GLIOLAN

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

5-AMINOLEVULINIC ACID AS HYDROCHLORIDE

Fáanlegur frá:

TZAMAL BIO-PHARMA LTD

ATC númer:

L01XD04

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

5-AMINOLEVULINIC ACID AS HYDROCHLORIDE 1.5 G

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

MEDAC GESELLSCHAFT FUR KLINISCHE SPES. GmbH

Meðferðarhópur:

AMINOLEVULINIC ACID

Lækningarsvæði:

AMINOLEVULINIC ACID

Ábendingar:

Gliolan® is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).

Leyfisdagur:

2018-09-30

Upplýsingar fylgiseðill

•
you are hypersensitive (allergic) to the active ingredient
(5-aminolevulinic acid
hydrochloride), or to porphyrin.
•
in case of porphyria or suspected acute or chronic porphyria (acquired
or inherited disorder of
certain enzymes in the synthesis pathway of the red blood pigment).
•
you are pregnant or suspect you are pregnant.
DO NOT USE THE MEDICINE IF:
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
This medicine can be sold with a doctorיs prescription only
GLIOLAN
POWDER FOR ORAL SOLUTION
Active ingredient and its quantity in a dosage unit:
Each vial contains:
5-aminolevulinic acid hydrochloride 1.5gr
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet
contains concise information about the medicine.
If you have any further questions,
ask the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
•
visualization of certain brain tumors (called malignant glioma) during
brain
surgery.
THERAPEUTIC GROUP:
Imaging agents
2.
BEFORE YOU TAKE THE MEDICINE:
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TREATMENT WITH GLIOLAN TELL THE DOCTOR IF:
You have a heart disease or had heart disease in the past.
•
The eyes and skin should be protected from exposure to strong light
(such
as: direct sunlight or bright lighting) for a period of 24 hours after
taking the
medicine.
•
If you have a heart disease or had heart disease in the past – you
should tell
your doctor. Use with caution since blood pressure may drop.
•
No studies have been performed in patients with impaired liver or
renal function -
use this medicine with caution in these patients.
Children and adolescents
This drug is not intended for children and adolescents under the age
of 18, as there is no experience
with Gliolan in this age group.
TELL THE DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTL

Vara einkenni

1
GLIOLAN
®
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Gliolan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One vial contains 1.17 g of 5-aminolevulinic acid (5-ALA),
corresponding to 1.5 g 5-aminolevulinic
acid hydrochloride (5-ALA HCl).
One ml of reconstituted solution contains 23.4 mg of 5-ALA,
corresponding to 30 mg 5-ALA HCl.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
The powder is a white to off-white cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gliolan is indicated in adult patients for visualisation of malignant
tissue during surgery for malignant
glioma (WHO grade III and IV).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product 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.
Posology
The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
_Patients with renal or hepatic impairment _
No trials have been performed in patients with clinically relevant
hepatic or renal impairment.
Therefore, this medicinal product should be used with caution in such
patients.
_Elderly patients _
There are no special instructions for use in elderly patients with
regular organ function.
_Paediatric population _
The safety and efficacy of Gliolan in children and adolescents aged 0
to 18 years have 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
5-ALA under conditions other than the ones used in the clinical trials
entail an undetermined risk.
_Precautions to be taken before handling or administering the
medicinal product _
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
2
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or porphyrins.
•
Acute or chronic types of porphyria.
•
Pregnancy (see sections 4.6 and 5.3