
yellow powder. Each vial
contains 100 mg of Hexaminolevulinate hydrochloride, equivalent to
85mg of the active
ingredient hexaminolevulinate. There are no excipients.
The diluent for reconstitution is a sterile, clear, colourless
solution containing dibasic sodium
phosphate dihydrate, monobasic potassium phosphate, sodium chloride,
hydrochloric acid,
sodium hydroxide and water for injections.
NH
3
+
O
OCH
2
(CH
2
)
4
CH
3
O
Cl
Hexvix PI Juno Pharmaceuticals Pty Ltd
Doc ID: 39.HX.P.1.10
Page 2 of 11
After
reconstitution
in
50
mL
of
diluent,
1
mL
of
the
solution
contains
1.7
mg
hexaminolevulinate which corresponds to an 8 mmol/L solution of
hexaminolevulinate.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other diagnostic agents, ATC code: V04CX
_In vitro _studies have shown a considerable build-up of porphyrin
fluorescence in malignant
urothelium after exposure to hexaminolevulinate.
In humans, a higher degree of accumulation of porphyrins in lesions
compared to normal
bladder urothelium has been demonstrated with Hexvix. After
instillation of the reconstituted
solution for 1 hour and subsequent illumination with b