Gliolan (aminolevulinic acid HCl) powder for oral solution, 30 mg/mL, vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

aminolevulinic acid hydrochloride, Quantity: 1.5 g

Saadav alates:

Specialised Therapeutics Glio Pty Ltd

INN (Rahvusvaheline Nimetus):

Aminolevulinic acid hydrochloride

Ravimvorm:

Oral Liquid, powder for

Koostis:

Excipient Ingredients:

Manustamisviis:

Oral

Ühikuid pakis:

10 vials, 2 vials, 1 vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (GBM) on preoperative imaging, and who are intended for resection of the tumour.

Toote kokkuvõte:

Visual Identification: Gliolan is supplied as white to off white powder in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Registered

Loa andmise kuupäev:

2013-11-07

Infovoldik

GLI_CMI_AUNZ_ Change in AU sponsor Address_01May18_clean
CORE CMI FOR GLIOLAN
GLIOLAN
®
_ _
_(Glio _
_–_
_lan or Glee _
_–_
_ o _
_–_
_lan or _
_Gl-io-lan) _
_Aminolevulinic acid _
_hydrochloride (ALA HCl)_
CONSUMER MEDICINE
INFORMATION
_Date of _
_Dispensing_
_Consumer Name_
_Pharmacist Name_
_Consumer Address_
_Pharmacist Address_
_Consumer Address_
_Pharmacist Address_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Gliolan. 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
.
Your doctor has weighed
the risks of you taking Gliolan
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
WHAT GLIOLAN IS USED
FOR
This medicine is used
_ _
for the
visualisation of certain brain
tumours (called glioblastoma
multiforme) during tumour surgery.
Gliolan contains a substance called
aminolevulinic acid hydrochloride
(ALA HCl). ALA HCl accumulates
preferably in tumour cells where it
is transformed into another similar
substance. If the tumour is then
exposed to blue light this new
substance emits a red-violet light,
which helps the surgeon to better
see what is normal tissue and what
is tumour tissue. This helps the
surgeon to remove the tumour
while sparing healthy tissue.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
_This medicine is not addictive._
_This medicine is available only with _
_a doctor’s prescription._
_This medicine is not expected to _
_affect your ability to drive a car or _
_operate machinery._
_There is not enough information to _
_recommend the use of this medicine _
_for children under the age of 18 _
_years. _
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
-
any medicine containing
aminolevulinic acid
hydrochloride or porphyrins
(

Toote omadused

GLI_PI_AU_ SRR_6 July 2021 (clean)
1
Australian Product Information – GLIOLAN
®
(aminolevulinic acid
hydrochloride) Powder for Oral Solution
1
NAME OF THE MEDICINE
aminolevulinic acid hydrochloride 30 mg/mL powder for oral solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 1.5 g of aminolevulinic acid hydrochloride (ALA
HCl), equivalent to 1.17 g of
aminolevulinic acid.
One mL of reconstituted solution contains 30 mg of aminolevulinic acid
hydrochloride (ALA HCl),
equivalent to 23.4 mg of aminolevulinic acid.
Excipient(s) with known effect
For the full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL
FORM
GLIOLAN is supplied in a vial as a powder for oral solution.
The powder is a white to off-white cake.
4
CLINICAL
PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
GLIOLAN is indicated in adult patients for visualisation of malignant
tissue during surgery for
malignant gliomas that are glioblastoma multiforme (GBM) on
preoperative imaging, and who are
intended for resection of the tumour.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GLIOLAN should only be used by experienced neurosurgeons conversant
with surgery of malignant
gliomas and in-depth knowledge of functional brain anatomy who have
completed a training course
in fluorescence-guided surgery.
Dose
The recommended dose is 20 mg aminolevulinic acid hydrochloride per
kilogram body weight.
Special Populations
Elderly
There are no special instructions for use in elderly patients with
regular organ function.
Renal or Hepatic Impairment
No trials have been performed in patients with clinically relevant
hepatic or renal impairment.
Therefore, GLIOLAN should be used with caution in such patients.
GLI_PI_AU_ SRR_6 July 2021 (clean)
2
Paediatric population
The safety and efficacy of ALA in children and adolescents aged 0 to
18 years has not yet been
established. No data are available.
Method of administration
The solution should be administered orally three hours (range 2-4
hours) before anaesthesia.
Use
of ALA under conditions other