GLIOLAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

5-AMINOLEVULINIC ACID HYDROCHLORIDE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

L01XD04

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

5-AMINOLEVULINIC ACID HYDROCHLORIDE 1.5 G

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MEDAC GESELLSCHAFT FUR KLINISCHE SPES. GmbH

Therapeutic area:

AMINOLEVULINIC ACID

Therapeutic indications:

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

Authorization date:

2019-04-17

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
Gliolan
Powder for the preparation of an oral solution
The active ingredient and its quantity in a dosage unit:
Each vial contains:
5-aminolevulinic acid hydrochloride 1.5 g
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any other
questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may
harm them even if it seems to you 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 class:
imaging agents
2.
Before using the medicine
Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient
(5-aminolevulinic acid
hydrochloride) or to porphyrin.
•
You have porphyria or are suspected to have acute or chronic porphyria
(an
acquired or hereditary disorder of certain enzymes in the synthesis
pathway of the
red pigment in the blood).
•
You are pregnant or suspect you are pregnant.
Special warnings regarding the use of the medicine
•
Before treatment with Gliolan, tell the doctor if:
You have a
heart disease
or have previously had a heart disease. In this case, use
the medicine with caution as blood pressure may drop.
•
After taking the medicine, protect the eyes and skin from exposure to
strong light
(such as: direct sunlight or strong lighting) for a duration of 24
hours.
•
No studies have been performed in patients with impaired liver or
kidney function –
use this preparation cautiously in these patients.
Children and adolescents
This medicine is not intended for children and adolescents under the
age of 18, as there is
no experience with Gliolan in this age group.
Drug interactions
If you are taking, or have recently taken, other medicines includi

Summary of Product characteristics

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.
The total number of vials needed to achieve the intended dose for the
individual patient can be
determined according to the equation below (rounded up to the nearest
whole vial):
_ _
_Patient body weight (kg) _
_Number of vials = _
_——————————————_
_ _
_ _
_75 kg/vial _
The administration volume needed to achieve the intended dose for the
individual patient can be
calculated according to the equation below:
_ _
_Patient body weight (kg) x 20 mg/kg _
_Administration volume (ml) = _
_———————————————————_
_ _
_ _
_30 mg/ml _
_ _
_ _
2
_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_
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 ar